Levetiracetam Clonmel 500 mg film-coated tablets

Država: Irska

Jezik: angleščina

Source: HPRA (Health Products Regulatory Authority)

Aktivna sestavina:

Levetiracetam

Dostopno od:

Clonmel Healthcare Ltd

Koda artikla:

N03AX14

INN (mednarodno ime):

Levetiracetam

Odmerek:

500 milligram(s)

Farmacevtska oblika:

Film-coated tablet

Terapevtsko območje:

levetiracetam

Status dovoljenje:

Marketed

Datum dovoljenje:

2021-02-12

Navodilo za uporabo

Page 1 of 6
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Levetiracetam Clonmel 250 mg film-coated tablets
Levetiracetam Clonmel 500 mg film-coated tablets
Levetiracetam Clonmel 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 Clonmel is and what it is used for
2.
What you need to know before you take Levetiracetam Clonmel
3.
How to take Levetiracetam Clonmel
4.
Possible side effects
5.
How to store Levetiracetam Clonmel
6.
Contents of the pack and other information
1.
WHAT LEVETIRACETAM CLONMEL IS AND WHAT IT IS USED FOR
Levetiracetam is an antiepileptic medicine (a medicine used to treat
seizures in epilepsy).
Levetiracetam Clonmel 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 is used for the epilepsy form in which the fits
initially affect only one side of the brain,
but could thereafter extend to larger areas on both sides of the brain
(partial onset seizure with or
without secondary generalisation). Levetiracetam 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 jerks of a muscle or group of
muscles) in adults a

Lastnosti izdelka

Health Products Regulatory Authority
09 November 2021
CRN00CJ41
Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Levetiracetam Clonmel 500 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 500 mg levetiracetam.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Yellow, oval shaped film coated tablets with a score line on one side
with dimensions 16.5 x 7.7 mm. The tablet can be divided
into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Levetiracetam Clonmel 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 Clonmel 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
_Partial onset seizures_
The recommended dosing for monotherapy (from 16 years of age) and
adjunctive therapy is the same; as outlined below.
_All indications_
_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. However, a lower initial
dose of 250 mg twice daily may be given based on physician assessment
of seizure reduction versus potential side effects. This
can be increased to 500 mg twice daily after two weeks.
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 250 mg