NEVANAC TM 0.1% Eye Drops

Transcription

1 NEVANAC TM 0.1% Eye Drops Nepafenac CONSUMER MEDICINE INFORMATION What is in this leaflet Please read this leaflet carefully before you use Nevanac Eye This leaflet answers some common questions about Nevanac Eye It does not contain all of the available information. It does not take the place of talking to your doctor or pharmacist. The information in this leaflet was last updated on the date listed on the final page. More recent information on the medicine may be available. You should ensure that you speak to your pharmacist or doctor to obtain the most up to date information on the medicine. You can also download the most up to date leaflet from The updates may contain important information about the medicine and its use of which you should be aware. All medicines have risks and benefits. Your doctor has weighed the expected benefits of you using Nevanac against the risks this medicine could have for you. The information in this leaflet applies to Nevanac only. This information does not apply to similar products, even if they contain the same ingredients. If you have any concerns about using this medicine, ask your Keep this leaflet with the medicine. You may need to read it again. What Nevanac is used for Nevanac Eye Drops contain the active ingredient nepafenac which belongs to a group of medicines called non-steroidal anti - inflammatory drugs (NSAIDs). NSAIDs relieve pain and reduce inflammation (e.g. swelling, redness and throbbing). Nevanac Eye Drops are used to treat the pain and inflammation of the eye associated with cataract surgery. Nevanac Eye Drops are also used to reduce the risk of the swelling of the macula, which is the centre of the retina, after cataract surgery in diabetic patients. Your doctor may have prescribed it for another reason. This medicine is only available with a doctor s prescription. Ask your doctor if you have any questions about why this medicine has been prescribed for you. Use in Children under the age of 10 years as the safety and effectiveness in this age group have not been established. Before you use Nevanac When you must not it Nevanac Eye Drops should not be used if you have an allergy to: Nepafenac Any of the ingredients listed under Product description Any other NSAIDs. Some of the symptoms of an allergic reaction may include: shortness of breath wheezing or difficulty breathing swelling of the face, lips, tongue or other parts of the body rash, itching or hives on the skin. after the expiry date printed on the pack if the packaging is torn if the seal around the cap is broken if the bottle shows signs of tampering. Nevanac Eye Drops are not recommended for use in children Internal document code 1

2 If it has expired or is damaged, return it to your pharmacist for disposal. if you are wearing contact lenses. You can put your contact lenses into your eyes 15 minutes after you using Nevanac Eye If you are not sure whether you should be given this medicine talk to your doctor. Before you start to use it allergies to any other medicines or any substances such as foods, preservatives or dyes. or have had any medical conditions, especially the following: Any condition that affects the cornea Eye diseases such as dry eye syndrome Have had repeated eye surgery in a short period of time A tendency to bleed Diabetes Rheumatoid arthritis. ever experienced a reaction to any other NSAID. Tell your doctor if you are pregnant or plan to become pregnant. Your doctor will discuss the risks and benefits of using Nevanac when pregnant. Tell your doctor if you are breast feeding. Your doctor will discuss the risks and benefits of using Nevanac when breast-feeding. If you have not told your doctor about any of the above, tell them before you use Nevanac. Taking or using other medicines Tell your doctor or pharmacist if you are taking or using any other medicines, including medicines that you buy at a pharmacy or health food shop. Some medicines and Nevanac may interfere with each other. Tell your doctor if you are using any other NSAID together with a steroid in either your eyes or on the skin. This combination can increase your chances of bleeding. Your doctor will advise you and decide whether or not to give you Nevanac. How to use Nevanac Follow all directions given to you by your doctor carefully. They may differ from the information contained in this leaflet. If you do not understand the instructions on the box ask your doctor or pharmacist for help. How much to use The usual dose of Nevanac Eye Drops is one drop in the affected eye(s) three times daily beginning one day before your cataract surgery and continued on the day of surgery and for 2 weeks after your surgery. Diabetic patients may need to use Nevanac for up to 60 days after cataract surgery. You may find it easier to put drops in your eye while you are sitting or lying down. Before opening the bottle for the first time, make sure the safety seal joining the cap to the bottle is not broken. If it is, do not use the bottle and return it to your pharmacist. If you are wearing contact lenses, remove them before putting the drops in your eye. Follow these steps to use Nevanac Eye Drops: 1. Wash your hands well with soap and water. 2. Remove the safety seal and cap from the bottle. 3. Hold the bottle upside down in one hand between your thumb and first index finger. It will not leak (see Diagram 1). Diagram 1 4. Using your other hand, gently pull down your lower eye lid to form a pouch. 5. Tilt your head back and look up. 6. Place the tip of your bottle close to your lower lid. Do not let it touch your eye. 7. Release one drop in the pouch formed between your eye and eye lid by gently tapping or pressing the base of the bottle. See Diagrams 2 and 3. Do not squeeze the bottle. Internal document code 2

