TAMBOCOR 100 MG TABLETS

Valsts: Izraēla

Valoda: angļu

Klimata pārmaiņas: Ministry of Health

Aktīvā sastāvdaļa:

FLECAINIDE ACETATE

Pieejams no:

MEGAPHARM LTD

ATĶ kods:

C01BC04

Zāļu forma:

TABLETS

Kompozīcija:

FLECAINIDE ACETATE 100 MG

Ievadīšanas:

PER OS

Receptes veids:

Required

Ražojis:

ROTTAPHARM LTD, IRELAND

Ārstniecības grupa:

FLECAINIDE

Ārstniecības joma:

FLECAINIDE

Ārstēšanas norādes:

Serious sustained life threatening ventricular arrhytmias that have not responsed to other drugs. Paroxymal atrial flutter.

Autorizācija datums:

2021-11-30

Lietošanas instrukcija

PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) -
1986
This medicine is dispensed with a physician’s prescription only
TAMBOCOR 50 MG TABLETS
TAMBOCOR 100 MG TABLETS
ACTIVE INGREDIENT:
EACH TABLET CONTAINS:
flecainide acetate 50 mg, 100 mg
For a list of inactive ingredients and allergens, see section 6
‘Additional information’.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE. This leaflet contains concise
information about this medicine. If you have any further questions,
consult your physician or pharmacist.
This medicine has been prescribed to treat your illness. Do not pass
it on to others. It may harm them,
even if it seems to you that their illness is similar to yours.
1.
WHAT IS THIS MEDICINE INTENDED FOR?
TAMBOCOR 50 MG TABLETS: to treat serious sustained life-threatening
supraventricular arrhythmias that
have not responded to other drugs.
To treat paroxysmal atrial fibrillation and atrial flutter.
TAMBOCOR 100 MG TABLETS: to treat serious sustained life-threatening
ventricular arrhythmias that
have not responded to other drugs.
To treat paroxysmal atrial flutter.
THERAPEUTIC GROUP: antiarrhythmic agents.
2.
BEFORE USING THIS MEDICINE
DO NOT USE THIS MEDICINE IF:

You are sensitive (allergic) to the active ingredient flecainide
acetate or to any of the other
ingredients in this medicine (see section 6 ‘Additional
information’).

You have heart failure or certain types of heart rhythm disorders.

You have heart valve disease.

You have a serious heart condition called cardiogenic shock. This is a
condition in which the
heart is unable to supply the body its required amount of blood and
this causes rapid breathing,
weakness, looking pale, confusion and can lead to loss of
consciousness.

You have a history of heart attack.

You have low blood pressure or slow heart rhythm.

You have a genetic disease (Brugada syndrome), which causes serious
heart rhythm disorders
and may cause sudden death.

You are already taking disopyr

Produkta apraksts

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
TAMBOCOR 100 MG TABLETS
TAMBOCOR 50 MG TABLETS
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Flecainide Acetate 50mg, 100mg.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Tablets.
50 mg tablets: White, circular, biconvex tablets. The tablet diameter
is approximately 6.35
mm.
100 mg tablets: White, circular, biconvex tablets with a break-line.
The tablet diameter is
approximately 8.5 mm.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Tambocor Tablets 50mg:
a) Serious sustained life threatening supraventricular arrhythmias
that have not
responded to other drugs.
b) Paroxysmal atrial fibrillation and atrial flutter.
Tambocor Tablets 100mg:
a) Serious sustained life threatening ventricular arrhythmias that
have not responded to
other drugs.
b) Paroxysmal atrial flutter.
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 TABLETS is not recommended in children under 12, as
there is
insufficient evidence of its use in this age group.
Elderly Patients: The rate of flecainide elimination from plasma may
be reduced in
elderly people. This should be taken into consideration when making
dose adjustments.
Plasma levels: Based on PVC suppression, it appears that plasma levels
of 200-1000
ng/ml may be needed to obtain the maximum thera