Combigan 2 mg/ml + 5 mg/ml eye drops, solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Brimonidine tartrate; Timolol Maleate

Available from:

AbbVie Limited

ATC code:

S01ED; S01ED51

INN (International Name):

Brimonidine tartrate; Timolol Maleate

Pharmaceutical form:

Eye drops, solution

Therapeutic area:

Beta blocking agents1); timolol, combinations

Authorization status:

Marketed

Authorization date:

2005-12-22

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
COMBIGAN
2 MG/ML + 5 MG/ML EYE DROPS, SOLUTION
Brimonidine tartrate and timolol
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 COMBIGAN is and what it is used for
2.
What you need to know before you use COMBIGAN
3.
How to use COMBIGAN
4.
Possible side effects
5.
How to store COMBIGAN
6.
Contents of the pack and other information
1.
WHAT COMBIGAN IS AND WHAT IT IS USED FOR
COMBIGAN is an eye drop that is used to control glaucoma. It contains
two different
medicines (brimonidine and timolol) that both reduce high pressure in
the eye. Brimonidine
belongs to a group of medicines called alpha-2 adrenergic receptor
agonists. Timolol belongs
to a group of medicines called beta-blockers. COMBIGAN is prescribed
to reduce high
pressure in the eye when beta-blocker eye drops used alone are not
enough.
Your eye contains a clear, watery liquid that feeds the inside of the
eye. Liquid is constantly
being drained out of the eye and new liquid is made to replace this.
If the liquid cannot drain
out quickly enough, the pressure inside the eye builds up and could
eventually damage your
sight. COMBIGAN works by reducing the production of liquid and
increasing the amount of
liquid that is drained. This reduces the pressure inside the eye
whilst still continuing to feed
the eye.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE COMBIGAN
DO NOT USE COMBIGAN:

if you are
ALLERGIC
(hypersensitive) to
BRIMONIDINE TARTRATE, TIMOLOL, BETA-BLOCKERS
or
any of the
OTHER INGREDIENTS

Summary of Product characteristics

Health Products Regulatory Authority
01 April 2022
CRN00CNKV
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Combigan 2 mg/ml + 5 mg/ml eye drops, solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml solution contains:
2.0 mg brimonidine tartrate, equivalent to 1.3 mg of brimonidine
5.0 mg timolol as 6.8 mg timolol maleate
Excipient(s) with known effect
Contains benzalkonium chloride 0.05 mg/mL.
Contains phosphates 10.58 mg/mL.
3 PHARMACEUTICAL FORM
Eye drops, solution.
Clear, greenish-yellow solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Reduction of intraocular pressure (IOP) in patients with chronic
open-angle glaucoma or ocular hypertension who are
insufficiently responsive to topical beta-blockers.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Recommended dosage in adults (including the elderly)
The recommended dose is one drop of Combigan in the affected eye(s)
twice daily, approximately 12 hours apart.
_Paediatric population_
Combigan is contraindicated in neonates and infants aged less than 2
years (see section 4.3 Contraindications, section 4.4
Special warnings and precautions for use, section 4.8 Undesirable
effects and section 4.9 Overdose).
The safety and efficacy of Combigan in children and adolescents aged 2
to 17 years have not been established and therefore,
its use is not recommended in children or adolescents (see also
section 4.4, section 4.8 and section 4.9).
_Use in renal and hepatic impairment_
Combigan has not been studied in patients with hepatic or renal
impairment. Therefore, caution should be used in treating
such patients.
Method of administration
As with any eye drops, to reduce possible systemic absorption, it is
recommended that the lachrymal sac be compressed at the
medial canthus (punctual occlusion) or eyelids are closed for two
minutes. This should be performed immediately following the
instillation of each drop. This may result in a decrease of systemic
side effects and an increase in local activity.
To avoid contamination