Flecainide acetate 50 mg and 100 mg Tablets
Flecainide acetate
Read all of this leaflet carefully before you take this medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or nurse.
- 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.
In this leaflet:
1. What Flecainide acetate tablets are for
2. Before you take Flecainide acetate tablets
3. How to take Flecainide acetate tablets
4. Possible side effects
5. How to store Flecainide acetate tablets
6. Further information.
What Flecainide acetate tablets are for
Flecainide acetate tablets belong to a group of medicines called anti-arrhythmics. Anti-arrhythmics work by controlling the rate and rhythm of the heart.
Flecainide acetate 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.
Before you take Flecainide acetate tablets
Do not take Flecainide acetate tablets if:
- You are allergic to flecainide acetate or any of the other ingredients of Flecainide acetate tablets (see Section 6)
- You have heart failure
- You have heart block (your heart misses beats)
- You have long-standing atrial fibrillation (rapid contractions of muscles in the heart)
- You have or have ever had any heart problems including problems with the valves in your heart or conduction problems
- You have sinus node dysfunction (a specific condition where your heart beats abnormally)
- You have had a myocardial infarction (heart attack)
- You are pregnant or breast-feeding.
Flecainide acetate tablets are not recommended for use in children under 12 years of age.
If any of the above applies to you tell your doctor or nurse.
Before you take Flecainide acetate tablets your doctor or nurse may check:
- Your fluid levels are correct
- Your liver and kidney functions.
This is to check that flecainide acetate tablets are right for you and to help the doctor calculate the dose you need.
Check with your doctor or nurse before taking Flecainide acetate tablets if:
- You have high blood pressure
- You have angina (chest pains)
- You have heart disease
- You have kidney disease or kidney problems
- You have liver disease or liver problems
- You wear a pacemaker.
Tell your doctor or nurse if you are taking any of the following medicines:
- Any other medicine used to treat heart arrhythmias or heart problems such as cardiac glycosides, beta-blockers, verapamil or amiodarone
- Medicines to treat high blood pressure
- Antidepressants (medicines used to treat depression), such as tricyclic antidepressants, Prozac, fluoxetine or reboxetine
- Anticonvulsants (medicines used to prevent epileptic fits) such as phenytoin, phenobarbital or carbamazepine
- Antipsychotics (medicines to treat mental illness) such as clozapine
- Antihistamines (medicines to treat allergic reactions) such as mizolastine or terfenadine
- Quinine (medicine to treat malaria)
- Medicines to treat HIV such as ritonavir, lopinavir or indinavir
- Diuretics (water tablets)
- Cimetidine (medicine to treat stomach ulcers)
- Bupropion (a medicine to help stop you smoking)
- Any other medicine, including medicines obtained without a prescription.
These medicines may interfere with your treatment.
Pregnancy and breast-feeding
If you are pregnant, trying to become pregnant or breast-feeding, ask the doctor or nurse for advice before taking Flecainide acetate tablets.
How to take Flecainide acetate tablets
Always take Flecainide acetate tablets exactly as your doctor has told you.
Important:
Your doctor will choose the dose that is right for your condition. Usually your treatment with Flecainide acetate tablets will be started in hospital.
Adults:
Supraventricular arrhythmias (Irregular heart beat that starts in the upper chambers of your heart)
- Flecainide acetate 50 mg tablets: The usual dose is one tablet twice a day.
- Flecainide acetate 100 mg 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 x 100 mg tablets or 6 x 50 mg tablets).
Ventricular arrhythmias (Irregular heart beat that starts in the lower chambers of your heart)
- Flecainide acetate 50 mg tablets: The usual dose is two tablets twice a day.
- Flecainide acetate 100 mg tablets: The usual dose is one tablet twice a day.
Your doctor may prescribe up to a total dose of 400 mg daily (4 x 100 mg tablets or 8 x 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.
Children:
- Flecainide acetate tablets are not recommended for children under 12 years of age.
If you take more Flecainide acetate tablets than you should
If you accidentally take too much, immediately go to the nearest hospital casualty department.
If you forget to take Flecainide acetate tablets
Do not take a double dose to make up for a missed dose. Simply take the next dose as planned.
If you stop taking Flecainide acetate tablets
Do not stop taking Flecainide acetate tablets without first talking to your doctor.
If you have any further questions about the use of this medicine, ask your doctor or nurse.
Flecainide Acetate Side Effects
Like all medicines Flecainide acetate tablets can cause side effects, although not everybody gets them.
Seek immediate medical help if you have any of the following symptoms:
- 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 faint or you feel faint
- You have ringing in your ears
- Your skin and eyes begin to go yellow (jaundice)
- You have a fever, become flushed or sweat
- You have fits (convulsions).
Other side effects:
- Feeling or being sick
- Constipation
- Feeling bloated
- Wind
- Diarrhoea
- Stomach pain or indigestion
- Loss of appetite
- Confusion and hallucinations
- Forgetfulness
- Difficulty sleeping
- Feeling anxious (worried)
- Depression
- Red, itchy or swollen skin rash
- Hair loss
- Sensitivity to sunlight
- Feeling weak or tired
- Headache
- Double or blurred vision
- Small cloudy spots on the eyeball
- Feeling giddy or lightheaded
- Dizziness or feeling that the room is spinning (vertigo)
- Shaking (tremors)
- Unsteady walking, uncontrolled movements or poor coordination
- Numb or tingling hands or feet
- Swelling.
If any of these side effects get serious, or you notice any side effects not listed in this leaflet, tell your doctor or nurse.
How to store Flecainide acetate tablets
Keep out of the reach and sight of children.
Do not store above 30°C.
Keep the container in the outer carton to protect the tablets from light.
Do not use Flecainide acetate tablets after the expiry date on the carton. The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Return any medicine you no longer need to your pharmacist.
Further information
What Flecainide acetate tablets contain
- The active substance in Flecainide acetate tablets 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 pregelatinised starch, croscarmellose sodium, microcrystalline cellulose (E460i), hydrogenated vegetable oil, magnesium stearate (E572).
What Flecainide acetate tablets look like
Flecainide acetate 50 mg tablets are round, white and marked '3M' on one side and 'TR50' on the other.
Flecainide acetate 100 mg tablets are round, white and marked '3M' on one side and 'TR100' with a break line on the other.
Both strengths of Flecainide acetate tablets come in blister packs containing 60 tablets.
Marketing Authorisation Holder:
Manufacturer:
This leaflet was last updated February 2010
If this leaflet is difficult to see or read and you would like it in a different format, please contact
CM22 6PU
70703-A
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