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MAXITROL EYE DROPS

Transcript

PMS ZWART a 100%

Package Leaflet - Information for the User

eye drops, suspension Dexamethasone, Neomycin sulphate, Polymyxin B sulphate 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 any further questions, ask your doctor or your 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 get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

IN THIS LEAFLET 1. What MAXITROL is and what it is used for 2. Before you use MAXITROL 3. How to use MAXITROL

6. Further information

It is used for the short term treatment of inflammation of the eye, where administration of an antibiotic is also required to prevent an eye infection.

BEFORE YOU USE MAXITROL

Do not use MAXITROL. • If you have any type of infection of the eye that is not being treated. Use of steroids may make infections worse. • If you have a red eye that has not been seen by a doctor. • If you are allergic to neomycin or to any of the other ingredients listed in section 6. Ask your doctor for advice.

Take special care. • Do not inject or swallow this medicine. • Consult your doctor or pharmacist before using this medicine if you have a disorder causing a thinning of the eye tissues. • You should have your eye pressure checked regularly while using this medicine. This is especially important for children. • The risk of increase in eye pressure and / or cataract formation is higher in susceptible patients ( e. g. patients with diabetes ) using steroids. • Consult your doctor or pharmacist if your eye pain, redness, swelling, or irritation gets worse or persists. • Steroids applied to the eye may delay the healing of your eye wound. Topical NSAIDs ( Non-Steroidal Anti Inflammatory DrugsMedications ) are also known to slow or delay healing. Simultaneous use of topical NSAIDs and topical steroids may increase the potential for healing problems. • As with any antibiotic, use of MAXITROL for a long time may lead to other infections. If your symptoms get worse or suddenly return tell your doctor.

5. How to store MAXITROL

WHAT MAXITROL* IS AND WHAT IT IS USED FOR

MAXITROL contains a steroid, dexamethasone and two antibiotics, neomycin sulphate and polymyxin B sulphate.

4. Possible side effects

Pregnancy and breast-feeding MAXITROL is not recommended during pregnancy or breast-feeding. If you are pregnant or might get pregnant, or if you are breast-feeding a baby, talk to your doctor before you use MAXITROL.

Driving and using machines You may experience blurred vision after using MAXITROL. Do not drive or use any machines unless your vision is normal.

Using other medicines Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Taking MAXITROL with other medicines may increase the seriousness of the side effects. Tell your doctor if you are using topical NSAIDs. Simultaneous use of topical steroids and topical NSAIDs may increase healing problems in your eye.

Important information if you wear Contact Lenses Wearing contact lenses is not advisable during the treatment of an eye infection, as they may make your condition worse. If you do continue to wear your lenses, you must remove them before using MAXITROL and wait at least 15 minutes after use before putting your lenses back in. There is a preservative in MAXITROL ( benzalkonium chloride ) that can discolour soft contact lenses.

HOW TO USE MAXITROL

The usual dose The usual dose is 1 or 2 drops into the space between your eyelid and eye 6 times daily, or more frequently if required. Remove the loose collar from the cap when the bottle is first opened.

Always use MAXITROL exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. MAXITROL should not be used for a long period of time unless advised by your doctor.

PMS ZWART a 100% - 20%

HOW TO USE MAXITROL* ( continued )

Wash your hands before you start. Shake the bottle well. Twist off the bottle cap. Hold the bottle pointing down, between your thumb and fingers. 1 • Tilt your head back. • Pull down your lower eyelid with a finger, until there is a ‘pocket’ between the eyelid and your eye. The drop will go in here 2 ( picture 1 ).

• If a drop misses your eye, try again. • If you forget to take MAXITROL, do not worry, just take it as soon as possible. Do not take a double dose to make up. • If you use more MAXITROL than you should it can be washed out of your eye with warm water.

• Bring the bottle tip close to the eye. Do this in front of a mirror if it helps. • Do not touch your eye or eyelid, surrounding areas or other surfaces with the dropper. It could infect the drops. • Gently press on the base of the bottle to release one drop at a time ( picture 2 ). • Do not squeeze the bottle, only a gentle press on the bottom is needed. • If you use drops in both eyes, repeat the steps for your other eye. Put the bottle cap firmly back on immediately after use.

• If you are using other eye drops, wait at least 5 minutes after putting in MAXITROL before using the other eye drops. Eye ointments should be administered last. If you have any further questions on the use of MAXITROL, ask your doctor or pharmacist.

POSSIBLE SIDE EFFECTS

Like all medicines, MAXITROL can cause side effects, although not everybody gets them. You may experience some or all of the following effects in your eyes : Uncommon ( affect 1 to 10 users in 1000 ) : eye surface inflammation, increased pressure in eye, blurred vision, sensitivity to light, change in pupil size, drooping of eye lid, eye pain, swelling or redness, eye irritation, itching or discomfort, abnormal eye sensation, increased tear production, Thinning of the surface of the eye has also been reported. It is not known how many users may have experienced this side effect.

You may also experience effects in other parts of your body : Hypersensitivity or general allergy to MAXITROL and headache have been reported. It is not known how many users may have experienced these side effects

Reporting of side effects 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 national reporting system ( see details below ). By reporting side effects you can help provide more information on the safety of this medicine. United Kingdom Yellow Card Scheme Website. www. mhra. gov. uk / yellowcard

HOW TO STORE MAXITROL

Keep out of the reach and sight of children. Do not refrigerate or store above 25 °C. Keep the bottle tightly closed. Keep away from direct sunlight. Do not use the drops after the expiry date ( marked ‘Exp’ ) on the bottle and the carton. The expiry date refers to the last day of that month.

• Stop using the bottle 4 weeks after first opening, to prevent infections. • Medicines should not be disposed of via waste water or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment. • Do not pass this medicine on to others. It may harm them even if their symptoms are the same as yours.

What MAXITROL contains • The active substances are dexamethasone 1 mg / ml, neomycin sulphate 3500 IU / ml, polymyxin B sulphate 6000 IU / ml. • The other ingredients are sodium chloride, polysorbate 20, hypromellose, benzalkonium chloride, hydrochloric acid and / or sodium hydroxide ( to adjust pH ) and purified water.

Marketing authorisation holder : Alcon Laboratories ( UK ) Ltd. Frimley Business Park Frimley, Camberley Surrey GU16 7SR United Kingdom. * a trademark of Novartis

What MAXITROL looks like and contents of the pack MAXITROL Eye Drops is a cloudy, white liquid supplied in a pack containing a 5 ml or 10 ml plastic bottle with a screw cap.

Manufacturer : SA Alcon-Couvreur NV Rijksweg 14, B-2870 Puurs, Belgium. This leaflet was last revised in July 2014.

© 2010, 2013, 2014 Novartis 07-2014

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.