Online PLR Article Directory Eritrea: May 2012

Thursday, May 31, 2012

Cyclomydril

Generic Name: atropine, homatropine, and scopolamine (Ophthalmic route)

Commonly used brand name(s)

In the U.S.

AK-Dilate

AK-Pentolate

Altafrin

Atropine Care

Cyclogyl

Cyclomydril

Eye Cool

Homatropaire

Isopto Atropine

Isopto Homatropine

Isopto Hyoscine

Mydfrin

Mydral

Mydriacyl

Neofrin

Neo-Synephrine

Paremyd

In Canada

Ak-Dilate

Ak-Pentolate

Atropine

Atropine-Ak

Atropine Eye Ointment

Atropine Ointment

Atropisol

Minims Phenylephrine Hydrochloride

Available Dosage Forms:

Ointment

Solution

Uses For Cyclomydril

Ophthalmic atropine, homatropine, and scopolamine are used to dilate (enlarge) the pupil of the eye. They are used before eye examinations, before and after eye surgery, and to treat certain eye conditions, such as uveitis or posterior synechiae.

These medicines are available only with your doctor's prescription.

Before Using Cyclomydril

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Infants and young children and children with blond hair or blue eyes may be especially sensitive to the effects of atropine, homatropine, or scopolamine. This may increase the chance of side effects during treatment . Children should use a lower strength of this medicine.

Geriatric

Elderly people are especially sensitive to the effects of atropine, homatropine, or scopolamine. This may increase the chance of side effects during treatment.

Pregnancy

Studies on effects in pregnancy have not been done in either humans or animals. However, these medicines may be absorbed into the body.

Breast Feeding

These medicines may be absorbed into the body. Atropine passes into the breast milk in very small amounts and may cause side effects, such as fast pulse, fever, or dry skin, in babies of nursing mothers using ophthalmic atropine. It is not known whether homatropine or scopolamine passes into breast milk. Although most medicines pass into breast milk in small amounts, many of them may be used safely while breast-feeding. Mothers who are using one of these medicines and who wish to breast-feed should discuss this with their doctor.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of atropine, homatropine, and scopolamine

This section provides information on the proper use of a number of products that contain atropine, homatropine, and scopolamine. It may not be specific to Cyclomydril. Please read with care.

To use the ophthalmic solution (eye drops) form of this medicine:

First, wash your hands. Tilt the head back and, pressing your finger gently on the skin just beneath the lower eyelid, pull the lower eyelid away from the eye to make a space. Drop the medicine into this space. Let go of the eyelid and gently close the eyes. Do not blink. Keep the eyes closed and apply pressure to the inner corner of the eye with your finger for 2 or 3 minutes to allow the medicine to be absorbed by the eye.

Immediately after using the eye drops, wash your hands to remove any medicine that may be on them. If you are using the eye drops for an infant or child, be sure to wash his or her hands immediately afterwards also, and do not let any of the medicine get in his or her mouth. In addition, wipe off any medicine that may have accidentally gotten on the infant or child, including his or her face or eyelids.

To keep the medicine as germ-free as possible, do not touch the applicator tip to any surface (including the eye). Also, keep the container tightly closed.

To use the ointment form of this medicine:

First, wash your hands. Tilt the head back and, pressing your finger gently on the skin just beneath the lower eyelid, pull the lower eyelid away from the eye to make a space. Squeeze a thin strip of ointment into this space. A 1/3- to ½;-cm (approximately ⅛-inch in infants and young children and ¼-inch in older children and adults) strip of ointment is usually enough, unless you have been told by your doctor to use a different amount. Let go of the eyelid and gently close the eyes. Keep the eyes closed for 1 or 2 minutes to allow the medicine to be absorbed by the eye.

Immediately after using the eye ointment, wash your hands to remove any medicine that may be on them. If you are using the eye ointment for an infant or child, be sure to wash his or her hands immediately afterwards also, and do not let any of the medicine get in his or her mouth. In addition, wipe off any medicine that may have accidentally gotten on the infant or child, including his or her face or eyelids.

To keep the medicine as germ-free as possible, do not touch the applicator tip to any surface (including the eye). After using the eye ointment, wipe the tip of the ointment tube with a clean tissue and keep the tube tightly closed.

Use this medicine only as directed. Do not use more of it and do not use it more often than your doctor ordered. To do so may increase the chance of too much medicine being absorbed into the body and the chance of side effects. This is especially important when this medicine is used in infants and children, since overdose is very dangerous in infants and children.

Dosing

The dose medicines in this class will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of these medicines. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For atropine

For ophthalmic ointment dosage form:
- For uveitis:
  - Adults—Use a thin strip of the ointment in the eye one or two times a day.
  - Children—Use a thin strip of the ointment in the eye one to three times a day.
- For eye examinations:
  - Adults—Use and dose must be determined by your doctor.
  - Children—Use a thin strip of the ointment in the eye three times a day for one to three days before the examination.

For ophthalmic solution (eye drops) dosage form:
- For uveitis:
  - Adults—Use one drop in the eye one or two times a day.
  - Children—Use one drop in the eye one to three times a day.
- For eye examinations:
  - Adults—Use and dose must be determined by your doctor.
  - Children—Use one drop in the eye two times a day for one to three days before the examination.

For homatropine

For ophthalmic solution (eye drops) dosage form:
- For uveitis:
  - Adults and children—Use 1 or 2 drops in the eye two or three times a day.
- For eye examinations:
  - Adults—Use 1 or 2 drops in the eye. May be repeated every five to ten minutes for two or three doses.
  - Children—Use 1 or 2 drops in the eye every ten minutes for two or three doses.

For scopolamine

For ophthalmic solution (eye drops) dosage form:
- For uveitis:
  - Adults and children—Use one drop in the eye up to four times a day.
- For eye examinations:
  - Adults—Use one drop in the eye one hour before the examination.
  - Children—Use one drop in the eye two times a day for two days before the examination.
- For posterior synechiae:
  - Adults—Use one drop in the eye every ten minutes for three doses.
  - Children—Use and dose must be determined by your doctor.
- For use before and after surgery:
  - Adults and children—Use one drop in the eye one to four times a day.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you miss a dose of this medicine and your dosing schedule is:

One dose a day—Apply the missed dose as soon as possible. However, if you do not remember the missed dose until the next day, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

More than one dose a day—Apply the missed dose as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Cyclomydril

After you apply this medicine to your eyes:

Your pupils will become unusually large and you will have blurring of vision, especially for close objects. Make sure your vision is clear before you drive, use machines, or do anything else that could be dangerous if you are not able to see well.

Your eyes will become more sensitive to light than they are normally. Wear sunglasses to protect your eyes from sunlight and other bright lights.

These effects may continue for several days after you stop using this medicine. However, check with your doctor if they continue longer than:

14 days if you are using atropine.

3 days if you are using homatropine.

7 days if you are using scopolamine.

