KEPPRA 500 MG

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

LEVETIRACETAM

متاح من:

CTS LTD

ATC رمز:

N03AX14

الشكل الصيدلاني:

FILM COATED TABLETS

تركيب:

LEVETIRACETAM 500 MG

طريقة التعاطي:

PER OS

نوع الوصفة الطبية :

Required

المصنعة من قبل:

UCB PHARMA S.A., BELGIUM

المجموعة العلاجية:

LEVETIRACETAM

المجال العلاجي:

LEVETIRACETAM

الخصائص العلاجية:

- Keppra 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. - Keppra is indicated as adjunctive therapy in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with Juvenile Myoclonic Epilepsy. - Keppra 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. - Keppra is indicated as adjunctive therapy in the treatment of primary gneralized tonic-clonic seizures in adults and adolescents from 12 years of age with idiopathic generalised epilepsy.

تاريخ الترخيص:

2015-02-28

نشرة المعلومات

PATIENT LEAFLET IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986
The medicine is dispensed with a doctor’s prescription only
Keppra 250 mg coated tablets
Keppra 500 mg coated tablets
Keppra 1000 mg coated tablets
The active ingredient and its quantity:
Each tablet of Keppra 250 mg contains:
Levetiracetam 250 mg
Each tablet of Keppra 500 mg contains:
Levetiracetam 500 mg
Each tablet of Keppra 1000 mg contains:
Levetiracetam 1000 mg
For a list of inactive ingredients and allergens - see section 6.
Read the entire leaflet carefully before using the medicine. This
leaflet contains concise information about the medicine. If you have
any other questions, refer to the doctor or the pharmacist.
This medicine has been prescribed for treatment of 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 children 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 Generalized Epilepsy.
Therapeutic class: The active ingredient belongs to the
anticonvulsants group.
2. Before using the medicine:
Do not use this medicine if:
•
You are sensitive (allergic) to Levetiracetam or other
Pyrrolidone derivatives or any of the additional components the
medicine contains (see section 6 below).
Special warnings regarding the use of the medicine:
Before treatment with Keppra, inform the doctor if:
•
You suffer from renal 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

خصائص المنتج

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Keppra 250 mg film-coated tablets.
Keppra 500 mg film-coated tablets.
Keppra 1000 mg film-coated tablets.
Keppra 100 mg/ml oral solution.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet of Keppra 250 mg film-coated tablets contains
250 mg levetiracetam.
Each film-coated tablet of Keppra 500 mg film-coated tablets contains
500 mg levetiracetam
Each film-coated tablet of Keppra 1000 mg film-coated tablets contains
1000 mg levetiracetam
Each ml of Keppra oral solution contains 100 mg levetiracetam.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Keppra 250 mg:
Blue, oblong, scored and debossed with the code “ucb” and
“250” on one side
.
Keppra 500 mg:
Yellow, oblong, scored and debossed with the code “ucb” and
“500” on one side.
Keppra 1000 mg:
White, oblong, scored and debossed with the code “ucb” and
“1000” on one side.
The score line is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
Keppra Oral solution: Clear liquid.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Keppra 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.
Keppra 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.

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 dos