Zonisamide Chanelle 100 mg harde capsules

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

ZONISAMIDE

Beschikbaar vanaf:

Chanelle Medical

ATC-code:

N03AX15

INN (Algemene Internationale Benaming):

ZONISAMIDE

farmaceutische vorm:

Capsule, hard

Samenstelling:

CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSPOVIDON (E 1202) ; ERYTHROSINE (E 127) ; GELATINE (E 441) ; HYPROMELLOSE (E 464) ; MACROGOL 3350 ; NATRIUMSTEARYLFUMARAAT ; PATENTBLAUW V (E131) ; TITAANDIOXIDE (E 171),

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Zonisamide

Product samenvatting:

Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); CROSPOVIDON (E 1202); ERYTHROSINE (E 127); GELATINE (E 441); HYPROMELLOSE (E 464); MACROGOL 3350; NATRIUMSTEARYLFUMARAAT; PATENTBLAUW V (E131); TITAANDIOXIDE (E 171);

Autorisatie datum:

2016-04-22

Bijsluiter

ID: PL 181-183M
(DCP#3483)
VERSION:
03
REVISION DATE:
31/01/2017
Page 1 of
8
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Zonisamide Chanelle 25 mg harde capsules
Zonisamide Chanelle 50 mg harde capsules
Zonisamide Chanelle 100 mg harde capsules
ZONISAMIDE
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 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 < Invented name > is and what it is used for
2.
What you need to know before you take < Invented name >
3.
How to take < Invented name >
4.
Possible side effects
5.
How to store < Invented name >
6.
Contents of the pack and other information
1.
WHAT < INVENTED NAME > IS AND WHAT IT IS USED FOR
This medicine contains the active substance zonisamide and is used as
an antiepileptic
medicine.
< Invented name > is used to treat seizures that affect one part of
the brain (partial
seizure), which may or may not be followed by a seizure affecting all
of the brain
(secondary generalisation).
< Invented name > may be used:

On its own to treat seizures in adults.

With other antiepileptic medicines to treat seizures in adults,
adolescents, and
children aged 6 years and above.
2.
WHAT DO YOU NEED TO KNOW BEFORE YOU TAKE < INVENTED NAME >
DO NOT TAKE < INVENTED NAME >
If you:

are allergic to zonisamide or any of the other ingredients of this
medicine
(listed in section 6).

are allergic to other sulphonamide medicines. Examples include:
sulphonamide antibiotics, thiazide diuretics, and sulfonylurea
antidiabetic
medicines.
WARNINGS AND PRECAUTIONS
ID: PL 181-183M
(DCP#3483)
VERSION:
03
RE

Productkenmerken

ID: S 181-183M
(DCP#3483)
VERSION:
05
REVIEW DATE:
08/10/2017
SUMMARY OF THE PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
25 mg hard capsules
50 mg hard capsules
100 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
25 mg hard capsules:
Each hard capsule contains 25 mg of zonisamide.
50 mg hard capsules:
Each hard capsule contains 50 mg of zonisamide.
100 mg hard capsules:
Each hard capsule contains 100 mg of zonisamide.
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Hard capsule
25 mg:
Approximately 14 mm white opaque body and white opaque cap containing
white powder.
50 mg:
Approximately 16 mm white opaque body and grey opaque cap containing
white powder.
100 mg:
Approximately 19 mm white opaque body and red opaque cap containing
white powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
is indicated as:

monotherapy
in
the
treatment
of
partial
seizures,
with
or
without
secondary
generalisation, in adults with newly diagnosed epilepsy (see section
5.1);

adjunctive therapy in the treatment of partial seizures, with or
without secondary
generalisation, in adults, adolescents, and children aged 6 years and
above.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
ID: S 181-183M
(DCP#3483)
VERSION:
05
REVIEW DATE:
08/10/2017
_Posology-Adults _
_Dosage escalation and maintenance _
_ _
Zonisamide_ _may be taken as monotherapy or added to existing therapy
in adults. The dose
should be titrated on the basis of clinical effect. Recommended
escalation and maintenance
doses are given in Table 1. Some patients, especially those not taking
CYP3A4-inducing
agents, may respond to lower doses.
_Withdrawal _
When zonisamide treatment is to be discontinued, it should be
withdrawn gradually (see
section 4.4). In clinical studies of adult patients, dose reductions
of 100 mg at weekly
intervals have been used with concurre