Brizadopt 10 mg/ml, oogdruppels, suspensie

Pays: Pays-Bas

Langue: néerlandais

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

Ingrédients actifs:

BRINZOLAMIDE 10 mg/ml

Disponible depuis:

Bausch Health Ireland Limited 3013 Lake Drive, Citywest Business Campus D24 PPT3 DUBLIN 24 (IERLAND)

Code ATC:

S01EC04

DCI (Dénomination commune internationale):

BRINZOLAMIDE 10 mg/ml

forme pharmaceutique:

Oogdruppels, suspensie

Composition:

BENZALKONIUMCHLORIDE ; CARBOMEER 974P ; DINATRIUMEDETAAT 2-WATER ; MANNITOL (D-) (E 421) ; NATRIUMCHLORIDE ; NATRIUMHYDROXIDE (E 524) ; WATER, GEZUIVERD ; ZOUTZUUR (E 507),

Mode d'administration:

Oculair gebruik

Domaine thérapeutique:

Brinzolamide

Descriptif du produit:

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

Date de l'autorisation:

1900-01-01

Notice patient

PACKAGE LEAFLET: INFORMATION FOR THE USER
BRIZADOPT 10 MG/ML, OOGDRUPPELS, SUSPENSIE
Brinzolamide
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 your 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 Brizadopt 10 mg/ml eye drops suspension is and what it is used
for
2. What you need to know before you use Brizadopt 10 mg/ml eye drops
suspension
3. How to use Brizadopt 10 mg/ml eye drops suspension
4. Possible side effects
5. How to store Brizadopt 10 mg/ml eye drops suspension
6. Contents of the pack and other information
1. WHAT BRIZADOPT 10 MG/ML EYE DROPS SUSPENSION IS AND WHAT IT IS USED
FOR
Brizadopt 10 mg/ml eye drops suspension contains brinzolamide which
belongs to a group of
medicines called carbonic anhydrase inhibitors. It reduces pressure
within the eye.
Brizadopt 10 mg/ml eye drops suspension 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 BRIZADOPT 10 MG/ML EYE DROPS
SUSPENSION
DO NOT USE BRIZADOPT 10 MG/ML EYE DROPS SUSPENSION
-
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).
Brizadopt 10 mg/ml eye drops
suspension may cause the same allergy.
-
if you have too much acidity in your blood (a condition called
hyperchloraemic aci

Résumé des caractéristiques du produit

1
1. NAME OF THE MEDICINAL PRODUCT
Brizadopt 10 mg/ml oogdruppels, suspensie
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of suspension contains 10 mg brinzolamide.
One drop contains 0.27 mg brinzolamide.
Excipients 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.
A white to off-white homogenous suspension.
Osmolality: 250~300 mOsmol/kg
pH: 7.3 – 7.7
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Brinzolamide 10 mg/ml eye drops suspension 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
10 mg/ml eye drops suspension 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.
2
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 10 mg/ml eye
drops suspension is therefore contraindicated 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 have not been established. Currently available data are
described in sections 4.8 and 5.1.
Brinzolamide 10 mg/ml eye