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FLECAINIDE ACETATE TABLETS 100MG

Active substance(s): FLECAINIDE ACETATE

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Flecainide Acetate 50mg
and 100mg tablets
Read all of this leaflet carefully before you
start taking this medicine because it contains
important information for you.
• K
 eep this leaflet. You may need to read it
again.
•  If you have any further questions, ask your
doctor, pharmacist 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.
•  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
1 What Flecainide Acetate tablets are
and what they are used for
2 What you need to know before you
take Flecanide Acetate tablets
 ow to take Flecanide Acetate
3 H
tablets
4 Possible side effects
 ow to store Flecanide Acetate
5 H
tablets
 ontents of the pack and other
6 C
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).

2 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.
• s uffer from conduction problems of the heart, such as a
slow or fast heart beat or heart block
• s uffer from heart failure
•h
 ave severely low blood pressure
•h
 ave had a heart attack (myocardial infarction)
• a re in shock due to heart problems (cardiogenic shock)
•h
 ave rapid and irregular heart beat (long standing atrial
fibrillation)
• a re taking disopyramide (medicine to treat irregular heart
rhythms).
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•h
 ave 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:
• s uffer from low or high levels of potassium in the blood
•h
 ave liver or kidney disease
•h
 ave a pacemaker
•h
 ave any heart disease or an enlarged heart
•h
 ave rapid or irregular heart beats after heart surgery
•h
 ave 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.
• v erapamil or beta blockers (e.g. propranolol to treat heart
diseases)
• laxatives (to treat constipation)
•d
 iuretics (water tablets)
• s teroids (e.g. betamethasone, hydrocortisone or prednisolone)
• s odium channel blockers (e.g. lidocaine to treat irregular
heartbeat (arrhythmia) or as a local anaesthetic)
•p
 henytoin, phenobarbital or carbamazepine (to treat epilepsy)
•d
 igoxin (to treat heart conditions)
• a miodarone, quinidine or disopyramide (to treat irregular
heart rhythms)
• c imetidine (to treat stomach ulcers)
• f luoxetine or tricyclic antidepressants (e.g. amitriptyline to
treat depression)
• t erfenadine, mizolastine or astemizole (to treat allergic
reactions)
•q
 uinine or halofantrine (to treat or prevent malaria)
• r itonavir, lopinavir and indinavir (to treat HIV)
• c lozapine (antipsychotics)
• t erbinafine (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.

Continued over page

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:

•A
 dults 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 of 400mg per day.
•U
 se in children and adolescents (under 12 years of age) - not
recommended
•E
 lderly patients or those fitted with pacemakers, with kidney
or liver problems or taking amiodarone or cimetidine - a lower
dose of flecainide may be given.

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

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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.

5 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.

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
01271 385257.

Actavis, Barnstaple, EX32 8NS, UK

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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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