Cyclomydril Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Symptoms of too much medicine being absorbed into the body

Clumsiness or unsteadiness

confusion or unusual behavior

dryness of skin

fast or irregular heartbeat

fever

flushing or redness of face

seeing, hearing, or feeling things that are not there

skin rash

slurred speech

swollen stomach in infants

thirst or unusual dryness of mouth

unusual drowsiness, tiredness, or weakness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Blurred vision

brief burning or stinging of the eyes

eye irritation not present before use of this medicine

increased sensitivity of eyes to light

swelling of the eyelids

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

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Wednesday, May 30, 2012

Glycerin Lemon and Honey with Glucose and Ipecacuanha

1. Name Of The Medicinal Product

Glycerin Lemon and Honey with Glucose and Ipecacuanha

2. Qualitative And Quantitative Composition

Each 5ml of solution contains:-

Glycerol 1.36g

Ipecacuanha Liquid Extract 0.01ml

Excipients: Each 5ml contains 1.7g of Syrup (sucrose) and 280.0mg of Liquid Glucose

For a full list of excipients see section 6.1

3. Pharmaceutical Form

Oral Solution

4. Clinical Particulars

4.1 Therapeutic Indications

A soothing preparation for relief of the symptoms of coughs and sore throats.

4.2 Posology And Method Of Administration

Oral.

Recommended doses

Adults and children over 12 years: two 5ml spoonfuls.

May be repeated every four hours if required. Not more than 4 doses should be given in any 24 hours.

The product may be taken for up to 5 days, following which, if symptoms persist, medical advice should be sought.

4.3 Contraindications

Patients in shock, at risk of seizure, or with cardiovascular disorders.

Hypersensitivity to any of the ingredients.

Children under 12 years of age.

4.4 Special Warnings And Precautions For Use

Keep all medicines out of the reach and sight of children.

Not suitable for use in diabetics.

Do not give to children under 12 years

Do not exceed the stated dose

Do not take with any other cough and cold medicine

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

No adverse effects are considered likely if this product is used in the above conditions, however, as with all medicines, its use should be avoided unless recommended by a doctor.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

None anticipated at the recommended dosage.

4.9 Overdose

Overdose with this preparation is unlikely to occur, however, large doses of glycerin may cause thirst, headache, nausea, vomiting, diarrhoea, hyperglycaemia, dehydration, dizziness and mental confusion. Cardiac arrhythmias have been reported. Treatment should be symptomatic.

Large doses of ipecacuanha may irritate the gastrointestinal tract, and give rise to nausea, persistent bloody vomiting or bloody diarrhoea.

Mucosal erosions of the entire gastrointestinal tract have been reported. Overdosage is unlikely as a result of the emetic action of ipecacuanha, however, if emetine is absorbed in sufficient amounts it may have adverse effects on the heart, such as conduction abnormalities or myocardial infarction. These symptoms may also be combined with dehydration due to vomiting, and may cause vasomotor collapse followed by death.

Acute overdosage of ipecacuanha should be treated with activated charcoal to delay absorption. Prolonged vomiting should be controlled by intramuscular injection of anti-emetics. Supportive measures should be taken to correct fluid and electrolyte imbalance and cardiac effects.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Glycerol acts as a demulcent to soothe the passage of the upper respiratory tract.

Ipecacuanha has a reflex expectorant action as a result of its irritant action on the respiratory tract.

5.2 Pharmacokinetic Properties

Glycerol is readily absorbed from the intestine and is metabolised to carbon dioxide and glycogen.

Emetine one of the major alkaloids of ipecacuanha is excreted or metabolised slowly.

5.3 Preclinical Safety Data

None known.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Lemon soluble essence

Syrup

Purified water

Lemon juice

Citric acid monohydrate

Honey

Liquid glucose

6.2 Incompatibilities

None stated.

6.3 Shelf Life

200ml: 24 months unopened.

6.4 Special Precautions For Storage

Store below 25°C.

6.5 Nature And Contents Of Container

200ml: glass bottle with polypropylene cap or white 28mm Child-resistant cap with Tamper Evident band and EPE/Saranex Liner.

6.6 Special Precautions For Disposal And Other Handling

None.

7. Marketing Authorisation Holder

L.C.M. Ltd

Linthwaite Laboratories

Huddersfield

HD7 5QH

8. Marketing Authorisation Number(S)

PL 12965/0014

9. Date Of First Authorisation/Renewal Of The Authorisation

06.04.99

10. Date Of Revision Of The Text

06.01.10

Prohist CF

Generic Name: chlophedianol and triprolidine (KLOE fe DYE a nol and trye PROE li deen)

Brand Names: Prohist CF

What is Prohist CF (chlophedianol and triprolidine)?

Chlophedianol is a cough suppressant. It affects the signals in the brain that trigger cough reflex.

Triprolidine is an antihistamine that reduces the effects of the natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.

The combination of chlophedianol and triprolidine is used to treat cough, runny nose, sneezing, itching, or watery eyes caused by allergies, the common cold, or the flu.

Chlophedianol and triprolidine may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Prohist CF (chlophedianol and triprolidine)?

Do not give this medication to a child younger than 4 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children. You should not use this medication if you have severe constipation, a blockage in your stomach or intestines, or if you are unable to urinate. Do not use cough or cold medicine if you have untreated or uncontrolled diseases such as glaucoma, asthma or COPD, heart disease, or overactive thyroid.

What should I discuss with my healthcare provider before taking Prohist CF (chlophedianol and triprolidine)?

You should not use this medication if you have severe constipation, a blockage in your stomach or intestines, or if you are unable to urinate. Do not use cough or cold medicine if you have untreated or uncontrolled diseases such as glaucoma, asthma or COPD, heart disease, or overactive thyroid.

To make sure you can safely use this medicine, tell your doctor if you have any of these other conditions:

a blockage in your digestive tract (stomach or intestines), a colostomy or ileostomy;

liver or kidney disease;

enlarged prostate or urination problems;

low blood pressure; or

if you take potassium (Cytra, Epiklor, K-Lyte, K-Phos, Kaon, Klor-Con, Polycitra, Urocit-K).

It is not known whether this medicine will harm an unborn baby. Do not use cough or cold medicine without telling your doctor if you are pregnant or plan to become pregnant while using the medicine. Chlophedianol and triprolidine may pass into breast milk and may harm a nursing baby. Antihistamines and decongestants may also slow breast milk production. Do not use cough or cold medicine without telling your doctor if you are breast-feeding a baby.

How should I take Prohist CF (chlophedianol and triprolidine)?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Cough or cold medicine is usually taken only for a short time until your symptoms clear up.

Do not take for longer than 7 days in a row. Talk with your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache or skin rash.

Measure liquid medicine with a special dose measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose measuring device, ask your pharmacist for one.

If you need surgery or medical tests, tell the surgeon or doctor ahead of time if you have taken a cough or cold medicine within the past few days. Store at room temperature away from moisture and heat. Do not freeze.

What happens if I miss a dose?

Since cough or cold medicine is taken when needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include severe forms of some of the side effects listed in this medication guide.

What should I avoid while taking Prohist CF (chlophedianol and triprolidine)?

This medicine may cause blurred vision or impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert and able to see clearly. Ask a doctor or pharmacist before using any other cold, allergy, cough, or sleep medicine. Antihistamines, antitussives, and decongestants are contained in many combination medicines. Taking certain products together can cause you to get too much of a certain drug. Check the label to see if a medicine contains an antihistamine or decongestant. Drinking alcohol can increase certain side effects of chlophedianol and triprolidine. Avoid becoming overheated or dehydrated during exercise and in hot weather. Chlophedianol and triprolidine can decrease sweating and you may be more prone to heat stroke.

Prohist CF (chlophedianol and triprolidine) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Stop using this medicine and call your doctor at once if you have a serious side effect such as:

pounding heartbeats or fluttering in your chest;

fast, slow, or uneven heart rate;

severe dizziness or anxiety, feeling like you might pass out;

severe headache, mood changes, hallucinations;

chest tightness, wheezing;

tremor, seizure (convulsions);

fever; or

urinating less than usual or not at all.

