LEVETIRACETAM SANDOZ FILM COATED TABLETS 500MG

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Levetiracetam

Available from:

SANDOZ SINGAPORE PTE. LTD.

ATC code:

N03AX14

Pharmaceutical form:

TABLET, FILM COATED

Composition:

Levetiracetam 500mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

Lek Pharmaceuticals d.d.

Authorization status:

ACTIVE

Authorization date:

2015-12-17

Summary of Product characteristics

1.
NAME OF THE MEDICINAL PRODUCT
Levetiracetam Sandoz Film Coated Tablets 250 mg
Levetiracetam Sandoz Film Coated Tablets 500 mg
Levetiracetam Sandoz Film Coated Tablets 1000 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Levetiracetam Sandoz Film Coated Tablets 250 mg:
Each film-coated tablet contains 250 mg levetiracetam.
Levetiracetam Sandoz Film Coated Tablets 500 mg:
Each film-coated tablet contains 500 mg levetiracetam.
Levetiracetam Sandoz Film Coated Tablets 1000 mg:
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 Sandoz Film Coated Tablets 250 mg:
Light blue, oval, biconvex film-coated tablets, scored on both sides,
debossed with LVT / 250 on one
side.
Levetiracetam Sandoz Film Coated Tablets 500 mg:
Yellow, oval, biconvex film-coated tablets, scored on both sides,
debossed with LVT / 500 on one
side.
Levetiracetam Sandoz Film Coated Tablets 1000 mg:
White, oval, biconvex film-coated tablets, scored on both sides,
debossed with LVT / 1000 on one
side.
The tablet can be divided into equal halves.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Levetiracetam 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 is indicated as adjunctive therapy in the treatment of:
•
partial onset seizures with or without secondary generalisation in
adults, adolescents and
children from 4 years of age with epilepsy.
•
myoclonic seizures in adults and adolescents from 12 years of age with
Juvenile Myoclonic
Epilepsy.
•
primary generalised tonic-clonic seizures in adults and adolescents
from 12 years of age
with Idiopathic Generalised Epilepsy.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
ADULTS
•
Monotherapy
_ _
Adults and adolescents from 16 years of age
The recommended starting dose is 250 mg twice daily which should be
increased to an initial