Levetiracetam Teva

Country: Եվրոպական Միություն

language: անգլերեն

source: EMA (European Medicines Agency)

active_ingredient:

levetiracetam

MAH:

Teva B.V.

ATC_code:

N03AX14

INN:

levetiracetam

therapeutic_group:

Nervous system

therapeutic_area:

Epilepsy

therapeutic_indication:

Levetiracetam Teva 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 Teva 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.

leaflet_short:

Revision: 20

authorization_status:

Authorised

authorization_date:

2011-08-25

PIL

37
B. PACKAGE LEAFLET
38
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LEVETIRACETAM TEVA 250 MG FILM-COATED TABLETS
LEVETIRACETAM TEVA 500 MG FILM-COATED TABLETS
LEVETIRACETAM TEVA 750 MG FILM-COATED TABLETS
LEVETIRACETAM TEVA 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 Teva is and what it is used for
2.
What you need to know before you take Levetiracetam Teva
3.
How to take Levetiracetam Teva
4.
Possible side effects
5.
How to store Levetiracetam Teva
6.
Contents of the pack and other information
1.
WHAT LEVETIRACETAM TEVA IS AND WHAT IT IS USED FOR
Levetiracetam is an antiepileptic medicine (a medicine used to treat
seizures in epilepsy).
Levetiracetam Teva 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 m

SPC

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Levetiracetam Teva 250 mg film-coated tablets
Levetiracetam Teva 500 mg film-coated tablets
Levetiracetam Teva 750 mg film-coated tablets
Levetiracetam Teva 1000 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Levetiracetam Teva 250 mg film-coated tablets
Each film-coated tablet contains 250 mg levetiracetam.
Levetiracetam Teva 500 mg film-coated tablets
Each film-coated tablet contains 500 mg levetiracetam.
Excipient with known effect: Each film-coated tablet contains 0.06 mg
colouring agent tartrazine
(E102).
Levetiracetam Teva 750 mg film-coated tablets
Each film-coated tablet contains 750 mg levetiracetam.
Excipient with known effect: Each film-coated tablet contains 0.35 mg
colouring agent sunset yellow
(E110).
Levetiracetam Teva 1000 mg film-coated tablets
Each film-coated tablet contains 1000 mg levetiracetam.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Levetiracetam Teva 250 mg film-coated tablets
Blue, oblong shaped, film coated tablets, scored on one side and
debossed with "9" on one side of the
score and with "3" on the other side of the score. Debossed with
"7285" on the other side of the tablet.
The scoreline is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
Levetiracetam Teva 500 mg film-coated tablets
Yellow, oblong shaped, film coated tablets, scored on one side and
debossed with "9" one side of the
score and with "3" on the other side of the score. Debossed with
"7286" on the other side of the tablet.
The scoreline is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
Levetiracetam Teva 750 mg film-coated tablets
Orange, oblong shaped, film coated tablets, scored on one side and
debossed with "9" on one side of
the score and with "3" on the other side of the score. Debossed with
"7287" on the other side of the
tablet. The scoreline is only to facilitate breaking for ease of
sw