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Home , Brimonidine

COMBIGAN® EYE DROPS (brimonidine tartrate 2.0 mg per mL and (as maleate) 5.0 mg per mL)

Consumer Medicine Information

What is in this leaflet aware of this gradual loss of sight. any of the ingredients listed at Sometimes even normal eye the end of this leaflet, some This leaflet answers some common pressure is associated with damage symptoms of an allergic reaction questions about COMBIGAN® eye to the back of the eye. include skin rash, itching, drops. It does not contain all the There are usually no symptoms of shortness of breath or swelling available information. It does not . The only way of of the face, lips or tongue, which take the place of talking to your knowing that you have glaucoma is may cause difficulty in doctor or pharmacist. to have your eye pressure, optic swallowing or breathing All medicines have risks and nerve and visual field checked by an • you are taking monoamine benefits. Your doctor has weighed eye specialist or optometrist. If oxidase the risks of you using glaucoma is not treated it can lead COMBIGAN® eye drops against to serious problems, including total • you have bronchospasm, the benefits they expect it will have blindness. In fact, untreated bronchial asthma or have a for you. glaucoma is one of the most history of bronchial asthma or common causes of blindness. other lung disease If you have any concerns about using this medicine, ask your doctor COMBIGAN® eye drops lower the • you have a severe or unstable or or pharmacist. pressure in the eye by decreasing uncontrolled heart condition Keep this leaflet with the the fluid produced and helping the • the seal around the cap is broken medicine. You may need to read it flow of fluid out of the eye • the bottle/packaging shows again. chamber. signs of tampering Although COMBIGAN® eye drops • the product does not look quite help control your condition, it does right not cure it. • the expiry date on the bottle has What COMBIGAN® COMBIGAN® eye drops are passed. eye drops are used for onlavailable with a If you use this medicine after the doctor’prescription from expiry date has passed, it may not COMBIGAN® eye drops are used pharmacies.Your doctor may have work effectively. to lower raised pressure in the eye prescribed COMBIGAN® eye and to treat glaucoma. Do not put the eye drops into your drops for another reason. Ask your eye(s) while you are wearing soft Glaucoma is a condition in which doctor if you have any questions contact lenses. The preservative in the pressure of fluid in the eye may about why COMBIGAN® eye COMBIGAN® eye drops be high. However, some people drops have been prescribed for you. (benzalkonium chloride) may be with glaucoma may have normal deposited in soft contact lenses. eye pressure. Glaucoma is usually You can put your soft contact lenses caused by a build up of the fluid back into your eyes 15 minutes after which flows through the eye. This Before you use you have used COMBIGAN® eye build up occurs because the fluid COMBIGAN® eye drops. drains out of your eye more slowly drops than it is being pumped in. Since Do not use COMBIGAN® eye new fluid continues to enter the eye, drops in a child or adolescent. When you must not use it joining the fluid already there, the Safety and effectiveness in pressure continues to rise. This Do not use COMBIGAN® eye paediatric patients have not been raised pressure may damage the drops if: established. It is particularly important that the medicine is not back of the eye resulting in gradual • you have an to used in children under the age of 2 loss of sight. Damage can progress brimonidine tartrate, timolol or so slowly that the person is not years. COMBIGAN® EYE DROPS Published by MIMS/myDr July 2017 1 These drops are for topical use only. • certain medicines to treat the same time each day will have depression, such as monoamine the best effect on your eye pressure. Before you start to use it oxidase inhibitors and tricyclics