Levetiracetam Apotex 1000 mg, filmomhulde tabletten

מדינה: הולנד

שפה: הולנדית

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

מרכיב פעיל:

LEVETIRACETAM

זמין מ:

Apotex Europe BV Archimedesweg 2 2333 CN LEIDEN

קוד ATC:

N03AX14

INN (שם בינלאומי):

LEVETIRACETAM

טופס פרצבטיות:

Filmomhulde tablet

הרכב:

CITROENZUUR 0-WATER (E 330) ; COPOVIDON ; HYPROLOSE (E 463) ; HYPROMELLOSE (E 464) ; MACROGOL 8000 ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171), CITROENZUUR 0-WATER (E 330) ; COPOVIDON ; HYPROLOSE (E 463) ; HYPROMELLOSE (E 464) ; MACROGOL 8000 ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171),

מסלול נתינה (של תרופות):

Oraal gebruik

איזור תרפויטי:

Levetiracetam

leaflet_short:

Hulpstoffen: CITROENZUUR 0-WATER (E 330); COPOVIDON; HYPROLOSE (E 463); HYPROMELLOSE (E 464); MACROGOL 8000; SILICIUMDIOXIDE (E 551); TITAANDIOXIDE (E 171);

תאריך אישור:

2011-11-21

עלון מידע

LEVETIRACETAM APOTEX 250, 500, 750, 1000 MG FILM-COATED TABLETS
RVG 108430/1/2/3
MODULE 1.3
Product Information
Version: 2019-12
MODULE 1.3.1
Patient Information Leaflet
Replaces : 2019-08
1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LEVETIRACETAM APOTEX 250 MG, FILMOMHULDE TABLETTEN
LEVETIRACETAM APOTEX 500 MG, FILMOMHULDE TABLETTEN
LEVETIRACETAM APOTEX 750 MG, FILMOMHULDE TABLETTEN
LEVETIRACETAM APOTEX 1000 MG, FILMOMHULDE TABLETTEN
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 Apotex is and what it is used for
2.
What you need to know before you take Levetiracetam Apotex
3.
How to take Levetiracetam Apotex
4.
Possible side effects
5.
How to store Levetiracetam Apotex
6.
Contents of the pack and other information
1.
WHAT LEVETIRACETAM APOTEX IS AND WHAT IT IS USED FOR
Levetiracetam is an antiepileptic medicine (a medicine used to treat
seizures in epilepsy).
Levetiracetam Apotex 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 antiepil

מאפייני מוצר

LEVETIRACETAM APOTEX 250, 500, 750, 1000 MG FILM-COATED TABLETS
RVG 108430/1/2/3
MODULE 1.3
Product Information
Version: 2019-12
MODULE 1.3.1
Summary of Product Characteristics
Replaces : 2019-08
1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Levetiracetam Apotex 250 mg, filmomhulde tabletten
Levetiracetam Apotex 500 mg, filmomhulde tabletten
Levetiracetam Apotex 750 mg, filmomhulde tabletten
Levetiracetam Apotex 1000 mg, filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_<_Levetiracetam Apotex 250 mg film-coated tablets:> Each film-coated
tablet contains 250 mg
levetiracetam.
Each film-coated
tablet contains 500 mg
levetiracetam.
Each film-coated
tablet contains 750 mg
levetiracetam.
Each film-coated
tablet contains 1,000 mg
levetiracetam.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
white, oval,
biconvex, film-coated tablets of
7 x 14 mm, engraved ‘LEV’ score ‘250’ on one side and
‘APO’ on the other side.
yellow, oval,
biconvex, film-coated tablets of
8 x 18 mm, engraved ‘LEV’ score ‘500’ on one side and
‘APO’ on the other side.
orange, oval,
biconvex, film-coated tablets of
9 x 19 mm, engraved ‘LEV’ score ‘750’ on one side and
‘APO’ on the other side.
white, oval,
biconvex, film-coated tablets of
10 x 19 mm, engraved ‘LEV’ score ‘1000’ on one side and
‘APO’ on the other side.
The tablets can be divided into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Levetiracetam Apotex is indicated as monotherapy in the treatment of
partial onset seizures with or
LEVETIRACETAM APOTEX 250, 500, 750, 1000 MG F