ZONEGRAN zonisamide 100mg capsule blister pack

País: Austrália

Língua: inglês

Origem: Department of Health (Therapeutic Goods Administration)

Ingredientes ativos:

zonisamide, Quantity: 100 mg

Disponível em:

Amdipharm Mercury Australia Pty Ltd

DCI (Denominação Comum Internacional):

Zonisamide

Forma farmacêutica:

Capsule, hard

Composição:

Excipient Ingredients: allura red AC; sodium lauryl sulfate; hydrogenated vegetable oil; titanium dioxide; microcrystalline cellulose; sunset yellow FCF; Gelatin; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; purified water; Shellac; strong ammonia solution; iron oxide black; potassium hydroxide

Via de administração:

Oral

Unidades em pacote:

56 capsules

Tipo de prescrição:

(S4) Prescription Only Medicine

Indicações terapêuticas:

ZONEGRAN is indicated as: - Monotherapy in the treatment of partial seizures, with or without secondary generalisation, in adults with newly diagnosed epilepsy who are intolerant to other agents or where other agents are contraindicated. - Adjunctive therapy in the treatment of adult patients with partial seizures, with or without secondary generalisation.

Resumo do produto:

Visual Identification: A white opaque body and a red opaque cap and printed with ZONEGRAN 100 in black on the capsule body. Capsule size No 1 containing white powder free from visible impurities.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Status de autorização:

Licence status A

Data de autorização:

2007-07-31

Folheto informativo - Bula

Eisai Australia Pty. Ltd.
Version 1
1
ZONEGRAN
®
ZONISAMIDE HARD CAPSULES
_(zon-is-a-mide) _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some
common questions about
Zonegran hard capsules.
It does not contain all the
available information. It does
not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has
weighed the risks of you taking
this medicine against the
benefits they expect it will have
for you.
IF YOU HAVE ANY CONCERNS
ABOUT TAKING THIS MEDICINE,
ASK YOUR DOCTOR OR
PHARMACIST. KEEP THIS LEAFLET
WITH THE MEDICINE.
You may need to read it again.
WHAT ZONEGRAN IS
USED FOR
The name of your medicine is
Zonegran. The active ingredient
in Zonegran is called
zonisamide.
Zonegran is used to treat certain
types of epilepsy in adults.
Zonegran may be used:
•
On its own to treat seizures
in adults.
•
With other antiepileptic
medicines to treat seizures in
adults.
Epilepsy is caused by a
disruption in the electrical
activity of the brain. The
abnormal electrical impulses
occur due to altered levels of
some chemicals in the brain.
Zonegran can control brain
chemicals which send signals to
nerves so that seizures do not
happen.
Zonegran is used in partial
seizures that affect only one part
of the brain, with or without
generalized seizures that may
affect the whole brain.
Your doctor may have
prescribed Zonegran for another
use.
ASK YOUR DOCTOR IF YOU HAVE
ANY QUESTIONS ABOUT WHY THIS
MEDICINE HAS BEEN PRESCRIBED
FOR YOU.
There is no evidence that
Zonegran is addictive.
This medicine is only available
with a doctor’s prescription.
Zonegran capsules is not
recommended for children and
adolescents under 18 years of
age as there is not enough
information on its use in
children and adolescents.
BEFORE YOU TAKE
ZONEGRAN
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE THIS MEDICINE IF
YOU HAVE AN ALLERGY TO:
•
Zonisamide
•
Sulphonamide drugs
including furosemide (Lasix)
and bumetanide (Burinex)
(diuretic medicines)
•
Any of the ingr

Características técnicas

ZONEGRAN
1
AUSTRALIAN PRODUCT INFORMATION
ZONEGRAN
®
(ZONISAMIDE)
HARD CAPSULES
1
NAME OF THE MEDICINE
Zonisamide
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Zonegran 25 mg hard capsule contains 25 mg zonisamide.
Each Zonegran 50 mg hard capsule contains 50 mg zonisamide.
Each Zonegran 100 mg hard capsule contains 100 mg zonisamide.
List of excipients with known effect: None.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Hard capsule.
Zonegran 25 mg hard capsules have a white opaque body and a white
opaque cap and
printed with “ZONEGRAN 25” in black on the capsule body. Capsule
size No 4 containing
white powder free from visible impurities.
Zonegran 50 mg hard capsules have a white opaque body and a grey
opaque cap and printed
with “ZONEGRAN 50” in black on the capsule body. Capsule Size No 3
containing white
powder free from visible impurities.
Zonegran 100 mg hard capsules have a white opaque body and a red
opaque cap and printed
with “ZONEGRAN 100” in black on the capsule body. Capsule size No
1 containing white
powder free from visible impurities.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Zonegran is indicated as:
ZONEGRAN
2
•
monotherapy
in
the
treatment
of
partial
seizures,
with
or
without
secondary
generalisation, in adults with newly diagnosed epilepsy who are
intolerant to other
agents or where other agents are contraindicated;
•
adjunctive therapy in the treatment of adult patients with partial
seizures, with or
without secondary generalisation.
4.2 DOSE AND METHOD OF ADMINISTRATION
Zonegran capsules are for oral use.
DOSAGE
_Adults _
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.
TABLE 1: ADULTS – RECOMMENDED DOSAGE ESCALATION AND MAINTENANCE
REGIMEN
TREATMENT
REGIMEN
TITRATION