AZARGA 10MG/ML + 5MG/ML EYE DROPS, SUSPENSION

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

BRINZOLAMIDE; TIMOLOL

Boleh didapati daripada:

NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

BRINZOLAMIDE; TIMOLOL

Unit dalam pakej:

5ml mL

Dikeluarkan oleh:

S.A. ALCON-COUVREUR N.V.

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
_ _
AZARGA
_® _
Eye Drops
_Brinzolamide/ Timolol (10mg/ml, 5mg/ml)_
_ _
1
WHAT IS IN THIS LEAFLET
1.
What AZARGA is used for
2.
How AZARGA works
3.
Before you use AZARGA
4.
How to use AZARGA
5.
While you are using AZARGA
6.
Side effects of AZARGA
7.
Storage
and
disposal
of
AZARGA
8.
Product Description
9.
Manufacturer
10.
Product Registration Holder
11.
Date of revision
WHAT AZARGA IS USED FOR
Azarga is used to treat high pressure in
the
eyes,
also
called
glaucoma
or
ocular hypertension, in adult patients
and in whom high pressure in the eyes
cannot
be
controlled
effectively
by
one medicine alone.
HOW AZARGA WORKS
Azarga
contains
two
active
substances: brinzolamide and timolol
which
work
together
to
reduce
pressure within the eye.
BEFORE YOU USE AZARGA
_When you must not use it _
Do not use Azarga:
_ _
•
If
you
are
allergic
to
brinzolamide, timolol, or any of
the
other
ingredients
of
this
medicine.
•
If you are allergic to medicines
called sulphonamides. Examples
include medicines used to treat
diabetes,
infections
and
also
diuretics (water tablets). Azarga
may cause allergic reaction.
•
If you have now or have had in the
past respiratory problems such as
asthma,
severe
long
lasting
obstructive
bronchitis
(severe
lung condition which may cause
wheezing, difficulty in breathing
and/or long standing cough) or
other types of breathing problems.
•
If you have a slow heart beat,
heart failure or disorders of heart
rhythm.
•
If
you
have
severe
kidney
problems.
•
If you have too much acidity in
your
blood
(a
condition
called
hyperchloraemic acidosis).
_ _
_Pregnancy, _
_breast-feeding _
_and _
_fertility _
Do not use Azarga if you are pregnant
unless
your
doctor
considers
it
necessary.
Do not use Azarga if you are breast-
feeding. Timolol may get into your
milk.
_Before you start to use it _
A
preservative
in
Azarga
(benzalkonium
chloride)
may
cause
eye irritation and is also known to
discolour soft contact lenses. If you
wear
contact
lenses,
you
should
remo

Ciri produk

1. NAME OF THE MEDICINAL PRODUCT
AZARGA* 10 mg/ml + 5 mg/ml eye drops, suspension
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of suspension contains 10 mg brinzolamide and 5 mg timolol (as timolol maleate).
Preservative: 1 ml of suspension contains 0.1 mg benzalkonium chloride.
For the full list of excipients: see section 6.1.
3. PHARMACEUTICAL FORM
Eye drops, suspension.
W hite to off -white uniform suspension.
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
Decrease of intraocular pressure (IOP) in adult patients with open -angle glaucoma or ocular
hypertension for whom monotherapy provi des insufficient IOP reduction. (see section 5.1).
4.2 Posology and method of administration
Posology
Use in adults, including the elderly The dose is one drop of AZARGA* eye drops, suspension in the conjunctival sac of the affected
eye(s) twice daily.
If a dose is missed, treatment should be continued with the next dose as planned. The dose should not exceed one drop in the affected eye(s) twice daily. When substituting another ophthalmic antiglaucoma agent with AZARGA eye drops, suspension, the
other agent should be discontinued and AZARGA eye drops, suspension should be started the
following day.
Use in paediatric patients AZARGA eye drops, suspension is not recommended for use in children below 18 years due to a lack
of data on safety and efficacy.
Use in geriatric patients No overall differences in safety and effectiveness have been observed between elderly and other adult populations. Use in patients with hepatic or renal impairment No studies have been conducted with AZARGA eye drops, suspension or with timolol 5 mg/ml eye
drops in patients with hepatic or renal impairment. No dosage adjustment is necessary in patients with
hepatic impairment or in patients with mild to moderate renal impairment.
AZARGA eye drops, suspension has not been studied in patients with severe renal impairment
(creatinine clearance < 30 ml/min) or in patients with hyperchloraemic ac idosis. Since brinzolamide
and its main metabolite are