Medication Guide App

TAMBOCOR XL 200MG CAPSULES

Active substance: FLECAINIDE ACETATE

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Patient Information Leaflet

Tambocor XL 200 mg Capsules
Flecainide acetate

What is in this leaflet:
1. What Tambocor XL is and what it is used for
2. what you need to know 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. Contents of the pack and other information.
1. 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:
• 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. What you need to know 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 cardiogenic shock (your heart is unable to
pump as much blood as your body needs)
• 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.
• 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.
Tambocor XL capsules 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 Tambocor XL is absorbed in children
and infants.
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.

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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, propranol or amiodarone
• Medicines to treat high blood pressure
• Medicines used to treat depression (antidepressants),
such as tricyclic antidepressants, Prozac, fluoxetine,
paroxetine or reboxetine
• Medicines used to prevent epileptic fits
(anticonvulsants) such as phenytoin, phenobarbital
or carbamazepine
• 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
indinavir
• 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
If you are pregnant or breast-feeding, think you may be
pregnant or are planning to have a baby, 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.
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 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.
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.

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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. Do not pass
it on to others. It may harm them, even if their symptoms
are the same as yours.

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 Tambocor XL 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 about the use of this
medicine, ask your doctor or nurse.
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 (affects 1 in 100 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 (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)
• Forgetfulness
• Difficulty sleeping
• Numbness, tingling, tickling, prickling or burning
sensation of the skin

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• 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 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.
6. Contents of the pack and other 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.
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 2365 3
56UK1833410-02
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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284

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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