Lamal 25mg tablets

Riik: Armeenia

keel: inglise

Allikas: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Toimeaine:

lamotrigine

Saadav alates:

Alkaloid AD Skopje

ATC kood:

N03AX09

INN (Rahvusvaheline Nimetus):

lamotrigine

Annus:

25mg

Ravimvorm:

tablets

Ühikuid pakis:

(30/3x10/) in blister

Retsepti tüüp:

Prescription

Volitamisolek:

Registered

Loa andmise kuupäev:

2017-11-07

Toote omadused

LAMAL
®
25 mg, 50 mg, 100 mg and 200 mg tablets
Summary of Product Characteristics
1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
LAMAL
® 25 mg tablets
LAMAL
® 50 mg tablets
LAMAL
® 100 mg tablets
LAMAL
® 200 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 25 mg, 50 mg, 100 mg or 200 mg of lamotrigine.
Excipients:
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
*
tablets
Lamal 25 mg tablets – white, round, biconvex tablets.
Lamal 50 mg, 100 mg, 200 mg tablets – white, round, biconvex tablets
with break mark on
one side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
EPILEPSY
_Adults and adolescents aged 13 years and above _
-
Adjunctive or monotherapy treatment of partial seizures and
generalized seizures,
including tonic-clonic seizures.
-
Seizures associated with Lennox-Gastaut Syndrome. Lamotrigin is given
as adjunctive
therapy but may be the initial antiepileptic drug (AED) to start with
in Lennox-Gastaut
Syndrome.
_Children and adolescents aged 2 to 12 years _
-
Adjunctive treatment of partial seizures and generalized seizures,
including tonic-clonic
seizures and the seizures associated with Lennox-Gastaut Syndrome.
-
Monotherapy of typical absence seizures.
BIPOLAR DISORDER
_Adults aged 18 years and above _
_-_
Prevention of depressive episodes in patients with bipolar I disorder
who experience
predominantly depressive episodes (see section 5.1).
Lamotrigin is not indicated for the acute treatment of manic or
depressive episodes.
LAMAL
®
25 mg, 50 mg, 100 mg and 200 mg tablets
Summary of Product Characteristics
2
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Lamal tablets should be swallowed whole, and should not be chewed or
crushed.
If the calculated dose of lamotrigine (e.g. for use in children and
patients with hepatic
impairment) does not equate to whole tablets the dose to be
administered is that equal to the
lower number of whole tablets.
Restarting Therapy
Prescribers should assess the need for escalation to mainten