Lamotrigin BMM Pharma 100 mg Tablett

Negara: Swedia

Bahasa: Swedia

Sumber: Läkemedelsverket (Medical Products Agency)

Bahan aktif:

lamotrigin

Tersedia dari:

Ebb Medical AB

Kode ATC:

N03AX09

INN (Nama Internasional):

lamotrigine

Dosis:

100 mg

Bentuk farmasi:

Tablett

Komposisi:

laktosmonohydrat Hjälpämne; lamotrigin 100 mg Aktiv substans

Kelas:

Apotek

Jenis Resep:

Receptbelagt

Area terapi:

Lamotrigin

Status otorisasi:

Avregistrerad

Tanggal Otorisasi:

2015-02-11

Karakteristik produk

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