LEVETIRACETAM MYLAN

国家: 爱尔兰

语言: 英文

来源: HPRA (Health Products Regulatory Authority)

有效成分:

LEVETIRACETAM

可用日期:

McDermott Laboratories Ltd t/a Gerard Laboratories

ATC代码:

N03AX14

INN（国际名称）:

LEVETIRACETAM

剂量:

1000 Milligram

药物剂型:

Film Coated Tablet

处方类型:

Product subject to prescription which may be renewed (B)

治疗领域:

levetiracetam

授权状态:

Not Marketed

授权日期:

2012-04-27

资料单张

PAGE 1 OF 6
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LEVETIRACETAM MYLAN 250 MG FILM-COATED TABLETS
LEVETIRACETAM MYLAN 500 MG FILM-COATED TABLETS
LEVETIRACETAM MYLAN 1000 MG FILM-COATED TABLETS
levetiracetam
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU OR YOUR CHILD START
TAKING THIS MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even
if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Levetiracetam Mylan is and what it is used for
2.
What you need to know before you take Levetiracetam Mylan
3.
How to take Levetiracetam Mylan
4.
Possible side effects
5.
How to store Levetiracetam Mylan
6.
Contents of the pack and other information
1.
WHAT LEVETIRACETAM MYLAN IS AND WHAT IT IS USED FOR
Levetiracetam Mylan contains the active substance levetiracetam, which
is an antiepileptic medicine (a
medicine used to treat seizures in epilepsy).
Levetiracetam Mylan is used:

on its own in adults and adolescents from 16 years of age with newly
diagnosed epilepsy, to treat a
certain form of epilepsy. Epilepsy is a condition where the patients
have repeated fits (seizures).
Levetiracetam Mylan is used for the epilepsy form in which the fits
initially affect only one side of the
brain, but could then extend to larger areas on both sides of the
brain (partial onset seizures with or
without secondary generalisation). Levetiracetam Mylan has been given
to you by your doctor to reduce
the number of fits.

as an add-on to other antiepileptic medicines to treat:
- partial onset seizures with or without generalisation in adults,
adolescents, children and infants from
one month of age
- myoclonic seizures (short, shock-like je

产品特点

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Levetiracetam Mylan 1000mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1000 mg tablet contains 1000 mg of levetiracetam
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated Tablets
A white film-coated, oblong shaped, biconvex, beveled-edge tablet of
10mm x 21 mm debossed with “M” on the left of
the score and “619” on the right of the score on one side of the
tablet and blank on the other 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 Mylan 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 Mylan 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 tolerabili