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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.
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 h
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产品特点
1. NAME OF THE MEDICINAL PRODUCT
Tambocor™100 mg tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 100 mg of flecainide acetate
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Tablet
4. CLINICAL PARTICULARS
Tambocor is a potent sodium channel blocking agent for the treatment of theconditions listed
below:
The effect on the JT interval is insignificant at
therapeutic levels.
4.1 THERAPEUTIC INDICATIONS
Tambocor tablets are indicated for:
a) AV nodal reciprocating tachycardia; arrhythmias associated with Wolff-Parkinson-White
Syndrome and similar conditions with accessory pathways.
b) Paroxysmal atrial
fibrillation in patients with disabling symptoms when treatment need
has
been established and in
the absence of left ventricular dysfunction
(see 4.4, Special warnings
and special precautions for use). Arrhythmias of recent onset
will respond more readily.
c) Symptomatic sustained ventricular tachycardia.
d) Premature ventricular contractions and/or non-sustained ventricular tachycardia which are
causing disabling symptoms, where these are
resistant to other therapy or when other treatment
has not been tolerated.
Tambocor tablets can be used
for the maintenance of normal rhythm following conversion by
other means.
Tambocor tablets are for oral administration.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adults: Supraventricular arrhythmias:
The recommended starting dosage is 50mgtwice daily
and most patients will be controlled at this dose. If required
the dose may be increased to a
maximum of 300mg daily.
Ventricular arrhythmias: The recommended starting dosage is 100mg twice daily.
The maximum daily dose is 400mg and
this is normally reserved for patients of large build or
where rapid c
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