Flecainide Acetate Tablets 50mg
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This meidicine 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet Q What Flecainide Acetate tablets are and what they are used for 12 What you need to know before you take Flecanide Acetate tablets |3 How to take Flecanide Acetate tablets
Possible side effects
How to store Flecanide Acetate
tablets
|6 Contents of the pack and other information
|1 What Flecainide Acetate tablets are and what they are used for
Flecainide Acetate tablets belong to a group of medicines called anti-arrhythmics. They work by regulating the heart rate. Flecainide Acetate tablets may be used to treat the following conditions when other drugs are not effective:
• irregular beats of the upper heart chambers (atria) including Wolff-Parkinson-White Syndrome
• irregular beats of the lower heart chambers (ventricles).
12 What you need to know before you take Flecanide Acetate tablets
Do not take Flecainide Acetate tablets if you:
•are allergic to flecainide acetate or any of the other ingredients of this medicine listed in see section 6.
• suffer from conduction problems of the heart, such as a slow or fast heart beat or heart block
• suffer from heart failure
• have severely low blood pressure
• have had a heart attack (myocardial infarction)
• are in shock due to heart problems (cardiogenic shock)
• have rapid and irregular heart beat (long standing atrial fibrillation)
• are taking disopyramide (medicine to treat irregular heart rhythms).
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• have known brugada syndrome (genetic disease that is characterised by abnormal electrocardiogram)
Warnings and precautions:
Talk to your doctor or pharmacist before taking Flecanide Acetate tablets if you:
• suffer from low or high levels of potassium in the blood
• have liver or kidney disease
• have a pacemaker
• have any heart disease or an enlarged heart
• have rapid or irregular heart beats after heart surgery
• have been told you have disturbances in heart rhythm known as sick sinus syndrome.
Other medicines and Flecanide Acetate tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicine.
• verapamil or beta blockers (e.g. propranolol to treat heart diseases)
• laxatives (to treat constipation)
• diuretics (water tablets)
• steroids (e.g. betamethasone, hydrocortisone or prednisolone)
• sodium channel blockers (e.g. lidocaine to treat irregular heartbeat (arrhythmia) or as a local anaesthetic)
• phenytoin, phenobarbital or carbamazepine (to treat epilepsy)
• digoxin (to treat heart conditions)
• amiodarone, quinidine or disopyramide (to treat irregular heart rhythms)
• cimetidine (to treat stomach ulcers)
• fluoxetine or tricyclic antidepressants (e.g. amitriptyline to treat depression)
• terfenadine, mizolastine or astemizole (to treat allergic reactions)
• quinine or halofantrine (to treat or prevent malaria)
• ritonavir, lopinavir and indinavir (to treat HIV)
• clozapine (antipsychotics)
• terbinafine (antifungals)
Pregnancy and breast-feeding
If you are pregnant, think you may be pregnant or are planning to have a baby please tell your doctor before taking this medicine.
During pregnancy Flecainide Acetate tablets should not be used unless clearly necessary, since Flecainide Acetate tablets has been shown to cross the placenta in patients taking Flecainide Acetate tablets during pregnancy. If Flecainide Acetate tablets are 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 a child.
Flecainide is secreted in the mother's milk. Nursing mothers should not breast-feed whilst taking Flecainide Acetate tablets. Ask your doctor or your pharmacist for advice before taking medicines.
Driving and using machines
Flecainide Acetate tablets may cause dizziness or affect your vision. Make sure you are not affected before you drive or operate machinery.
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Tests
Your doctor will monitor your progress on a regular basis with ECG (electrocardiogram) and blood tests, and may alter the dose if necessary.
If you see another doctor or go into hospital, let them know what medicines you are taking.
"3| How to take Flecanide Acetate tablets
Always take Flecainide Acetate tablets exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Treatment may be started in hospital.
Swallow these tablets whole with water on an empty stomach or one hour before food.
Doses:
• Adults and adolescents (13-17 years of age)
- treatment of irregular beats of the upper heart chambers (atria): the recommended starting dose is 50mg twice a day up to a maximum dose of 300mg per day.
