Azarga

מדינה: האיחוד האירופי

שפה: אנגלית

מקור: EMA (European Medicines Agency)

מרכיב פעיל:

brinzolamide, timolol maleate

זמין מ:

Novartis Europharm Limited

קוד ATC:

S01ED51

INN (שם בינלאומי):

brinzolamide, timolol

קבוצה תרפויטית:

Ophthalmologicals

איזור תרפויטי:

Glaucoma, Open-Angle; Ocular Hypertension

סממני תרפויטית:

Decrease of intraocular pressure (IOP) in adult patients with open angle glaucoma or ocular hypertension for whom monotherapy provides insufficient IOP reduction.

leaflet_short:

Revision: 16

מצב אישור:

Authorised

תאריך אישור:

2008-11-25

עלון מידע

22
B. PACKAGE LEAFLET
23
PACKAGE LEAFLET: INFORMATION FOR THE USER
AZARGA 10 MG/ML + 5 MG/ML EYE DROPS, SUSPENSION
brinzolamide/timolol
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU
.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them
even if their signs of illnesses are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What AZARGA is and what it is used for
2.
What you need to know before you use AZARGA
3.
How to use AZARGA
4.
Possible side effects
5.
How to store AZARGA
6.
Contents of the pack and other information
1.
WHAT AZARGA IS AND WHAT IT IS USED FOR
AZARGA contains two active substances, brinzolamide and timolol, which
work together to reduce
pressure within the eye.
AZARGA is used to treat high pressure in the eyes, also called
glaucoma or ocular hypertension, in
adult patients that are more than 18 years of age and in whom high
pressure in the eyes cannot be
controlled effectively by one medicine alone.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE AZARGA
DO NOT USE AZARGA
•
If you are allergic to brinzolamide, medicines called sulphonamides
(examples include
medicines used to treat diabetes, infections and also diuretics (water
tablets)), timolol, beta-
blockers (medicines used to lower blood pressure or to treat heart
disease) or any of the other
ingredients of this medicine (listed in section 6).
•
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, hea

מאפייני מוצר

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
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.
_Hepatic and renal impairment _
No studies have been conducted with AZARGA 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.
3
AZARGA has not been studied in patients with severe renal impairment
(creatinine
clearance <30 ml/min) or in pat