3 Diagram 2 Diagram 3 8. Close your eye and keep it closed. Do not blink or rub your eye. With the eye closed place your index finger against the corner of your eye and press against your nose for a couple of minutes. 9. If necessary, repeat the above steps from 3 to 8 for your other eye. 10. Replace the cap on the bottle, close it tightly. 11. Wash your hands again with soap and water to remove any residue. Wait at least 15 minutes before inserting your contact lenses. You may feel a slight burning sensation in the eye shortly after using the eye drops. If this persists, or is very uncomfortable, contact your Be careful not to touch the dropper tip against your eye, eye lid or anything else to avoid contaminating the eye drops. Contaminated eye drops may give you an eye infection. When to use it Use Nevanac every day, at about the same times each day, unless your doctor tells you otherwise. Using your eye drops at the same times each day will have the best effect. It will also help you remember when to use the eye drops. How long to use it Continue to use Nevanac Eye Drops for as long as your doctor tells you. If you are unsure about when or how to stop using Nevanac Eye Drops you should talk to your If you forget to use it If you forget to use Nevanac Eye Drops, you should put the drops that you missed in the eye(s) as soon as you remember and then go back to using them as recommended by your doctor. If it is almost time for your next dose, skip the dose you missed and use your next dose when you are meant to. Do not use double the amount to make up for the dose that you missed. Using multiple doses may cause unwanted side effects. If you are not sure whether to skip the dose, talk to your If you have trouble remembering to use your eye drops, ask your pharmacist for some hints. If you use too much (overdose) If you think that you or someone else has swallowed any or all of the contents of Nevanac immediately telephone your doctor or the National Poisons Centre on 0800 POISON or for advice, or go to Accident and Emergency at the nearest hospital. Do this even if there are no signs of discomfort or poisoning. If Nevanac Eye Drops are accidentally swallowed, or if you use too many drops, you may feel light-headed, nausea or dizzy. While you are using Nevanac Things you must do Tell your doctor if your symptoms persist, worsen or recur. Tell your doctor if, for any reason, you have not used or stopped using Nevanac Eye Otherwise your doctor may think that it was not effective and change the treatment unnecessarily. any crusty discharge from your eyes will using Nevanac. You may have developed an eye infection. Your doctor may tell you to use a new container of Nevanac Eye Drops because of possible contamination of the old one, or advise you to stop your treatment with Nevanac. Using NSAIDs, such as Nevanac may result in inflammation of the corneal surface of the eye or other corneal problems. eye pain, watery eyes, blurred vision or any other changes to the surface of the eye. If this happens stop using Nevanac immediately. Internal document code 3

