Zonisamide Rowex 50 mg hard capsules

País: Irlanda

Idioma: inglés

Fuente: HPRA (Health Products Regulatory Authority)

Ingredientes activos:

Zonisamide

Disponible desde:

Rowex Ltd

Código ATC:

N03AX15

Designación común internacional (DCI):

Zonisamide

formulario farmacéutico:

Capsule, hard

Área terapéutica:

zonisamide

Estado de Autorización:

Not marketed

Fecha de autorización:

2024-01-12

Información para el usuario

PACKAGE LEAFLET: INFORMATION FOR THE USER
ZONISAMIDE ROWEX 25 MG HARD CAPSULES
ZONISAMIDE ROWEX 50 MG HARD CAPSULES
ZONISAMIDE ROWEX 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 Rowex is and what it is used for
2.
What you need to know before you take Zonisamide Rowex
3.
How to take Zonisamide Rowex
4.
Possible side effects
5.
How to store Zonisamide Rowex
6.
Contents of the pack and other information
1.
WHAT ZONISAMIDE ROWEX IS AND WHAT IT IS USED FOR
Zonisamide Rowex contains the active substance zonisamide, and is used
as an anti-epileptic
medicine.
Zonisamide Rowex 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 Rowex 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 ROWEX
DO NOT TAKE ZONISAMIDE ROWEX
:

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.
SERIOUS RASHES OCCUR IN ASSOCIATION WITH ZONISAMIDE THERAPY, INCLUDING
CASES OF STEVENS-
JOHNSON SYNDROME.
Preventing overheating and dehydration in children
Zon

Ficha técnica

Health Products Regulatory Authority
12 January 2024
CRN00DQDR
Page 1 of 17
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Zonisamide Rowex 50 mg hard capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 50 mg of zonisamide
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Hard capsule.
White capsule size No 3, 15.8 mm. A white opaque body and a white
opaque cap, marked "Z 50" in red.
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_
_ _
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
diagnosed
adult patients
​
WEEK 1 + 2
WEEK 3 + 4
WEEK 5 +
6
300 mg per day (once a day).
If a higher dose is required: increase at two-
weekly intervals in increments of 100 mg up to
a maximum of 500 mg
​
100 mg/day
(once a day)
200 mg/day
(once a day)
300
mg/day
(once a day)
ADJUNCTIVE
THERAPY
- with CYP3A4
– inducing
agents