AZARGA® Eye Drops 10 mg/mL and 5 mg/mL CONSUMER MEDICINE INFORMATION

What Is In This Leaflet Although AZARGA helps control your , it does not cure it. Please read this leaflet carefully For more information about before you use any AZARGA Eye What AZARGA is used glaucoma, contact Glaucoma drops. for Australia on 1800 500 880 or Glaucoma New Zealand on 09 373 This leaflet answers some common AZARGA is used to lower pressure 8779. questions about AZARGA. It does in the eye and to treat glaucoma. not contain all of the available Glaucoma is a condition in which the Your doctor may have prescribed information. It does not take the pressure of fluid in the eye may be AZARGA for another reason. Ask place of talking to your doctor or high. However, some people with your doctor if you have any questions pharmacist. glaucoma may have normal eye about why AZARGA has been The information in this leaflet was pressure. prescribed for you. last updated on the date listed on the Glaucoma is usually caused by a There is no evidence that AZARGA final page. More recent information build-up of the fluid which flows is addictive. on the medicine may be available. through the eye. This build up occurs You should ensure that you speak because the fluid drains out of your Use in Children to your pharmacist or doctor to eye more slowly than it is being There is not enough information to obtain the most up to date pumped in. Since new fluid continues recommend the use of this medicine information on the medicine. to enter the eye, joining the fluid in children under the age of 18 years. already there, the pressure continues You can also download the most up to rise. This raised pressure may to date leaflet in Australia from damage the back of the eye resulting www.novartis.com.au and in New in gradual loss of sight. Damage can Zealand from Before you use progress so slowly that the person is www.medsafe.govt.nz. not aware of this gradual loss of AZARGA The updates may contain important sight. Sometimes even normal eye information about the medicine and pressure is associated with damage to When you must not use it its use of which you should be aware. the back of the eye. Do not use AZARGA if you have an All medicines have risks and There are usually no symptoms of allergy to: benefits. Your doctor has weighed glaucoma. The only way of knowing • Brinzolamide the expected benefits of you using that you have glaucoma is to have • Timolol or other beta blockers AZARGA against the risks this your eye pressure, optic nerve and which are used to treat high blood medicine could have for you. visual field checked by an eye pressure, heart problems, angina, If you have any concerns about specialist. If glaucoma is not treated, migraine, anxiety and glaucoma taking this medicine, ask your it can lead to serious problems, doctor or pharmacist. including total blindness. In fact, • Sulphonamides or sulpha- containing medicines Keep this leaflet with the medicine. untreated glaucoma is one of the most common causes of blindness. • Any of the other ingredients in You may need to read it again. AZARGA combines two ingredients, AZARGA listed at the end of this brinzolamide and timolol. leaflet. Brinzolamide is a carbonic anhydrase Some of the symptoms of an allergic inhibitor and timolol is a beta- reaction may include: blocker. Both brinzolamide and • shortness of breath timolol work by reducing the production of fluid within the eye. • wheezing or difficulty breathing

AZARGA® EYE DROPS 1 • swelling of the face, lips, tongue Your doctor will discuss the possible a prescription from your pharmacy, or other parts of the body risks and benefits of using AZARGA supermarket or health food shop. • rash, itching or hives on the skin. during pregnancy. Some medicines and AZARGA may Do not use AZARGA if: You are breast-feeding or intend to interfere with each other or add to the breast-feed. effects of AZARGA. These include: • the safety seal around the closure and neck area is broken Your doctor will discuss the possible • medicines for high blood pressure risks and benefits of using AZARGA or heart conditions, including a • the bottle/packaging is torn or when you are breast feeding. group of medicines called beta- shows signs of tampering You have or have had any medical blockers and calcium channel • the expiry date on the conditions such as: blockers bottle/carton has passed. • • problems with your kidneys digoxin, a medicine used to treat If it has expired or is damaged, return heart failure it to your pharmacist for disposal. If • diabetes mellitus • medicines such as quinidine or you use this medicine after the expiry • Raynaud's disease amiodarone used to treat slow or date has passed, it may not work. • severe heart disease irregular heart beat Tell your doctor if you have or • Prinzmetal angina, blood • , a medicine used to have had any medical conditions, circulation problems or low treat high blood pressure and particularly the following: blood pressure migraines • respiratory problems such as • impaired corneas which can • other medicines or eye drops for asthma, chronic obstructive occur in diabetes mellitus glaucoma lung disease (emphysema), • • bronchitis or other types of problems with your corneas medicines used to treat diabetes breathing problems such as low endothelial cell • carbonic anhydrase inhibitors counts or corneal dystrophies • bronchial hyper-reactivity seen such as • in chronic asthma and narrow angle glaucoma • medicines such as cimetidine obstructive lung disease • thyrotoxicosis, a condition used to treat stomach or bowel • heart and circulation where there is too much thyroid ulcers

