Skip to Content

TAMBOCOR 100MG TABLETS

Active substance: FLECAINIDE ACETATE

View full screen / Print PDF » Download PDF ⇩
Transcript
Patient Information Leaflet

Tambocor 50 mg & 100 mg Tablets
Flecainide acetate

What is in this leaflet:
1. What Tambocor is and what it is used for
2. What you need to know before you take Tambocor
tablets
3. How to take Tambocor tablets
4. Possible side effects
5. How to store Tambocor tablets
6. Contents of the pack and other information.
1. What Tambocor is and what it is used for
Tambocor tablets belong to a group of medicines called
anti-arrhythmics. Anti-arrhythmics work by controlling the
rate and rhythm of the heart.
Tambocor tablets are used to treat:
• Arrhythmias (irregular heart beat)
• Tachycardia (heart beat too fast)
• Atrial fibrillation (rapid contractions of muscles in the
heart).
It is important for your doctor to treat these conditions
quickly and effectively in order to prevent more serious
heart problems from developing.
There are two strengths of tablet available, 50 mg and
100 mg.
2. What you need to know before you take
Tambocor tablets
Do not take Tambocor tablets if:
• You are allergic to flecainide acetate or any of the other
ingredients of Tambocor tablets (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 heart block (your heart misses beats)
• You have long-standing atrial fibrillation
(rapid contractions of muscles in the heart)
• You have or have ever had any heart problems including
problems with the valves in your heart or conduction
problems
• You have sinus node dysfunction (a specific condition
where your heart beats abnormally)
• You have had a myocardial infarction (heart attack)
• 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.
• You are pregnant or breast-feeding.
Tambocor tablets 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 is absorbed in children and
infants.
If any of the above applies to you tell your doctor or
nurse.
Before you take Tambocor tablets your doctor or
nurse may check:
• Your fluid levels are correct
• Your liver and kidney functions.
This is to check that Tambocor tablets are right for you
and to help the doctor calculate the dose you need.

1014_GI_Tambocor-Tabs_56UK1833210-02.indd 1

Check with your doctor or nurse before taking
Tambocor tablets if:
• You have high blood pressure
• You have angina (chest pains)
• 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 heart arrhythmias
or heart problems such as cardiac glycosides,
beta-blockers, verapamil, propranol or amiodarone
• Medicines to treat high blood pressure
• Antidepressants (medicines used to treat
depression), such as tricyclic antidepressants,
Prozac, 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)
• Medicines to treat HIV such as ritonavir, lopinavir or
indinavir
• Diuretics (water tablets)
• Cimetidine (medicine to treat stomach ulcers)
• Bupropion (a medicine to help stop you smoking)
• 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 the doctor
or nurse for advice before taking Tambocor tablets.
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 tablets
Always take Tambocor tablets 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
tablets will be started in hospital.
If you have switched from a different formulation
(e.g. from an injection of Flecainide) your doctor
should do so with caution and monitor you closely.
Adults:
Supraventricular arrhythmias (Irregular heart beat that
starts in the upper chambers of your heart)
• Tambocor 50mg tablets: The usual dose is one tablet
twice a day.
• Tambocor 100mg tablets: The usual dose is half a tablet
twice a day.
Your doctor may prescribe up to a total dose of 300 mg
daily (3 x 100 mg tablets or 6 x 50 mg tablets).
Ventricular arrhythmias (Irregular heart beat that
starts in the lower chambers of your heart)
• Tambocor 50mg tablets: The usual dose is two tablets
twice a day.
• Tambocor 100mg tablets: The usual dose is one tablet
twice a day

09.12.14 14:19

288

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.

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 tablets 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 is absorbed in children and infants.
If you take more Tambocor tablets than you should
If you accidentally take too much, immediately go to the
nearest hospital casualty department.
If you forget to take Tambocor tablets
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 tablets
Do not stop taking Tambocor tablets 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 tablets 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
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

1014_GI_Tambocor-Tabs_56UK1833210-02.indd 2

• 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 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 tablets
Keep out of the reach and sight of children.
Do not store above 30°C.
Keep tablets in the outer carton in order to protect from
light and moisture.
Do not use Tambocor tablets 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 tablets contain
• The active substance in Tambocor tablets is flecainide
acetate. Each 50 mg tablet contains 50 mg of flecainide
acetate. Each 100 mg tablet contains 100 mg flecainide
acetate.
• The other ingredients are pregelatinised starch, croscarmellose sodium, microcrystalline cellulose (E460i),
hydrogenated vegetable oil, magnesium stearate (E572).
What Tambocor tablets look like
Tambocor 50 mg tablets are round, white and marked
‘3M’ on one side and ‘TR50’ on the other.
Tambocor 100 mg tablets are round, white and marked
‘3M’ on one side and ‘TR100’ with a break line on the
other.
Both strengths of Tambocor tablets come in blister packs
containing 60 tablets.
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
Pharmaceuticals Ltd, Skyway House,
Parsonage Road, Takeley, Bishop‘s
Stortford, CM22 6PU, UK.
56UK1833210-02
6204 2362 0
Tambocor is a trademark of MEDA AB.
The Triangle Logo on the packaging is a
trademark of 3M and is used under license.

09.12.14 14:19

288

Your doctor may prescribe up to a total dose of
400 mg daily (4 x 100 mg tablets or 8 x 50 mg tablets).

Expand view ⇕

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.

Hide