Zonisamide 50mg hard capsules

Kraj: Malta

Język: angielski

Źródło: Medicines Authority

Składnik aktywny:

ZONISAMIDE

Dostępny od:

Endo Ventures Limited First Floor, Minerva House, Simmonscourt Road, Ballsbridge, Dublin 4, Ireland

Kod ATC:

N03AX15

INN (International Nazwa):

ZONISAMIDE 50 mg

Forma farmaceutyczna:

HARD CAPSULE

Skład:

ZONISAMIDE 50 mg

Typ recepty:

POM

Dziedzina terapeutyczna:

ANTIEPILEPTICS

Status autoryzacji:

Withdrawn

Data autoryzacji:

2016-03-18

Ulotka dla pacjenta

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PACKAGE LEAFLET: INFORMATION FOR THE USER
ZONISAMIDE 25 MG HARD CAPSULES
ZONISAMIDE 50 MG HARD CAPSULES
ZONISAMIDE 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 Zonisamide is and what it is used for
2. What you need to know before you take Zonisamide
3. How to take Zonisamide
4. Possible side effects
5. How to store Zonisamide
6. Contents of the pack and other information
1.
WHAT ZONISAMIDE IS AND WHAT IT IS USED FOR
Zonisamide contains the active substance zonisamide, and is used as an
antiepileptic medicine.
Zonisamide 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).
Zonisamide 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 ZONISAMIDE
DO NOT TAKE ZONISAMIDE
:
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 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.
Page 2 of 8
Possi

Charakterystyka produktu

Page 1 of 20
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Zonisamide 100 mg hard capsules
Zonisamide 50 mg hard capsules
Zonisamide 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.
_ _
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_ _
_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 concurrent adjustment of other antiepileptic medicine doses
(where necessary).
TABLE 1.
ADULTS – RECOMMENDED DOSAGE ESCALATION AND MAINTENANCE REGIMEN
TREATMENT
REGIMENT
TITRATION PHASE
USUAL MAINTENANCE
DOSE
MONOTHERAPY
Newly
diagnoses