FLECAINIDE ACETATE 100 MG TABLETS - patient leaflet, side effects, dosage

What Flecainide is and what it is used for

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

Flecainide 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.

2

What you need to know before you take Flecainide

Do not take Flecainide:

! if you are allergic to flecainide acetate or any of the other ingredients of Flecainide Tablets (see Section 6)

! if you have heart failure

! if you have cardiogenic shock (your heart is unable to pump as much blood as your body needs)

!if you have heart block (your heart misses beats)

! if you have long-standing atrial fibrillation (rapid contractions of muscles in the heart)

! if you have or have ever had any heart problems including problems with the valves in your heart or conduction problems

! if you have sinus node dysfunction (a specific condition where your heart beats abnormally)

! if you have had a myocardial infarction (heart attack)

! if you have Brugada Syndrome, a genetic disease that causes severe disturbances of the rhythm of the heart and may lead to sudden death in apparently healthy individuals.

! if you are pregnant or breast-feeding.

Flecainide Tablets are not recommended for use in children under 12 years of age, however, dairy products such as milk, infant formula and possibly yoghurt, may reduce how much flecainide acetate is absorbed in children and infants. If any of the above applies to you tell your doctor or nurse.

Before you take Flecainide your doctor or nurse may check:

! your fluid levels are correct

! your liver and kidney functions.

This is to check that Flecainide Tablets are right for you and to help the doctor calculate the dose you need.

Check with your doctor or nurse before taking Flecainide if:

! you have high blood pressure

!you have angina (chest pains)

How to take Flecainide

Always take Flecainide Tablets exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Important:

Your doctor will choose the dose that is right for your condition. Usually your treatment with Flecainide will be started in hospital. If you have switched from a different formulation (e.g. from an injection of Flecainide) your doctor should do so with caution and monitor you closely.

Adults:

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

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

! Flecainide100mg 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 × 100 mg tablets or 6 × 50 mg tablets).

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

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

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

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

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Some side effects could be serious. If you have any of the side effects listed below, seek immediate medical help:

Common (affects 1in 100 people):

! 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 have a fever, become flushed or sweat

! you faint or you feel faint

Rare (affects1 in 10,000 people):

! you have ringing in your ears

! your skin and eyes begin to go yellow (jaundice)

! you have fits (convulsions).

Other side effects (how often they happen is unknown):

!heart attack

! cardiac failure/arrest (loss of breathing, and consciousness and loss of heart function)

Other side effects include the following, if they get serious, please tell your doctor:

Very common (affects more than 1 in 10 people):

! dizziness

! double or blurred vision

Common (affects 1in 100 people):

! feeling weak or tired

! lack of energy and strength

! swelling (fluid retention)

Uncommon (affects 1in 1,000 people):

! blood disorders (reduced red and white blood cell count and reduced platelet count)

! feeling or being sick

! constipation

! stomach pain or indigestion

! loss of appetite

! diarrhoea

! wind

! feeling bloated

!red, itchy or swollen skin rash

!hair loss

Rare (affects 1 in 10,000 people):

! vertigo (feeling like the room is spinning)

! confusion and hallucinations

! depression

! feeling anxious (worried)

! forgetfulness

! difficulty sleeping

!numbness, tingling, tickling, prickling or burning sensation of the skin

! unsteady walking, uncontrolled movements or poor coordination, difficulty speaking

! reduced sense of touch

! excessive sweating and flushed skin

! shaking (tremors)

! a strong desire to sleep or sleep for long periods

! headache

Very rare (affects less than 1in 10,000 people):

! small cloudy spots on the eyeball

! sensitivity of the skin to sunlight

Other side-effects (how often they happen is unknown):

! lung disease and scarring of the lungs

! liver disease

How to store Flecainide

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date, which is stated on the carton after EXP. The expiry date referes to the last day of that month.

This medicinal product does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

3 Contents of the pack and other information

What Flecainide Tablets contain

– The active substance 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 microcrystalline cellulose (pH 101 and pH 102), croscarmellose sodium and magnesium stearate.

What Flecainide looks like and contents of the pack

The 50 mg tablets are white to off white, round, biconvex tablets, approximately 6.5 mm in diameter, debossed with „HP“ on one side and „183“ on the other side.

The 100 mg tablets are white to off white, round, biconvex tablets, approximately 8.5 mm in diameter, debossed with break line separating ‚H‘ and ‚P‘ on one side and „184“ on the other side. The tablet can be divided into equal doses.

The 50 mg tablets are available in blister packs of 20, 30, 50, 60 and 100 tablets.

The 100 mg tablets are available in blister packs of 20, 50, 60 and 100 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Tillomed Laboratories Limited

220 Butterfield

Great Marlings

Luton, LU2 8DL

United Kingdom

This medicinal product is authorised in the Member States of the EEA under the following names:

United Kingdom Flecainide acetate 50 mg and 100 mg Tablets

Germany Flecainid Tillomed 50 mg and

100 mg tabletten

Italy Flecainide EG