It will also help you remember when to use the eye drops. Tell your doctor if: • sedative-type medicines, alcohol and If you are using more than one eye 1. you have had an allergy to any • sympathomimetic medicines drop product, wait 5 to 10 minutes medicines or any other before using the second product. substances, such as foods, • antidiabetic agents preservatives or dyes. • some drugs prescribed for heart If you are being changed from one 2. you have severe or unstable or problems/conditions (e.g. to another, follow your uncontrolled heart disease or a , digitalis doctor’s instructions carefully as to history of severe heart disease. glycosides, anti-arrhythmics and when to stop the old drops and ) when to start the new drops. 3. you have a disease affecting your blood vessels, including • any drugs used to increase the How to use it Raynaud’s phenomenon. size of blood vessels (e.g. ). 4. you have depression. You may find it easier to put drops Medicines used to treat asthma, 5. you have a lung disease in your eye while you are sitting or severe headaches or coughs and including asthma. lying down. colds may belong in the 6. you have or kidney disease. If you are wearing soft contact sympathomimetic group. lenses, remove them before 7. you have diabetes mellitus or an These medicines may be affected by putting the drops in your eye. overactive thyroid. COMBIGAN® eye drops, or may 8. you have low blood pressure. To open a new bottle of affect how well it works. You may COMBIGAN® eye drops first tear 9. you have a disease called need different amounts of your off the protective seal from the myasthenia gravis which can medicines, or you may need to take bottle. The contents are sterile if the cause muscle weakness or other different medicines. seal is intact. symptoms common to that Your doctor or pharmacist has more disease. The seal will break and you can pull information on medicines to be 10. you are pregnant or intend to it off and then throw it away. careful with or avoid while using become pregnant. Like most 1. Wash your hands well with soap COMBIGAN® eye drops. medicines COMBIGAN® eye and water. drops should not be used during 2. Remove the lid/cap. , unless the benefits 3. Hold the bottle upside down in outweigh the risk to the baby. How to use one hand between your thumb 11. you are breast-feeding or intend COMBIGAN® eye and forefinger or index finger. to breast-feed. Your baby may drops 4. Using your other hand, gently absorb this medicine from breast pull down your lower eyelid to milk and therefore there is a How much to use form a pouch or pocket. possibility of harm to the baby. 5. Tilt your head back and look up. Your doctor will tell you how many 12. you are due to have surgery 6. Put the tip of the bottle close to drops you need to use each day. Use under general anaesthetic. your lower eyelid. Do not let it COMBIGAN® eye drops only as touch your eye. Taking other medicines prescribed by your doctor. 7. Release one drop into the pouch Tell your doctor if you are taking The usual dose of COMBIGAN® or pocket formed between your any other medicines, including any eye drops is one drop in the affected eye and eyelid by gently that you buy without a prescription eye(s) twice daily, approximately squeezing the bottle. 12 hours apart. from your pharmacy, supermarket 8. Close your eye. Do not blink or or health food shop. Follow all directions given to you rub your eye. Some medicines and by your doctor carefully. The 9. While your eye is closed, place COMBIGAN® eye drops may directions may differ from the your index finger against the interfere with each other. These information contained in this leaflet. inside corner of your eye and include: Use COMBIGAN® eye drops every press against your nose for • medicines for high blood day, at about the same time each about two minutes. This will pressure day, unless your doctor tells you help to stop the medicine from otherwise. Using your eye drops at draining through the tear duct to

