AZOPT 10MG/ML OPHTHALMIC SUSPENSION

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

BRINZOLAMIDE

Boleh didapati daripada:

NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

BRINZOLAMIDE

Unit dalam pakej:

5ml mL

Dikeluarkan oleh:

S.A. ALCON-COUVREUR N.V.

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
_ _
AZOPT
® EYE DROPS_ _
Brinzolamide (10mg/ml)
1
WHAT IS IN THIS LEAFLET
1.
What AZOPT is used for
2.
How AZOPT works
3.
Before you use AZOPT
4.
How to use AZOPT
5.
While you are using AZOPT
6.
Side effects of AZOPT
7.
Storage
and
disposal
of
AZOPT
8.
Product description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT AZOPT IS USED FOR
Azopt is used to treat high pressure in
the
eyes,
also
called
glaucoma
or
ocular hypertension.
HOW AZOPT WORKS
Azopt
contains
brinzolamide
which
reduces the pressure in the eye by
reducing the production of fluid.
BEFORE YOU USE AZOPT
-
_When you must not use it _
Do not use Azopt:
•
if
you
have
severe
kidney
problems.
•
if you are allergic to brinzolamide
or any of the other ingredients of
this medicine.
•
if you are allergic to medicines
called sulphonamides. Examples
include
medicine
used
to
treat
diabetes and infections and also as
diuretics
(water
tablets).
Azopt
may cause the same allergy.
•
if you have too much acidity in
your
blood
(a
condition
called
hyperchloraemic acidosis).
The safety and efficacy of Azopt in
people below the age of 18 have not
been established and its use is not
recommended in these people.
_Pregnancy and breast-feeding _
If you are pregnant or breastfeeding,
you think you may be pregnant or are
planning to have a baby, ask your
doctor or pharmacist for advice before
you using this medicine. Azopt is not
recommended
during
pregnancy
or
breastfeeding.
-
_Before you start to use it _
Talk to your doctor
•
if you have kidney problems
_ _
•
if
you
have
eye
or
cornea
problems.
_ _
•
if you have liver problems
_ _
_ _
A
preservative
in
Azopt
(benzalkonium
chloride)
may
cause
eye irritation and is also known to
discolour soft contact lenses. If you
wear
contact
lenses,
you
should
remove them before using Azopt and
wait at least 15 minutes before putting
your lenses back in.
_ _
-
_Taking other medicines _
Tell your doctor or pharmacist if you
are using, have recently u

Ciri produk

1. NAME OF THE MEDICINAL PRODUCT
AZOPT* Brinzolamide 10 mg/ml Eye Drops, Ophthalmic Suspension 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of suspension contains 10 mg brinzolamide. Excipients: Each ml of suspension contains 0.1 mg benzalkonium chloride. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Eye drops, suspension. 4. CLINICAL PARTICULARS 4.1. Therapeutic Indications AZOPT* 10mg/ml Ophthalmic Suspension is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open- angle glaucoma. 4.2. Posology and Method of Administration Recommended Dose and Dosage Adjustment When used as monotherapy or adjunctive therapy, the dose is one drop of AZOPT Ophthalmic Suspension in the conjunctival sac of the affected eye(s) twice daily. Some patients may have a better response with one drop three times a day. If a dose is missed, treatment should be continued with the next dose as planned. The dose should not exceed 1 drop in the affected eye(s) 3 times daily. Pediatric population The safety and efficacy of AZOPT in patients below the age of 18 have not been established and its use is not recommended in these patients. Hepatic and renal impairment AZOPT* 10mg/ml Ophthalmic Suspension has not been studied in patients with hepatic impairment and is therefore not recommended in such patients. AZOPT* 10mg/ml Ophthalmic Suspension has not been studied in patients with severe renal impairment (creatinine clearance < 30 mL/min/1.73 m 2). Since brinzolamide and its major metabolite are excreted predominately by the kidney, AZOPT * 10mg/ml Ophthalmic Suspension is therefore contra-indicated i n such patients. However, in patients with moderate renal impairment (creatinine clearance 30- 60 mL/min/1.73 m 2) there is no need for dose adjustments with topical administration of brinzolamide 1%. Geriatric population No overall differences in safety or effectiveness have been observed between elderly and younger patients. No dose adjustment in elderly patients is