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Active substance: FLECAINIDE ACETATE

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Patient Information Leaflet

Tambocor XL 200 mg Capsules
Read all of this leaflet carefully before you take this
• 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 Tambocor XL capsules are for
2. Before you take Tambocor XL capsules
3. How to take Tambocor XL capsules
4. Possible side effects
5. How to store Tambocor XL capsules
6. Further information.
1. What Tambocor XL capsules are 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:
• Irregular heart beat (arrhythmias)
• Heart beat too fast (tachycardia)
• Rapid contractions of muscles in the heart (atrial fibrillation).
Tambocor XL capsules are not used for initial therapy.
They are only used as maintenance therapy after your
condition is under control.
2. Before you take Tambocor XL capsules
Do not take Tambocor XL capsules and tell your
doctor or nurse if:
• You are allergic to active substance flecainide acetate
or any of the other ingredients of Tambocor XL
capsules (See section 6)
• You have heart failure
• You have had a heart attack (myocardial infarction)
• Your heart misses beats (have heart block)
• You have long-standing rapid contractions of muscles
in the heart (atrial fibrillation)
• You have or have ever had any heart problems
including problems with the valves in your heart or
conduction problems
• You have a specific condition where your heart beats
abnormally (sinus node dysfunction)
• You are pregnant or breast-feeding.
Tambocor XL capsules 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 Tambocor XL capsules your doctor
or nurse 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.
Check with your doctor or nurse before taking
Tambocor XL capsules if:
• You have high blood pressure
• You have chest pains (angina)
• 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 irregular heart
beat (heart arrhythmias) or heart problems. Examples
of such medicines include cardiac glycosides,
beta-blockers, verapamil or amiodarone
• Medicines to treat high blood pressure
• Medicines used to treat depression (antidepressants),
such as tricyclic antidepressants, Prozac, fluoxetine
or reboxetine
• Medicines used to prevent epileptic fits
(anticonvulsants) such as phenytoin, phenobarbital
or carbama zepine
• Medicines to treat mental illness (antipsychotics) such
as clozapine
• Medicines to treat allergic reactions (antihistamines)
such as mizolastine or terfenadine
• Medicine to treat malaria (quinine)
• Medicine to treat HIV such as ritonavir, lopinavir or
• Water tablets (diuretics)
• Medicine to treat stomach ulcers (cimetidine)
• Medicine to help stop you smoking (bupropion)
• Any other medicine, including medicines obtained
without a prescription.
These medicines may interfere with your treatment.
Pregnancy and breast-feeding
Do not take Tambocor XL capsules if you are pregnant,
are trying to become pregnant, or are breast-feeding.
If you are uncertain about anything, ask your nurse or
doctor for advice.
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 Tambocor XL capsules
Always take Tambocor XL capsules exactly as your
doctor has told you.
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.
• The usual 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.


Flecainide acetate

4. Possible side effects
Like all medicines Tambocor XL capsules 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 or
lung 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
• Sensitivity of the skin to sunlight
• Hair loss
• 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
• Numb or tingling hands or feet
• Swelling.

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:
By reporting side effects you can help provide more
information on the safety of this medicine.
5. How to store Tambocor XL capsules
Keep out of the reach and sight 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
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.

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.
• Tambocor XL capsules are not recommended for
children under 12 years of age.
If you take more Tambocor XL capsules than you
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 about the use of this
medicine, ask your doctor or nurse.

6. Further information
What Tambocor XL capsules contain
• The active substance in Tambocor XL capsules 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), and erythrosine
(E 127), shellac (E 904) and propylene glycol (E 152).
• Ingredients for printing ink, 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 lcohol, isopropyl alcohol,
propylene glycol, strong ammonia solution, black iron
oxide (E172), potassium hydroxide, purified water.
What Tambocor XL capsules look like
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:
Meda Pharmaceuticals Ltd, Skyway House, Parsonage
Road, Takeley, Bishop’s Stortford, CM22 6PU, UK.
3M Health Care Limited, 1 Morley Street, Loughborough,
Leicester, LE11 1EP, UK.
This leaflet was last revised 11/2013.

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

6204 2213 5
Tambocor is a trademark of MEDA AB.
The Triangle Logo on the packaging is a
trademark of 3M and is used under license.

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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.