Zonisamide - 1 A Pharma Capsules Hard 50mg

Nazione: Malta

Lingua: inglese

Fonte: Malta Medicines Authority

Principio attivo:

ZONISAMIDE

Commercializzato da:

1 A Pharma GmbH Keltenring 1+3, 82041 Oberhaching, Germany

Codice ATC:

N03AX15

INN (Nome Internazionale):

ZONISAMIDE 50 mg

Forma farmaceutica:

HARD CAPSULE

Composizione:

ZONISAMIDE 50 mg

Tipo di ricetta:

POM

Area terapeutica:

ANTIEPILEPTICS

Stato dell'autorizzazione:

Withdrawn

Data dell'autorizzazione:

2016-08-26

Foglio illustrativo

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PACKAGE LEAFLET: INFORMATION FOR THE USER
ZONISAMIDE – 1A PHARMA 100 MG HARD CAPSULES
ZONISAMIDE – 1A PHARMA 50 MG HARD CAPSULES
ZONISAMIDE – 1A PHARMA 25 MG HARD CAPSULES
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 – 1A Pharma is and what it is used for
2. What you need to know before you take Zonisamide – 1A Pharma
3. How to take Zonisamide – 1A Pharma
4. Possible side effects
5. How to store Zonisamide – 1A Pharma
6. Contents of the pack and other information
1.
WHAT ZONISAMIDE – 1A PHARMA IS AND WHAT IT IS USED FOR
Zonisamide – 1A Pharma contains the active substance zonisamide, and
is used as an antiepileptic
medicine.
Zonisamide – 1A Pharma 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 – 1A Pharma 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 – 1A PHARMA
DO NOT TAKE ZONISAMIDE – 1A PHARMA:

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 belongs to a group o

Scheda tecnica

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1.
NAME OF THE MEDICINAL PRODUCT
Zonisamide – 1A Pharma 100 mg hard capsules
Zonisamide – 1A Pharma 50 mg hard capsules
Zonisamide – 1A Pharma 25 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 100 mg of zonisamide.
Each hard capsule contains 50 mg of zonisamide
Each hard capsule contains 25 mg of zonisamide
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.
White capsule size No 3, 15.8 mm. A white opaque body and a white
opaque cap, marked “Z 50” in
red.
White capsule size No 4, 14.4 mm. A white opaque body and a white
opaque cap, marked “Z 25” in
black.
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
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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).
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TABLE 1.
ADULTS – RECOMMENDED DOSAGE ESCALATION AND MAINTENANCE REGIMEN
TREATMENT
REGIMEN
TITRATION PHASE
USUAL MAINTENANCE
DOSE
MONOTHERAPY
N