Flecainide Acetate 50 mg tablets

• 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Flecainide Acetate is and what it is used for
2. What you need to know before you take Flecainide Acetate
3. How to take Flecainide Acetate
4. Possible side effects
5. How to store Flecainide Acetate
6. Contents of the pack and other information

• if you are allergic to flecainide or any of the other ingredients of this medicine (listed in section 6).
• 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)

• Talk to your doctor or pharmacist before taking 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,

The rate of flecainide elimination from plasma may be reduced in the elderly. This should be taken into consideration when making dose adjustments.

Treatment with oral flecainide should be under direct hospital or specialist supervision for patients with:

• Certain rapid cardiac arrhythmias (AV reciprocation tachycardia); Cardiac arrhythmias associated with WPW syndrome (Wolff-Parkinson-White syndrome) and other disorders of conduction pathways.
• Occasionally occurring irregular heartbeat (Paroxysmal fibrillation) with disabling symptoms.

Treatment for patients with other indications should continue to be initiated in hospital.

A lowered or elevated level of potassium in the blood may influence the effect of flecainide.

Electrolyte disturbances (e.g. hypo- and hyperkalaemia) should be corrected before using 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.

Flecainide Acetate tablets are not recommended for use in children under 12 years of age, however flecainide toxicity has been reported during treatment with flecainide in children who reduced their intake of milk, and in infants who were switched from milk formula to dextrose feedings

Tell your doctor or pharmacist if you are taking, have recently taken or might take any 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).

There may be life threatening or even fatal side effects caused by increased concentration of the drug in the blood due to interactions (see section 4 “Possible side effects”)

Consult a doctor or go to a hospital casualty department straight away.

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 such as propranolol (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.
• astemizole, mizolastine and terfenadine (medicines against allergies),
• ritonavir, lopinavar and indinavir (medicines to treat HIV-infections),
• fluoxetine, paroxetine, reboxetine 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, haloperidol and risperidol (to treat psychotic disorders),
• quinine, quinidine and halofantrine (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

Dairy products (milk, infant formula and possibly yoghurt) may reduce the absorption of flecainide in children and infants. Flecainide is not approved for use in children below the age of 12 years, however flecainide toxicity has been reported during treatment with flecainide in children who reduced their intake of milk, and in infants who were switched from milk formula to dextrose feedings

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

If Flecainide and activated charcoal (e.g. charcoal tablets) are given at the same time, this should only be done after consultation with the doctor, since the absorption of Flecainide from the intestine into the bloodstream and thus the effectiveness of Flecainide is affected.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

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 breast-feed whilst taking flecainide

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

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.

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

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 recommended 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).

Use in 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.

Switch over from IV administration to tablets Due to the near complete oral bioavailability of flecainide, switching from IV flecainide application to oral flecainide administration is possible without a new dose adjustment. As a rule, an interval of 8 to 12 hours should elapse between the completion of IV administration and the ingestion of the first tablet. Because flecainide has a narrow therapeutic spectrum, close follow up monitoring is required.

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

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 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 get any side effects, talk to your doctor or pharmacist or nurse . This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

• 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.

Tablets

Flecainide Acetate 50mg tablets:

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

Flecainide Acetate 100mg tablets:

White to off-white, round, biconvex, scored tablets debossed with ‘1’ and ‘2’ separated by deep score line on one side and ‘CC’ on the other side. The tablet can be divided into equal doses.

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: 20,500 and 1000 tablets.

Not all pack sizes may be marketed.

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