Levetiracetam AMETAS 100 mg/ml, Drank

Land: Nederland

Taal: Nederlands

Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Werkstoffen:

LEVETIRACETAM 100 mg/ml

Beschikbaar vanaf:

AMETAS medical GmbH Christophstrasse 6-8 09212 LIMBACH-OBERFROHNA (DUITSLAND)

INN (Algemene Internationale Benaming):

LEVETIRACETAM 100 mg/ml

farmaceutische vorm:

Drank

Samenstelling:

BANANENSMAAKSTOF ; CITROENZUUR 1-WATER (E 330) ; METHYLPARAHYDROXYBENZOAAT (E 218) ; NATRIUMCHLORIDE ; PROPYLPARAHYDROXYBENZOAAT ; SACCHAROIDE NATRIUM X-WATER (E 954) ; SORBITOL, VLOEIBAAR, NIET-KRISTALLISEERBAAR (E 420) ; TRINATRIUMCITRAAT 2-WATER (E 331) ; WATER, GEZUIVERD, BANANENSMAAKSTOF ; CITROENZUUR 1-WATER (E 330) ; METHYLPARAHYDROXYBENZOAAT (E 218) ; NATRIUMCHLORIDE ; PROPYLPARAHYDROXYBENZOAAT (E 216) ; SACCHAROIDE NATRIUM X-WATER (E 954) ; SORBITOL, VLOEIBAAR, NIET-KRISTALLISEERBAAR (E 420) ; TRINATRIUMCITRAAT 2-WATER (E 331) ; WATER, GEZUIVERD

Toedieningsweg:

Oraal gebruik

Autorisatie datum:

1900-01-01

Bijsluiter

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LEVETIRACETAM AMETAS 100 MG/ML, DRANK
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 AMETAS is and what it is used for
2.
What you need to know before you take Levetiracetam AMETAS
3.
How to take Levetiracetam AMETAS
4.
Possible side effects
5.
How to store Levetiracetam AMETAS
6.
Contents of the pack and other information
1.
WHAT LEVETIRACETAM AMETAS IS AND WHAT IT IS USED FOR
Levetiracetam is an antiepileptic medicine (a medicine used to treat
seizures in epilepsy).
Levetiracetam AMETAS 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 and adolescents from 12 years of age with juvenile myoclonic
epilepsy
-
primary generalised tonic-clonic seizures (major fits, inclu

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Levetiracetam AMETAS 100 mg/ml, Drank
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 100 mg levetiracetam
Excipients with known effect:
Each ml contains 1 mg of methyl parahydroxybenzoate (E218), 0.2 mg of
propyl
parahydroxybenzoate (E216), 0.02 mg benzyl alcohol (E1519), 2.9 mg
propylene glycol (E1520) and
300 mg sorbitol liquid (non crystallising) (E420).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral solution.
Clear liquid.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Levetiracetam AMETAS 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 AMETAS 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