Less serious side effects may include:

mild dizziness or drowsiness;

mild headache;

dry mouth, nose, or throat;

nausea, constipation, upset stomach, loss of appetite;

feeling nervous or restless;

blurred vision; or

sleep problems (insomnia).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Prohist CF (chlophedianol and triprolidine)?

Before using this medication, tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by chlophedianol or triprolidine.

Tell your doctor about all other medicines you use, especially:

atropine (Atreza, Sal-Tropine);

benztropine (Cogentin);

topiramate (Topamax);

zonisamide (Zonegran);

an antidepressant such as citalopram (Celexa), duloxetine (Cymbalta), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem, Symbyax), paroxetine (Paxil, Pexeva), sertraline (Zoloft), venlafaxine (Effexor), and others;

anti-nausea medications such as belladonna (Donnatal), dimenhydrinate (Dramamine), droperidol (Inapsine), methscopolamine (Pamine), or scopolamine (Transderm Scop);

bladder or urinary medications such as darifenacin (Enablex), flavoxate (Urispas), oxybutynin (Ditropan, Oxytrol), solifenacin (Vesicare), tolterodine (Detrol), or Urogesic Blue;

bronchodilators such as ipratropium (Atrovent) or tiotropium (Spiriva);

irritable bowel medications such as dicyclomine (Bentyl), hyoscyamine (Hyomax), or propantheline (Pro Banthine); or

ulcer medicine such as glycopyrrolate (Robinul) or mepenzolate (Cantil).

This list is not complete and other drugs may interact with chlophedianol and triprolidine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Prohist CF resources

Prohist CF Side Effects (in more detail)
Prohist CF Use in Pregnancy & Breastfeeding
Prohist CF Drug Interactions
0 Reviews · Be the first to review/rate this drug

Prohist CF Liquid MedFacts Consumer Leaflet (Wolters Kluwer)

Where can I get more information?

Your pharmacist can provide more information about chlophedianol and triprolidine.

See also: Prohist CF side effects (in more detail)

Flecainide Acetate

Flecainide acetate 50 mg and 100 mg Tablets

Flecainide acetate

Read all of this leaflet carefully before you take this medicine.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or nurse.

This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

In this leaflet:

1. What Flecainide acetate tablets are for

2. Before you take Flecainide acetate tablets

3. How to take Flecainide acetate tablets

4. Possible side effects

5. How to store Flecainide acetate tablets

6. Further information.

What Flecainide acetate tablets are for

Flecainide acetate tablets belong to a group of medicines called anti-arrhythmics. Anti-arrhythmics work by controlling the rate and rhythm of the heart.

Flecainide acetate tablets are used to treat:

Arrhythmias (irregular heart beat)

Tachycardia (heart beat too fast)

Atrial fibrillation (rapid contractions of muscles in the heart).

It is important for your doctor to treat these conditions quickly and effectively in order to prevent more serious heart problems from developing.

There are two strengths of tablet available, 50 mg and 100 mg.

Before you take Flecainide acetate tablets

Do not take Flecainide acetate tablets if:

You are allergic to flecainide acetate or any of the other ingredients of Flecainide acetate tablets (see Section 6)

You have heart failure

You have heart block (your heart misses beats)

You have long-standing atrial fibrillation (rapid contractions of muscles in the heart)

You have or have ever had any heart problems including problems with the valves in your heart or conduction problems

You have sinus node dysfunction (a specific condition where your heart beats abnormally)

You have had a myocardial infarction (heart attack)

You are pregnant or breast-feeding.

Flecainide acetate tablets are not recommended for use in children under 12 years of age.

If any of the above applies to you tell your doctor or nurse.

Before you take Flecainide acetate tablets your doctor or nurse may check:

Your fluid levels are correct

Your liver and kidney functions.

This is to check that flecainide acetate tablets are right for you and to help the doctor calculate the dose you need.

Check with your doctor or nurse before taking Flecainide acetate tablets if:

You have high blood pressure

You have angina (chest pains)

You have heart disease

You have kidney disease or kidney problems

You have liver disease or liver problems

You wear a pacemaker.

Tell your doctor or nurse if you are taking any of the following medicines:

Any other medicine used to treat heart arrhythmias or heart problems such as cardiac glycosides, beta-blockers, verapamil or amiodarone

Medicines to treat high blood pressure

Antidepressants (medicines used to treat depression), such as tricyclic antidepressants, Prozac, fluoxetine or reboxetine

Anticonvulsants (medicines used to prevent epileptic fits) such as phenytoin, phenobarbital or carbamazepine

Antipsychotics (medicines to treat mental illness) such as clozapine

Antihistamines (medicines to treat allergic reactions) such as mizolastine or terfenadine

Quinine (medicine to treat malaria)

Medicines to treat HIV such as ritonavir, lopinavir or indinavir

Diuretics (water tablets)

Cimetidine (medicine to treat stomach ulcers)

Bupropion (a medicine to help stop you smoking)

Any other medicine, including medicines obtained without a prescription.

These medicines may interfere with your treatment.

Pregnancy and breast-feeding

If you are pregnant, trying to become pregnant or breast-feeding, ask the doctor or nurse for advice before taking Flecainide acetate tablets.

How to take Flecainide acetate tablets

Always take Flecainide acetate tablets exactly as your doctor has told you.

Important:

Your doctor will choose the dose that is right for your condition. Usually your treatment with Flecainide acetate tablets will be started in hospital.

Adults:

Supraventricular arrhythmias (Irregular heart beat that starts in the upper chambers of your heart)

Flecainide acetate 50 mg tablets: The usual dose is one tablet twice a day.

Flecainide acetate 100 mg tablets: The usual dose is half a tablet twice a day.

Your doctor may prescribe up to a total dose of 300 mg daily (3 x 100 mg tablets or 6 x 50 mg tablets).

Ventricular arrhythmias (Irregular heart beat that starts in the lower chambers of your heart)

Flecainide acetate 50 mg tablets: The usual dose is two tablets twice a day.

Flecainide acetate 100 mg tablets: The usual dose is one tablet twice a day.

Your doctor may prescribe up to a total dose of 400 mg daily (4 x 100 mg tablets or 8 x 50 mg tablets).

The elderly and patients with kidney or heart problems:

For elderly patients, and patients with kidney or heart problems, the doctor may tell you to take a lower dose.

While you are taking this medicine, your doctor may ask you to have check-ups. These are to make sure that your medicine is working properly and that the dose you are taking is right for you.

Children:

Flecainide acetate tablets are not recommended for children under 12 years of age.

If you take more Flecainide acetate tablets than you should

If you accidentally take too much, immediately go to the nearest hospital casualty department.

If you forget to take Flecainide acetate tablets

Do not take a double dose to make up for a missed dose. Simply take the next dose as planned.

If you stop taking Flecainide acetate tablets

Do not stop taking Flecainide acetate tablets without first talking to your doctor.

If you have any further questions about the use of this medicine, ask your doctor or nurse.

Flecainide Acetate Side Effects

Like all medicines Flecainide acetate tablets can cause side effects, although not everybody gets them.

Seek immediate medical help if you have any of the following symptoms:

Your heartbeat changes; it starts to pound, or it gets faster or slower

You have chest pain

You become breathless or have other breathing problems

You faint or you feel faint

You have ringing in your ears

Your skin and eyes begin to go yellow (jaundice)

You have a fever, become flushed or sweat

You have fits (convulsions).

