APO-ZONISAMIDE zonisamide 50 mg capsule blister pack

Երկիր: Ավստրալիա

Լեզու: անգլերեն

Աղբյուրը: Department of Health (Therapeutic Goods Administration)

Ակտիվ բաղադրիչ:

zonisamide

Հասանելի է:

Apotex Pty Ltd

INN (Միջազգային անվանումը):

Zonisamide

Լիազորման կարգավիճակը:

Registered

Տեղեկատվական թերթիկ

APO-ZONISAMIDE
_Contains the active ingredient Zonisamide_
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055_
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about this medicine. 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 THIS MEDICINE IS
USED FOR
The name of your medicine is APO-
Zonisamide capsules. It contains the
active ingredient zonisamide.
It is used to treat certain types of
epilepsy in adults. Zonisamide may
be used:
•
on its own to treat seizures in
adults
•
with other antiepileptic medicines
to treat seizure 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. Zonisamide
can control brain chemicals which
send signals to nerves so that seizures
do not happen.
Zonisamide is used in partial seizure
that affects only one part of brain,
with or without generalized seizures
that may affect the whole brain.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed this
medicine for another reason.
There is no evidence that this
medicine is addictive.
This medicine is available only with
a doctor's prescription.
_USE IN CHILDREN_
The safety and efficacy of
zonisamide in children under 18
years of age have not been
established.
BEFORE YOU TAKE THIS
MEDICINE
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE THIS MEDICINE IF YOU
HAVE AN ALLERGY TO:
•
any medicine containing
zonisamide
•
sulfonamide drugs including
frusemide and bumetanide
(diuretic medicines)
•
any of the ingredients lis

Ապրանքի հատկությունները

1
AUSTRALIAN PRODUCT INFORMATION
APO-ZONISAMIDE (ZONISAMIDE) CAPSULES
1
NAME OF THE MEDICINE
Zonisamide
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 25 mg, 50 mg or 100 mg Zonisamide, as the active
ingredient.
EXCIPIENTS WITH KNOWN EFFECT
Gelatin (contains sulfites)
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS
3
PHARMACEUTICAL FORM
25 MG CAPSULES:
White - White opaque coloured hard gelatin capsules of size "4"
imprinted with “I” on cap and
"22' on body with black ink containing white to off white powder.
50 MG CAPSULES:
Gray-White opaque coloured hard gelatin capsules of size “3”
imprinted with "I" on cap and
"21' on body with black ink containing white to off white powder.
100 MG CAPSULES:
Red-White opaque coloured hard gelatin capsules of size "1" imprinted
with “I” on cap and "20"
on body with black ink containing white to off white powder.
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 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
APO-Zonisamide Capsules are intended for oral administration.
DOSAGE
ADULTS
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.
2
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
inc