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.
- Keep this leaflet. You may need to read it again.
- If you have further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
- 1. What COMBIGAN is and what it is used for
- 2. Before you use COMBIGAN
- 3. How to use COMBIGAN
- 4. Possible side effects
- 5. How to store COMBIGAN
- 6. Further information
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.
Before You Use Combigan
Do not use COMBIGAN
- if you are allergic (hypersensitive) to brimonidine tartrate, timolol or any of the other ingredients of COMBIGAN. Symptoms of an allergic reaction may include swelling of the face, lips and throat, wheeziness, feeling faint, shortness of breath, itching or redness around the eye.
- if you have any breathing illnesses such as asthma or a history of asthma, or severe chronic obstructive lung disease.
- if you have heart problems such as heart beat disorders (unless controlled by a pacemaker) or heart weakness.
- if you are taking monoamine oxidase (MAO) inhibitors or certain other antidepressant drugs.
COMBIGAN should not be used in children less than 2 years old and should not usually be used in children aged 2 to 17.
If you think any of these points apply to you, do not use COMBIGAN until you have talked again to your doctor.
Take special care with COMBIGAN
Before you take this medicine, tell your doctor
- if you have now or have had in the past
- depression or other psychiatric problems
- heart or blood pressure problems
- reduced or altered blood supply affecting the brain, legs or arms
- diabetes or low blood sugar levels (hypoglycaemia)
- overactivity of the thyroid
- kidney or liver problems
- tumour of the adrenal gland
- eye surgery to lower the pressure in your eye
- if you suffer or have suffered from any allergy (e.g. hayfever, eczema) or a severe allergic reaction be aware that the usual dose of adrenaline used to control a severe reaction may need to be increased.
- if you need to have a general anaesthetic, tell the doctor or dentist that you are using COMBIGAN.
Using other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any 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:
- pain killers
- medicines to help you sleep or for anxiety
- medicines to treat high blood pressure (hypertension)
- medicines for heart conditions (for example an abnormal heartbeat) such as beta blockers or digoxin
- another eyedrop used to lower high pressure in the eye (glaucoma)
- medicines for depression
- medicines to treat severe allergic reactions
- medicines that affect some of the hormones in your body, like adrenaline and dopamine
- medicines that affect the muscles in your blood vessels
- medicines to treat diabetes or high blood sugar
- medicines to treat heartburn or stomach ulcers.
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.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine. Tell your doctor if you are pregnant or planning to become pregnant. COMBIGAN should not be used during pregnancy unless your doctor still recommends it.
COMBIGAN should not be used if you are breast-feeding.
Driving and Using Machines
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.
Important information about some of the ingredients of COMBIGAN
Contact Lenses
- Do not use COMBIGAN while your contact lenses are in your eyes. Wait at least 15 minutes after using COMBIGAN before putting your lenses back in.
- A preservative in COMBIGAN (benzalkonium chloride) may cause eye irritation and is also known to discolour soft contact lenses.
How To Use Combigan
Always use COMBIGAN exactly as your doctor has told you. You should 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 usual 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.
Instructions for use
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 one minute.
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.
If you use more COMBIGAN than you should
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 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
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.
If you stop using COMBIGAN
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.
Combigan Side Effects
Like all medicines, COMBIGAN can cause side effects, although not everybody gets them.
If you experience any of the following side effects, please contact your doctor immediately:
- Heart failure (eg. chest pain) or irregular heart rate
- Increased or decreased heart rate or low blood pressure
The chance of having a side effect is described by the following categories:
Very common: Occurs in more than 1 out of 10 patients
Common: Occurs in fewer than 1 out of 10 patients
Uncommon: Occurs in fewer than 1 out of 100 patients
The following side effects may be seen with COMBIGAN.
Very common: Eye redness or burning.
Common: Stinging, an allergic reaction in the eye or on the skin around the eye, small breaks in the surface of the eye (with or without inflammation), high blood pressure, swelling and redness of the eyelid, irritation, or a feeling of something in the eye, depression, headache, itching of the eye and eyelid, blurred vision, sleepiness, dry mouth, general weakness or an increase in blood-test results that show how your liver is working.
Uncommon: Heart failure, irregular heart rate, light-headedness, dry nose or taste disturbances, white spots under the eyelid or sensitivity to light.
Not known: Increased or decreased heart rate or low blood pressure
Some of these effects may be due to an allergy to any of the ingredients.
The following side effects have been seen with brimonidine or timolol and so may possibly be seen with COMBIGAN:
chest pain, effects on the heart beat, shortness of breath, general allergic reactions, wheeziness, cough, inflammation of the iris, small pupils, reduced feeling in the eye, drooping eyelid, insomnia, cold-like symptoms, nausea, diarrhoea, heartburn, skin rash, hair loss, nightmares, reduced sexual urge, memory loss, ringing in the ears and a worsening of myasthenia gravis (increased muscle weakness).
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
How To Store Combigan
Keep out of the reach and sight 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 COMBIGAN 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.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Further Information
What COMBIGAN contains
- The active substances are brimonidine tartrate and timolol.
- One millilitre of solution contains 2 milligrams of brimonidine tartrate and timolol maleate equivalent to 5 milligrams of timolol.
- The other ingredients are benzalkonium chloride (a preservative), sodium phosphate monobasic monohydrate, sodium phosphate dibasic heptahydrate and purified water. Small amounts of hydrochloric acid or sodium hydroxide may be added to bring the solution to the correct pH (a measure of the acidity or alkalinity of the solution).
What COMBIGAN looks like and contents of the pack
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 and Manufacturer
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
This leaflet was last approved in November 2008.
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