Other side effects:

Feeling or being sick

Constipation

Feeling bloated

Wind

Diarrhoea

Stomach pain or indigestion

Loss of appetite

Confusion and hallucinations

Forgetfulness

Difficulty sleeping

Feeling anxious (worried)

Depression

Red, itchy or swollen skin rash

Hair loss

Sensitivity to sunlight

Feeling weak or tired

Headache

Double or blurred vision

Small cloudy spots on the eyeball

Feeling giddy or lightheaded

Dizziness or feeling that the room is spinning (vertigo)

Shaking (tremors)

Unsteady walking, uncontrolled movements or poor coordination

Numb or tingling hands or feet

Swelling.

If any of these side effects get serious, or you notice any side effects not listed in this leaflet, tell your doctor or nurse.

How to store Flecainide acetate tablets

Keep out of the reach and sight of children.

Do not store above 30°C.

Keep the container in the outer carton to protect the tablets from light.

Do not use Flecainide acetate tablets after the expiry date on the carton. The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste. Return any medicine you no longer need to your pharmacist.

Further information

What Flecainide acetate tablets contain

The active substance in Flecainide acetate tablets is flecainide acetate. Each 50 mg tablet contains 50 mg of flecainide acetate. Each 100 mg tablet contains 100 mg flecainide acetate.

The other ingredients are pregelatinised starch, croscarmellose sodium, microcrystalline cellulose (E460i), hydrogenated vegetable oil, magnesium stearate (E572).

What Flecainide acetate tablets look like

Flecainide acetate 50 mg tablets are round, white and marked '3M' on one side and 'TR50' on the other.

Flecainide acetate 100 mg tablets are round, white and marked '3M' on one side and 'TR100' with a break line on the other.

Both strengths of Flecainide acetate tablets come in blister packs containing 60 tablets.

Marketing Authorisation Holder:

Meda Pharmaceuticals Ltd

Skyway House

Parsonage Road

Takeley

Bishop's Stortford

CM22 6PU

Manufacturer:

3M Health Care Limited

1 Morley Street

Loughborough

Leicester

LE11 1EP

This leaflet was last updated February 2010

If this leaflet is difficult to see or read and you would like it in a different format, please contact

Meda Pharmaceuticals Ltd

Skyway House

Parsonage Road

Takeley

Bishop's Stortford

CM22 6PU

70703-A

Sunday, May 27, 2012

Ibutilide

Pronunciation: eye-BYOO-tih-lide
Generic Name: Ibutilide
Brand Name: Corvert

Ibutilide can cause potentially deadly irregular heart rhythms, which can be reversed if treated promptly.

Ibutilide is used for:

Treating irregular heart rhythms. It may also be used for other conditions as determined by your doctor.

Ibutilide is an antiarrhythmic. It works by slowing the conduction of the irregular heartbeat throughout the heart, which allows an opportunity for the regular heart rhythm to take over.

Do NOT use Ibutilide if:

you are allergic to any ingredient in Ibutilide

you have prolonged QT interval in electrocardiogram

you are taking itraconazole

Contact your doctor or health care provider right away if any of these apply to you.

Before using Ibutilide:

Some medical conditions may interact with Ibutilide. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding

if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

if you have allergies to medicines, foods, or other substances

if you have an irregular or slow heartbeat, congestive heart failure, other heart problems, or low levels of magnesium or potassium

Some MEDICINES MAY INTERACT with Ibutilide. Tell your health care provider if you are taking any other medicines, especially any of the following:

Arsenic, cisapride, itraconazole, ketolides (eg, telithromycin), macrolides (eg, erythromycin), phenothiazines (eg, promethazine), and other medications that prolong the QT interval because they may increase the risk abnormal heart rhythms, including fatal heart rhythms, such as torsades de pointes

This may not be a complete list of all interactions that may occur. Ask your health care provider if Ibutilide may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Ibutilide:

Use Ibutilide as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Ibutilide is administered as an infusion at the hospital.

If Ibutilide contains particles or is discolored, or if the vial is cracked or damaged in any way, do not use it.

Keep this product, as well as syringes and needles, out of the reach of children and away from pets. Do not reuse needles, syringes, or other materials. Dispose of properly after use. Ask your doctor or pharmacist to explain local regulations for proper disposal.

If you miss a dose of Ibutilide, contact your doctor immediately.

Ask your health care provider any questions you may have about how to use Ibutilide.

Important safety information:

Ibutilide may cause dizziness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Ibutilide. Using Ibutilide alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.

Ibutilide is not recommended for use in CHILDREN. Safety and effectiveness have not been confirmed.

PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using Ibutilide during pregnancy. It is unknown if Ibutilide is excreted in breast milk. Do not breast-feed while taking Ibutilide.

Possible side effects of Ibutilide:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Dizziness; headache; nausea; rapid heartbeat.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; fainting; fast or slow heartbeat; heart block; heart failure; shortness of breath; swelling of feet or ankles; worsening of heart rhythm problems.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Ibutilide side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include abnormal heart rhythms; heart block.

Proper storage of Ibutilide:

Ibutilide is usually handled and stored by a health care provider. If you are using Ibutilide at home, store Ibutilide as directed by your pharmacist or health care provider.

General information:

If you have any questions about Ibutilide, please talk with your doctor, pharmacist, or other health care provider.

Ibutilide is to be used only by the patient for whom it is prescribed. Do not share it with other people.

If your symptoms do not improve or if they become worse, check with your doctor.

Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Ibutilide. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

More Ibutilide resources

Ibutilide Side Effects (in more detail)
Ibutilide Use in Pregnancy & Breastfeeding
Ibutilide Drug Interactions
Ibutilide Support Group
0 Reviews for Ibutilide - Add your own review/rating

ibutilide Concise Consumer Information (Cerner Multum)

Corvert Prescribing Information (FDA)

Corvert Monograph (AHFS DI)

Compare Ibutilide with other medications

Atrial Fibrillation
Atrial Flutter

Wednesday, May 23, 2012

Alrex Drops

Pronunciation: low-TEH-PRED-nole
Generic Name: Loteprednol
Brand Name: Alrex

Alrex Drops are used for:

Providing temporary relief of itching, redness, swelling, and irritation of the eye caused by seasonal allergies.

Loteprednol is an ophthalmic corticosteroid. It decreases inflammation (eg, redness, swelling, warmth, pain) of the eye.

Do NOT use Alrex Drops if:

you are allergic to any ingredient in Alrex Drops

you have a bacterial, viral, or mycobacterial infection of the eye

Contact your doctor or health care provider right away if any of these apply to you.

Before using Alrex Drops:

Some medical conditions may interact with Alrex Drops. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding

if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

if you have allergies to medicines, foods, or other substances

if you wear soft contact lenses

if you have cataract surgery, diabetes, eye discharge, thinning of the cornea or sclera, or glaucoma

if you have a history of herpes simplex of the eye

Some MEDICINES MAY INTERACT with Alrex Drops. However, no specific interactions with Alrex Drops are known at this time.

Ask your health care provider if Alrex Drops may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Alrex Drops:

Use Alrex Drops as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Alrex Drops are only for the eye. Do not get it in your nose or mouth.

Shake well before each use.