COMBIGAN® EYE DROPS Published by MIMS/myDr July 2017 2 the nose and throat, from where POISON or 0800 764 766) for Things to be careful of it can be absorbed into other advice, or go to Accident and Be careful driving or operating parts of your body. Ask your Emergency at your nearest hospital. machinery until you know how doctor for more specific Do this even if there are no signs of COMBIGAN® eye drops affect instructions on this technique. discomfort or poisoning. you. COMBIGAN® eye drops 10. Replace the lid/cap, sealing it generally should not cause any tightly. problems with your ability to drive 11. Wash your hands again with While you are using or operate machinery. However, soap and water to remove any COMBIGAN® eye drops may residue. COMBIGAN® eye cause blurred vision/ dizziness/ Wait 15 minutes before replacing drops drowsiness/ tiredness in some your contact lenses. people. Make sure you know how Things you must do Be careful not to touch the dropper you react to COMBIGAN® eye tip against your eye, eyelid or Have your eye pressure checked drops or that your vision is clear anything else to avoid when your eye specialist says, to before driving or operating contaminating the eye drops. make sure COMBIGAN® eye machinery. drops are working. How long to use it If you develop an eye infection, COMBIGAN® eye drops help receive an eye injury, or have eye Side effects control your condition, but do not surgery tell your doctor. cure it. Therefore, COMBIGAN® Your doctor may tell you to use a Tell your optical practitioner, doctor eye drops must be used every day. new container of COMBIGAN® or pharmacist as soon as possible if Continue using COMBIGAN® eye eye drops because of possible you do not feel well while you are drops for as long as your doctor contamination of the old one. using COMBIGAN® eye drops. prescribes. If you become pregnant while using COMBIGAN® eye drops help most COMBIGAN® eye drops tell your people with high eye pressure and If you forget to use it doctor immediately. glaucoma, but it may have If it is almost time for your next If you wear soft contact lenses, unwanted side effects in a few dose, skip the dose you missed and remove them before using people. use your next dose when you are COMBIGAN® eye drops. Leave All medicines can have side effects. meant to. Otherwise, use the drops your lenses out for at least 15 Sometimes they are serious, most of as soon as you remember, and then minutes after putting in the eye the time they are not. You may need go back to using them as you would drops. medical treatment if you get some normally. Tell your doctor if your condition of the side effects. If you are not sure whether to skip gets worse or does not get better Do not be alarmed by this list of the dose, talk to your doctor or while using COMBIGAN® eye possible side effects. You may not pharmacist. drops. experience any of them. Ask your Do not use double the amount to If you are about to start any new doctor or pharmacist to answer any make up for the dose that you medicine tell your doctor and questions you may have. missed. pharmacist that you are using Tell your doctor if you notice any of COMBIGAN® eye drops. the following and they worry you: If you use too much • Red, congested eyes (overdose) Things you must not do • Burning or stinging sensation in If you accidentally put several drops Do not give COMBIGAN® eye the eye in your eye(s), immediately rinse drops to anyone else, even if they • Conjunctivitis (discharge with your eye(s) with warm water. have the same condition as you. itching of the eye and crusty If you think that you or anyone else Do not stop using COMBIGAN® eyelids) may have swallowed any or all of eye drops without first talking to • Inflammation of the the contents of a bottle of your doctor. If you stop using your undersurface of the eyelids COMBIGAN® eye drops, eye drops, your eye pressure may • Visual disturbance or abnormal immediately telephone your doctor rise again and damage to your eye vision or Poisons Information Centre may occur. • Nodules on the undersurface of (Australia : telephone 13 11 26; the eyelid New Zealand: telephone 0800 COMBIGAN® EYE DROPS Published by MIMS/myDr July 2017 3 • Overflow of tears down the Do not leave the top/lid off the Toll free: 1800 252 224 (Australia) cheek bottle for any length of time to ALLERGAN NEW ZEALAND • Eye dryness, pain/ache, avoid contaminating the eye drops. LIMITED irritation, tiredness or itchiness Cnr Manu Tapu Drive & Joseph • Red, swollen or itchy eyelids Disposal Hammond Place, • Discharge from the eye Throw out any remaining solution Auckland International Airport, • Feeling of something in the after four weeks from the date of New Zealand eye(s) opening. Freephone: 0800 659 912 (NZ) • Decrease in sharpness of vision Eye drops contain a preservative COMBIGAN® eye drops can be • Swelling of the white part of the which helps prevent germs growing identified by registration number: eye or the front part of the in the solution for the first four AUST R 97690 eyeball weeks after opening the bottle. For more information about • Small images floating through After this time there is a greater risk glaucoma, contact Glaucoma or across your vision that the drops may become Australia on 1800 500 880 or contaminated and cause an eye • Excessive sensitivity to bright Glaucoma New Zealand on 09 373 infection. A new bottle should be light 8779 opened. • Eyelid pain If your doctor tells you to stop using Date of preparation: • Whitening of the conjunctiva the eye drops or they have passed • Detachment of the gel like January 2017 their expiry date, ask your substance from the back of the ® marks owned by Allergan, Inc. pharmacist what to do with any eye remaining solution. • Abnormalities of the front surface of the eye. Other side effects that may be experienced are as follows: Product description Tiredness and weakness, sleepiness/drowsiness, headache, What COMBIGAN® eye dizziness, fainting, depression, drops look like: heart failure, fast or irregular heart Clear, greenish-yellow sterile beat, high blood pressure, skin rash, solution. runny nose, nasal dryness, abnormal liver function tests, oral dryness and Ingredients abnormal taste. Active ingredient: Other side effects not listed above Brimonidine tartrate 2.0 mg/mL and may also occur in some patients. timolol (as maleate) 5.0 mg/mL Tell your doctor if you notice any other effects. Preservative: Benzalkonium chloride Inactive ingredients: Dibasic sodium phosphate After using heptahydrate COMBIGAN® eye Monobasic sodium phosphate drops monohydrate Hydrochloric acid Storage Sodium hydroxide Purified water Keep your COMBIGAN® eye drops in a cool place where the Manufacturer/Supplier temperature stays below 25°C. ALLERGAN AUSTRALIA PTY Keep the bottle where children LTD cannot reach it. 810 Pacific Highway, Gordon NSW 2072 ABN 85 000 612 831

COMBIGAN® EYE DROPS Published by MIMS/myDr July 2017 4