Brinzolamide Moosmann drops eye (suspension)

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

brinzolamide

Available from:

Lusomedicamenta Sociedade Tecnica Farmaceutica

ATC code:

S01EC04

INN (International Name):

brinzolamide

Dosage:

10mg/ml

Pharmaceutical form:

drops eye (suspension)

Units in package:

plastic vial 5ml

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2022-11-03

Patient Information leaflet

PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
BRINZOLAMIDE MOOSMANN 10 MG/ML EYE DROPS,
SUSPENSION
brinzolamide
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 illness 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 Moosmann is and what it is used for
2.
What you need to know before you use Brinzolamide Moosmann
3.
How to use Brinzolamide Moosmann
4.
Possible side effects
5.
How to store Brinzolamide Moosmann
6.
Contents of the pack and other information
1.
WHAT BRINZOLAMIDE MOOSMANN IS AND WHAT IT IS USED FOR
Brinzolamide Moosmann contains the active ingredient brinzolamide
which belongs
to a group of medicines called carbonic anhydrase inhibitors. It
reduces pressure
within the eye.
Brinzolamide Moosmann 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.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE BRINZOLAMIDE MOOSMANN
DO NOT USE BRINZOLAMIDE MOOSMANN :
•
if you have severe kidney problems.
•
if you are allergic to brinzolamide or any of the other ingredients of
this
medicine (listed in section 6).
•
if you are allergic to medicines called sulfonamides. Examples include
medicines used to treat diabetes and infections and also diuretics
(water tablets).
Brinzolamide 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.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist or nurse b

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Brinzolamide Moosmann 10 mg/ml Eye Drops, Suspension
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of suspension contains 10 mg brinzolamide.
Excipient(s) with known effect:
Each ml of suspension contains 0.15 mg benzalkonium chloride.
For the 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
Brinzolamide Moosmann is indicated to decrease elevated intraocular
pressure in:
•
ocular hypertension
•
open-angle glaucoma
as monotherapy in adult patients unresponsive to beta-blockers or in
adult patients in whom beta-
blockers are contraindicated, or as adjunctive therapy to
beta-blockers or prostaglandin analogues
(see also section 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
When used as monotherapy or adjunctive therapy, the recommended dose
is one drop
of Brinzolamide Moosmann 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.
_Patients with hepatic and renal impairment _
Brinzolamide Moosmann has not been studied in patients with hepatic
impairment and is
therefore not recommended in such patients.
Brinzolamide
Moosmann
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 metabolite are excreted predominantly by the
kidney, Brinzolamide
Moosmann is therefore contra-indicated in such patients (see also
section 4.3).
_Paediatric population _
The efficacy and safety of brinzolamide in infants, children and
adolescents aged 0 to 17 years
has not been established. Currently available data are described in
sections 4.8 and 5.1.
Brinzolamide is not recommended for use in infants, children and
adolescents.
Method o