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Package leaflet: Interactions may occur when using this Information for the user medicine with for example: • channel blockers (class I anti Flecainide Acetate 50 mg arrhythmics), such as tablets and : see section “Do not use Flecainide Acetate 100 mg Flecainide Acetate “, • beta blockers such as tablets (medicines that reduce the heart’s pumping Flecainide acetate function), • (for heart conditions); the dose Read all of this leaflet carefully before of Flecainide Acetate must be reduced for you start taking this medicine because it some patients, contains important information for you. • blockers, such as - Keep this leaflet. You may need to read it (lower the blood pressure), again. • diuretics, laxatives (medicines that stimulate - If you have any further questions, ask your bowel movement) and adrenal cortex doctor or pharmacist. hormones (corticosteroids): your doctor may - This medicine has been prescribed for you have the amount of potassium in your blood only. Do not pass it on to others. It may checked. harm them, even if their signs of illness are • mizolastine and (medicines the same as yours. against allergies), - If you get any side effects, talk to your • , lopinavar and indinavir (medicines doctor or pharmacist. This includes any to treat HIV-infections), possible side effects not listed in this leaflet. • , and certain See section 4. other antidepressants named “tricyclic antidepressants”, What is in this leaflet • , phenobarbital and 1. What Flecainide Acetate is and what it is (medicines against used for epilepsy): the breakdown of flecainide may 2. What you need to know before you take be accelerated by these substances, Flecainide Acetate • (to treat psychotic disorders), 3. How to take Flecainide Acetate • quinine (medicine against malaria), 4. Possible side effects • terbinafine (to treat fungal infections), 5. How to store Flecainide Acetate • (an antacid); this may increase 6. Contents of the pack and other information the effect of Flecainide Acetate, • bupropion (anti-smoking medicine), 1. What Flecainide Acetate is and what it • (a medicine to stimulate the heart); is used for Flecainide Acetate may raise the level of Flecainide belongs to the group of medicines digoxin in your blood that work against cardiac (known as Flecainide Acetate with food and drink anti-arrhythmics). It inhibits stimulus conduction Dairy products (milk, infant formula and in the heart and extends the time during which possibly yoghurt) may reduce the absorption the heart is at rest, causing the heart to pump of flecainide in children and infants. Flecainide normally again. is not approved for use in children below the Flecainide Acetate is used age of 12 years, however flecainide toxicity has - for certain serious cardiac , been reported during treatment with flecainide which are often expressed as serious in children who reduced their intake of milk, and palpitations of the heart or . in infants who were switched from milk formula to dextrose feedings - for serious cardiac arrhythmias that did not respond well to treatment with other Flecainide should be taken on an empty medicines, or when other treatments cannot stomach or at least one hour before a meal. be tolerated. Pregnancy, breast-feeding and fertility 2. What you need to know before you take If you are pregnant or breast-feeding, think Flecainide Acetate you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice Do not take Flecainide Acetate before taking this medicine. • if you are allergic to flecainide or any of the During pregnancy flecainide should not be used other ingredients of this medicine (listed in unless clearly necessary since flecainide has section 6). been shown to cross the placenta in patients • If you suffer from another heart taking flecainide during pregnancy. If flecainide condition, different from the heart condition is used during pregnancy maternal flecainide for which you are taking this medicine. plasma levels should be monitored. You must If you are unsure, or if you would like consult your doctor as soon as you suspect you additional information, consult your doctor or are pregnant, or if you want to have children. pharmacist. Flecainide is secreted in the mothers milk. • you are taking certain other antiarrhythmics Nursing mothers should not breast-feed whilst ( blockers) as well; taking flecainide • If you know that you have a genetic disease Ask your doctor or your pharmacist for advice [] characterized by before taking medicines. abnormal electrocardiogram (ECG) Driving and using machines Warnings and precautions If you suffer from side effects such as dizziness, • Talk to your doctor or pharmacist before double vision or blurred vision, or if you feel taking Flecainide Acetate. light in the head, then your ability to react • if you suffer from a reduced liver function may be reduced. This may be