BRINZOLAMIDE SK

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

BRINZOLAMIDE

Available from:

K.S.KIM INTERNATIONAL (SK- PHARMA) LTD., ISRAEL

ATC code:

S01EC04

Pharmaceutical form:

OPHTHALMIC SUSPENSION

Composition:

BRINZOLAMIDE 10 MG/ML

Administration route:

OCULAR

Prescription type:

Required

Manufactured by:

AZAD PHARMA AG, SWITZERLAND

Therapeutic area:

BRINZOLAMIDE

Therapeutic indications:

Brinzolamide S.K. is indicated to decrease elevated intraocular pressure in: ocular hypertension open-angle glaucoma as monotherapy in patients unresponsive to beta-blockers or in patients in whom beta-blockers are contra-indicated or as adjunctive therapy to beta-blockers.

Authorization date:

2020-01-08

Patient Information leaflet

PATIENT PACKAGE INSERT IN ACCORDANCE
WITH THE PHARMACISTS’ REGULATIONS
(PREPARATIONS) - 1986
The medicine is dispensed with a doctor’s
prescription only.
BRINZOLAMIDE S.K.
EYE DROPS (SUSPENSION)
ACTIVE INGREDIENT:
EACH 1 ML CONTAINS:
brinzolamide 10 mg (1%)
The inactive ingredients are listed in section 6 - “Further
Information”.
Also see “Important information about some of the
ingredients of
the medicine” in Section 2.
READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE
USING THE
MEDICINE.
This leaflet
contains concise
information about the medicine. If you have further
questions, refer to the doctor or pharmacist.
This medicine has been prescribed for you. Do not pass
it on to others. It may harm them even if it seems to you
that their medical condition is similar.
This medicine is not intended for use in infants, children
and adolescents under the age of 18, since there is no
data about the safety and efficacy of the preparation in
this population.
1.
WHAT IS THE MEDICINE INTENDED FOR?
Brinzolamide
S.K. eye drops are used to decrease
intraocular
pressure
in
patients
with
ocular
hypertension or in open-angle glaucoma patients, in
patients who are unresponsive to beta-blockers, who
cannot take beta-blockers or as adjunctive therapy to beta-
blockers.
THERAPEUTIC GROUP:
Carbonic anhydrase inhibitors –
intraocular
pressure-reducing medicines.
Intraocular pressure that is too high can damage your
vision.
2.
BEFORE USING THE MEDICINE
SPECIAL WARNINGS REGARDING USE OF THE MEDICINE
! BEFORE TREATMENT WITH
BRINZOLAMIDE S.K., TELL THE
DOCTOR IF:
•
You suffer from liver or kidney problems.
•
You
suffer
from
dryness
of
the
eyes
or
cornea
problems.
•
You are taking other sulfonamides.
•
You have a certain form of glaucoma in which the
pressure inside the eye rises due to deposits that
block fluid drainage (pseudoexfoliative glaucoma or
pigmentary glaucoma) or a certain form of glaucoma
in
which
the
pressure
in
the
eye
increases
(sometimes rapidly) due to the eye protruding forward
and blocking fluid d

Summary of Product characteristics

1/7
BRINZOLAMIDE SK
EYE DROPS, SUSPENSION
Summary of Product Characteristics
1.
NAME OF THE MEDICINAL PRODUCT
BRINZOLAMIDE SK 10 mg/ml eye drops, suspension
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 a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Eye drops, suspension.
White to off-white homogenous suspension.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
BRINZOLAMIDE SK
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 (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 SK
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 SK
has not been studied in patients with hepatic impairment and is
therefore not recommended in such
patients.
BRINZOLAMIDE SK
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 SK
is therefore contra-indicated in such patients (see also section 4.3).
_Paediatric population _
The safety and efficacy of
BRINZOLAMIDE SK
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 SK
is not recommended
for use in infants, children and adolescents.
Method of administration
For ocular use.
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