PACKAGE LEAFLET: INFORMATION FOR THE USER

Flecainide Acetate 50 mg tablets Flecainide Acetate 100 mg tablets

Flecainide acetate

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 Flecainide Acetate is and what it is used for

2.    Before you take Flecainide Acetate

3.    How to take Flecainide Acetate

4.    Possible side effects

5.    How to store Flecainide Acetate

6.    Further information

1. WHAT FLECAINIDE ACETATE IS AND WHAT IT IS USED

Flecainide belongs to the group of medicines that work against cardiac arrhythmia (known as anti-arrhythmics). It inhibits stimulus conduction in the heart and extends the time during which the heart is at rest, causing the heart to pump normally again.

Flecainide Acetate is used

for certain serious cardiac arrhythmias, which are often expressed as serious palpitations of the heart or tachycardia, for serious cardiac arrhythmias that did not respond well to treatment with other medicines, or when other treatments cannot be tolerated.

2. BEFORE YOU TAKE FLECAINIDE ACETATE

Do not take Flecainide Acetate

•    if you are allergic (hypersensitive) to flecainide or any of the other ingredients of Flecainide Acetate (see Section 6: Further Information).

•    If you suffer from another heart condition, different from the heart condition for which you are taking this medicine. If you are unsure, or if you would like additional information, consult your doctor or pharmacist.

•    you are taking certain other antiarrhythmics (sodium channel blockers) as well;

•    If you know that you have a genetic disease [Brugada syndrome] characterized by abnormal electrocardiogram (ECG)

Take special care with Flecainide Acetate

•    if you suffer from a reduced liver function and/or reduced kidney function, since the concentration of flecainide in the blood may increase. In that event, your doctor may regularly have the concentration of flecainide in the blood checked,

•    if you have a permanent pacemaker or temporary pacing electrodes,

•    if you have suffered from cardiac arrhythmias after heart surgery.

•    If you have experienced a heart attack.

•    if you suffer from severe bradycardia or pronounced hypotension. These conditions should be corrected before using Flecainide Acetate,

A lowered or elevated level of potassium in the blood may influence the effect of flecainide. Diuretics, medicines that stimulate bowel movement (laxatives) and adrenal cortex hormones (corticosteroids) may lower the level of potassium in the blood. In that event, your doctor may have the amount of potassium in your blood checked.

Taking other medicines

If you use certain other medicines along with flecainide, the medicines can sometimes affect the way each other work and/or their side effects (i.e. there may be interactions).

Interactions may occur when using this medicine with for example:

•    sodium channel blockers (class I anti arrhythmics), such as disopyramide and quinidine: see section “Do not use Flecainide Acetate",

•    beta blockers (medicines that reduce the heart’s pumping function),

•    amiodarone (for heart conditions); the dose of Flecainide Acetate must be reduced for some patients,

•    calcium channel blockers, such as verapamil (lower the blood pressure),

•    diuretics, laxatives (medicines that stimulate bowel movement) and adrenal cortex hormones (corticosteroids): your doctor may have the amount of potassium in your blood checked.

•    mizolastine and terfenadine (medicines against allergies),

•    ritonavir, lopinavar and indinavir (medicines to treat HIV-infections),

•    fluoxetine and certain other antidepressants named “tricyclic antidepressants”,

•    phenytoin, phenobarbital and carbamazepine (medicines against epilepsy): the breakdown of flecainide may be accelerated by these substances,

•    clozapine (to treat psychotic disorders),

•    quinine (medicine against malaria),

•    terbinafine (to treat fungal infections),

•    cimetidine (an antacid); this may increase the effect of Flecainide Acetate,

•    bupropion (anti-smoking medicine),

•    digoxin (a medicine to stimulate the heart); Flecainide Acetate may raise the level of digoxin in your blood

Inform your doctor or your pharmacist if you are using (or have recently used) other medicines. This also applies for other medicines that are available without prescription, herbal medication, or natural products.

