Combigan

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Brimonidine tartrate 2 mg/mL;  ; Timolol maleate 6.8 mg/mL equivalent to timolol base 5 mg/mL;  

Available from:

AbbVie Limited

INN (International Name):

Brimonidine tartrate 2 mg/mL

Dosage:

2mg/mL, 5mg/mL

Pharmaceutical form:

Eye drops, solution

Composition:

Active: Brimonidine tartrate 2 mg/mL   Timolol maleate 6.8 mg/mL equivalent to timolol base 5 mg/mL   Excipient: Benzalkonium chloride Dibasic sodium phosphate heptahydrate Hydrochloric acid Monobasic sodium phosphate monohydrate Purified water Sodium hydroxide

Units in package:

Bottle, dropper, LDPE x 5mL, 5 mL

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Piramal Enterprises Limited

Therapeutic indications:

COMBIGAN® eye drops are indicated for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension not adequately responding to monotherapy.

Product summary:

Package - Contents - Shelf Life: Bottle, dropper, LDPE - 5 mL - 24 months from date of manufacture stored at or below 25°C protect from light 28 days opened stored at or below 25°C

Authorization date:

2003-10-15

Patient Information leaflet

COMBIGAN
®
Eye Drops-CMI Version 3.0 – PIv7.0
1
COMBIGAN
® EYE DROPS
(BRIMONIDINE TARTRATE 2.0 MG PER ML AND TIMOLOL (AS MALEATE) 5.0 MG
PER ML)
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about COMBIGAN
®
eye
drops. It does not contain all the
available information. It does not
take the place of talking to your
doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using COMBIGAN
®
eye drops against the benefits they
expect it will have for you.
If you have any concerns about
using this medicine, ask your
doctor or pharmacist.
KEEP THIS LEAFLET WITH THE
MEDICINE. YOU MAY NEED TO READ
IT AGAIN.
WHAT COMBIGAN
® EYE DROPS ARE
USED FOR
COMBIGAN
®
eye drops are used to
lower raised pressure in the eye
and to treat glaucoma.
Glaucoma is a condition in which
the pressure of fluid in the eye may
be high. However, some people
with glaucoma may have normal
eye pressure. Glaucoma is usually
caused by a build up of the fluid
which flows through the eye. This
build up occurs because the fluid
drains out of your eye more slowly
than it is being pumped in. Since
new fluid continues to enter the
eye, joining the fluid already there,
the pressure continues to rise. This
raised pressure may damage the
back of the eye resulting in gradual
loss of sight. Damage can
progress so slowly that the person
is not aware of this gradual loss of
sight. Sometimes even normal eye
pressure is associated with
damage to the back of the eye.
There are usually no symptoms of
glaucoma. The only way of
knowing that you have glaucoma is
to have your eye pressure, optic
nerve and visual field checked by
an eye specialist or optometrist. If
glaucoma is not treated it can lead
to serious problems, including total
blindness. In fact, untreated
glaucoma is one of the most
common causes of blindness.
COMBIGAN
®
eye drops lower
the pressure in the eye by
decreasing the fluid produced and
helping the flow of fluid out
of the eye chamber.
Although COMBI

Summary of Product characteristics

COMBIGAN
®
brimonidine tartrate/timolol Datasheet Version 7.0-CCDS v3.1 NEW ZEALAND DATA SHEET
1. PRODUCT NAME
COMBIGAN
®
brimonidine tartrate 0.2% and timolol (as maleate) 0.5% eye drops
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL of COMBIGAN
®
eye drops contains brimonidine tartrate 2.0 mg/mL and timolol
(as maleate) 5.0 mg/mL
For the full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
Sterile ophthalmic solution.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
COMBIGAN
®
eye drops are indicated for the reduction of elevated intraocular
pressure
in patients with open angle glaucoma or ocular hypertension not
adequately responding
to monotherapy.
4.2 DOSAGE AND METHOD OF ADMINISTRATION
The recommended dose is one drop of COMBIGAN
®
in the affected eye(s) twice daily,
approximately 12 hours apart.
In order to minimise systemic absorption of COMBIGAN
®
eye drops, apply pressure to
the tear duct immediately following administration of the drug.
As with all eye drops containing benzalkonium chloride as a
preservative, there is
potential for incompatibility with other topical ophthalmic
medications. If more than one
topical ophthalmic drug is to be used, other eye drops should not be
used within five to
ten minutes of using COMBIGAN
®
eye drops.
To avoid contamination of the solution, keep container tightly closed.
Do not touch
dropper tip to any surface. Discard contents 4 weeks after opening the
bottle. Contents
are sterile if seal is intact.
PAEDIATRIC USE
Safety and effectiveness in paediatric patients have not been
established. During post-
marketing surveillance, apnea, bradycardia, coma, hypotension,
hypothermia, hypotonia,
lethargy, pallor, respiratory depression and somnolence have been
reported in
neonates, infants and children receiving brimonidine either for
congenital glaucoma or by
accidental ingestion. See also Contraindications.
COMBIGAN
®
brimonidine tartrate/timolol Datasheet Version 7.0-CCDS v3.1
GERIATRIC USE
No overall differences in safety and effectiveness have b