Brinzolamide Sandoz 10mg/ml eye drops, suspension

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Brinzolamide

Available from:

Rowex Ltd

ATC code:

S01EC; S01EC04

INN (International Name):

Brinzolamide

Dosage:

10 milligram(s)/millilitre

Pharmaceutical form:

Eye drops, suspension

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Carbonic anhydrase inhibitors; brinzolamide

Authorization status:

Marketed

Authorization date:

2014-07-04

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
BRINZOLAMIDE SANDOZ 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 Sandoz is and what it is used for
2.
What you need to know before you use Brinzolamide Sandoz
3.
How to use Brinzolamide Sandoz
4.
Possible side effects
5.
How to store Brinzolamide Sandoz
6.
Contents of the pack and other information
1. WHAT BRINZOLAMIDE SANDOZ IS AND WHAT IT IS USED FOR
BRINZOLAMIDE SANDOZ
CONTAINS BRINZOLAMIDE WHICH BELONGS TO A GROUP OF MEDICINES
called
carbonic anhydrase inhibitors. It reduces pressure within the eye.
BRINZOLAMIDE SANDOZ
EYE DROPS 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 SANDOZ
DO NOT USE BRINZOLAMIDE SANDOZ
-
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 SULPHONAMIDES
Examples include medicines used to treat diabetes and infections and
also diuretics (water tablets).
Brinzolamide Sandoz 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 before using Brinzolamide Sandoz
-
IF YOU HAVE KIDNEY OR LIVE

Summary of Product characteristics

Health Products Regulatory Authority
22 August 2022
CRN00D4CF
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Brinzolamide Sandoz 10mg/ml eye drops, suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of suspension contains 10 mg brinzolamide (0.33 mg
brinzolamide per drop).
Excipient(s) with known effect
Each 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.
White to off-white suspension, pH 7.1 – 7.9 and osmolality 270 –
320 m Osm/kg.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Brinzolamide Sandoz 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 dose is one drop
of Brinzolamide Sandoz 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.
Hepatic and renal impairment
Brinzolamide has not been studied in patients with hepatic impairment
and is therefore not recommended in such patients.
Brinzolamide has not been studied in patients with severe renal
impairment (creatinine clearance <30ml/min) or in patients
with hyperchloraemic acidosis. Since brinzolamide and its main
metabolite are excreted predominantly by the kidney,
Brinzolamide Sandoz is therefore contraindicated in such patients (see
also section 4.3).
Paediatric population
The safety and efficacy of Brinzolamide Sandoz in infants, children
and adolescents aged 0 to 17 years has not been
established. Currently available data are described insections 4.8 and
5.1. Br