Zoniselle 25 mg hard capsules

Maa: Irlanti

Kieli: englanti

Lähde: HPRA (Health Products Regulatory Authority)

Aktiivinen ainesosa:

Zonisamide

Saatavilla:

Chanelle Medical

ATC-koodi:

N03AX; N03AX15

INN (Kansainvälinen yleisnimi):

Zonisamide

Annos:

25 milligram(s)

Lääkemuoto:

Capsule, hard

Prescription tyyppi:

Product subject to prescription which may be renewed (B)

Terapeuttinen alue:

Other antiepileptics; zonisamide

Valtuutuksen tilan:

Not marketed

Valtuutus päivämäärä:

2016-04-15

Pakkausseloste

ID: PL 181-183M
(DCP#3475- IE)
VERSION: 04
REVISION DATE: 18/06/2017
Page 1 of 7
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ZONISELLE 25 MG HARD CAPSULES
ZONISELLE 50 MG HARD CAPSULES
ZONISELLE 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 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
This medicine 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 DO 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 antidiabetic
medicines.
WARNINGS AND PRECAUTIONS
Zonisamide belongs to a group of medicines (sulphonamides) which can
cause severe allergic
reactions, severe skin rashes, and blood

Valmisteyhteenveto

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Zoniselle 25 mg hard capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 25 mg of zonisamide.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Hard capsule
Approximately 14mm white opaque body and white opaque cap containing
white powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Zoniselle 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_
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
REGIMEN
TITRATION PHASE
USUAL
MAINTENANCE
DOSE
MONOTHERAPY
- Newly
Week 1+2
Week 3+4
Week 5+6
300 mg per day
(once a
day).
If a higher
dose is required:
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