Brinzolamide Timolol Moosmann drops eye (suspension)

Land: Armenia

Språk: engelsk

Kilde: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktiv ingrediens:

brinzolamide, timolol (timolol maleate)

Tilgjengelig fra:

Lusomedicamenta Sociedade Tecnica Farmaceutica

ATC-kode:

S01ED51

INN (International Name):

brinzolamide, timolol (timolol maleate)

Dosering :

10mg/ml+ 5mg/ml

Legemiddelform:

drops eye (suspension)

Enheter i pakken:

plastic vial-dropper 5ml

Resept typen:

Prescription

Autorisasjon status:

Registered

Autorisasjon dato:

2022-11-03

Informasjon til brukeren

1
PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE USER
Brinzolamide+Timolol Moosmann
Brinzolamide/Timolol
10 mg/ml + 5 mg/ml eye drops, suspension
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 Brinzolamide+Timolol Moosmann is and what it is used for
2.
What you need to know before you use Brinzolamide+Timolol Moosmann
3.
How to use Brinzolamide+Timolol Moosmann
4.
Possible side effects
5.
How to store Brinzolamide+Timolol Moosmann
6.
Contents of the pack and other information
1.
WHAT BRINZOLAMIDE+TIMOLOL MOOSMANN IS AND WHAT IT IS USED FOR
Brinzolamide+Timolol Moosmann contains two active substances,
brinzolamide and timolol, which
work together to reduce pressure within the eye.
Brinzolamide+Timolol Moosmann 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 BRINZOLAMIDE+TIMOLOL MOOSMANN
DO NOT USE BRINZOLAMIDE+TIMOLOL MOOSMANN :
-
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
obstructiv

Preparatomtale

1
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Brinzolamide+Timolol Moosmann
_ _
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 Brinzolamide+Timolol Moosmann 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 Brinzolamide+Timolol
Moosmann, the other medicinal product should be discontinued and
Brinzolamide+Timolol
Moosmann should be started the following day.
Special populations
_Paediatric population _
The safety and efficacy of Brinzolamide+Timolol Moosmann in children
and adolescents aged 0 to 18
years have not yet been established. No data are available.
_Hepatic and renal impairment _
3
No studies have been conducted with Brinzolamide+Timolol Moosmann 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.
Brinzolamide+Timolol