AZARGA 10MGML + 5MGML EYE DROPS SUSPENSION

Država: Malezija

Jezik: angleščina

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

Aktivna sestavina:

BRINZOLAMIDE; TIMOLOL

Dostopno od:

NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.

INN (mednarodno ime):

BRINZOLAMIDE; TIMOLOL

Enote v paketu:

5ml mL

Izdeluje:

S.A. ALCON-COUVREUR N.V.

Navodilo za uporabo

_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 severe hay fever.

If you have a slow heart beat,
heart failure or disorders of heart
rhythm (irregular heartbeats).

If you have too much acidity in
your
blood
(a
condition
called
hyperchloraemic acidosis).

If
you
have
severe
kidney
problems.
_ _
_Pregnancy and breast-feeding _
You should not use Azarga if you are
pregnant or might get pregnant, unless
your
doctor
considers
it
necessary.
Talk to your doctor before you use
Azarga.
Do not use Azarga if you are breast-
feeding. Timolol may get into your
milk.
Ask
your
doctor
for
advice
before
taking
any
medicine
during
breastfeeding.
_Before you

Lastnosti izdelka

Novartis
Page 2
CDS v4.1
26-May-2022
Azarga
®
2
1.
NAME OF THE MEDICINAL PRODUCT
AZARGA 10 mg/ml + 5 mg/ml eye drops, suspension
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml of suspension contains 10 mg brinzolamide and 5 mg timolol (as
timolol maleate).
Excipient with known effect
One ml of suspension contains 0.10 mg benzalkonium chloride.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Eye drops, suspension (eye drops)
White to off-white uniform suspension, pH 7.2 (approximately).
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 provides 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 in the conjunctival sac of the affected
eye(s) twice daily.
When using nasolacrimal occlusion or closing the eyelids, the systemic
absorption is reduced.
This may result in a decrease in systemic side effects and an increase
in local activity (see
section 4.4).
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 medicinal product
with AZARGA, the
other medicinal product should be discontinued and AZARGA should be
started the following
day.
_Special populations _
_Paediatric population _
The safety and efficacy of AZARGA in children and adolescents aged 0
to 18 years have not
yet been established. No data are available.
Novartis
Page 3
CDS v4.1
26-May-2022
Azarga
®
3
_Hepatic and renal impairment _
No studies have been conducted with AZARGA 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
has
not
been
studied
in
patients
with
severe
renal
impairment
(creatinine
cleara