Taking Flecainide Acetate with food and drink

Flecainide should be taken on an empty stomach or at least one hour before a meal.

Pregnancy and breast-feeding

During pregnancy flecainide should not be used unless clearly necessary since flecainide has been shown to cross the placenta in patients taking flecainide during pregnancy. If flecainide is used during pregnancy maternal flecainide plasma levels should be monitored. You must consult your doctor as soon as you suspect you are pregnant, or if you want to have children. Flecainide is secreted in the mothers milk. Nursing mothers should not breastfeed whilst taking flecainide

Ask your doctor or your pharmacist for advice before taking medicines.

Driving and using machines

If you suffer from side effects such as dizziness, double vision or blurred vision, or if you feel light in the head, then your ability to react may be reduced. This may be dangerous in situations that demand concentration and attentiveness, such as using the road, handling dangerous machinery or working at heights. If you are unsure whether flecainide is having a negative effect on your ability to drive, discuss this with your doctor.

3. HOW TO TAKE FLECAINIDE ACETATE

Always take Flecainide Acetate exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Posology

Your doctor will prescribe a personalised dose, adjusted to fit your complaints. Treatment with flecainide will normally be started under medical supervision (if necessary, in the hospital). Follow your doctor's advice closely when taking flecainide. You should check with your doctor or pharmacist if you are unsure.

When and how should the tablets be taken?

Take the tablets by swallowing them with sufficient fluid (e.g. water). The daily dose is usually taken split up over the day, on an empty stomach, or at least one hour before meals.

The general dose is just a guideline and is as follows:

the usual starting dose lies between 50 and 200 mg. The dose may

be increased by your doctor to a maximum of 400 mg a day.

More elderly patients

Your doctor may prescribe a lower dose for you. The dose for elderly patients should not exceed 300mg daily (or 150mg twice daily).

Children

These tablets should not be taken by children under the age of 12 years.

Patients with a reduced kidney or liver function Your doctor may prescribe a lower dose for you.

Patients with a permanent pacemaker

The daily dose must not exceed 100mg twice a day.

Patients who are simultaneously being treated with cimetidine (medicine against gastric disorders) or amiodarone (medicine against cardiac arrhythmia)

The doctor will check you regularly, and a lower dose will be prescribed for some patients.

During treatment, your doctor will regularly determine the level of flecainide in the blood and what is known as an electrocardiogram (ECG) of the heart will be taken. A simple ECG must be taken once a month and a more extensive ECG once every three months. An ECG will be taken every 2 to 4 days at the start of the treatment and when the dose is raised.

An ECG must be taken more frequently for patients who are receiving a smaller dose than is usually prescribed. The doctor can adjust the doses at intervals of 6 to 8 days. An ECG will be taken for these patients at weeks 2 and 3 after the start of the treatment.

If you take more Flecainide Acetate than you should

If you take more flecainide than you should, tell a doctor or go to a hospital casualty department straight away.

If you forget to take Flecainide Acetate

Take the dose when you discover that you have forgotten to take it, unless you only discover this when it is almost time to take your next dose. In the latter case, you must not take the dose that you forgot as an addition but should continue to follow your schedule. It is important to take the tablets according to the schedule. Consult your doctor if you have any doubts.

Do not take a double dose to make up for a forgotten tablet.

If you stop taking Flecainide Acetate

If you suddenly stop taking flecainide you will not get withdrawal symptoms. However, the cardiac arrhythmia will no longer be being controlled as intended. So never stop using it without your doctor knowing.

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

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.

5. HOW TO STORE FLECAINIDE ACETATE

Keep out of the reach and sight of children

Do not use Flecainide Acetate after the expiry date which is stated on the carton after EXP. 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.

