Zonisamide Mylan

Страна: Европейски съюз

Език: английски

Източник: EMA (European Medicines Agency)

Активна съставка:

zonisamide

Предлага се от:

Mylan Pharmaceuticals Limited

АТС код:

N03AX15

INN (Международно Name):

zonisamide

Терапевтична група:

Antiepileptics,

Терапевтична област:

Epilepsy

Терапевтични показания:

Monotherapy in the treatment of partial seizures, with or without secondary generalisation, in adults with newly diagnosed epilepsy;adjunctive therapy in the treatment of partial seizures, with or without secondary generalisation, in adults, adolescents, and children aged 6 years and above.

Каталог на резюме:

Revision: 9

Статус Оторизация:

Authorised

Дата Оторизация:

2016-03-31

Листовка

35
B. PACKAGE LEAFLET
36
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ZONISAMIDE MYLAN 25 MG HARD CAPSULES
ZONISAMIDE MYLAN 50 MG HARD CAPSULES
ZONISAMIDE MYLAN 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 Mylan is and what it is used for
2.
What you need to know before you take Zonisamide Mylan
3.
How to take Zonisamide Mylan
4.
Possible side effects
5.
How to store Zonisamide Mylan
6.
Contents of the pack and other information
1.
WHAT ZONISAMIDE MYLAN IS AND WHAT IT IS USED FOR
Zonisamide Mylan contains the active substance zonisamide, and is used
as an antiepileptic medicine.
Zonisamide Mylan 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 Mylan 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 MYLAN
DO NOT TAKE ZONISAMIDE MYLAN
-
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 sulfonamide medicines. Examples include:
sulfonamide
antibiotics, thiazide diuretics, and sulfonylurea antidiabetes
medicines.
WARNINGS AND PRECAUTIONS
Zonisamide Mylan belongs to a group of medicines (sulfonamides) which
can cause severe allergic
reactions, severe skin ras

Данни за продукта

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Zonisamide Mylan 25 mg hard capsules
Zonisamide Mylan 50 mg hard capsules
Zonisamide Mylan 100 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Zonisamide Mylan 25 mg hard capsules
Each hard capsule contains 25 mg of zonisamide.
Zonisamide Mylan 50 mg hard capsules
Each hard capsule contains 50 mg of zonisamide.
Zonisamide Mylan 100 mg hard capsules
Each hard capsule contains 100 mg of zonisamide.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule.
Zonisamide Mylan 25 mg hard capsules
A white opaque body and a white opaque cap, marked ‘Z 25’ in black
containing white/almost white
powder. Each hard capsule is approximately 14.4 mm in length.
Zonisamide Mylan 50 mg hard capsules
A white opaque body and a white opaque cap, marked ‘Z 50’ in red
containing white/almost white
powder. Each hard capsule is approximately 15.8 mm in length.
Zonisamide Mylan 100 mg hard capsules
A white opaque body and a white opaque cap, marked ‘Z 100’ in
black containing white/almost white
powder. Each hard capsule is approximately 19.3 mm in length.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Zonisamide Mylan 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
3
_Dosage escalation and maintenance_
Zonisamide Mylan 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 Mylan treatment is to be dis