COMBIGAN

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

BRIMONIDINE TARTRATE; TIMOLOL AS MALEATE

Available from:

ABBVIE BIOPHARMACEUTICALS LTD, ISRAEL

ATC code:

S01EA05

Pharmaceutical form:

EYE DROPS SOLUTION

Composition:

TIMOLOL AS MALEATE 0.5 %W/V; BRIMONIDINE TARTRATE 0.2 %W/V

Administration route:

OCULAR

Prescription type:

Required

Manufactured by:

ALLERGAN INC., USA

Therapeutic group:

BRIMONIDINE

Therapeutic area:

BRIMONIDINE

Therapeutic indications:

Combigan is indicated for lowering intraocular pressure in patients with open-angle glaucoma or ocular hypertension.

Authorization date:

2022-11-30

Patient Information leaflet

COM
APL MAY
23
CL
PATIENT LEAFLET IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986
This medicine is dispensed with a
doctor’s
prescription only
COMBIGAN
®
OPHTHALMIC SOLUTION
ACTIVE INGREDIENTS AND THEIR CONCENTRATIONS:
Brimonidine tartrate
0.2%
w/v and timolol (as maleate) 0.5% w/v
Inactive
ingredients
and
allergens
in
the
medicine:
See
section
2
under
‘Important
information
about
some
of
this
medicine’s
ingredients’,
and
section
6
‘Additional
information'.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THE MEDICINE. This
leaflet contains concise
information about the medicine. If you have any further questions,
consult your doctor or
pharmacist.
This medicine has been prescribed for the treatment of your
ailment/for you. Do not pass
it on to others.
It may harm them, even if it seems to you that their ailment/medical
condition is similar to yours.
1.
WHAT IS THIS MEDICINE INTENDED FOR?
Combigan is used for lowering high intraocular pressure in patients
with open-angle
glaucoma or ocular hypertension.
THERAPEUTIC GROUP: The medicine contains two active ingredients -
brimonidine, which
belongs to a group of medicines called alpha-adrenergic receptor
agonists. Timolol,
which belongs to a group of medicines called beta-blockers.
Both of these active ingredients reduce pressure in the eye.
2.
BEFORE USING THE MEDICINE
DO NOT USE THIS MEDICINE IF:
•
you are sensitive (allergic) to the active ingredients or to any of
the additional
ingredients in this medicine (detailed in section 6
‘Additional information
').
•
you are suffering or suffered in the past from breathing problems,
including
bronchial asthma, chronic obstructive pulmonary disease.
•
you suffer from overt cardiac failure, sinus bradycardia, second- or
third-degree atrioventricular block, cardiogenic shock.
•
in neonates and infants under the age of 2 years.
SPECIAL WARNINGS REGARDING THE USE OF THIS MEDICINE
•
BEFORE TREATMENT WITH COMBIGAN, TELL THE DOCTOR IF YOU SUFFER NOW, OR
HAVE
SUFFERED IN THE PAST FROM:

Summary of Product characteristics

COM API MAY 23 CL
COMBIGAN
®
QUALITATIVE AND QUANTITATIVE COMPOSITION
brimonidine tartrate 0.2% w/v
timolol (as maleate) 0.5% w/v
For the full list of excipients, see section 11.
1
PHARMACEUTICAL
FORM
ophthalmic solution
2
INDICATIONS AND USAGE
Combigan is indicated for lowering intraocular pressure in patients
with open-angle glaucoma or
ocular hypertension.
3
DOSAGE AND ADMINISTRATION
The recommended dose is one drop of
COMBIGAN
®
in the affected eye(s) twice daily
approximately 12 hours apart.
If more than one topical ophthalmic product is to be used, the
different products should be instilled at
least 5 minutes apart.
4
CONTRAINDICATIONS
4.1
REACTIVE AIRWAY DISEASE INCLUDING ASTHMA, COPD
COMBIGAN
®
is contraindicated in patients with reactive airway disease including
bronchial asthma;
a history of bronchial asthma; severe chronic obstructive pulmonary
disease
_[see Warnings and _
_Precautions (5.1, 5.3)]. _
_ _
4.2
SINUS BRADYCARDIA, AV BLOCK, CARDIAC FAILURE, CARDIOGENIC SHOCK
COMBIGAN
®
is contraindicated in patients with sinus bradycardia; second or third
degree
atrioventricular block; overt cardiac failure
_[see Warnings and Precautions (5.2)]_
; cardiogenic shock.
4.3
NEONATES AND INFANTS (UNDER THE AGE OF 2 YEARS)
COMBIGAN
®
is contraindicated in neonates and infants (under the age of 2 years).
4.4
HYPERSENSITIVITY REACTIONS
Local hypersensitivity reactions have occurred following the use of
different components of
COMBIGAN
®
. COMBIGAN
®
is contraindicated in
patients who have exhibited a
hypersensitivity reaction to any component of this medication in the
past.
5
WARNINGS AND PRECAUTIONS
5.1
POTENTIAL FOR SEVERE RESPIRATORY OR CARDIAC REACTIONS
COMBIGAN
®
contains timolol maleate; and although administered topically can be
absorbed
systemically. Therefore, the same types of adverse reactions found
with systemic administration of
beta-adrenergic blocking agents may occur with topical administration.
For example, severe
respiratory reactions and cardiac reactions including death due to
bronchosp