Brinzolamide Actavis 10 mg/ml oogdruppels, suspensie

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

BRINZOLAMIDE

Beschikbaar vanaf:

Actavis Group PTC ehf Reykjavikurvegur 76-78 220 HAFNARFJÖRDUR (IJSLAND)

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) ; WATER VOOR INJECTIE ; ZOUTZUUR (E 507),

Toedieningsweg:

Oculair gebruik

Therapeutisch gebied:

Brinzolamide

Product samenvatting:

Hulpstoffen: BENZALKONIUMCHLORIDE; CARBOMEER 974P; DINATRIUMEDETAAT 2-WATER; MANNITOL (D-) (E 421); NATRIUMCHLORIDE; NATRIUMHYDROXIDE (E 524); WATER VOOR INJECTIE; ZOUTZUUR (E 507);

Autorisatie datum:

2015-12-28

Bijsluiter

Brinzolamide, NL/H/2973/001, January 2020
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
BRINZOLAMIDE ACTAVIS 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 /…/ is and what it is used for
2.
What you need to know before you use /…/
3.
How to use /…/
4.
Possible side effects
5.
How to store /…/
6.
Contents of the pack and other information
1.
WHAT /…/ IS AND WHAT IT IS USED FOR
/…/ CONTAINS BRINZOLAMIDE WHICH BELONGS TO A GROUP OF MEDICINES
called carbonic anhydrase
inhibitors. It reduces pressure within the eye.
/…/ IS 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 /…/
DO NOT USE /…/:
-
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).
/…/ 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 /…/
-
IF YOU HAVE KIDNEY OR LIVER PROBLEMS.
-
IF YOU HAVE DRY EYES OR CORNEA PROBLEMS.
-
IF YOU ARE TAKING OTHER SULPHONAMIDE MED

Productkenmerken

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Brinzolamide Actavis 10 mg/ml oogdruppels, suspensie
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of suspension contains 10 mg brinzolamide.
Excipient 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
/…/ 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 /…/ 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 _
2
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, /…/ is
therefore contra-
indicated in such patients (see also section 4.3).
_ _
_ _
_Paediatric population _
The safety and efficacy 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.
/.../ is not recommended for use in infants, children and adolescents.
Method of administration
For ocular use.
Nasolacrimal occlusion or gently closing the eyelid after ins