Țară: Suedia
Limbă: suedeză
Sursă: Läkemedelsverket (Medical Products Agency)
lamotrigin
Ebb Medical AB
N03AX09
lamotrigine
100 mg
Tablett
laktosmonohydrat Hjälpämne; lamotrigin 100 mg Aktiv substans
Apotek
Receptbelagt
Lamotrigin
Avregistrerad
2015-02-11
1 SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Lamotrigin Bluefish 25 mg tablet Lamotrigin Bluefish 50 mg tablet Lamotrigin Bluefish 100 mg tablet Lamotrigin Bluefish 200 mg tablet 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet Lamotrigin Bluefish 25 mg contains 25 mg lamotrigine. Each tablet Lamotrigin Bluefish 50 mg contains 50 mg lamotrigine. Each tablet Lamotrigin Bluefish 100 mg contains 100 mg lamotrigine. Each tablet Lamotrigin Bluefish 200 mg contains 200 mg lamotrigine. Excipient(s) with known effect: Each tablet Lamotrigin Bluefish 25 mg contains 52.50 mg lactose monohydrate Each tablet Lamotrigin Bluefish 50 mg contains 105 mg lactose monohydrate Each tablet Lamotrigin Bluefish 100 mg contains 210 mg lactose monohydrate Each tablet Lamotrigin Bluefish 200 mg contains 420 mg lactose monohydrate For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet. Lamotrigin Bluefish 25 mg tablets are yellow, round tablets marked “25” on one side and with a score line on the other. Size: 6 mm. Lamotrigin Bluefish 50 mg tablets are yellow, round tablets marked “50” on one side and with a score line on the other. Size: 8 mm. Lamotrigin Bluefish 100 mg tablets are yellow, round tablets marked “100” on one side and with a score line on the other. Size: 10 mm. Lamotrigin Bluefish 200 mg tablets are yellow, capsule shaped, biconvex tablets marked “200” on one side. Size: 8x18 mm. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Epilepsy _Adults and adolescents aged 13 years and above_ Adjunctive or monotherapy treatment of partial seizures and generalised seizures, including tonic- clonic seizures. Seizures associated with Lennox-Gastaut syndrome. Lamotrigin Bluefish 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 tr Citiți documentul complet