TIMONIL 600 RETARD

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

CARBAMAZEPINE

Available from:

MEGAPHARM LTD

ATC code:

N03AF

Pharmaceutical form:

TABLETS PROLONGED RELEASE

Composition:

CARBAMAZEPINE 600 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

DESITIN ARZNEIMITTEL GMBH, GERMANY

Therapeutic group:

CARBOXAMIDE DERIVATIVES

Therapeutic indications:

Treatment of epilepsy, trigeminal neuralgia, mania, prophylactic in manic depressive illness .

Authorization date:

2020-09-30

Summary of Product characteristics

Megapharm Ltd.
Timonil SPC
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
TIMONIL 300 RETARD,
300 mg/prolonged-release tablets
TIMONIL 600 RETARD,
600 mg/prolonged-release tablets
Active substance: Carbamazepine
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 prolonged-release tablet conains: 300 or 600 mg carbamazepine.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Prolonged-release tablets
Timonil 300 retard
Round, white, flat tablet cross-scored on both sides
The tablet can be divided into equal doses.
Timonil 600 retard
White, oval, biconvex tablet scored on one side and engraved ‘T’
on the other side and
with a protruding edge.
The tablet can be divided into equal doses.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
For the treatment of:
-
Epilepsy
-
Trigeminal neuralgia
-
Mania
-
Prophylactic in manic depressive illness.
Note:
When switching from previous (non-prolonged release) pharmaceutical
forms to Timonil
retard, ensure a sufficiently high serum carbamazepine concentration.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Treatment with Timonil retard should be started with a low,
individualised, initial dose
depending on the nature and severity of the disease. This is then
gradually increased until
the most effective maintenance dose is found.
The daily dose is generally given in 1 – 2 single doses.
The general daily dosage range lies between 400 -1200 mg
carbamazepine.
A total daily dose of 1600 mg should generally not be exceeded, since
increased side effects
occur at higher doses.
Page 1 of 22
Megapharm Ltd.
Timonil SPC
The therapeutic dose should be established, especially in combination
therapy, by
measuring the plasma levels and depending on the efficacy. Experience
has shown that the
therapeutic carbamazepine concentration is between 4 and 12 µg/mL.
In some instances the required dosage can vary considerably from the
specified initial and
maintenance doses (e.g. due to acceleration of metabolism by enzyme
induction or due to
drug in