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

• 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.

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

• if you are allergic (hypersensitive) to brimonidine tartrate, timolol, beta-blockers or any of the other ingredients of this medicine (listed in section 6). 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 now or have had in the past respiratory problems such as asthma, severe chronic obstructive bronchitis (severe lung disease which may cause wheeziness, difficulty in breathing and/or long-standing cough).
• if you have heart problems such as low heart rate, heart failure, heart beat disorders (unless controlled by a pacemaker).
• if you are taking monoamine oxidase (MAO) inhibitors or certain other antidepressant drugs.

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

• if you have now or have had in the past
  • coronary heart disease (symptoms can include chest pain or tightness, breathlessness or choking), heart failure, low blood pressure
  • disturbances of heart rate such as slow heart beat
  • breathing problems, asthma or chronic obstructive pulmonary disease
  • poor blood circulation disease (such as Raynaud’s disease or Raynaud’s syndrome)
  • diabetes as timolol may mask signs and symptoms of low blood sugar levels
  • over activity of the thyroid gland as timolol may mask signs and symptoms
  • 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.
• Tell the doctor before you have an operation that you are using COMBIGAN, as the timolol may change effects of some medicines during anaesthesia.

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:

• 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, digoxin or quinidine (used to treat heart conditions and some types of malaria)
• medicines to treat diabetes or high blood sugar
• medicines for depression such as fluoxetine and paroxetine
• another eye drop used to lower high pressure in the eye (glaucoma)
• 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 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.

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.

• Benzalkonium chloride may be absorbed by soft contact lenses and may change the colour of the contact lenses. You should remove contact lenses before using this medicine and put them back 15 minutes afterwards.
• Benzalkonium chloride may also cause eye irritation, especially if you have dry eyes or disorders of the cornea (the clear layer at the front of the eye). If you feel abnormal eye sensation, stinging or pain in the eye after using this medicine, talk to your doctor

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.

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 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 the Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

• 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).

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.

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