conditions, such as a very slow in the body. • medicines such as ketoconazole, heart rate, an irregular If you are unsure if you have any of itraconazole, clotrimazole and heartbeat, heart failure, chest these conditions ask your doctor. ritonavir pain or low blood pressure If you have not told your doctor • parasympathomimetics. • a condition called about any of the above, tell them These medicines may be affected by hyperchloraemic acidosis (too before you use AZARGA. AZARGA, or may affect how well it much acidity in your blood) Do not put AZARGA Eye Drops works. You may need different • severe kidney impairment into your eye(s) while you are amounts of your medicines, or you

• severe allergic rhinitis or wearing contact lenses. may need to take different medicines. hayfever. Do not put the eye drops into your If you are unsure if you are taking or eye(s) while you are wearing soft If you are not sure whether you using any of these medicines ask contact lenses. The preservative in should start using AZARGA, talk your doctor or pharmacist. AZARGA (benzalkonium chloride) to your doctor. Your doctor or pharmacist has more may be deposited in soft contact information on medicines to be Before you start to use it lenses. careful with or avoid while using You can put your soft contact lenses AZARGA. Tell your doctor if you have had an back into your eyes 15 minutes after allergy to any other medicines or you have used AZARGA. any other substances, such as foods, preservatives or dyes. Using other medicines How to use AZARGA Tell your doctor if: Tell your doctor if you are taking or You are pregnant or plan to using any other medicines, including Carefully follow all directions become pregnant. other eye drops or ointments, and any given to you by your doctor and other medicines that you buy without pharmacist.

AZARGA® EYE DROPS 2 They may differ from the 5. Hold the bottle upside down in 11. If necessary, repeat the above information contained in this leaflet. one hand between your thumb steps for the other eye. If you are being changed from one and middle finger (see Diagram 12. Your eyelids can only hold less medicine to another, follow your 1). than one drop at a time, so it is doctor’s instructions carefully as to normal for a small amount of the when to stop the medicine and when eye drop to spill onto your cheek. to start the new eye drops. You should wipe away any If you do not understand the spillage with a tissue. instructions on the carton, ask 13. Replace the cap on the bottle, your doctor or pharmacist for closing it tightly. Diagram 1 help. 14. Wash your hands again with soap 6. While tilting your head back, and water to remove any residue. How much to use gently pull down the lower eyelid of your eye to form a You may feel a slight burning Use AZARGA only when prescribed pouch/pocket. sensation in the eye shortly after by your doctor. using the eye drops. If this persists, 7. Place the tip of the bottle close to or is very uncomfortable, contact The usual dose of AZARGA is ONE your eye. Do not let it touch your your doctor or pharmacist. DROP in the affected eye(s) TWICE eye. Do not squeeze the bottle. DAILY. Usually, this means ONE Be careful not to touch the dropper 8. Release ONE DROP into the DROP in the affected eye(s) first tip against your eye, eyelid or pouch/pocket formed between thing in the morning, and ONE anything else. DROP in the evening. your eye and eyelid by gently tapping or pressing the base of This will help prevent the drops Your doctor will tell you how many the bottle with your forefinger becoming dirty or contaminated. drops you need to use each day. (see Diagrams 2 and 3). If you have trouble knowing whether These dosing instructions will be you have placed your drops correctly, printed on the label your pharmacist you may want to store them in the adds. fridge. Some people find it easier to feel the drops in the eye if they are

How to use it cold.