- treatment of irregular heart beats of the lower heart chambers (ventricular) : the recommended starting dose is 100mg twice a day up to a maximum dose of400mg per day.
• Use in children and adolescents (under 12 years of age) - not recommended
• Elderly patients or those fitted with pacemakers, with kidney or liver problems or taking amiodarone or cimetidine - a lower dose of flecainide may be given.
Uncommon (occurs in less than 1 in 100 users): changes in the numbers and types of your blood cells, hallucinations, confusion, memory loss, convulsions, lung disease (pneumonitis), dry mouth, impairment of taste, damage to nerves in fingers and toes causing numbness, decreased appetite, flatulence (wind), hair loss.
Rare (occurs in less than 1 in 1,000 users): affects on your immune system which may be associated with inflammation, nervousness. Very rare (occurs in less than 1 in 10,000 users): particles in the front of the eye (corneal deposits), joint and muscle pain, impotence. Frequency not known: sensitivity of the skin to light, chest pain.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this medicine.
T| How to store Flecanide Acetate tablets
Keep out of the sight and reach of children.
Do not store the tablets above 25°C and store in the original packaging.
Do not use this medicine after the expiry date stated on the label/ carton/bottle. The expiry date refers to the last day of that month.
Do not throw away any medicine via wastewater or household waste. Ask your pharmacist how to throw away of medicines you no longer use. These measures will help to protect the environment.
If you take more Flecainide Acetate tablets than you should
If you have accidentally taken more than the prescribed dose, contact your nearest casualty department or tell your doctor or pharmacist at once.
If you forget to take Flecainide Acetate tablets
If you forget to take a dose take it as soon as you remember, unless it is nearly time to take the next dose. Then go on as before. Never double up on the next dose to make up for the one missed.
If you stop taking the tablets
Talk to your doctor before you stop taking the tablets and follow their advice.
"4 Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Flecainide Acetate tablets and contact your doctor at once if the following allergic reaction happens: allergic skin reactions which may be itchy, swelling of the face, lips, tongue or throat, or difficulty breathing or swallowing. Low blood count (sore throat, fever, unexplained bruising or bleeding, mouth sores), raised liver enzyme levels or jaundice (yellow skin and/or whites of the eyes), signs of your heart condition getting worse or development of new heart symptoms, a change in heart beat pattern (especially in patients with existing heart problems).
Tell your doctor if you notice any of the following side effects or
notice any other effects not listed:
Very common (occurs in more than 1 in 10 users): dizziness, giddiness, light headedness, headache, double or blurred vision
Common (occurs in less than 1 in 10 users): difficulty breathing, feeling or being sick, depression, anxiety, disturbances of movement, 'pins and needles, problems with co-ordination, flushing, increased sweating, difficulty sleeping, fainting, tremor, spinning sensation, ringing in the ears, tiredness, fever, weakness, diarrhoea, constipation, abdominal pain
"6 Contents of the pack and other information
What Flecainide Acetate tablets contain
• The active substance is flecainide acetate. Each tablets contains either 50mg or 100mg of the active ingredient.
• The other ingredients are croscarmellose sodium, magnesium stearate, maize starch, pregelatinised maize starch, microcrystalline cellulose (E460).
What Flecainide Acetate tablets look like and contents of the pack
50mg:
White, circular, biconvex uncoated tablets embossed "C"on once face and the identifying letters "FI"on the reverse.
100 mg:
White, circular, biconvex, uncoated tablets one side embossed with a break line and the identifying letters "C" above the line and "FJ"below, the reverse side embossed with a breakline.
The score line is only there to help you break the tablet if you have difficulty swallowing it whole.
Pack sizes are 60 tablets
Marketing Authorisation Holder and Manufacturer
Actavis, Barnstaple, EX32 8NS, UK.
Date of last revision: August 2015
If you would like a leaflet with larger text, please contact 01271385257.
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Actavis, Barnstaple, EX32 8NS, UK
148x210 Leaflet Reel Fed Profile (BST)