Optilamid 10 mg/ml, oogdruppels, suspensie

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

BRINZOLAMIDE 10 mg/ml

Beschikbaar vanaf:

Pharmaceutical Works Polpharma S.A. 19, Pelplinska Street 83-200 STAROGARD GDANSKI (POLEN)

ATC-code:

S01EC04

INN (Algemene Internationale Benaming):

BRINZOLAMIDE 10 mg/ml

farmaceutische vorm:

Oogdruppels, suspensie

Samenstelling:

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

Autorisatie datum:

1900-01-01

Bijsluiter

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
OPTILAMID 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, please ask your doctor, your
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 or pharmacist or
nurse. This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Optilamid 10 mg/ml, oogdruppels suspensie is and what it is
used for
2. What you need to know before you use Optilamid 10 mg/ml,
oogdruppels suspensie
3. How to use Optilamid 10 mg/ml, oogdruppels suspensie
4. Possible side effects
5. How to store Optilamid 10 mg/ml, oogdruppels suspensie
6. Contents of the pack and other information
1. WHAT OPTILAMID 10 MG/ML, OOGDRUPPELS SUSPENSIE IS AND WHAT IT IS
USED FOR
OPTILAMID 10 MG/ML, OOGDRUPPELS SUSPENSIE CONTAINS BRINZOLAMIDE WHICH
BELONGS TO A GROUP OF
MEDICINES called carbonic anhydrase inhibitors. It reduces pressure
within the eye.
OPTILAMID 10 MG/ML, OOGDRUPPELS SUSPENSIE 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 OPTILAMID 10 MG/ML,
OOGDRUPPELS SUSPENSIE
DO NOT USE OPTILAMID 10 MG/ML, OOGDRUPPELS SUSPENSIE
-
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).
OPTILAMID 10 MG/ML,
OOGDRUPPELS SUSPENSIE may cause the same allergy.
-
IF YOU HAVE TOO MUCH ACIDITY IN YOUR BL

Productkenmerken

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Optilamid 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
Optilamid 10 mg/ml, oogdruppels suspensie 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 Optilamid 10
mg/ml, oogdruppels suspensie 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.
2
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,
Optilamid 10 mg/ml,
oogdruppels suspensie 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 has not been established. Currently available data are described
in sections 4.8 and