dangerous in and/or reduced kidney function, since the situations that demand concentration and concentration of flecainide in the blood attentiveness, such as using the road, handling may increase. In that event, your doctor dangerous machinery or working at heights. If may regularly have the concentration of you are unsure whether flecainide is having a Flecainide in the blood checked, negative effect on your ability to drive, discuss • if you have a permanent pacemaker or this with your doctor. temporary pacing electrodes, Flecainide contains sodium • if you have suffered from cardiac This medicine contains less than 1 mmol arrhythmias after heart surgery. sodium (23 mg) per tablet, that is to say • If you have experienced a heart attack. essentially ‘sodium-free’. • if you suffer from severe bradycardia or pronounced hypotension. These conditions 3. How to take Flecainide Acetate should be corrected before using Flecainide Always take this medicine exactly as your Acetate, doctor has told you. Check with your doctor or A lowered or elevated level of potassium in the pharmacist if you are not sure. blood may influence the effect of flecainide. Diuretics, medicines that stimulate bowel Posology movement (laxatives) and adrenal cortex Your doctor will prescribe a personalised dose, hormones (corticosteroids) may lower the level adjusted to fit your complaints. Treatment with of potassium in the blood. In that event, your flecainide will normally be started under medical doctor may have the amount of potassium in supervision (if necessary, in the hospital). your blood checked. Follow your doctor’s advice closely when taking flecainide. You should check with your doctor or Children pharmacist if you are unsure. Flecainide Acetate tablets are not recommended for use in children under 12 When and how should the tablets be taken? years of age, however flecainide toxicity has Take the tablets by swallowing them with been reported during treatment with flecainide sufficient fluid (e.g. water). The daily dose is in children who reduced their intake of milk, and usually taken split up over the day, on an empty in infants who were switched from milk formula stomach, or at least one hour before meals. to dextrose feedings The general dose is just a guideline and is as Other medicines and Flecainide Acetate follows: the recommended starting dose lies between Tell your doctor or pharmacist if you are taking, 50 and 200 mg. The dose may be increased by have recently taken or might take any other your doctor to a maximum of 400 mg a day. medicines. More elderly patients If you use certain other medicines along with Your doctor may prescribe a lower dose flecainide, the medicines can sometimes affect for you. The dose for elderly patients the way each other work and/or their side should not exceed 300mg daily (or 150mg effects (i.e. there may be interactions). twice daily). P15XXXXX

Black Use in childrenThese tablets should not • yellowing of the skin or whites of the eyes be taken by children under the age of 12 caused by liver or blood problems (jaundice) years. • hives (urticaria) Patients with a reduced kidney or liver Very rare (may affect up to 1 in 10,000 function people): Your doctor may prescribe a lower dose • elevated levels of certain antibodies for you. • small cloudy spots on the eyeball Patients with a permanent pacemaker • sensitivity to sunlight The daily dose must not exceed 100mg Not known (frequency cannot be estimated twice a day. from the available data) Patients who are simultaneously being treated Changes in electrocardiogram (ECG) with cimetidine (medicine against gastric increase in pacing threshold in patients with disorders) or amiodarone (medicine against pacemakers or temporary pacing electrodes, cardiac arrhythmia) impairment of the conduction between the The doctor will check you regularly, and a lower atria and ventricles of the heart (second or dose will be prescribed for some patients. third degree atrioventricular block), stopped heart beat, slower or faster heart beat, loss During treatment, your doctor will regularly of the heart’s ability to pump enough blood determine the level of flecainide in the blood to the body’s tissues, chest pain, low blood and what is known as an electrocardiogram pressure, heart attack, feeling your heart beat, (ECG) of the heart will be taken. A simple a pause in the normal cardiac rhythm (sinus ECG must be taken once a month and a more arrest), appearance of a certain pre-existing extensive ECG once every three months. An heart disease (Brugada syndrome) which was ECG will be taken every 2 to 4 days at the start not seen before the treatment with [Nationally of the treatment and when the dose is raised. completed name], scarring of the lungs or lung An ECG must be taken more frequently for disease (named interstitial lung disease which patients who are receiving a smaller dose than causes