Zonegran
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
23-02-2023
Charakterystyka produktu
(SPC)
23-02-2023
Sprawozdanie z oceny publicznego
(PAR)
18-10-2013
Składnik aktywny:
zonisamide
Dostępny od:
Amdipharm Limited
Kod ATC:
N03AX15
INN (International Nazwa):
zonisamide
Grupa terapeutyczna:
Antiepileptics,
Dziedzina terapeutyczna:
Epilepsies, Partial
Wskazania:
Zonegran is indicated as: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 six years and above.
Podsumowanie produktu:
Revision: 36
Status autoryzacji:
Authorised
Data autoryzacji:
2005-03-10
Ulotka dla pacjenta
75
B. PACKAGE LEAFLET
76
PACKAGE LEAFLET: INFORMATION FOR THE USER
ZONEGRAN 25 MG, 50 MG, AND
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 Zonegran is and what it is used for
2.
What you need to know before you take Zonegran
3.
How to take Zonegran
4.
Possible side effects
5.
How to store Zonegran
6.
Contents of the pack and other information
1.
WHAT ZONEGRAN IS AND WHAT IT IS USED FOR
Zonegran contains the active substance zonisamide, and is used as an
antiepileptic medicine.
Zonegran 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).
Zonegran 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 ZONEGRAN
DO NOT TAKE ZONEGRAN
:
•
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,
•
if you are allergic to peanut or soya, do not use this medicinal
product.
WARNINGS AND PRECAUTIONS
Zonegran belongs to a group of medicines (sulphonamides) which can
cause severe allergic reactions,
severe skin rashes, and blood disorders, which very rarely can be
fatal (see
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Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Zonegran 25 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 25 mg of zonisamide.
Excipient with known effect:
Each hard capsule contains 0.75 mg hydrogenated vegetable oil (from
soyabean)
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule.
A white opaque body and a white opaque cap printed with “ZONEGRAN
25” in black.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Zonegran 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 _
Zonegran 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 Zonegran 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).
3
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 intervals in
increments of 100 mg
up to a maximum of
500 mg.
100 mg/day
(once a day)
200 mg /day
(once a day)
300 mg / day
(once a day)
ADJUNCTIVE
THERAPY
- with CYP3A4-
ind
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