Brinzolamide Pharmathen 10 mg/ml oogdruppels, suspensie

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

BRINZOLAMIDE 10 mg/ml

Beschikbaar vanaf:

Pharmathen S.A. 6, Dervanakion St. 153 51 PALLINI ATTICA (GRIEKENLAND)

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) ; 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:

2015-04-13

Bijsluiter

PACKAGE LEAFLET: INFORMATION FOR THE USER
BRINZOLAMIDE PHARMATHEN 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 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 Pharmathen is and what it is used for
2.
What you need to know before you use Brinzolamide Pharmathen
3.
How to use Brinzolamide Pharmathen
4.
Possible side effects
5.
How to store Brinzolamide Pharmathen
6.
Contents of the pack and other information
1.
WHAT BRINZOLAMIDE PHARMATHEN IS AND WHAT IT IS USED FOR
Brinzolamide Pharmathen contains brinzolamide which belongs to a group
of medicines
called carbonic anhydrase inhibitors. It reduces pressure within the
eye.
Brinzolamide Pharmathen 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 PHARMATHEN
DO NOT USE BRINZOLAMIDE PHARMATHEN
-
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 Pharmathen
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 u

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Brinzolamide Pharmathen 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.
Excipients with known effect
Each mL of suspension contains approximately 0.1 mg benzalkonium
chloride.
One drop contains approximately 3.1 micrograms 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 Pharmathen 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
Pharmathen 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 < 30 mL/min) or in patients with hyperchloraemic acidosis.
Since brinzolamide and
its main metabolite are excreted predominantly by the kidney,
Brinzolamide Pharmathen 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 a