TEGRETOL 200 MG

Država: Izrael

Jezik: angleščina

Source: Ministry of Health

Aktivna sestavina:

CARBAMAZEPINE

Dostopno od:

NOVARTIS ISRAEL LTD

Koda artikla:

N03AF01

Farmacevtska oblika:

TABLETS

Sestava:

CARBAMAZEPINE 200 MG

Pot uporabe:

PER OS

Tip zastaranja:

Required

Izdeluje:

NOVARTIS FARMA S.P.A., ITALY

Terapevtska skupina:

CARBAMAZEPINE

Terapevtsko območje:

CARBAMAZEPINE

Terapevtske indikacije:

Epilepsy, trigeminal neuralgia, diabetes insipidus, mania, prophylactic in manic depressive illness.

Datum dovoljenje:

2021-04-30

Navodilo za uporabo

PATIENT PACKAGE INSERT IN ACCORDANCE
WITH THE PHARMACISTS’ REGULATIONS
(PREPARATIONS) – 1986
The medicine is dispensed with a
doctor’s prescription only
TEGRETOL
®
CR 200 mg
Slow Release Tablets
Active ingredient:
Each tablet contains:
Carbamazepine 200 mg
TEGRETOL
®
CR 400 mg
Slow Release Tablets
Active ingredient:
Each tablet contains:
Carbamazepine 400 mg
TEGRETOL
®
200 mg
Tablets
Active ingredient:
Each tablet contains:
Carbamazepine 200 mg
TEGRETOL
®
SYRUP 2%
Syrup
Active ingredient:
Each 5 ml contains:
Carbamazepine 100 mg
Inactive and allergenic ingredients in the
preparation:
See section 6 ‘Further Information’ and ‘Important
information about some of the ingredients of the
medicine’ in section 2.
Read the leaflet carefully in its entirety before
using the medicine. This leaflet contains concise
information about the medicine. If you have further
questions, refer to the doctor or pharmacist.
This medicine has been prescribed for you. Do not
pass it on to others. It may harm them, even if it
seems to you that their medical condition is similar.
1. WHAT IS THE MEDICINE INTENDED FOR?
Tegretol has a number of uses:
• To treat epilepsy, a condition of recurrent seizures
(convulsions). There are many and varied types
of seizures, ranging from mild to severe.
• To treat sudden recurrent attacks of pain in the
face, known as trigeminal neuralgia.
• To treat diabetes insipidus, a condition of
increased thirst and urination.
• To treat mania, a mental condition with episodes
of hyperactivity, elation or nervousness.
• For the preventative treatment of bipolar affective
disorder (manic depression), in which there are
periods of mania alternating with periods of
depression.
Therapeutic group:
Antiepileptic, neurotropic, psychotropic.
Tegretol belongs to a class of medicines called
anticonvulsants.
These medicines apparently work by modulating the
manner in which signals are conveyed in the brain
by nerves so that attacks will not occur. Tegretol
also regulates other neural functions in the

Lastnosti izdelka

1
TEG API FEB21 V6 REF: New Zealand September20
1.
PRODUCT NAME
TEGRETOL
®
200 mg Tablets
TEGRETOL
®
200 mg CR Tablets
TEGRETOL
®
400 mg CR Tablets
TEGRETOL
®
Syrup 2%
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE
Tablets
•
200 mg: Each tablet contains 200 mg carbamazepine
CR tablets
•
200
mg:
Each
slow-release
film-coated,
divisible
tablet
contains
200
mg
carbamazepine
•
400
mg:
Each
slow-release
film-coated,
divisible
tablet
contains
400
mg
carbamazepine
Syrup
•
5 mL: Each 5 mL of syrup contains 100 mg carbamazepine
For a full list of excipients, see section 6.1. The syrup contains
propylene glycol (refer to section
4.4, subsection _Excipients of known effect_).
3.
PHARMACEUTICAL FORM
•
Tablet containing 200mg carbamazepine. Round, white, flat tablet, 9mm
in diameter,
with bevelled edges. Imprinted CG on one side, and G/K on the scored
side. The tablet
can be divided into equal doses.
•
Controlled Release Tablet containing 200mg carbamazepine.
Beige-orange, ovaloid-
shaped, film-coated divisible tablet with slightly convex faces.
Approximate length is
12.2mm, and approximate width is 5.6mm. Both sides are scored; one
side is imprinted
C/G, and the other side H/C. The tablet can be divided into equal
doses.
•
Controlled Release Tablet containing 400mg carbamazepine.
Brown-orange, ovaloid-
shaped, film-coated divisible tablet, with slightly convex faces.
Approximately 16.7mm
in length, and approximately 6.7mm in width. Imprinted CG/CG on one
side, and
ENE/ENE on the other side; both sides are scored. The tablet can be
divided into equal
doses.
•
Syrup containing 100mg/5mL carbamazepine. A viscous white suspension
with a
caramel odour and taste. It contains sorbitol (875mg/5mL), which is
converted slowly
into glucose, making the syrup suitable for diabetics.
2
TEG API JUL23 V7 REF: New Zealand May 2023
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Epilepsy, Trigeminal neuralgia, Diabetes insipidus, Mania,
prophylactic in manic-depressive
illness.
4.2
POSOLOGY AND METHOD OF