LEVETRIM 500

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

LEVETIRACETAM

Available from:

TRIMA ISRAEL PHARMACEUTICAL PRODUCTS MAABAROT LTD

ATC code:

N03AX14

Pharmaceutical form:

FILM COATED TABLETS

Composition:

LEVETIRACETAM 500 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

TRIMA ISRAEL PHARMACEUTICAL PRODUCTS MAABAROT LTD, ISRAEL

Therapeutic group:

LEVETIRACETAM

Therapeutic area:

LEVETIRACETAM

Therapeutic indications:

- Levetrim is indicated as adjunctive therapy in the treatment of partial onset seizures with or without secondary generalisation in adults and children from 4 years of age with epilepsy. - Levetrim is indicated as adjunctive therapy in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with Juvenile Myoclonic Epilepsy. - Levetrim is indicated as monotherapy in the treatment of partial onset seizures with or without secondary generalization in patient from 16 years of age with newly diagnosed epilepsy. - Levetrim is indicated in the treatment of primary gneralized tonic-clonic seizures in adults and adolescents from 12 years of age with idiopathic generalised epilepsy.

Authorization date:

2015-05-31

Patient Information leaflet

PATIENT LEAFLET IN ACCORDANCE
WITH THE PHARMACISTS’ REGULATIONS
(PREPARATIONS) – 1986
The medicine is dispensed with a doctor’s
prescription only
Levetrim 250
Levetrim 500
Levetrim 1000
Coated tablets
The active ingredient and its quantity:
Each tablet of Levetrim 250 contains levetiracetam
250 mg
Each tablet of Levetrim 500 contains levetiracetam
500 mg
Each tablet of Levetrim 1000 contains levetiracetam
1000 mg
Inactive ingredients and allergens: see section 6
“Additional information”.
Read the entire leaflet carefully before using the
medicine. This leaflet contains concise information
about the medicine. If you have any other questions,
contact the doctor or the pharmacist.
This medicine has been prescribed to treat your
illness. Do not pass it on to others. It may harm them
even if it seems to you that their medical condition
is similar.
This medicine is not intended for use in babies and
children under 4 years of age.
1. What is the medicine intended for?
1. As monotherapy in different types of epilepsy in
adults from 16 years of age.
2. As
adjunctive
therapy
to
other
anti-epileptic
medicines in:
Adult and pediatric patients from 4 years of
age with different types of epilepsy.
Adult and adolescent patients from 12 years
of age with Juvenile Myoclonic Epilepsy or
Idiopathic Generalised Epilepsy.
Therapeutic group: anticonvulsants.
2. Before using the medicine
Do not use this medicine if:
You are sensitive (allergic) to levetiracetam or
other pyrrolidone derivatives or to any of the
additional ingredients contained in the medicine
(see section 6).
Special
warnings
regarding
the
use
of
the
medicine
BEFORE TREATMENT WITH LEVETRIM, INFORM THE DOCTOR
if:
You suffer from renal function impairment. The
doctor may change the medicine’s dosage.
You
observed
slower
growth
or
unexpected
puberty of your child, contact the attending doctor.
You experience symptoms of depression and/or
suicidal thoughts. A small number of people who
were treated with anti-epileptic medicines such as
Levetrim have experienced