Oxcarbazepine STADA 150 mg, filmomhulde tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

OXCARBAZEPINE

Beschikbaar vanaf:

Stada Arzneimittel AG

ATC-code:

N03AF02

INN (Algemene Internationale Benaming):

OXCARBAZEPINE

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSPOVIDON (E 1202) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; IJZEROXIDE ZWART (E 172) ; MACROGOL 8000 ; MAGNESIUMSTEARAAT (E 470b) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171),

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Oxcarbazepine

Product samenvatting:

Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); CROSPOVIDON (E 1202); HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464); IJZEROXIDE GEEL (E 172); IJZEROXIDE ROOD (E 172); IJZEROXIDE ZWART (E 172); MACROGOL 8000; MAGNESIUMSTEARAAT (E 470b); SILICIUMDIOXIDE (E 551); TALK (E 553 B); TITAANDIOXIDE (E 171);

Autorisatie datum:

2014-02-07

Bijsluiter

PACKAGE LEAFLET: INFORMATION FOR THE USER
OXCARBAZEPINE STADA 150 MG, FILMOMHULDE TABLETTEN
OXCARBAZEPINE STADA 300 MG, FILMOMHULDE TABLETTEN
OXCARBAZEPINE STADA 600 MG, FILMOMHULDE TABLETTEN
Oxcarbazepine
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU 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 or your child 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 is and what it is used for
2. What you need to know before you take
3. How to take
4. Possible side effects
5. How to store
6. Contents of the pack and other information
1. WHAT IS AND WHAT IT IS USED FOR
What is
The active ingredient of is oxcarbazepine.
belongs to a group of medicines called anticonvulsants
or antiepileptics.
What is used for
Medicines such as are the standard treatment for
epilepsy.
Epilepsy is a brain disorder that causes people to have recurring
seizures and convulsions.
Seizures happen because of a temporary fault in the brain’s
electrical activity. Normally brain
cells coordinate body movements by sending out signals through the
nerves to the muscles
in an organised, orderly way. In epilepsy, brain cells send out too
many signals in a
disorderly fashion. The result can be uncoordinated muscular activity
that is called an
epileptic seizure.
is used to treat partial seizures with or without
secondarily generalised
tonic-clonic seizures.
Partial seizures involve a limited area of the brain, but may spread
to the whole brain and
may cause a generali

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Oxcarbazepine STADA 150 mg filmomhulde tabletten
Oxcarbazepine STADA 300 mg filmomhulde tabletten
Oxcarbazepine STADA 600 mg filmomhulde tabletten
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
One 150 mg film-coated tablet contains 150 mg
oxcarbazepine.
One 300 mg film-coated tablet contains 300 mg
oxcarbazepine.
One 600 mg film-coated tablet contains 600 mg
oxcarbazepine.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablet
_ _
150 mg:
pale
grey
green
coloured,
oval
shaped,
biconvex
film-coated
tablets,
of
approximately 4.4 mm thickness, approximately 11.1 mm length and
approximately 5.6 mm
width, scored on both sides and debossed with ‘150’ on one side of
the score line on one
side of the tablet._ _
300 mg: yellow coloured, oval shaped, biconvex film-coated tablets, of
approximately 5.4 mm
thickness, approximately 15.1 mm length and approximately 6.6 mm
width, scored on both
sides and debossed with ‘300’ on one side of the score line on one
side of the tablet._ _
600 mg: pink coloured, oval shaped, biconvex film-coated tablets, of
approximately 7.0 mm
thickness, approximately 18.6 mm length and approximately 8.1 mm
width, scored on both
sides and debossed with ‘600’ on one side of the score line on one
side of the tablet._ _
The score line is only to facilitate breaking for ease of swallowing
and not to divide into equal
doses.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Oxcarbazepine is indicated for the treatment of partial seizures with
or without secondarily
generalised tonic-clonic seizures.
Oxcarbazepine is indicated for use as monotherapy or adjunctive
therapy in adults and in
children of 6 years of age and above.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
In mono- and adjunctive therapy, treatment with oxcarbazepine is
initiated with a clinically
effective dose given in two divided doses. The dose may be increased
depending on t