Zonisamide Doc Generici 100mg hard capsules

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

ZONISAMIDE

Available from:

Doc Generici srl Via Turati, 40-20121, Milano, Italy

ATC code:

N03AX15

INN (International Name):

ZONISAMIDE 100 mg

Pharmaceutical form:

HARD CAPSULE

Composition:

ZONISAMIDE 100 mg

Prescription type:

POM

Therapeutic area:

ANTIEPILEPTICS

Authorization status:

Authorised

Authorization date:

2016-04-07

Patient Information leaflet

03/2019: approved var.03 psusa; 02/2021: approved var. 06 – 08/2022:
EoP var 08 – Proposed var 09
Page 1 of 8
PACKAGE LEAFLET: INFORMATION FOR THE USER
ZONISAMIDE DOC GENERICI 25 MG HARD CAPSULES
ZONISAMIDE DOC GENERICI 50 MG HARD CAPSULES
ZONISAMIDE DOC GENERICI 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 Doc Generici is and what it is used for
2. What you need to know before you take Zonisamide Doc Generici
3. How to take Zonisamide Doc Generici
4. Possible side effects
5. How to store Zonisamide Doc Generici
6. Contents of the pack and other information
1.
WHAT ZONISAMIDE DOC GENERICI IS AND WHAT IT IS USED FOR
Zonisamide Doc Generici contains the active substance zonisamide, and
is used as an antiepileptic
medicine.
Zonisamide Doc Generici 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 Doc Generici 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 DOC GENERICI
DO NOT TAKE ZONISAMIDE DOC GENERICI
:
•
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 diuretic

Summary of Product characteristics

Page 1 of 20
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Zonisamide Doc Generici 100 mg hard capsules.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 100 mg of zonisamide.
Excipient with known effect:
Each hard capsule contains less than 1 mmol sodium (23 mg).
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.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Zonisamide Doc Generici 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 Doc Generici 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 Doc Generici 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).
Page 2 of 20
TABLE 1.
ADULTS – RECOMMENDED DOSAGE ESCALATION AND MAINTENANCE REGIMEN
TREATMENT
REGIMENT
TITRATION PHASE
USUAL MAINTENANCE
DOSE
MONOTHERAPY
Newly
diagnoses
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