Tambocor 50mg tablets

Држава: Велика Британија

Језик: Енглески

Извор: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активни састојак:

Flecainide acetate

Доступно од:

Teva UK Ltd

АТЦ код:

C01BC04

INN (Међународно име):

Flecainide acetate

Дозирање:

50mg

Фармацеутски облик:

Oral tablet

Пут администрације:

Oral

Класа:

No Controlled Drug Status

Тип рецептора:

Valid as a prescribable product

Резиме производа:

BNF: 02030200; GTIN: 5000485084101

Информативни летак

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TAMBOCOR
® 50 MG & 100 MG TABLETS
Flecainide acetate
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 pharmacist.

This medicine has been prescribed for you only. Do not pass it on to
others. It may harm
them, even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
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 beating 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 this medicine (listed in Section 6)
• have heart failure
• have cardiogenic shock (your heart is unable to pump as much blood
as your body needs)
• have heart block (your heart misses beats)
• have long-standing atrial fibrillation (rapid contractions of
muscles in the heart)
• have or have ever had any heart problems, including problems with
the valves in your hear

Карактеристике производа

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Tambocor
®
50 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains flecainide acetate 50 mg
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet
White, circular, biconvex tablet coded ‘TR50’ on one face and
‘3M’ on the other
face.
4
CLINICAL PARTICULARS
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
section 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
50mg twice 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 control of the arrhythmia is
required.
After 3-5 days it is recommended that the dosage be progressively
adjusted to
the lowest level which maintains control of the arrhythmia. It may be
possible
to reduce dosage during long-term treatment.
Children: Tambocor is not recommended in children under 12, as there
is
insufficient evi