SIMBRINZA

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

BRIMONIDINE TARTRATE; BRINZOLAMIDE

Available from:

NOVARTIS ISRAEL LTD

ATC code:

S01EC54

Pharmaceutical form:

EYE DROPS, SUSPENSION

Composition:

BRIMONIDINE TARTRATE 2 MG/ML; BRINZOLAMIDE 10 MG/ML

Administration route:

OCULAR

Prescription type:

Required

Manufactured by:

ALCON COUVREUR N.V., BELGIUM

Therapeutic area:

BRINZOLAMIDE, COMBINATIONS

Therapeutic indications:

Decrease of elevated intraocular pressure (IOP) in adult patients with open-angle glaucoma or ocular hypertension for whom monotherapy provides insufficient IOP reduction.

Authorization date:

2022-05-31

Patient Information leaflet

PATIENT PACKAGE INSERT IN ACCORDANC
WITH THE PHARMACISTS’ REGULATIONS
(PREPARATIONS) - 1986
The medicine is dispensed with a doctor’s
prescription only
SIMBRINZA
®
EYE DROPS, SUSPENSION
ACTIVE INGREDIENTS:
Brimonidine tartrate 2 mg/ml
Brinzolamide 10 mg/ml
Inactive and allergenic ingredients in the
preparation appear in section 6 “Further
Information” and in section 2 “Important information
about some of the ingredients of the medicine”.
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 the treatment
of your ailment. Do not pass it on to others. It may
harm them, even if it seems to you that their medical
condition is similar.
The medicine is intended for use by adults over
the age of 18.
1. WHAT IS THE MEDICINE INTENDED
FOR?
The medicine is intended for the reduction of
intraocular pressure in adults (over 18 years
of age) in cases of glaucoma or intraocular
hypertension in patients who do not fully respond
to treatment for intraocular pressure with a single
medicine.
THERAPEUTIC GROUP:
Brimonidine tartrate – alpha-2 adrenergic receptor
agonist.
Brinzolamide – carbonic anhydrase inhibitor.
Both ingredients work together to reduce
intraocular pressure.
2.
BEFORE USING THE MEDICINE
DO NOT USE THIS MEDICINE IF:
• You have a known sensitivity (allergy) to
brinzolamide or brimonidine tartrate or to any
of the other ingredients of the medicine (see
section 6 “Further Information”).
• You are sensitive (allergic) to medicines from
the sulphonamide group (such as: medicines
for the treatment of diabetes, for the treatment
of infections and diuretics).
• You are taking medicines that inhibit the enzyme
monoamine oxidase (such as medicines for the
treatment of depression or Parkinson’s disease)
or certain anti-depressants. You must inform the
doctor if you are taking any anti-depressants.
• You suffer from s

Summary of Product characteristics

SIM API JAN23 V2
1. NAME OF THE MEDICINAL PRODUCT
SIMBRINZA
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
1 mL of suspension contains 10 mg of brinzolamide and 2 mg of
brimonidine tartrate
equivalent to 1.3 mg of brimonidine.
Excipient with known effect
Each mL of suspension contains 0.03 mg of benzalkonium chloride.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Eye drops suspension
White to off-white uniform suspension, pH 6.5 (approximately).
4.CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Decrease of elevated intraocular pressure (IOP) in adult patients with
open-angle
glaucoma or ocular hypertension for whom monotherapy provides
insufficient IOP
reduction (see section 5.1).
_ _
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_ncluding the elderly_
_Use in adults, i_
_ _
The recommended dose is one drop of SIMBRINZA in the affected eye(s)
two times
daily.
_Missed dose_
_ _
If a dose is missed, treatment should be continued with the next dose
as planned.
_nal impairment_
_Hepatic and/or re_
_ _
SIMBRINZA has not been studied in patients with hepatic impairment and
caution is
therefore recommended in this population (see section 4.4).
SIMBRINZA has not been studied in patients with severe renal
impairment (CrCl <
30 mL/min) or in patients with hyperchloraemic acidosis. Since the
brinzolamide
component of SIMBRINZA and its metabolite are excreted predominantly
by the
kidney, SIMBRINZA is contraindicated in such patients (see section
4.3).
SIM API JAN23 V2
_c population_
_Paediatri_
_ _
_ _
_ _
The safety and efficacy of SIMBRINZA in children and adolescents aged
2 to 17
not been established. No data are available.
ve
ha
years
_ _
SIMBRINZA is contraindicated in neonates and infants aged less than 2
years in the
decrease of elevated intraocular pressure (IOP) with open-angle
glaucoma or ocular
hypertension for whom monotherapy provides insufficient IOP reduction
because of
safety concerns (see section 4.3).
Method of administration
For ocular use.
Patients should be instructed to sha