Flecainide Acetate Tablets 50mg, 100mg  (Actavis UK Ltd)


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Flecainide Acetate Tablets 50mg, 100mg (Actavis UK Ltd)


Flecainide Acetate 50mg and 100mg tablets

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. Index 1 What Flecainide Acetate tablets are and what they are used for 2 Before you take 3 How to take 4 Possible side effects 5 How to store 6 Further information What Flecainide Acetate tablets are and what they are used for

Flecainide Acetate tablets belong to a group of medicines called anti-arrhythmics. They work by regulating the heart rate.

Flecainide Acetate tablets may be used to treat the following conditions when other drugs are not effective: irregular beats of the upper heart chambers (atria) including Wolff-Parkinson-White Syndrome irregular beats of the lower heart chambers (ventricles). Before you take

Do not take Flecainide Acetate tablets and tell your doctor if you:

are allergic (hypersensitive) to flecainide acetate or any of the other ingredients (see section 6) suffer from conduction problems of the heart, such as a slow or fast heart beat or heart block suffer from heart failure have severely low blood pressure have had a heart attack (myocardial infarction) are in shock due to heart problems (cardiogenic shock) have rapid and irregular heart beat (atrial fibrillation) are taking disopyramide (medicine to treat irregular heart rhythms).

Take special care with Flecainide Acetate tablets and tell your doctor if you:

suffer from low or high levels of potassium in the blood have liver or kidney disease have a pacemaker have any heart disease or an enlarged heart have rapid or irregular heart beats after heart surgery have been told you have disturbances in heart rhythm known as sick sinus syndrome. Taking other medicines

Before taking Flecainide Acetate tablets, tell your doctor if you are taking or have recently taken the following medicines, or are taking any non-prescribed medicines:

verapamil or beta blockers (e.g. propranolol to treat heart diseases) laxatives (to treat constipation) diuretics (‘water tablets’) steroids (e.g. betamethasone, hydrocortisone or prednisolone) sodium channel blockers (e.g. lidocaine to treat irregular heartbeat (arrhythmia) or as a local anaesthetic) phenytoin, phenobarbital or carbamazepine (to treat epilepsy) digoxin (to treat heart conditions) amiodarone, quinidine or disopyramide (to treat irregular heart rhythms) cimetidine (to treat stomach ulcers) fluoxetine or tricyclic antidepressants (e.g. amitriptyline to treat depression) terfenadine or astemizole (to treat allergic reactions) quinine or halfantrine (to treat or prevent malaria) Pregnancy and breast-feeding

Your doctor will only prescribe Flecainide Acetate tablets if it is absolutely necessary. Breast feeding is not recommended whilst taking Flecainide Acetate tablets. Check with your doctor if you are unsure.

Driving and using machines

Flecainide Acetate tablets may cause dizziness or affect your vision. Make sure you are not affected before you drive or operate machinery.


Your doctor will monitor your progress on a regular basis with ECG (electrocardiogram) and blood tests, and may alter the dose if necessary.

If you see another doctor or go into hospital, let them know what medicines you are taking.

How to take

Always take Flecainide Acetate tablets exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist. Treament may be started in hospital.

Swallow these tablets whole with water on an empty stomach or one hour before food.

Doses: Adults and adolescents (13-17 years of age) treatment of irregular beats of the upper heart chambers (atria) : starting dose is 50mg twice a day up to a maximum dose of 300mg per day. treatment of irregular heart beats of the lower heart chambers (ventricular) : starting dose is 100mg twice a day up to a maximum dose of 400mg per day. Children under 12 years of age - not recommended Elderly patients or those fitted with pacemakers, with kidney or liver problems or taking amiodarone or cimetidine - a lower dose of flecainide may be given. If you take more Flecainide Acetate tablets than you should

If you have accidentally taken more than the prescribed dose, contact your nearest casualty department or tell your doctor or pharmacist at once.

If you forget to take Flecainide Acetate tablets

If you forget to take a dose take it as soon as you remember, unless it is nearly time to take the next dose. Then go on as before. Never double up on the next dose to make up for the one missed.

If you stop taking the tablets

Talk to your doctor before you stop taking the tablets and follow their advice.

Possible side effects

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

Stop taking Flecainide Acetate tablets and contact your doctor at once if the following allergic reaction happens: skin rash, swelling of the face, lips, tongue or throat, or difficulty breathing or swallowing.

Tell your doctor if you notice any of the following side effects or notice any other effects not listed:

Very common (occurs in more than 1 in 10 users): dizziness, giddiness, light headedness, headache, double or blurred vision

Common (occurs in less than 1 in 10 users): signs of your heart condition getting worse or development of new heart symptoms, a change in heart beat pattern (especially in patients with existing heart problems)

Uncommon (occurs in less than 1 in 100 users): changes in the numbers and types of your blood cells, difficulty breathing, feeling or being sick

Rare (occurs in less than 1 in 1,000 users): affects on your immune system which may be associated with inflammation, hallucinations, depression, confusion, memory loss, nervousness, anxiety, disturbances of movement, convulsions, ‘pins and needles’ or numbness, problems with co-ordination, raised liver enzyme levels or jaundice (yellow skin and/or whites of the eyes)

Very rare (occurs in less than 1 in 10,000 users): particles in the front of the eye (corneal deposits), lung disease (pneumonitis), sensitivity of the skin to light, flushing or increased sweating, allergic skin reactions (which may be itchy), dry mouth, impairment of taste, joint and muscle pain, impotence.

If you notice any side effects, they get worse, or if you notice any not listed, please tell your doctor or pharmacist.

How to store

Keep out of the reach and sight of children.

Do not store the tablets above 25°C and store in the original packaging.

Do not use Flecainide Acetate tablets after the expiry date stated on the label/carton/bottle. The expiry date refers to the last day of that month.

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 Flecainide Acetate tablets contain The active substance (the ingredient that makes the tablets work) is flecainide acetate. Each tablets contains either 50mg or 100mg of the active ingredient. The other ingredients are croscarmellose sodium, magnesium stearate, maize starch, pregelatinised maize starch, microcrystalline cellulose (E460). What Flecainide Acetate tablets look like and contents of the pack

Flecainide Acetate tablets are white, uncoated tablets.

Pack sizes are 60 tablets

Marketing Authorisation Holder and Manufacturer Actavis Barnstaple EX32 8NS UK

Date of last revision: July 2008.

If you would like a leaflet with larger text, please contact 01271 311257.

Actavis Barnstaple EX32 8NS UK


Flecainide Acetate Tablets 50mg 100mg Actavis UK Ltd

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