AZOPT 10MGML 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 eye drops are used to treat high
pressure in the eye.
This pressure can
lead to an illness called glaucoma.
If the pressure in the eye is too high, it
can damage your sight.
HOW AZOPT WORKS
Azopt
contains
brinzolamide
which
belongs to a group of medicines called
carbonic
anhydrase
inhibitors.
It
reduces the pressure within the eye.
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
diuretics
(water
tablets).
Azopt
may cause the same allergy.
•
if you have too much acidity in
your
blood
(a
condition
called
hyperchloraemic acidosis).
If you have further questions, ask your
doctor for advice.
_Children and adolescents _
Azopt is not to be used by infants,
children or adolescents under 18 years
of age.
_Pregnancy and breast-feeding _
If you are pregnant or breastfeeding,
think
you
may
be
pregnant
or
are
planning to have a baby, ask your
doctor or pharmacist for advice before
using this medicine.
Women who may become pregnant
are
advised
to
use
effective
contraception during Azopt treatment.
The use of Azopt is not recommended
during pregnancy or breast-feeding.
Do
not
use
Azopt
unless
clearly
indicated by your doctor.
Ask your
doctor
or
pharmacist
for
advice before taking any medicine.
-
_Before you start to use it _
Talk
to
your
doctor
or
pharmacist
before using Azopt:
•
if
you
have
kidney
or
liver
problems.
_ _
•
if you

Ciri produk

Novartis
Malaysia Package Insert 26-May-2022 Azopt
®
2
1.
NAME OF THE MEDICINAL PRODUCT
AZOPT 10 mg/ml eye drops, suspension
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of suspension contains 10 mg brinzolamide.
Excipient with known effect
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.
White to off-white suspension.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
AZOPT 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
Posology
When used as monotherapy or adjunctive therapy, the dose is one drop
of AZOPT 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.
_Special populations _
_Elderly population _
No dose adjustment in elderly patients is necessary.
_Hepatic and renal impairment _
AZOPT
has
not
been
studied
in
patients
with
hepatic
impairment
and
is
therefore
not
recommended in such patients.
AZOPT has not been studied in patients with severe renal impairment
(creatinine clearance
< 30 ml/min) or in patients with hyperchloraemic acidosis. Since
brinzolamide and its main
Novartis
Malaysia Package Insert
26-May-2022
Azopt
®
3
metabolite are excreted predominantly by the kidney, AZOPT is
therefore contra-indicated in such
patients (see also section 4.3).
_Paediatric population _
The safety and efficacy of AZOPT in infants, children and adolescents
aged 0 to 17 years have not
been established. Currently available data are described in sections
4.8 and 5.1. AZOPT is not
recommended for use in infants, children and adolescents.
METHOD OF ADMINISTRATION
For ocular use.
Nasolacrimal occlusion or gently closing the eyelid after instillation
is recommended. This may
reduce the systemic absorption of medicinal products administered via
the ocular route and result
in a decrease in systemic side effects.
Instru