PATIENT INFORMATION LEAFLET

Flecainide Acetate 50mg & 100mg Tablet

Please read this leaflet carefully before you start to take your medicine.

It gives you important information about your medicine.

If you want to know more, or you are not sure about anything, ask your pharmacist or doctor.

Keep the leaflet until you have finished the medicine.

About your medicine

Flecainide acetate is one of a group of medicines called antiarrhythmics. These medicines work by regulating the rate and rhythm of the heart.

Flecainide Acetate Tablets may be used for treating:

• Irregular beats of the upper heart chambers
• Irregular beats of the lower heart chambers.

BEFORE TAKING YOUR MEDICINE

Do not take Flecainide Acetate Tablets if you:

• have ever had an allergic reaction to Flecainide Acetate or any of the ingredients in the tablet. An allergic reaction may include a rash, itching, difficulty breathing or swelling of the face, lips, throat or tongue
• suffer from or have had heart failure
• have had a heart attack (myocardial infarction)
• suffer from heart block (missed heart beats)
• suffer from a slow heart beat
• have a heart that has difficulty pumping blood
• rapid and irregular heart beat (atrial fibrillation)
• suffer from very low blood pressure (feeling faint on standing)
• are taking disopyramide for regulating heart beats.

Check with your doctor or pharmacist before taking Flecainide Acetate Tablets if you:

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

Check with your doctor or pharmacist if you are taking any of the following:

• sodium channel blockers (e.g. lidocaine)
• calcium channel blockers (e.g. verapamil)
• corticosteroids (e.g. betamethasone, hydrocortisone or prednisolone)
• medicines to treat heart disease (e.g. digoxin)
• antidepressants (e.g. fluoxetine, and tricyclic antidepressants)
• antishistamines (e.g. astemizole and terfenadine)
• beta blockers (e.g. propranolol)
• antimalarials (e.g. quinine and halfantrine)
• medicines to treat epileptic attacks (e.g. carbamazapine, phenobarbital and phenytoin
• diuretics
• ulcer healing medicines (e.g. cimetidine)
• other antiarrhythmic drugs (e.g. amiodarone, disopyramide and quinidine)
• laxatives
• any medicines you can buy without a prescription.

Taking your medicine

Follow your doctor's instructions. Check the pharmacy label to see how many tablets to take and how often to take them. If you are still unsure ask your pharmacist or doctor.

After taking your medicine

Like all medicines, Flecainide Acetate Tablets can sometimes cause unwanted side effects.

If the following happens, stop taking Flecainide Acetate Tablets and tell your doctor immediately or contact the casualty department at your nearest hospital:

• An allergic reaction: skin rash, swelling of the face, lips, tongue or throat, or difficulty breathing or swallowing.

This is a very serious but rare side effect. You may need urgent medical attention or hospitalisation.

Known side effects are:

• Effects on the blood: changes in the number and types of blood cells can occur but are uncommon.
• Effects on the immune system: Flecainide Acetate may affect your immune system which may be associated with swelling (inflammation).
• Effects on mental health: seeing things which are not there (hallucinations), depression, confusion, memory loss, nervousness and anxiety have been reported.
• Effects on the central nervous system: dizziness, giddiness, light headedness and headache are very common but usually short-lived. Disturbances of movement and convulsions have been reported rarely. During long term treatment reports of numbness or tingling to hands or feet and problems of co-ordination have occurred rarely.
• Effects on the eyes: double vision and blurred vision are very common and usually temporary in nature.
• Effects on the heart: if you notice any signs of your heart condition getting worse or you develop new heart symptoms please tell your doctor. A change in heart beat pattern has also been reported, commonly in patients with existing heart problems.
• Effects on the lungs: difficulty breathing is uncommon. Lung disease (pneumonitis) is very rare.
• Effects on the stomach: feeling and/or being sick are uncommon. A dry mouth and impairment of taste are very rare.
• Effects on the liver: jaundice (yellow skin and/or whites of the eyes) is rare.
• Effects on the skin: sensitivity of the skin to light, allergic skin reactions (which may be itchy), flushing and increased sweating have occurred.
• Effects on muscles and bones: joint and muscle pain are very rare.
• Effects on the reproductive system: impotence is very rare.

Tell your doctor if you notice or are worried by any of the side effects listed or notice any other effects not listed.

STORING YOUR MEDICINE

• Do not use the tablets after the end of the expiry month shown on the product packaging.
• Do not store the tablets above 25°C.
• Store them in the original packaging.
• Keep flecainide acetate tablets out of the reach and sight of children in a secure place.
• Remember that this medicine is for you only. NeveR give it to anyone else. It may harm them, even if their symptoms are the same as yours.
• Return all unused medicines to your pharmacist for safe disposal.