Patient leaflet - Flecainide Acetate tablets 50 mg
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 controlling the rate and rhythm of the heart. Flecainide Acetate tablets are used to treat:
- Arrhythmias (irregular heart beat)
- Tachycardia (heart beating too fast)
- Atrial fibrillation (rapid contractions of muscles in the heart).
2 What you need to know 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 this medicine (listed in section 6)
- suffer from heart failure
- have cardiogenic shock (your heart is unable to pump as much blood as your body needs)
- have heart block (your heart misses beats)
- have long standing atrial fibrillation (rapid contractions of muscles in the heart)
- have or have ever had any heart problems, including problems with the valves in your heart or conduction problems
- have sinus node dysfunction (a specific condition where your heart beats abnormally)
- have had a heart attack (myocardial infarction)
- have Brugada syndrome (a genetic disease that causes severe disturbances of the rhythm of the heart and may lead to sudden death in apparently healthy individuals).
Before you take Flecainide Acetate tablets your doctor 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.
Warnings and precautions
Talk to your doctor or pharmacist before taking Flecainide 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 beat after heart surgery.
Children
Flecainide Acetate tablets are not recommended for children under 12 years of age.
Other medicines and Flecainide Acetate tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, especially:
- any other medicine used to treat heart arrhythmias or heart problems, such as cardiac glycosides, beta-blockers, verapamil, propranolol or amiodarone
- diuretics (water tablets)
- phenytoin, phenobarbital or carbamazepine (to treat epilepsy)
- cimetidine (to treat stomach ulcers)
- fluoxetine, paroxetine, reboxetine or tricyclic antidepressants (medicines used to treat depression)
- terfenadine and mizolastine (to treat allergic reactions)
- quinine (to treat or prevent malaria)
- ritonavir (to treat HIV)
- clozapine (to treat mental illness)
- bupropion (a medicine to help you stop smoking).
Pregnancy and breast-feeding
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 Acetate tablets should not be used unless clearly necessary, since Flecainide Acetate has been shown to cross the placenta. 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.
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.
This medicine contains less than 1 mmol sodium (23mg) per tablet, that is to say essentially ‘sodium-free’.
3 How to take Flecainide Acetate tablets
Always take this medicine 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.
Date Sent:
Technologist:
Technically Approved
Flecainide Acetate, Tablet, 50mg, 100mg, 60 Pack, UK
R.Paul
26.04.2024
Date sent:
Date received:
Item number:
Originator:
Origination Date:
Revision Date:
Revised By:
3.
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6.
CRF number:
3.
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Digital signature
Flecainide Acetate 50mg & 100mg 60 Tablets PIL - UK
S.Anson
03/05/2024
09-05-24
RH
148x210mm
7pts
Accord Barnstaple BBBB9969
n/a
Version 11 06.12.2023 51027326 BBBB9969
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Doses:
- Adults:
Supraventricular arrhythmias (irregular heart beat that starts in the upper chambers of your heart):
- Flecainide Acetate 50mg tablets: The recommended dose is one tablet twice a day.
- Flecainide Acetate 100mg tablets: The recommended dose is half a tablet twice a day.
Your doctor may prescribe up to a total dose of 300mg daily (3 x 100mg tablets or 6 x 50mg tablets).
Ventricular arrhythmias (irregular heart beat that starts in the lower chambers of your heart):
- Flecainide Acetate 50mg tablets: The recommended dose is two tablets twice a day.
- Flecainide Acetate 100mg tablets: The recommended dose is one tablet twice a day.
Your doctor may prescribe up to a total dose of 400mg daily (4 x 100mg tablets or 8 x 50mg tablets).
- Use in children (under 12 years of age) - not recommended.
- The elderly and patients with kidney or heart problems - a lower dose of flecainide may be given.
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.
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. Do not take a double dose to make up for a forgotten tablet.
If you stop taking the Flecainide Acetate 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.
Some side effects could be serious. If you have any of the side effects listed below, contact your doctor immediately and stop taking Flecainide Acetate tablets:
Common (may affect up to 1 in 10 people): a change in your heart beat; it starts to pound or it gets faster or slower, chest pain, you become breathless or have breathing problems.
Uncommon (may affect up to 1 in 100 people): low blood count (sore throat, fever, unexplained bruising or bleeding, mouth sores).
Rare (may affect up to 1 in 1,000 people): your skin and/or whites of the eyes begin to go yellow (jaundice), you have fits (convulsions).
Not known (frequency cannot be estimated from the available data): signs of your heart condition getting worse or development of new heart symptoms, heart attack, heart failure, allergic skin reactions which may be itchy, swelling of the face, lips, tongue or throat, or difficulty breathing or swallowing.
Tell your doctor if you notice any of the following side effects or notice any other effects not listed:
Very common (may affect more than 1 in 10 people): dizziness, double or blurred vision.
Common (may affect up to 1 in 10 people): feeling weak or tired, lack of energy and strength, swelling (fluid retention).
Uncommon (may affect up to 1 in 100 people): increased heart rate, feeling or being sick, diarrhoea, constipation, stomach pain or indigestion, loss of appetite, flatulence (wind), hair loss, red, itchy or swollen skin rash.
Rare (may affect up to 1 in 1,000 people): confusion and hallucination, depression, feeling anxious (worried), memory loss, difficulty sleeping, a strong desire to sleep or sleeping for long periods, numbness, tingling, tickling, prickling or burning sensation of the skin, unsteady walking, uncontrolled movements or poor co-ordination, difficulty speaking, reduced sense of touch, fainting, shaking (tremors), flushing, headache, increased sweating and flushed skin, ringing in the ears, spinning sensation, inflammation of the lungs which can cause weakness, breathlessness and cough (pneumonitis).
Very rare (may affect up to 1 in 10,000 people): effects on your immune system which may be associated with inflammation, particles in the front of the eye (corneal deposits), sensitivity of the skin to light.
Not known (frequency cannot be estimated from the available data): lung disease and scarring of the lung, liver disease, joint and muscle 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 Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects you can help provide more information on the safety of this medicine.
5 How to store Flecainide Acetate tablets
Keep this medicine 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 which is stated on the label/ carton/bottle. The expiry date refers to the last day of that month. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6 Contents of the pack and other information What Flecainide Acetate tablets contain
- The active substance is flecainide acetate. Each tablet 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 one face and the identifying letters “FI” on the reverse.
100mg: 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:
Blister: 20s, 28s, 30s, 50s, 56s, 60s, 84s, 90s, 100s, 112s, 120s, 168s, 180s.
Tablet container: 100s, 250s, 500s, 1000s.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Accord, Barnstaple, EX32 8NS, UK
This leaflet was last revised in April 2024.
If you would like a leaflet with larger text, please contact 01271 385257.