4 If you wear soft contact lenses, stop wearing them until you stop using Nevanac Eye If you become pregnant while using Nevanac Eye Drops tell your doctor immediately. If you are about to be started on any new medicine, remind your doctor and pharmacist that you are using Nevanac Eye Tell any other doctors, dentists and pharmacists who treat you that you are using Nevanac Eye Things you must not do Do not stop using Nevanac Eye Drops without first asking your doctor. to treat other complaints unless your doctor or pharmacist tells you to. Do not give this medicine to anyone else, even if they appear to have the same condition as you. Do let children handle Nevanac Eye If a child accidentally swallows any of the drops read the instructions under If you use too much (overdose). Things to be careful of Be careful driving or operating machinery until you know how Nevanac affects you and your vision. Nevanac Eye Drops may cause temporary blurred vision which will affect your ability to drive or operate machinery. If blurred vision occurs when you use your drops, wait until your vision is clear before driving or operating machinery. Side effects Tell your doctor as soon as possible if you do not feel well while you are using Nevanac. Nevanac helps most people to treat pain and inflammation associated with cataract surgery but it may have unwanted effects in a few people. All medicines can have side effects. Sometimes they are serious, however most of the time they are not. You may need to medical treatment if you get some of the side effects. Do not feel alarmed the list of possible side effects. You may not experience any of them. Ask your doctor or pharmacist to answer any questions you may have. Tell your doctor or pharmacist if you notice any of the following and they worry you: changes in vision, blurred vision or temporary reduction of vision abnormal sensation in the eye increased pressure in your eye sticky sensation swelling of the eye dryness eye discharge eye discomfort and redness eye pain itching sensitivity to light tearing You may also experience reactions in other areas of your body, including: headache high blood pressure nausea/vomiting sinus inflammation. If any of the following happen, stop using Nevanac Eye Drops and tell your doctor immediately or go to Accident and Emergency at your nearest hospital: wheezing, difficulty in breathing shortness of breath very slow pulse chest pain fainting swelling of the face, lips, mouth, tongue or throat which may cause difficulty in breathing or swallowing severe and sudden onset of pinkish, itchy swellings on the skin, also called hives or nettlerash. These are hypersensitivity reactions and can be very serious. You may need urgent medical attention or hospitalisation. These side effects are very rare. Other side effects not listed above may also occur in some patients. After using Nevanac Storage Keep your eye drops in a cool place where the temperature Internal document code 4

5 stays below 30 C. Do not freeze. Do not leave Nevanac Eye Drops in the car, in the bathroom or in other warm, damp places. Heat and humidity can destroy some medicines. Do not leave the top off the bottle for any length of time, to avoid contaminating the eye drops. Keep it where children cannot reach it. A locked cupboard at least oneand-a-half metres above the ground is a good place to store medicines. Disposal Discard each bottle of Nevanac Eye Drops 4 weeks after it has been opened. Write the date the on the bottle label when it first opened to remind you when to discard the bottle. Nevanac Eye Drops contain a preservative which helps prevent germs growing in the solution for the first four weeks after opening the bottle. After this time, there is a greater risk that the drops may become contaminated and cause an eye infection. A new bottle should then be used. If your doctor tells you to stop using Nevanac Eye Drops or they have passed the expiry date, ask your pharmacist what to do with any that is left over. Product description What it looks like Nevanac Eye Drops are a sterile suspension that is supplied in a 4 ml Drop-Tainer TM dispenser with a screw cap. The bottle contains 3 ml of liquid. The safety seal must be removed before use. Ingredients Nevanac Eye Drops contain nepafenac 1 mg in 1 ml (0.1%) as the active ingredient. Nevanac Eye Drops also contain: benzalkonium chloride (as a preservative) carbomer disodium edetate dehydrate mannitol sodium chloride tyloxapol hydrochloric acid and/or sodium hydroxide (to adjust ph). purified water. Supplier Nevanac is supplied in New Zealand by: Novartis New Zealand Limited 109 Carlton Gore Road Newmarket Auckland PO Box Newmarket Auckland 1149 New Zealand. Free Phone: Date of Preparation This leaflet was prepared in October Nevanac TM is a trademark of Novartis. Novartis Pharmaceuticals Australia Pty Limited Internal document code 5