To use Alrex Drops in the eye, first, wash your hands. Tilt your head back. Using your index finger, pull the lower eyelid away from the eye to form a pouch. Drop the medicine into the pouch and gently close your eyes. Immediately use your finger to apply pressure to the inside corner of the eyelid for 1 to 2 minutes. Do not blink. Remove excess medicine around your eye with a clean, dry tissue, being careful not to touch your eye. Wash your hands to remove any medicine that may be on them.

To prevent germs from contaminating your medicine, do not touch the applicator tip to any surface, including the eye. Keep the container tightly closed.

If you miss a dose of Alrex Drops, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Alrex Drops.

Important safety information:

Alrex Drops may cause blurred vision. Use Alrex Drops with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

Soft contact lenses may absorb a chemical in Alrex Drops; wait 10 minutes after you use Alrex Drops before you put your contacts back in.

Do not wear contact lenses if your eyes are red.

If Alrex Drops are used for more than 10 days, your eyes will need to be re-evaluated by your eye care provider.

If your symptoms do not get better within 2 days or if they get worse, check with your doctor.

Alrex Drops should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.

PREGNANCY and BREAST-FEEDING: It is not known if Alrex Drops can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Alrex Drops while you are pregnant. It is not known if Alrex Drops are found in breast milk. If you are or will be breast-feeding while you use Alrex Drops, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Alrex Drops:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Blurred vision; discharge; dry eyes; eye redness; eye/eyelid swelling; foreign body sensation; headache; increased tearing; itching; runny nose; sensitivity to light; sore throat; stinging when placed in the eye.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); changes in vision; continued or worsening itching; delayed healing after surgery; eye pain; severe redness or swelling.

See also: Alrex side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Alrex Drops:

Store Alrex Drops at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store in an upright position. Do not freeze. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Alrex Drops out of the reach of children and away from pets.

General information:

If you have any questions about Alrex Drops, please talk with your doctor, pharmacist, or other health care provider.

Alrex Drops are to be used only by the patient for whom it is prescribed. Do not share it with other people.

If your symptoms do not improve or if they become worse, check with your doctor.

Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Alrex Drops. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

More Alrex resources

Alrex Side Effects (in more detail)
Alrex Use in Pregnancy & Breastfeeding
Alrex Drug Interactions
Alrex Support Group
0 Reviews for Alrex - Add your own review/rating

Compare Alrex with other medications

Conjunctivitis
Cyclitis
Iritis
Keratitis
Postoperative Ocular Inflammation
Rosacea
Seasonal Allergic Conjunctivitis

Tuesday, May 22, 2012

Eliphos

Generic Name: calcium acetate (Oral route)

KAL-see-um AS-e-tate

Commonly used brand name(s)

In the U.S.

Eliphos

PhosLo

Phoslyra

Available Dosage Forms:

Tablet

Solution

Capsule

Therapeutic Class: Calcium Supplement

Uses For Eliphos

Calcium acetate is used to treat hyperphosphatemia (too much phosphate in the blood) in patients with end stage kidney disease who are on dialysis.

Calcium acetate works by binding with the phosphate in the food you eat, so that it is eliminated from the body without being absorbed.

This medicine is available only with your doctor's prescription.

Before Using Eliphos

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of calcium acetate in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of calcium acetate in the elderly. However, elderly patients are more likely to have liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving calcium acetate.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Digoxin

Eltrombopag

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Chlorothiazide

Chlortetracycline

Ciprofloxacin

Dasatinib

Demeclocycline

Doxycycline

Enoxacin

Grepafloxacin

Itraconazole

Levofloxacin

Levothyroxine

Lomefloxacin

Methacycline

Minocycline

Norfloxacin

Oxytetracycline

Pefloxacin

Potassium Phosphate

Potassium Phosphate, Dibasic

Potassium Phosphate, Monobasic

Rolitetracycline

Sodium Phosphate

Sodium Phosphate, Dibasic

Sodium Phosphate, Monobasic

Sodium Polystyrene Sulfonate

Sparfloxacin

Tetracycline

Ticlopidine

Zalcitabine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Proper Use of calcium acetate

This section provides information on the proper use of a number of products that contain calcium acetate. It may not be specific to Eliphos. Please read with care.

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

It is best to take this medicine with meals.

Measure the oral liquid with a marked measuring spoon, oral syringe, or medicine cup. The average household teaspoon may not hold the right amount of liquid.

Follow carefully any diet program your doctor may recommend.

If you are taking other medicines, take them at least 1 hour before or 3 hours after you take calcium acetate oral liquid. If you need help deciding the best times to take your other medicines, ask your doctor or pharmacist.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

For too much phosphate in the blood:
- For oral dosage form (solution):
  - Adults—At first, the dose is usually 10 milliliters (mL) with each meal. The dose is adjusted by your doctor depending on how high your blood phosphorus level is.
  - Children—Use and dose must be determined by your doctor.
- For oral dosage form (tablets):
  - Adults—2 tablets three times a day with meals. Your doctor may increase your dose if needed.
  - Children—Use and dose must be determined by your doctor.

Missed Dose

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Throw away any unused oral liquid after 24 months.

Precautions While Using Eliphos

It is very important that your doctor check your progress at regular visits, especially during the first few months of treatment with this medicine, since your dose may have to be adjusted. This is to make sure that this medicine is working properly and does not cause unwanted effects. Blood tests may be needed to check for unwanted effects.

Sometimes, you might have hypercalcemia (too much calcium in the blood) and not have any warning signs. You may need to have blood tests on a regular schedule while you are being treated with this medicine to check the amount of calcium and phosphorus in your blood. Keep all appointments your doctor makes for you.

If you have mild hypercalcemia, you may lose your appetite and have nausea, vomiting, or constipation. If the problem is severe, you may feel confused or extremely excited. Stop using this medicine and call your doctor right away if you think you might have severe hypercalcemia.

Do not take other calcium-containing products including dietary supplements and antacids. Your doctor may adjust the amount of calcium-containing foods you eat. Taking too much calcium while you are taking this medicine can cause hypercalcemia.

Eliphos Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Abdominal or stomach pain

confusion

constipation

depression

dry mouth

full or partial loss of consciousness

headache

incoherent speech

increased urination

loss of appetite

metallic taste

muscle weakness

nausea or vomiting

thirst

unusual tiredness

weight loss

Incidence not known

Swelling

More common

Diarrhea

Less common

Itching

Incidence not known

Dizziness

weakness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Eliphos side effects (in more detail)

More Eliphos resources

Eliphos Side Effects (in more detail)
Eliphos Use in Pregnancy & Breastfeeding
Eliphos Drug Interactions
Eliphos Support Group
0 Reviews for Eliphos - Add your own review/rating

Eliphos Concise Consumer Information (Cerner Multum)

Calcium Acetate MedFacts Consumer Leaflet (Wolters Kluwer)

Eliphos Prescribing Information (FDA)

PhosLo Concise Consumer Information (Cerner Multum)

Phoslo Prescribing Information (FDA)

Phoslyra Prescribing Information (FDA)

Phoslyra Solution MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Eliphos with other medications

Hyperphosphatemia

Diamicron 30 mg MR

DIAMICRON 30 mg MR Tablets

modified release tablets

Gliclazide

Read all of this leaflet carefully before you start taking this medicine.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1. What DIAMICRON 30 mg MR is and what it is used for

2. Before you take DIAMICRON 30 mg MR

3. How to take DIAMICRON 30 mg MR

4. Possible side effects

5. How to store DIAMICRON 30 mg MR

6. Further information

What Diamicron 30 Mg Mr Is And What It Is Used For

DIAMICRON 30 mg MR is a medicine that reduces blood sugar levels (oral antidiabetic medicine belonging to the sulphonylurea group).

