TAMBOCOR XL 200MG CAPSULES

Active substance: FLECAINIDE ACETATE

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Patient Information Leaflet

Tambocor XL 200 mg Capsules
Flecainide acetate

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:
• rregular heart beat (arrhythmias)
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•  eart beat too fast (tachycardia)
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•  apid contractions of muscles in the heart (atrial
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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:
•  ou are allergic to active substance flecainide acetate
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or any of the other ingredients of Tambocor XL
c
­ apsules (See section 6)
•  ou have heart failure
Y
•  ou have had a heart attack (myocardial infarction)
Y
•  our heart misses beats (have heart block)
Y
•  ou have long-standing rapid contractions of muscles
Y
in the heart (atrial fibrillation)
Y
•  ou have or have ever had any heart problems
i
­ncluding problems with the valves in your heart or
conduction problems
•  ou have a specific condition where your heart beats
Y
abnormally (sinus node dysfunction)
•  ou are pregnant or breast-feeding.
Y
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:
•  our fluid levels are correct
Y
•  our liver and kidney functions.
Y
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:
•  ou have high blood pressure
Y
•  ou have chest pains (angina)
Y
•  ou have heart disease
Y
•  ou have kidney disease or kidney problems
Y
•  ou have liver disease or liver problems
Y
•  ou wear a pacemaker.
Y
Tell your doctor or nurse if you are taking any of
the following medicines:
•  ny other medicine used to treat irregular heart
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beat (heart arrhythmias) or heart problems. Examples
of such medicines include cardiac glycosides,
b
­ eta-blockers, verapamil or amiodarone
•  edicines to treat high blood pressure
M
•  edicines used to treat depression (antidepressants),
M
such as tricyclic antidepressants, Prozac, fluoxetine
or reboxetine
•  edicines used to prevent epileptic fits
M
(anticonvulsants) such as phenytoin, phenobarbital
or carbama­ epine
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•  edicines to treat mental illness (antipsychotics) such
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as clozapine
•  edicines to treat allergic reactions (antihistamines)
M
such as mizolastine or terfenadine
•  edicine to treat malaria (quinine)
M
•  edicine to treat HIV such as ritonavir, lopinavir or
M
indinavir
W
•  ater tablets (diuretics)
•  edicine to treat stomach ulcers (cimetidine)
M
•  edicine to help stop you smoking (bupropion)
M
•  ny other medicine, including medicines obtained
A
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.
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
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­ ambocor 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.

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Read all of this leaflet carefully before you take this
medicine.
• Keep this leaflet. You may need to read it again.
I
• f you have any further questions, ask your doctor or nurse.
•  his medicine has been prescribed for you. Do not
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pass it on to others. It may harm them, even if their
symptoms are the same as yours.

The elderly and patients with kidney or heart
­problems
•  or elderly patients, and patients with kidney or heart
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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
•  ambocor XL capsules are not recommended for
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children under 12 years of age.
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.
Seek immediate medical help if you have any of the
following symptoms:
•  our heartbeat changes; it starts to pound, or it
Y
gets faster or slower
Y
•  ou have chest pain
•  ou become breathless or have other breathing or
Y
lung problems
•  ou faint or you feel faint
Y
•  ou have ringing in your ears
Y
Y
•  our skin and eyes begin to go yellow (jaundice)
•  ou have a fever, become flushed or sweat
Y
•  ou have fits (convulsions).
Y
Other side effects:
•  eeling or being sick
F
•  onstipation
C
•  eeling bloated
F
•  ind
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•  iarrhoea
D
•  tomach pain or indigestion
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•  oss of appetite
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•  onfusion and hallucinations
C
•  orgetfulness
F
•  ifficulty sleeping
D
•  eeling anxious (worried)
F
•  epression
D
•  ed, itchy or swollen skin rash
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•  ensitivity of the skin to sunlight
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•  air loss
H
•  eeling weak or tired
F
•  eadache
H
•  ouble or blurred vision
D

•  mall cloudy spots on the eyeball
S
•  eeling giddy or lightheaded
F
•  izziness or feeling that the room is spinning (vertigo)
D
•  haking (tremors)
S
•  nsteady walking, uncontrolled movements or poor
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coordination
•  umb or tingling hands or feet
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•  welling.
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If any of these side effects get serious, or you notice any
side effects not listed in this leaflet, tell your doctor or nurse.
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. Further information
What Tambocor XL capsules contain
•  he active substance in Tambocor XL capsules is
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flecainide acetate. Each 200 mg capsule contains
200 mg flecainide acetate.
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•  he 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).
• ngredients for printing ink, n-butyl alcohol, purified water,
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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 July 2013.

If this leaflet is difficult to see or read
and you would like it in a different format,
please contact Meda ­ harmaceuticals Ltd,
P
Skyway House, Parsonage Road, Takeley,
Bishop’s Stortford, CM22 6PU, UK.
6 204 2084 0
56UK1833410-00
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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Adults
•  he usual dose is one 200 mg capsule per day.
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•  ccasionally your doctor may decide you need a higher
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or lower dose than this. If this is the case your doctor
may prescribe Tambocor tablets.

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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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