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FLECAINIDE ACETATE 100MG TABLETS

Active substance(s): FLECAINIDE ACETATE

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Patient Information Leaflet

Flecainide acetate 50 mg and 100 mg Tablets
Flecainide acetate

What is in this leaflet
1. What Flecainide acetate is and what it is used for
2. What you need to know 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. Contents of the pack and other information
1. What Flecainide acetate is and what it is used 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 fibrilation (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.
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 Flecainide acetate tablets
(see Section 6).
• You have heart failure
• You have cardiogenic shock (your heart is unable to
pump as much blood as your body needs)
• You have heart block (your heart missess 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 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.
• You are pregnant or breast-feeding.
Flecainide acetate tablets are not recommended for use
in children under 12 years of age, however, dairy products
such as milk, infant formula and possibly yoghurt, may
reduce how much flecainide acetate is absorbed in
children and infants.
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 does
you need.

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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,
betablockers, verapamil, propranol or amiodarone
• Medicines to treat high blood pressure
• Antidepressants (medicines used to treat depression),
such as tricyclic antidepressants, Prozac, fluoxetine,
paroxetine or reboxetine
• Anticonvulsants (medicines used to prevent epileptic fits)
such as phenytoin, phenobarbital or carbamazepine
• Antipsychotics (medicnies 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 (medicines 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 or breast-feeding, think you may
be pregnant or are planning to have a baby, ask your
doctor or nurse for advice before taking Flecainide
acetate tablets.
Driving and using machines:
Driving ability, operation of machinery and work without a
secure fit may be affected by adverse reactions such as
dizziness and visual disturbances (if present).
3. 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.
If you have switched from a different formulation
(e.g. from an injection of Flecainide) your doctor
should do so with caution and monitor you closely.
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).

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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 or
nurse.
• 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.

Children:
• Flecainide acetate tablets are not recommended for
children under 12 years of age, however, dairy products such as milk, infant formula and possibly yoghurt,
may reduce how much flecainide acetate is absorbed
in children and infants.
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.
4. Possible side effects
Like all medicines Flecainide acetate 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, seek immediate
medical help:
Common (affects 1 in 100 people):
• Your heartbeat changes; it starts to pound,
or it gets faster or slower
• You have chest pain
• You have fever, become flushed or sweat
• You become breathless or have other breathing
problems
• You faint or feel faint
Rare (affects 1 in 10,000 people):
• You have ringing in your ears
• Your skin and eyes begin to go yellow (jaundice)
• You have fits (convulsions).
Other side effects (how often they happen is unknown):
• heart attack
• cardiac failure/arrest (loss of breathing,
and consciousness and loss of heart function)
Other side effects include the following, if they get
serious, please tell your doctor:
Very common (affects more than 1 in 10 people):
• Dizziness
• Double or blurred vision
Common (affects 1 in 100 people):
• Feeling week or tired
• Lack of energy and strength
• Swelling (fluid retention)
Uncommon (affects 1 in 1,000 people):
• Blood disorders (reduced red and white blood cell
count and reduced platelet count)
• Feeling or being sick
• Constipation
• Stomach pain or indigestion
• Loss of appetite
• Diarrhoea
• Wind
• Feeling bloated
• Red, itchy or swollen skin rash
• Hair loss
Rare (affects 1 in 10,000 people):
• vertigo (feeling like the room is spinning)
• Confusion and hallucinations
• Depression
• Feeling anxious (worried)

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• Forgetfulness
• Difficulty sleeping
• Numbness, tingling, tickling, prickling or burning
sensation of the skin
• Unsteady walking, uncontrolled movements or poor
coordination, difficulty speaking
• Reduced sense of touch
• Excessive sweating and flushed skin
• Shaking (tremors)
• A strong desire to sleep or sleep for long periods
• Headache
Very rare (affects less than 1 in 10,000 people):
• Small cloudy spots on the eyeball
• Sensitivity of the skin to sunlight
Other side effects (how often they happen is
unknown):
• lung disease and scarring of the lungs
• liver disease
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.
5. 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 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 longer need to
your pharmacist.
6. Contents of the pack and other 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), hydorgenated 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
Meda Pharmaceuticals Ltd, Skyway House, Parsonage
Road, Takeley, Bishop’s Stortford, CM22 6PU, UK.
Manufacturer
3M Health Care Limited, 1 Morley Street,
Loughborough, Leicester, LE11 1EP, UK
This leaflet was last revised 12/2014.

If this leaflet is difficult to see or read
and you would like it in a different format,
please contact Meda Pharmaceutical Ltd,
Skyway House, Parsonage Road, Takeley,
Bishop’s Stortford, CM22 6PU, UK.

6204 2364 6
56UK1833220-01

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The elderly and patients with kidney or heart problems:
For elderly patients, and patients with kidney or heart
problem, 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.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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