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TAMBOCOR XL 200MG CAPSULES

Active substance(s): FLECAINIDE ACETATE

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Package leaflet: Information for the patient
Tambocor XL 200 mg Capsules
Flecainide acetate

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 pharmacist.

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 or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.

What is in this leaflet
1.
2.
3.
4.
5.
6.

1.

What Tambocor XL is and what it is used for
What you need to know before you take Tambocor XL capsules
How to take Tambocor XL capsules
Possible side effects
How to store Tambocor XL capsules
Contents of the pack and other information

What Tambocor XL is and what it is used for

Tambocor XL capsules belong to a group of medicines called anti-arrhythmics. Anti-arrhythmics
work by controlling the rate and rhythm of the heart.
Tambocor XL capsules are used to treat:
• Arrhythmias (irregular heart beat
• Tachycardia (heart beating too fast)
• Atrial fibrillation (rapid contractions of muscles in the heart).
Tambocor XL capsules are not used for initial therapy. They are only used as maintenance therapy
after your condition is under control.
2.

What you need to know before you take Tambocor XL capsules

Do not take Tambocor XL capsules if you:
• are allergic to flecainide acetate or any of the other ingredients of this medicine (listed in section 6)
• have heart failure
• have cardiogenic shock (your heart is unable to pump as much blood as your body needs)
• have had a myocardial infarction (heart attack)
• have heart block (your heart misses beats)
• have atrial fibrillation (long-standing 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)
• are pregnant or breast-feeding
• 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.

If any of the above applies to you tell your doctor or pharmacist.
Before you take Tambocor XL capsules your doctor may check:
• Your fluid levels are correct
• Your liver and kidney functions.
This is to check that Tambocor XL capsules 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 Tambocor XL capsules if you:
• have high blood pressure
• have chest pains (angina)
• have heart disease
• have kidney disease or kidney problems
• have liver disease or liver problems
• wear a pacemaker.
Children
Tambocor XL capsules are not recommended for children under 12 years of age.
Other medicines and Tambocor XL
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines, including those obtained without a prescription, and in particular, any of the following:
• Any other medicine used to treat heart arrhythmias (irregular heart beat) or heart problems.
Examples of such medicines include cardiac glycosides, beta- blockers, verapamil, propranolol or
amiodarone
• Medicines to treat high blood pressure
• Antidepressants (medicines used to treat depression) such as tricyclic antidepressants, fluoxetine,
paroxetine 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)
• Medicine to treat HIV such as ritonavir, lopinavir or indinavir
• Diuretics (water tablets)
• Cimetidine (medicine to treat stomach ulcers)
• Bupropion (a medicine to help you stop smoking).
These medicines may interfere with your treatment.
Pregnancy, breast-feeding and fertility
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.
Driving and using machines
Do not drive or operate machinery if you feel dizzy or drowsy, or have eyesight problems while
taking this medicine.

3.

How to take Tambocor XL capsules

Always take Tambocor XL capsules exactly as your doctor or pharmacist has told you. Check with
your doctor or pharmacist if you are not sure.

Important: Your doctor will choose the dose that is right for your condition. Usually your
treatment with Tambocor XL capsules will be started under hospital supervision.
Remember: Tambocor XL capsules are not used for initial therapy. They are only used as
maintenance therapy after your condition is under control.
Tambocor XL capsules should be swallowed whole with some water. They should not be broken open
or chewed.
If you have switched from a different formulation (e.g. from an injection of Tambocor), your doctor
should do so with caution and monitor you closely.
Adults
• The recommended dose is one 200 mg capsule per day.
• Occasionally your doctor may decide you need a higher or lower dose than this. If this is the case,
your doctor may prescribe Tambocor 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
• Tambocor XL capsules 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 Tambocor XL capsules than you should
If you accidentally take too much, immediately go to the nearest hospital casualty department.
If you forget to take Tambocor XL capsules
Do not take a double dose to make up for a missed dose.
Simply take the next dose as planned.
If you stop taking Tambocor XL capsules
Do not stop taking Tambocor XL capsules without first talking to your doctor.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4.

Possible side effects

Like all medicines Tambocor XL capsules 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 (may affect 1 in 10 people):
• Your heartbeat changes; it starts to pound, or it gets faster or slower
• You have chest pain
• You become breathless or have other breathing or lung problems
• You have a fever, become flushed or sweat
• You faint or you feel faint

Rare (may affect up to 1 in 1,000 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 (may affect more than 1 in 10 people):
• Dizziness
• Double or blurred vision
Common (may affect up to 1 in 10 people):
• Feeling week or tired
• Lack of energy and strength
• Swelling (fluid retention)
Uncommon (may affect 1 in 100 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 (may affect up to 1 in 1,000 people):
• Vertigo (feeling like the room is spinning)
• Confusion and hallucinations
• Depression
• Feeling anxious (worried)
• 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 sleeping for long periods
• Headache
Very rare (may affect up to 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
• Joint pain and muscle pain

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. 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, 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 Tambocor XL capsules

Keep this medicine out of the sight and reach of children.
Do not store above 25 °C. Keep the container in the outer carton to protect the capsules from light and
moisture.
Do not use Tambocor XL capsules after the expiry date which is stated on the carton after EXP. 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 Tambocor XL capsules contain
• The active substance is flecainide acetate. Each 200 mg capsule contains 200 mg flecainide acetate.
• The other ingredients are microcrystalline cellulose (E 460i), methacrylic acid-methyl methacrylate
copolymer, macrogol 400, talc (E 553b), gelatin, titanium dioxide (E 171), iron oxide black (E 172),
erythrosine (E 127), shellac (E 904) and propylene glycol (E 152).
• Ingredients of the printing ink are n-butyl alcohol, purified water, shellac glaze, iron oxide black (E
172), propylene glycol, dehydrated ethanol, isopropylene glycol, dehydrated ethanol, isopropyl
alcohol, ammonium hydroxide 28 % or shellac, dehydrated alcohol, isopropyl alcohol, propylene
glycol, strong ammonia solution, black iron oxide (E172), potassium hydroxide, purified water.
What Tambocor XL capsules look like and contents of the pack
Tambocor XL 200 mg capsules are light grey and pink with ‘3M 200’ printed in black ink.
Tambocor XL 200mg capsules come in packs containing 15, 30 or 60 capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
TEVA UK Limited, Eastbourne, BN22 9AG, United Kingdom
Manufacturer:
3M Health Care Limited, Derby Road, Loughborough, Leicester, LE11 5SF, UK
This leaflet was last revised in February 2018.
PL 00289/2212

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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