Levetiracetam Tiefenbacher 1000 mg Filmdragerad tablett

Maa: Ruotsi

Kieli: ruotsi

Lähde: Läkemedelsverket (Medical Products Agency)

Aktiivinen ainesosa:

levetiracetam

Saatavilla:

Alfred E Tiefenbacher (GmbH & Co. KG)

ATC-koodi:

N03AX14

INN (Kansainvälinen yleisnimi):

levetiracetam

Annos:

1000 mg

Lääkemuoto:

Filmdragerad tablett

Koostumus:

levetiracetam 1000 mg Aktiv substans

Prescription tyyppi:

Receptbelagt

Terapeuttinen alue:

Levetiracetam

Valtuutuksen tilan:

Avregistrerad

Valtuutus päivämäärä:

2012-04-12

Valmisteyhteenveto

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Levetiracetam Tiefenbacher 250 mg film-coated tablets.
Levetiracetam Tiefenbacher 500 mg film-coated tablets.
Levetiracetam Tiefenbacher 750 mg film-coated tablets.
Levetiracetam Tiefenbacher 1000 mg film-coated tablets.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_Levetiracetam Tiefenbacher 250 mg film-coated tablets_
Each film-coated tablet contains 250 mg levetiracetam.
_Levetiracetam Tiefenbacher 500 mg film-coated tablets_
Each film-coated tablet contains 500 mg levetiracetam.
_Levetiracetam Tiefenbacher 750 mg film-coated tablets_
Each film-coated tablet contains 750 mg levetiracetam.
Excipient with known effect: Each film-coated tablet contains 0.17 mg
of sunset yellow FCF
(E110).
_Levetiracetam Tiefenbacher 1000 mg film-coated tablets_
Each film-coated tablet contains 1000 mg levetiracetam.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
_Levetiracetam Tiefenbacher 250 mg film-coated tablets_
Blue coloured, capsule shaped tablets (12,7 x 5,9 mm) with deep notch
on one side.
The
tablets can be divided into equal halves.
_Levetiracetam Tiefenbacher 500 mg film-coated tablets_
Yellow coloured, capsule shaped tablets (16,3 x 7,6 mm)with deep notch
on one side.
The
tablets can be divided into equal halves.
_Levetiracetam Tiefenbacher 750 mg film-coated tablets_
Orange coloured, capsule shaped tablets (18,6 x 8,65 mm) with deep
notch on one side.
The tablets can be divided into equal halves.
_Levetiracetam Tiefenbacher 1000 mg film-coated tablets_
White coloured, capsule shaped tablets (19,1 x 10,2 mm) with deep
notch on one side.
The
tablets can be divided into equal halves.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Levetiracetam Tiefenbacher is indicated as monotherapy in the
treatment of partial onset
seizures with or without secondary generalisation in adults and
adolescents from 16 years of
age with newly diagnosed epilepsy.
Levetiracetam Tiefenbacher is indicated as adjunctive therapy