LEVETIRACETAM AUROBINDO 250 Milligram Film Coated Tablet

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

LEVETIRACETAM

Available from:

Milpharm Limited

ATC code:

N03AX14

INN (International Name):

LEVETIRACETAM

Dosage:

250 Milligram

Pharmaceutical form:

Film Coated Tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Other antiepileptics

Authorization status:

Authorised

Authorization date:

2011-11-04

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Levetiracetam Aurobindo 250 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 250 mg levetiracetam.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Blue oval shaped biconvex film-coated tablets debossed with a deep
break line separating 'E'
and '10'
on one side and
plain on the other side. The size is 14.7 mm X 6.9 mm.
The tablet can be divided into equal doses.
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, children
and infants from 1 month of age with epilepsy.
•
in the treatment of myoclonic seizures in adults and adolescents from
12 years of age with Juvenile Myoclonic
Epilepsy.
•
in the treatment of 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
_Monotherapy for adults and adolescents from 16 years of age_
The recommended starting dose is 250 mg twice daily which should be
increased to an initial therapeutic dose of 500
mg twice daily after two weeks. The dose can be further increased by
250 mg twice daily every two weeks depending
upon the clinical response. The maximum dose is 1500 mg twice daily.
_Add-on therapy for adults (_
_18 years) and adolescents (12 to 17 years) weighing 50 kg or more_
The initial therapeutic dose is 500 mg twice daily. This dose can be
started on the first day of treatment.
Depending upon the clinical response and tolerability, the daily dose
can be increased up to 1,500 mg twice daily. Dose
changes can be made in 500 mg twice da