ZonisaHexal Capsules Hard 50mg

País: Malta

Idioma: inglés

Fuente: Medicines Authority

Ingredientes activos:

ZONISAMIDE

Disponible desde:

Hexal AG Industriestrasse 25, Holzkirchen, D-83607, Germany

Código ATC:

N03AX15

Designación común internacional (DCI):

ZONISAMIDE 50 mg

formulario farmacéutico:

HARD CAPSULE

Composición:

ZONISAMIDE 50 mg

tipo de receta:

POM

Área terapéutica:

ANTIEPILEPTICS

Estado de Autorización:

Withdrawn

Fecha de autorización:

2016-08-26

Información para el usuario

PACKAGE LEAFLET: INFORMATION FOR THE USER
ZonisaHexal 25 MG HARD CAPSULES
ZONISAHEXAL 50 MG HARD CAPSULES
ZONISAHEXAL 100 MG HARD 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 your 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 ZonisaHexal is and what it is used for
2. What you need to know before you take ZonisaHexal
3. How to take ZonisaHexal
4. Possible side effects
5. How to store ZonisaHexal
6. Contents of the pack and other information
1.
WHAT ZONISAHEXAL IS AND WHAT IT IS USED FOR
ZonisaHexal contains the active substance zonisamide, and is used as
an antiepileptic
medicine.
ZonisaHexal 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).
ZonisaHexal 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 YOU NEED TO KNOW BEFORE YOU TAKE ZONISAHEXAL
DO NOT TAKE ZONISAHEXAL :

if you are allergic to zonisamide or any of the other ingredients of
this medicine
(listed in section 6).

if
you
are
allergic
to
other
sulphonamide
medicines.
Examples
include:
sulphonamide
antibiotics,
thiazide
diuretics,
and
sulfonylurea
antidiabetes
medicines.
WARNINGS AND PRECAUTIONS:
Zonisamide belongs to a group of medicines (sulphonamides) which can
cause severe
allergic reactions, severe skin rashes, and blood disorders, which
very rarely can be fatal
(see section 4. Possible s

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
ZonisaHexal 100 mg hard capsules
ZonisaHexal 50 mg hard capsules
ZonisaHexal 25 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 100 mg of zonisamide.
Each hard capsule contains 50 mg of zonisamide
Each hard capsule contains 25 mg of zonisamide
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule.
White capsule size No 1, 19.3 mm. A white opaque body and a white
opaque cap, marked “Z 100”
in black.
White capsule size No 3, 15.8 mm. A white opaque body and a white
opaque cap, marked “Z 50” in
red.
White capsule size No 4, 14.4 mm. A white opaque body and a white
opaque cap, marked “Z 25” in
black.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Zonisamide 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
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 _
_ _
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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 concurrent adjustment of other antiepileptic medicine doses
(where necessary).
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TABLE 1.
ADULTS – RECOMMENDED DOSAGE ESCALATION AND MAINTENANCE REGIMEN
TREATMENT
REGIMEN
TITRATION PHASE
USUAL MAINTENANCE
DOSE
MONOTHERAPY
Newly