DIAMICRON 30 mg MR is used in a certain form of diabetes (type 2 diabetes mellitus) in adults, when diet, exercise and weight loss alone do not have an adequate effect on keeping blood sugar at the correct level.

Before You Take Diamicron 30 Mg Mr

Do not take DIAMICRON 30 mg MR

if you are allergic (hypersensitive) to gliclazide or any of the other ingredients of DIAMICRON 30 mg MR, or to other medicines of the same group (sulphonylureas), or to other related medicines (hypoglycaemic sulphonamides);

if you have insulin-dependent diabetes (type 1);

if you have ketone bodies and sugar in your urine (this may mean you have diabetic keto-acidosis), a diabetic pre-coma or coma;

if you have severe kidney or liver disease;

if you are taking medicines to treat fungal infections (miconazole, see Section “Taking other medicines”);

if you are breastfeeding (see Section “Pregnancy and breastfeeding”).

Take special care with DIAMICRON 30 mg MR

You should observe the treatment plan prescribed by your doctor to achieve proper blood sugar levels. This means, apart from regular tablet intake, you observe the dietary regimen, have physical exercise and, where necessary, reduce weight.

During gliclazide treatment regular monitoring of your blood (and possibly urine) sugar level and also your glycated haemoglobin (HbA1c) is necessary.

In the first few weeks of treatment the risk of having reduced blood sugar levels (hypoglycaemia) may be increased. So particularly close medical monitoring is necessary.

Low blood sugar (Hypoglycaemia) may occur:

if you take meals irregularly or skip meals altogether,

if you are fasting,

if you are malnourished,

if you change your diet,

if you increase your physical activity and carbohydrate intake does not match this increase,

if you drink alcohol, especially in combination with skipped meals,

if you take other medicines or natural remedies at the same time,

if you take too high doses of gliclazide,

if you suffer from particular hormone-induced disorders (functional disorders of the thyroid gland, of the pituitary gland or adrenal cortex),

if your kidney function or liver function is severely decreased.

If you have low blood sugar you may have the following symptoms: headache, intense hunger, nausea, vomiting, weariness, sleep disorders, restlessness, aggressiveness, poor concentration, reduced alertness and reaction time, depression, confusion, speech or visual disorders, tremor, sensory disturbances, dizziness, and helplessness.

The following signs and symptoms may also occur: sweating, clammy skin, anxiety, fast or irregular heart beat, high blood pressure, sudden strong pain in the chest that may radiate into nearby areas (angina pectoris).

If blood sugar levels continue to drop you may suffer from considerable confusion (delirium), develop convulsions, lose self control, your breathing may be shallow and your heart beat slowed down, you may become unconscious.

In most cases the symptoms of low blood sugar vanish very quickly when you consume some form of sugar, e.g. glucose tablets, sugar cubes, sweet juice, sweetened tea.

You should therefore always carry some form of sugar with you (glucose tablets, sugar cubes). Remember that artificial sweeteners are not effective. Please contact your doctor or the nearest hospital if taking sugar does not help or if the symptoms recur.

Symptoms of low blood sugar may be absent, less obvious or develop very slowly or you are not aware in time that your blood sugar level has dropped. This may happen if you are an elderly patient taking certain medicines (e.g. those acting on the central nervous system and beta blockers).

If you are in stress-situations (e.g. accidents, surgical operations, fever etc.) your doctor may temporarily switch you to insulin therapy.

Symptoms of high blood sugar (hyperglycaemia) may occur when gliclazide has not yet sufficiently reduced the blood sugar, when you have not complied with the treatment plan prescribed by your doctor or in special stress situations ). These may include thirst, frequent urination, dry mouth, dry itchy skin, skin infections and reduced performance.

If these symptoms occur, you must contact your doctor or pharmacist.

If you have a family history of or know you have the hereditary condition glucose-6-phosphate dehydrogenase (G6PD) deficiency (abnormality of red blood cells), lowering of the haemoglobin level and breakdown of red blood cells (haemolytic anaemia) can occur.

Contact your doctor before taking this medicinal product.

DIAMICRON 30 mg MR is not recommended for use in children due to a lack of data.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription, as they may interact with your DIAMICRON 30 mg MR.

The blood sugar lowering effect of gliclazide may be strengthened and signs of low blood sugar levels may occur when one of the following medicines is taken:

other medicines used to treat high blood sugar (oral antidiabetics or insulin),

antibiotics (e.g. sulphonamides),

medicines to treat high blood pressure or heart failure (beta blockers, ACE-inhibitors such as captopril, or enalapril),

medicines to treat fungal infections (miconazole, fluconazole),

medicines to treat ulcers in the stomach or duodenum (H₂ receptor antagonists),

medicines to treat depression (monoamine oxidase inhibitors),

painkiller or antirheumatics (phenylbutazone, ibuprofen),

medicines containing alcohol.

The blood glucose lowering effect of gliclazide may be weakened and raised blood sugar levels may occur when one of the following medicines is taken:

medicines to treat disorders of the central nervous system (chlorpromazine),

medicines reducing inflammation (corticosteroids),

medicines to treat asthma or used during labour (intravenous salbutamol, ritodrine and terbutaline),

medicines to treat breast disorders, heavy menstrual bleeding and endometriosis (danazol).

DIAMICRON 30 mg MR may increase the effects of medicines which reduce blood clotting (e.g. warfarin).

Consult your doctor before you start taking another medicinal product. If you go into hospital tell the medical staff you are taking DIAMICRON 30 mg MR.

Taking DIAMICRON 30 mg MR with food and drink

DIAMICRON 30 mg MR can be taken with food and non-alcoholic drinks.

Drinking alcohol is not recommended as it can alter the control of your diabetes in an unpredictable manner.

Pregnancy and breastfeeding

DIAMICRON 30 mg MR is not recommended for use during pregnancy. If you are planning a pregnancy, or become pregnant, inform your doctor so that he may prescribe a more suitable treatment for you.

You must not take DIAMICRON 30 mg MR while you are breastfeeding.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Your ability to concentrate or react may be impaired if your blood sugar is too low (hypoglycaemia), or too high (hyperglycaemia) or if you develop visual problems as a result of such conditions.

Bear in mind that you could endanger yourself or others (e.g. when driving a car or using maschines).

Please ask your doctor whether you can drive a car if you:

have frequent episodes of low blood sugar (hypoglycaemia),

have few or no warning signals of low blood sugar (hypoglycaemia).

How To Take Diamicron 30 Mg Mr

Dosage

Always take DIAMICRON 30 mg MR exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

The dose is determined by the doctor, depending on your blood and possibly urine sugar levels.

Change in external factors (e.g. weight reduction, change in life style, stress) or improvements in the blood sugar control may require changed gliclazide doses.

The usual dose is one to four tablets (maximun 120 mg) in a single intake at breakfast time. This depends on the response to treatment.

If a combination therapy of DIAMICRON 30 mg MR with metformin, an alpha glucosidase inhibitor or insulin is initiated your doctor will determine the proper dose of each medicine individually for you.

Please talk to your doctor or pharmacist if you have the impression that DIAMICRON 30 mg MR is acting too strongly or not strongly enough.

