Zonisamide Accord 25 mg hard capsules

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Zonisamide

Available from:

Actavis Group PTC ehf

ATC code:

N03AX; N03AX15

INN (International Name):

Zonisamide

Dosage:

25 milligram(s)

Pharmaceutical form:

Capsule, hard

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Other antiepileptics; zonisamide

Authorization status:

Not marketed

Authorization date:

2016-04-15

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
ZONISAMIDE ACCORD 25 MG HARD CAPSULES
ZONISAMIDE ACCORD 50 MG HARD CAPSULES
ZONISAMIDE ACCORD 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 question, 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 Accord is and what it is used for
2.
What you need to know before you take Zonisamide Accord
3.
How to take Zonisamide Accord
4.
Possible side effects
5.
How to store Zonisamide Accord
6.
Contents of the pack and other information
1.
WHAT ZONISAMIDE ACCORD IS AND WHAT IT IS USED FOR
Zonisamide Accord contains the active substance zonisamide, and is
used as an antiepileptic
medicine.
Zonisamide Accord 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 Accord 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 ACCORD
DO NOT TAKE ZONISAMIDE ACCORD:
-
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 Accord belongs to a group of medicines (sulphonamides)
which can cause severe allergic
reactions, severe skin rashes, and blood

Summary of Product characteristics

Health Products Regulatory Authority
25 January 2019
CRN008RR7
Page 1 of 27
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Zonisamide Accord 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 capsules.
White to off-white granular powder in hard capsules, size 4 (14.3 mm x
5.31 mm),
with a white to off‑white capsule body and a white to off-white
capsule cap. The cap
is imprinted with “A730” in black ink.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Zonisamide Accord 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_
_ _
_Dosageescalation and maintenance_
Zonisamide Accord 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 Accord treatment is to be discontinued, it should be
withdrawn
gradually (see section 4.4). In clinical studies of adult patients,
dose reductions of
Health Products Regulatory Authority
25 January 2019
CRN008RR7
Page 2 of 27
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
TITRATIONPHASE
​
​
USUALMAINTENANCE
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: increas