It is important to use AZARGA After using AZARGA, wait at least 5 Diagram 2 exactly as your doctor or pharmacist minutes before putting any other eye has told you. If you use the drops less drops in your eye(s). often than prescribed, they may not Wait 15 minutes before replacing work as well and the eye problem your contact lenses. may not improve. Using the drops more often than prescribed may not When to use it improve the eye problem any faster and may cause increased side effects. Diagram 3 Use AZARGA every day, at about the same times each day, unless If you are wearing soft contact 9. Close your eye. Do not blink or your doctor tells you otherwise. lenses, remove them before putting rub your eye. the drops in your eye. Using your eye drops at the same 10. While your eye is closed, place times each day will have the best Follow these steps to use the eye your index finger against the effect on your eye pressure. It will drops: inside corner of your eye and also help you remember when to use 1. Wash your hands thoroughly with press against your nose for about the eye drops. soap and water. two minutes. This will help to 2. Immediately before using a bottle stop the medicine from draining How long to use it for the first time, break the safety through the tear duct to the nose and throat, from where it can be AZARGA helps control your seal around the neck area and condition but does not cure it. throw the loose plastic ring away. absorbed into other parts of your body. This will also reduce the AZARGA must be used every day. 3. Shake the bottle. unpleasant taste sensation that Continue using AZARGA for as long 4. Remove the cap from the bottle. some people experience when as your doctor prescribes. using these drops. If you are unsure about when or how to stop using AZARGA, you

AZARGA® EYE DROPS 3 should talk to your doctor or Your eye specialist will check your Side effects pharmacist. eye pressure to make sure AZARGA is working. Tell your doctor or pharmacist as If you forget to use it If you are about to start taking any soon as possible if you do not feel If it is almost time for your next new medicine, tell your doctor and well while you are using AZARGA. dose, skip the dose you missed and pharmacist that you are using AZARGA helps most people with use your next dose when you are AZARGA. high eye pressure and glaucoma, but meant to. Tell all the doctors, dentists and it may have unwanted side effects in Otherwise, use the drops as soon as pharmacists who are treating you a few people. you remember, and then go back that you are using AZARGA. All medicines can have side effects. to using them as you would Tell your doctor if, for any reason, Sometimes they are serious, most of normally. you have not used AZARGA the time they are not. You may need Do not use double the amount to exactly as prescribed. Otherwise medical treatment if you get some of make up for the dose that you your doctor may think that the eye the side effects. missed. drops were not effective and Do not be alarmed by the following change the treatment Using multiple doses may cause list of possible side effects. You unnecessarily. unwanted side effects. may not experience any of them. If you become pregnant or decide If you are not sure whether to skip Ask your doctor or pharmacist to to breastfeed while using the dose, talk to your doctor or answer any questions you may AZARGA, tell your doctor pharmacist. have. immediately. If you have trouble remembering Tell your doctor if you notice any to use your eye drops, ask your Things you must not do of the following effects in the eye(s) pharmacist for some hints. and the eye area, and they worry Do not use AZARGA to treat other you: complaints unless your doctor tells If you use too much • blurred vision you to. (overdose) • eye pain Do not give AZARGA to anyone If you accidentally put several drops else, even if they have the same • eye irritation in your eye(s), immediately rinse condition as you. • feeling of having something in your eye(s) with warm water. Do not stop using AZARGA the eye. If you think that you or anyone without first talking to your These are the more common side else may have swallowed any or all doctor. If you stop using your eye effects of your medicine. They are of the contents of a bottle of drops, your eye pressures may rise usually mild and short-lived. AZARGA, immediately telephone again and damage to your eye may your doctor or the Poisons Additional side effects that are occur. Information Centre on 13 1126 in noticed more rarely include: Australia or the National Poisons Things to be careful of • corneal erosion (pain, feeling of Centre on 0800 POISON or 0800 having something in the eye, 764 766 in New Zealand for advice, Be careful driving, operating sensitivity to bright light, or go to Accident and Emergency machinery or performing tasks excessive tears) at your nearest hospital. Do this requiring mental alertness and/or • eye surface inflammation with even if there are no signs of physical coordination until you surface damage discomfort or poisoning. know how AZARGA affects you and your vision. • dry eye As with any eye medicine, temporary • eye discharge blurred vision or other visual • itchy eye While you are using disturbances may affect the ability to • redness of the eye and/or eyelids AZARGA drive or use machinery in some people. If blurred vision occurs when • allergic conjunctivitis (eye allergy) Things you must do you use your drops, wait until your vision is clear before driving or • corneal disorder Keep all your doctor’s operating machinery. appointments so that your progress • inflammation inside the eye can be checked. • eyelid margin crusting

