Zonisamide Neuraxpharm 50 mg tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Zonisamide

Available from:

Neuraxpharm Ireland Limited

ATC code:

N03AX15

INN (International Name):

Zonisamide

Pharmaceutical form:

Tablet

Therapeutic area:

zonisamide

Authorization status:

Not marketed

Authorization date:

2022-11-18

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ZONISAMIDE NEURAXPHARM 25 MG TABLETS
ZONISAMIDE NEURAXPHARM 50 MG TABLETS
ZONISAMIDE NEURAXPHARM 100 MG TABLETS
ZONISAMIDE NEURAXPHARM 200 MG TABLETS
ZONISAMIDE NEURAXPHARM 300 MG TABLETS
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 Neuraxpharm is and what it is used for
2.
What you need to know before you take Zonisamide Neuraxpharm
3.
How to take Zonisamide Neuraxpharm
4.
Possible side effects
5.
How to store Zonisamide Neuraxpharm
6.
Contents of the pack and other information
1.
WHAT ZONISAMIDE NEURAXPHARM IS AND WHAT IT IS USED FOR
Zonisamide Neuraxpharm contains the active substance zonisamide, and
is used as an antiepileptic
medicine.
Zonisamide Neuraxpharm 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 Neuraxpharm 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 NEURAXPHARM
DO NOT TAKE ZONISAMIDE NEURAXPHARM
•
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

Summary of Product characteristics

Health Products Regulatory Authority
20 April 2023
CRN00DHDF
Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Zonisamide Neuraxpharm 50 mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 50 mg of zonisamide.
Excipient with known effect
Each tablet contains 16.91 mg of lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
White, round biconvex scored tablets, with the inscription "N1"
debossed on one side
Diameter: 6.5 mm
The tablet can be divided into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Zonisamide Neuraxpharm 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 Neuraxpharm 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 Neuraxpharm 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
Health Products Regulatory Authority
20 April 2