breathlessness), liver disorder is usually prescribed. The doctor can adjust the Reporting of side effects doses at intervals of 6 to 8 days. An ECG will If you get any side effects, talk to your doctor be taken for these patients at weeks 2 and 3 or pharmacist or nurse . This includes any after the start of the treatment. possible side effects not listed in this leaflet. If you take more Flecainide Acetate than you You can also report side effects directly via should Yellow Card Scheme If you take more flecainide than you should, tell Website: www.mhra.gov.uk/yellowcard. By a doctor or go to a hospital casualty department reporting side effects you can help provide straight away. more information on the safety of this medicine. If you forget to take Flecainide Acetate 5. How to store Flecainide Acetate Take the dose when you discover that you have forgotten to take it, unless you only discover this Keep this medicine out of the sight and reach of when it is almost time to take your next dose. In children the latter case, you must not take the dose that Do not use this medicine after the expiry date you forgot as an addition but should continue to which is stated on the carton after EXP. The follow your schedule. It is important to take the expiry date refers to the last day of that month. tablets according to the schedule. Consult your doctor if you have any doubts. This medicine does not require any special Do not take a double dose to make up for a storage conditions. forgotten tablet. Do not throw away any medicines via wastewater or household waste. Ask your If you stop taking Flecainide Acetate pharmacist how to throw away medicines you If you suddenly stop taking flecainide you will no longer use. These measures will help protect not get withdrawal symptoms. However, the the environment cardiac arrhythmia will no longer be being controlled as intended. So never stop using it 6. Contents of the pack and other without your doctor knowing. information If you have any further questions on the use of What Flecainide Acetate contains this medicine, ask your doctor or pharmacist - The active substance is flecainide acetate. Each tablet contains 50 mg or 100 mg of 4. Possible side effects flecainide acetate. Like all medicines, this medicine can cause side - The other ingredients are cellulose, effects, although not everybody gets them. microcrystalline, croscarmellose sodium, pregelatinized starch, hydrogenated Very common (may affect more than 1 in 10 vegetable oil, stearate. people ) • dizziness What Flecainide Acetate looks like and • visual disturbances, such as double vision, contents of the pack blurred vision and difficulty focusing Tablets Common (may affect up to 1 in 10 people): Flecainide Acetate 50mg tablets: • more frequent occurrence of pre-existing White to off-white, round, biconvex tablets arrhythmia (irregular heartbeat) embossed with ‘CC’ on one side and ‘11’ on the • shortness of breath other side. • weakness Flecainide Acetate 100mg tablets: • fatigue White to off-white, round, biconvex, scored • fever tablets debossed with ‘1’ and ‘2’ separated by • fluid in the tissues (edema) deep score line on one side and ‘CC’ on the Uncommon (may affect up to 1 in 100 people): other side. The tablet can be divided into equal • decrease in red and white blood cells and doses. platelets Flecainide Acetate tablets are available in Clear • irregular heart beat with increased heartbeat PVC/PVdC - Aluminium foil blister pack and • nausea HDPE bottle pack with polypropylene closure. • vomiting • constipation Blister: 20, 28, 30, 40, 50, 56, 60, 84, 90 and • abdominal pain 100 tablets • decreased appetite HDPE: 20,500 and 1000 tablets. • diarrhea Not all pack sizes may be marketed. • flatulence • pain in upper abdomen, fullness (dyspepsia) Marketing Authorization Holder • allergic skin reactions such as rashes, hives UK _ Milpharm Limited and baldness Ares Block Odyssey Business Park Rare (may affect up to 1 in 1000 people): West End Road • seeing things that are not there Ruislip HA4 6QD (hallucinations) United Kingdom • depression • confusion MT_ Aurobindo Pharma (Malta) Limited • anxiety Vault 14, Level 2, Valletta Waterfront • memory loss (amnesia) Floriana FRN 1913 • insomnia Malta • tingling or numbness Manufacturer • difficulty in controlling movements (ataxia) APL Swift Services (Malta) Limited • decrease of sensitivity HF26, Hal Far Industrial Estate, Hal Far • increased sweating Birzebbugia, BBG 3000 • fainting (syncope) Malta • tremor or • flushing • sleepiness Milpharm Limited • headache Ares Block • nervous disorders e.g. in the arms and legs Odyssey Business Park • convulsions West End Road • movement disorder (dyskinesia) Ruislip HA4 6QD • ringing in the ears United Kingdom • spinning sensation (vertigo) This leaflet was last revised in 09/2020. • lung inflammation (pneumonia) • elevated liver enzymes reversible on stopping treatment P15XXXXX