Carbamazepine tablets

Land: Armenien

Sprache: Englisch

Quelle: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Wirkstoff:

carbamazepine

Verfügbar ab:

Arpimed LLC

ATC-Code:

N03AF01

INN (Internationale Bezeichnung):

carbamazepine

Dosierung:

200mg

Darreichungsform:

tablets

Einheiten im Paket:

(40/4x10/) in blister, (50/5x10/) in blister

Verschreibungstyp:

Prescription

Berechtigungsstatus:

Registered

Berechtigungsdatum:

2019-10-29

Fachinformation

SUMMARY PRODUCT CHARACTERISTIC (SMPC)
CARBAMAZEPINE 200 MG TABLETS
1. NAME OF THE MEDICAL PRODUCT – CARBAMAZEPINE
1.2. INTERNATIONAL NON-PROPERTY NAME – CARBAMAZEPINE
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 200 mg of carbamazepine
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
White or off white, round biconvex, scored on one side tablets,
odorless.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Epilepsy - generalised tonic-clonic and partial seizures.
Note: Carbamazepine is not usually effective in absences (petit mal)
and myoclonic seizures.
Moreover, anecdotal evidence suggests that seizure exacerbation may
occur in patients with
atypical absences. The paroxysmal pain of trigeminal neuralgia.
For the prophylaxis of manic-depressive psychosis in patients
unresponsive to lithium therapy.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Carbamazepin is given orally, usually in two or three divided doses.
Carbamazepine
may be taken during, after or between meals, with a little liquid e.g.
a glass of water.
Before deciding to initiate treatment, patients of Han Chinese and
Thai origin should whenever
possible
be
screened
for
HLA-B*1502
as
this
allele
strongly
predicts
the
risk
of
severe
carbamazepine-associated Stevens-Johnson syndrome (See information on
genetic testings and
cutaneous reactions in section 4.4).
_ _
_Epilepsy_:
The dose of carbamazepine should be adjusted to the needs of the
individual patient to
achieve adequate control of seizures. Determination of plasma levels
may help in
establishing the optimum dosage. In the treatment of epilepsy, the
dose of carbamazepine
usually requires total plasma-carbamazepine concentrations of about 4
to 12
micrograms/mL (17 to 50 micromoles/litre) (see warnings and
precautions).
_Adults:_ It is advised that with all formulations of Carbamazepine, a
gradually increasing
dosage scheme is used and this should be adjusted to suit the needs of
the individual
patient.
Carbamazepine should be taken in a number of d