LEVETIRACETAM PENSA 250 Milligram Film Coated Tablet
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
30-04-2024
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Active ingredient:
LEVETIRACETAM
Available from:
Pensa Pharma AB
INN (International Name):
LEVETIRACETAM
Dosage:
250 Milligram
Pharmaceutical form:
Film Coated Tablet
Authorization status:
Authorised
Authorization date:
0000-00-00
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Levetiracetam Pensa 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, film-coated tablet scored in one side.
The scoreline is only to facilitate breaking for ease of swallowing and not to divide into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Levetiracetam Pensa is indicated as monotherapy in the treatment of partial onset seizures with or without
secondary generalisation in patients from 16 years of age with newly diagnosed epilepsy.
Levetiracetam Pensa is indicated as adjunctive therapy
•
in the treatment of partial onset seizures with or without secondary generalisation in adults, 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
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