4. POSSIBLE SIDE EFFECTS

6. FURTHER INFORMATION

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

Very common (more than 1 in 10 patients):

•    dizziness

•    visual disturbances, such as double vision, blurred vision and difficulty focusing

Common (more than 1 in 100 patients, but fewer than 1 in 10):

•    more frequent occurrence of pre-existing arrhythmia (irregular heartbeat)

•    shortness of breath

•    weakness

•    fatigue

•    fever

•    fluid in the tissues (edema)

Uncommon (more than 1 in 1000 patients but less than 1 in 100):

•    decrease in red and white blood cells and platelets

•    irregular heart beat with increased heartbeat

•    nausea

•    vomiting

•    constipation

•    abdominal pain

•    decreased appetite

•    diarrhea

•    flatulence

•    pain in upper abdomen, fullness (dyspepsia)

•    allergic skin reactions such as rashes, hives and baldness

Rare (more than 1 in 10,000 but less than 1 in 1000):

•    seeing things that are not there (hallucinations)

•    depression

•    confusion

•    anxiety

•    memory loss (amnesia)

•    insomnia

•    tingling or numbness

•    difficulty in controlling movements (ataxia)

•    decrease of sensitivity

•    increased sweating

•    fainting (syncope)

•    tremor

•    flushing

•    sleepiness

•    headache

•    nervous disorders e.g. in the arms and legs

•    convulsions

•    movement disorder (dyskinesia)

•    ringing in the ears

•    spinning sensation (vertigo)

•    lung inflammation (pneumonia)

•    elevated liver enzymes reversible on stopping treatment

•    yellowing of the skin or whites of the eyes caused by liver or blood problems Qaundice)

•    hives (urticaria)

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

•    elevated levels of certain antibodies

•    small cloudy spots on the eyeball

•    sensitivity to sunlight

Not known (cannot be estimated from the available data) Changes in electrocardiogram (ECG) increase in pacing threshold in patients with pacemakers or temporary pacing electrodes, impairment of the conduction between the atria and ventricles of the heart (second or third degree atrioventricular block), stopped heart beat, slower or faster heart beat, loss of the heart’s ability to pump enough blood to the body's tissues, chest pain, low blood pressure, heart attack, feeling your heart beat, a pause in the normal cardiac rhythm (sinus arrest), appearance of a certain preexisting heart disease (Brugada syndrome) which was not seen before the treatment with [Nationally completed name], scarring of the lungs or lung disease (named interstitial lung disease which causes breathlessness), liver disorder

What Flecainide Acetate contains

The active substance is flecainide acetate. Each tablet contains 50 mg or 100 mg of flecainide acetate.

The other ingredients are cellulose, microcrystalline, croscarmellose sodium, pregelatinized starch, hydrogenated vegetable oil, magnesium stearate.

What Flecainide Acetate looks like and contents of the pack

Tablets

Flecainide Acetate 50ma tablets:

White to off-white, round, biconvex tablets embossed with ‘CC’ on one side and ‘11 ’ on the other side.

Flecainide Acetate 100ma tablets:

White to off-white, round, biconvex, scored tablets debossed with ‘T and ‘2’ separated by deep score line on one side and ‘CC’ on the other side. The tablet can be divided into equal halves.

Flecainide Acetate tablets are available in Clear PVC/PVdC -Aluminium foil blister pack and HDPE bottle pack with polypropylene closure.

Blister: 20, 28, 30, 40, 50, 56, 60, 84, 90 and 100 tablets HDPE: 20, 1000 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder

UK_ Milpharm Limited Ares Block

Odyssey Business Park West End Road Ruislip HA4 6QD United Kingdom

MT_ Aurobindo Pharma (Malta) Limited Vault 14, Level 2, Valletta Waterfront Floriana FRN 1913 Malta

Manufacturer

APL Swift Services (Malta) Limited HF26, Hal Far Industrial Estate, Hal Far Birzebbugia, BBG 3000 Malta

or

Milpharm Limited Ares Block

Odyssey Business Park West End Road Ruislip HA4 6QD United Kingdom

This leaflet was last approved in 09/2012.