Brinzolamide Teva 10 mg/ml, oogdruppels, suspensie

Land: Nederland

Taal: Nederlands

Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Werkstoffen:

BRINZOLAMIDE

Beschikbaar vanaf:

Teva Nederland B.V.

ATC-code:

S01EC04

INN (Algemene Internationale Benaming):

BRINZOLAMIDE

farmaceutische vorm:

Oogdruppels, suspensie

Samenstelling:

BENZALKONIUMCHLORIDE ; CARBOMEER 974P ; DINATRIUMEDETAAT 2-WATER ; MANNITOL (D-) (E 421) ; NATRIUMCHLORIDE ; NATRIUMHYDROXIDE (E 524) ; POLOXAMEER 407 ; WATER VOOR INJECTIE,

Toedieningsweg:

Oculair gebruik

Therapeutisch gebied:

Brinzolamide

Product samenvatting:

Hulpstoffen: BENZALKONIUMCHLORIDE; CARBOMEER 974P; DINATRIUMEDETAAT 2-WATER; MANNITOL (D-) (E 421); NATRIUMCHLORIDE; NATRIUMHYDROXIDE (E 524); POLOXAMEER 407; WATER VOOR INJECTIE;

Autorisatie datum:

2015-02-24

Bijsluiter

PACKAGE LEAFLET: INFORMATION FOR THE USER
PACKAGE LEAFLET: INFORMATION FOR THE USER
BRINZOLAMIDE TEVA 10 MG/ML, OOGDRUPPELS, SUSPENSIE
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, pharmacist or
nurse.
-
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, pharmacist or nurse.
This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Brinzolamide Teva is and what it is used for
2.
What you need to know before you use Brinzolamide Teva
3.
How to use Brinzolamide Teva
4.
Possible side effects
5.
How to store Brinzolamide Teva
6.
Contents of the pack and other information
1.
WHAT BRINZOLAMIDE TEVA IS AND WHAT IT IS USED FOR
Brinzolamide Teva contains brinzolamide which belongs to a group of
medicines called carbonic
anhydrase inhibitors. It reduces pressure within the eye.
Brinzolamide Teva 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 TEVA
DO NOT USE BRINZOLAMIDE TEVA:
-
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 Teva 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, pharmacist or nurse before using Brin

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Brinzolamide Teva 10 mg/ml, oogdruppels, suspensie
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of suspension contains 10 mg brinzolamide.
One drop contains approximately 309 micrograms brinzolamide.
Excipient with known effect:
Each ml of suspension contains approximately 0.1 mg benzalkonium
chloride.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Eye drops, suspension.
White homogenous suspension.
pH: 7.1 – 7.9
Osmolality: 270 – 320 mOsm/Kg
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Brinzolamide Teva 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 Teva 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 _
Older People
No dose adjustment in older people is necessary.
Patients with 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
< 30 ml/min) or in patients with hyperchloraemic acidosis. Since
brinzolamide and its main metabolite
are excreted predominantly by the kidney, Brinzolamide Teva is
therefore contra-indicated in such
patients (see also section 4.3).
Paediatric population
The safety and efficacy of Brinzolamide Teva 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 Teva
is not recomme