AZARGA® EYE DROPS 4 • tired eyes doctor immediately or go to Eye drops contain a preservative • inflammation of the eyelids Accident and Emergency at your which helps prevent germs growing nearest hospital: in the solution for the first four • problems seeing clearly. • skin rash weeks after opening the bottle. After Occasionally some people notice this time there is a greater risk that • unwanted effects in the rest of their swelling of the face, hands or feet the drops may become contaminated body as a result of using AZARGA. • wheezing, difficulty in breathing and cause an eye infection. A new These effects may include: • shortness of breath bottle should then be used. • bad taste in the mouth • severe and sudden onset of If your doctor tells you to stop • dry mouth pinkish, itchy swellings on the using AZARGA or they have passed their expiry date, ask your • lung disease skin, also called hives or nettle rash pharmacist what to do with any • throat irritation and soreness remaining solution. These hypersensitivity reactions can • cough be very serious side effects. You may • asthma need urgent medical attention or hospitalisation. These side effects are • increased or decreased blood Product description pressure very rare. Other side effects not listed above • decreased heart rate What it looks like may also occur in some people. • changes to heart rhythm AZARGA is a liquid (white to off- • chest pain white uniform suspension) supplied • fatigue in a pack containing 5 mL in an 8 mL dropper bottle (DROP-TAINER®) • dizziness After using AZARGA with screw cap. • headache Storage Tamper evidence is provided with a • difficulty sleeping safety seal around the neck area of Store AZARGA in a cool dry place • abdominal pain or discomfort the bottle. where the temperature stays below • diarrhoea 25°C. It is not necessary to store Ingredients • nausea AZARGA in the refrigerator, but it is acceptable if you prefer to instil cold Active ingredient(s): • skin inflammation, redness or drops. Do not freeze. itching • brinzolamide 10 mg in 1 mL Do not store AZARGA or any • tingling or prickling sensation of • timolol maleate 5 mg in 1 mL other medicine in the car, in the the skin Inactive ingredients: bathroom or in other warm, damp • decreased white blood cells places. • benzalkonium chloride as a preservative • runny nose Heat and dampness can destroy some • nose bleed medicines. • carbomer 974P • ringing or buzzing in the ears Keep it where children cannot • disodium edetate reach it. • hair disorder • mannitol A locked cupboard at least one-and- • muscular pain • purified water a-half metres above the ground is a • sodium chloride • depression good place to store medicines. • • tyloxapol feeling or hearing things that are Do not leave the top off the bottle for not there (hallucination) any length of time, to avoid • hydrochloric acid and/or sodium • blood in the urine. contaminating the eye drops. hydroxide are added to adjust pH. Some of the above possible side Supplier effects (for example change in blood Disposal pressure) can only be found when Write the date on the bottle when This product is supplied in Australia your doctor does tests to check your you open the eye drops and throw by: progress. out any remaining solution after Novartis Pharmaceuticals Australia If any of the following happen, stop four weeks. Pty Limited using AZARGA and tell your ABN 18 004 244 160

AZARGA® EYE DROPS 5 54 Waterloo Road Macquarie Park NSW 2113 Telephone: 1-800-671-203 Web site: www.novartis.com.au This product is supplied in New Zealand by: Novartis New Zealand Limited PO Box 99102 Newmarket Auckland 1149 New Zealand Free Phone: 0800 354 335.

Australian registration number AUST R 156500. Date of preparation This leaflet was prepared in July 2020. ®a trademark of Novartis © Novartis Pharmaceuticals Australia Pty Limited 2020.

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AZARGA® EYE DROPS 6