Land: Armenië
Taal: Engels
Bron: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
lamotrigine
Alkaloid AD Skopje
N03AX09
lamotrigine
25mg
tablets
(30/3x10/) in blister
Prescription
Registered
2017-11-07
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 Lees het volledige document