Find similiar products:
The text only version may be available in large print, Braille or audio CD.
For further information call emc accessibility on
0800 198 5000.
The product code(s) for this leaflet is: PL 41042/0062.
Combigan
COMBIGAN 2 mg/ml + 5 mg/ml eye drops, solution
Brimonidine tartrate and timolol
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
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.
If you think any of these points apply to you, do not use COMBIGAN until you have talked again to your doctor.
Talk to your doctor before using COMBIGAN
COMBIGAN should not be used in children less than 2 years old and should not usually be used in children aged 2 to 17.
COMBIGAN can affect or be affected by other medicines you are using, including other eye drops for the treatment of glaucoma. Tell your doctor or pharmacist if you are taking, have recently taken or might take other medicines, including medicines for any condition, even if unrelated to your eye condition, including medicines obtained without a prescription. There are a number of medicines which may interfere with COMBIGAN, so it is particularly important to tell your doctor if you are taking:
If the dose of any of your current medicines is changed or if you are regularly consuming alcohol you should tell your doctor.
If you are due to have an anaesthetic, you should tell the doctor or dentist that you are taking COMBIGAN.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Do not use COMBIGAN if you are pregnant unless your doctor considers it necessary.
Do not use COMBIGAN if you are breast-feeding. Timolol may get into your milk. Ask your doctor for advice before taking any medicine during breast-feeding.
COMBIGAN may cause drowsiness, tiredness or blurred vision in some patients. Do not drive or use any tools or machines until the symptoms have cleared. If you experience any problems, talk to your doctor.
This medicine contains 0.25 mg benzalkonium chloride in each 5 ml of solution which is equivalent to 0.05 mg/ml.
This medicine contains 52.9 mg phosphates in each 5 ml of solution which is equivalent to 10.58 mg/ml.
If you suffer from severe damage to the clear layer at the front of the eye (the cornea), phosphates may cause in very rare cases cloudy patches on the cornea due to calcium build-up during treatment.
Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. COMBIGAN must not be used in infants below 2 years of age. COMBIGAN should not usually be used in children and adolescents (from 2 to 17 years).
The recommended dose is one drop of COMBIGAN, twice a day about 12 hours apart. Do not change the dose or stop taking it without speaking to your doctor.
If you have other eye drops as well as COMBIGAN, leave at least 5 minutes between using COMBIGAN and the other eye drops.
You must not use the bottle if the tamper-proof seal on the bottle neck is broken before you first begin to use it.
Wash your hands before opening the bottle. Tilt your head back and look at the ceiling.
1. Gently pull down the lower eyelid until there is a small pocket.
2. Turn the bottle upside down and squeeze it to release one drop into each eye that needs treatment.
3. Let go of the lower lid, and close your eye.
4. Keep the eye closed and press your finger against the corner of your eye (the side where your eye meets your nose) for two minutes. This helps stop COMBIGAN getting into the rest of the body.
If a drop misses your eye, try again.
To avoid contamination, do not let the tip of the bottle touch your eye or anything else. Put the screw-cap back on to close the bottle, straight after you have used it.
Adults
If you use more COMBIGAN than you should, it is unlikely to cause you any harm. Put your next drop in at the usual time. If you are worried, talk to your doctor or pharmacist.
Babies and Children
Several cases of overdose have been reported in babies and children receiving brimonidine (one of the ingredients of COMBIGAN) as part of medical treatment for glaucoma. Signs include sleepiness, floppiness, low body temperature, paleness and breathing difficulties. Should this happen, contact your doctor immediately.
Adults and Children
If COMBIGAN has been accidentally swallowed then you should contact your doctor immediately.
If you forget to use COMBIGAN, use a single drop in each eye that needs treatment as soon as you remember, and then go back to your regular routine. Do not take a double dose to make up for a forgotten dose.
COMBIGAN should be used every day to work properly.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any of the following side effects, please contact your doctor immediately:
Affecting the eye
Very common (May affect more than 1 in 10 people) :
Common (May affect up to 1 in 10 people):
Uncommon (May affect up to 1 in 100 people):
Not known (Frequency cannot be estimated from the available data):
Affecting the body:
Common (May affect up to 1 in 10 people):
Uncommon (May affect up to 1 in 100 people):
Not known (Frequency cannot be estimated from the available data):
Some of these effects may be due to an allergy to any of the ingredients. Additional side effects have been seen with brimonidine or timolol and therefore may potentially occur with COMBIGAN.
The following additional side effects have been seen with brimonidine:
Like other medicines applied into eyes, COMBIGAN (brimonidine/timolol) is absorbed into the blood. Absorption of timolol, a beta blocker component of COMGIBAN, may cause similar side effects as seen with intravenous” and /or “oral” beta-blocking agents. Incidence of side effects after topical ophthalmic administration is lower than when medicines are for example, taken by mouth or injected. Listed side effects include reactions seen within the class of beta-blockers when used for treating eye conditions:
Other side effects reported with eye drops containing phosphates:
Cases of corneal calcification have been reported very rarely in association with the use of phosphate containing eye drops in some patients with significantly damaged cornea.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via:
United Kingdom
or search for MHRA Yellow Card in the Google Play or Apple App Store
Ireland
By reporting side effects you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
Keep the bottle in the outer carton to protect it from light.
You should only use one bottle at a time.
Do not use this medicine after the expiry date which is stated on the label of the bottle and the carton after EXP:. The expiry date refers to the last day of that month.
You must throw away the bottle four weeks after you first opened it, even if there are still some drops left. This will help to prevent infections. To help you remember, write down the date that you opened it in the space on the carton.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
COMBIGAN is a clear, greenish-yellow eye drop solution in a plastic bottle with a screw-cap. Each bottle is about half full and contains 5 ml of solution. Packs are available containing either 1 or 3 bottles. Not all pack sizes may be marketed.
Marketing Authorisation Holder
Manufacturer
This leaflet was last revised in 02/2022