Methods and routes of administration

Oral use.

Swallow your tablets whole. Do not chew them.

Take your tablet(s) with a glass of water at breakfast time (and preferably at the same time each day).

You must always eat a meal after taking your tablet(s).

If you take more DIAMICRON 30 mg MR than you should

If you take too many tablets, contact your doctor or the nearest hospital Accident & Emergency department immediately. The signs of overdose are those of low blood sugar (hypoglycaemia) described in Section 2. The symptoms can be helped by taking sugar (4 to 6 lumps) or sugary drinks straight away, followed by a substantial snack or meal. If the patient is unconscious immediately inform a doctor and call the emergency services.

The same should be done if somebody, e.g. a child, has taken the product unintentionally. Unconscious patients must not be given food or drink.

It should be ensured that there is always a pre-informed person that can call a doctor in case of emergency.

If you forget to take DIAMICRON 30 mg MR

It is important to take your medicine every day as regular treatment works better.

However, if you forget to take a dose of DIAMICRON 30 mg MR, take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose.

If you stop taking DIAMICRON 30 mg MR

As the treatment for diabetes is usually life long, you should discuss with your doctor before stopping this medicinal product.

Stopping could cause high blood sugar (hyperglycaemia).

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Possible Side Effects

Like all medicines DIAMICRON 30 mg MR can cause side effects, although not everybody gets them.

The most commonly observed side effect is low blood sugar (hypoglycaemia). For symptoms and signs see "Take special care" in "Section 2 BEFORE YOU TAKE".

If left untreated these symptoms could progress to drowsiness, loss of consciousness or possibly coma. If an episode of low blood sugar is severe or prolonged, even if it is temporarily controlled by eating sugar, you should seek immediate medical attention.

Blood disorders:

Decrease in the number of cells in the blood has been reported (e.g. platelets, red and white blood cells).

This may cause:

Paleness

Prolonged bleeding

Bruising

Sore throat

Fever

These symptoms usually vanish when the treatment is discontinued.

Liver disorders

There have been isolated reports of abnormal liver function, which can cause yellow skin and eyes. If you get this, see your doctor immediately. The symptoms generally disappear if the medicine is stopped. Your doctor will decide whether to stop your treatment.

Skin disorders

Skin reactions have been reported such as:

Rash

Redness

Itching

Hives

Severe reactions may also appear.

Digestive disorders

Stomach pain or discomfort

Feeling or being sick

Indigestion

Diarrhoea

Constipation

These effects are reduced when Diamicron 30 mg MR is taken with a meal as recommended, See Section 3 “HOW TO TAKE”.

Eye disorders

Your vision may be affected for a short time especially at the start of treatment. This effect is due to changes in blood sugar levels.

With sulphonylureas, cases of severe changes in the number of blood cells and allergic inflammation of the wall of blood vessels have been described. Symptoms of liver impairment (e.g. jaundice) have been observed which in most cases disappeared after withdrawal of the sulphonylureas, but may lead to life-threatening liver failure in isolated cases.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

How To Store Diamicron 30 Mg Mr

Keep out of the reach and sight of children.

Do not use DIAMICRON 30 mg MR after the expiry date which is stated on the carton and the blister strip. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Further Information

What DIAMICRON 30 mg MR contains

The active substance is gliclazide. One tablet contains 30 mg of gliclazide, in a modified release formulation.

The other ingredients are: calcium hydrogen phosphate dihydrate, maltodextrin, hypromellose, magnesium stearate, anhydrous colloidal silica.

What DIAMICRON 30 mg MR looks like and contents of the pack

DIAMICRON 30 mg MR tablets are white oblong modified release tablets, engraved on both faces, ‘DIA 30’ on one face and the Servier logo on the other. The tablets are available in blister packed in cartons of 7, 10, 14, 20, 28, 30, 56, 60, 84, 90, 100, 112, 120, 180 or 500 tablets.

Not all pack sizes may be available.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Les Laboratoires Servier

rue Garnier

92200 Neuilly sur Seine

France

Local representative in UK

Servier Laboratories Ltd

Gallions

Wexham Springs

Framewood road

Wexham

Slough

SL3 6RJ

Manufacturer

Servier (Ireland) Industries Ltd.

Gorey Road

Arklow - Co. Wicklow

Ireland

This leaflet was last approved in March 2010.

Sunday, May 20, 2012

Urocit-K 15

Generic Name: citrate (Oral route)

Commonly used brand name(s)

In the U.S.

Citra pH

Cytra-K

Cytra-K Crystals

Liqui-DualCitra

Polycitra-K

Polycitra-K Crystals

Urocit-K 10

Urocit-K 15

Urocit-K 5

In Canada

Pms-Dicitrate

Available Dosage Forms:

Tablet

Solution

Tablet, Extended Release

Syrup

Powder for Suspension

Uses For Urocit-K 15

Citrates are used to make the urine more alkaline (less acid). This helps prevent certain kinds of kidney stones. Citrates are sometimes used with other medicines to help treat kidney stones that may occur with gout. They are also used to make the blood more alkaline in certain conditions

Citrates are available only with your doctor's prescription.

Before Using Urocit-K 15

Allergies

Pediatric

Although there is no specific information comparing use of citrates in children with use in other age groups, these medicines are not expected to cause different side effects or problems in children than they do in adults.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of citrates in the elderly with use in other age groups.

Pregnancy

Studies on effects in pregnancy have not been done in either humans or animals.

Breast Feeding

Although it is not known whether citrates pass into the breast milk, this medicine has not been reported to cause problems in nursing babies.

Interactions with Medicines

Interactions with Food/Tobacco/Alcohol

Proper Use of citrate

This section provides information on the proper use of a number of products that contain citrate. It may not be specific to Urocit-K 15. Please read with care.

For patients taking the tablet form of this medicine:

Swallow the tablets whole. Do not crush, chew, or suck the tablet.

Take with a full glass (8 ounces) of water.

If you have trouble swallowing the tablets or they seem to stick in your throat, check with your doctor at once. If this medicine is not completely swallowed and not properly dissolved, it can cause severe irritation.

For patients taking the liquid form of this medicine:

Dilute with a full glass (6 ounces) of water or juice and drink; follow with additional water, if desired.

Chill, but do not freeze, this medicine before taking it, for a better taste.

For patients taking the crystals form of this medicine:

Add the contents of one packet to at least 6 ounces of cool water or juice.

Stir well to make sure the crystals are completely dissolved.

Drink all the mixture to be sure you are taking the correct dose. Follow with additional water or juice, if desired.

Take each dose immediately after a meal or within 30 minutes after a meal or bedtime snack. This helps prevent the medicine from causing stomach pain or a laxative effect.

Drink at least a full glass (8 ounces) of water or other liquid (except milk) every hour during the day (about 3 quarts a day), unless otherwise directed by your doctor. This will increase the flow of urine and help prevent kidney stones.

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. This is especially important if you are also taking a diuretic (water pill) or digitalis medicine for your heart.

Dosing

For potassium citrate

For oral dosage form (tablets):
- To make the urine more alkaline (less acidic) and to prevent kidney stones:
  - Adults—At first, 1.08 to 2.16 grams three times a day with meals. Some people may take 1.62 grams four times a day with meals or within thirty minutes after a meal or bedtime snack. Your doctor may change your dose if needed. However, most people usually will not take more than 10.8 grams a day.
  - Children—Dose must be determined by your doctor.

For potassium citrate and citric acid

For oral dosage form (solution):
- To make the urine or blood more alkaline (less acidic) and to prevent kidney stones:
  - Adults—At first, 2 to 3 teaspoonfuls of solution, mixed with water or juice, four times a day, after meals and at bedtime. Your doctor may change the dose if needed.
  - Children—Dose must be determined by your doctor.
- To make the urine more alkaline (less acidic):
  - Children—At first, 1 to 3 teaspoonfuls of solution, mixed with water or juice, four times a day after meals and at bedtime. Your doctor may change the dose if needed.

For oral dosage form (crystals for solution):
- To make the urine or blood more alkaline (less acidic) and to prevent kidney stones:
  - Adults—At first, 3.3 grams of potassium citrate, mixed with water or juice, four times a day, after meals and at bedtime. Your doctor may change the dose if needed.
  - Children—Use is not recommended.

For potassium citrate and sodium citrate

For oral dosage form (tablets):
- To make the urine more alkaline (less acidic) and to prevent kidney stones:
  - Adults—At first, 1 to 4 tablets after meals and at bedtime.
  - Children—Dose must be determined by your doctor.

For sodium citrate and citric acid

For oral dosage form (solution):
- To make the urine and blood more alkaline (less acidic) and to prevent kidney stones:
  - Adults—At first, 2 to 6 teaspoonfuls of solution four times a day, after meals and at bedtime. The solution should be mixed in one to three ounces of water. Your doctor may change the dose if needed. However, most people will usually not take more than five ounces a day.
- To make the blood more alkaline (less acidic):
  - Adults—1 to 2 tablespoonfuls as a single dose. You may mix it in one to two tablespoonfuls of water.
- To make the contents of the stomach less acidic before surgery:
  - Children—At first, 1 to 3 teaspoonfuls of solution four times a day, after meals and at bedtime. The solution should be mixed in one to three ounces of water. Your doctor may change the dose if needed.

For tricitrates

For oral dosage form (solution):
- To make the urine and blood more alkaline (less acidic) and to prevent kidney stones:
  - Adults—At first, 1 to 2 tablespoonfuls of solution four times a day, after meals and at bedtime. Your doctor may change the dose if needed.
- To make the contents of the stomach less acidic before surgery:
  - Adults—1 tablespoonful as a single dose. You should mix the solution in one tablespoonful of water.
- To make the urine or blood more alkaline (less acidic):
  - Children—At first, 5 to 10 mL four times a day after meals and at bedtime. Your doctor may change the dose if needed.

Missed Dose

Storage

Keep out of the reach of children.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Urocit-K 15

It is important that your doctor check your progress at regular visits. This is to make sure the medicine is working properly and to check for unwanted effects.

Do not eat salty foods or use extra table salt on your food while you are taking citrates. This will help prevent kidney stones and unwanted effects.

Check with your doctor before starting any strenuous physical exercise, especially if you are out of condition and are taking any other medication. Exercise and certain medications may increase the amount of potassium in the blood.

For patients taking potassium citrate–containing medicines:

Do not use salt substitutes and low-salt milk unless told to do so by your doctor. They may contain potassium.

Check with your doctor at once if you are taking the tablet form and notice black, tarry stools or other signs of stomach or intestinal bleeding.

Do not be alarmed if you notice what appears to be a whole tablet in the stool after taking potassium citrate tablets. Your body has received the proper amount of medicine from the tablet and has expelled the tablet shell. However, it is a good idea to check with your doctor also.

If you are on a potassium-rich or potassium-restricted diet, check with your health care professional. Potassium citrate–containing medicines contain a large amount of potassium.

For patients taking sodium citrate–containing medicines:

If you are on a sodium-restricted diet, check with your health care professional. Sodium citrate–containing medicines contain a large amount of sodium.

Urocit-K 15 Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Stop taking this medicine and get emergency help immediately if any of the following effects occur:

Rare

Abdominal or stomach pain or cramping (severe)

black, tarry stools

vomiting (severe), sometimes with blood

Check with your doctor as soon as possible if any of the following side effects occur:

Confusion

convulsions (seizures)

dizziness

high blood pressure

irregular or fast heartbeat

irritability

mood or mental changes

muscle pain or twitching

nervousness or restlessness

numbness or tingling in hands, feet, or lips

shortness of breath, difficult breathing, or slow breathing

swelling of feet or lower legs

unexplained anxiety

unpleasant taste

unusual tiredness or weakness

weakness or heaviness of legs

Less common

Abdominal or stomach soreness or pain (mild)

diarrhea or loose bowel movements

nausea or vomiting

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Thursday, May 31, 2012

Commonly used brand name(s)

Uses For Cyclomydril

Before Using Cyclomydril

Allergies

Pediatric

Geriatric

Pregnancy

Breast Feeding

Interactions with Medicines

Interactions with Food/Tobacco/Alcohol

Other Medical Problems

Proper Use of atropine, homatropine, and scopolamine

Dosing

Missed Dose

Storage

Precautions While Using Cyclomydril

Cyclomydril Side Effects

Wednesday, May 30, 2012

1. Name Of The Medicinal Product

2. Qualitative And Quantitative Composition

3. Pharmaceutical Form

4. Clinical Particulars

4.1 Therapeutic Indications

4.2 Posology And Method Of Administration

4.3 Contraindications

4.4 Special Warnings And Precautions For Use

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

4.6 Pregnancy And Lactation

4.7 Effects On Ability To Drive And Use Machines

4.8 Undesirable Effects

4.9 Overdose

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

5.2 Pharmacokinetic Properties

5.3 Preclinical Safety Data

6. Pharmaceutical Particulars

6.1 List Of Excipients

6.2 Incompatibilities

6.3 Shelf Life

6.4 Special Precautions For Storage

6.5 Nature And Contents Of Container

6.6 Special Precautions For Disposal And Other Handling

7. Marketing Authorisation Holder

8. Marketing Authorisation Number(S)

9. Date Of First Authorisation/Renewal Of The Authorisation

10. Date Of Revision Of The Text

What is Prohist CF (chlophedianol and triprolidine)?

What is the most important information I should know about Prohist CF (chlophedianol and triprolidine)?

What should I discuss with my healthcare provider before taking Prohist CF (chlophedianol and triprolidine)?

How should I take Prohist CF (chlophedianol and triprolidine)?

What happens if I miss a dose?

What happens if I overdose?

What should I avoid while taking Prohist CF (chlophedianol and triprolidine)?

Prohist CF (chlophedianol and triprolidine) side effects

What other drugs will affect Prohist CF (chlophedianol and triprolidine)?

More Prohist CF resources

Where can I get more information?

Read all of this leaflet carefully before you take this medicine.

In this leaflet:

What Flecainide acetate tablets are for

Before you take Flecainide acetate tablets

Do not take Flecainide acetate tablets if:

Before you take Flecainide acetate tablets your doctor or nurse may check:

Check with your doctor or nurse before taking Flecainide acetate tablets if:

Tell your doctor or nurse if you are taking any of the following medicines:

Pregnancy and breast-feeding

How to take Flecainide acetate tablets

Important:

Adults:

Children:

If you take more Flecainide acetate tablets than you should

If you forget to take Flecainide acetate tablets

If you stop taking Flecainide acetate tablets

Flecainide Acetate Side Effects

Seek immediate medical help if you have any of the following symptoms:

Other side effects:

How to store Flecainide acetate tablets

Further information

What Flecainide acetate tablets contain