PRED FORTE 1% w/v Eye Drops, Suspension. Prednisolone acetate. Read all of this leaflet carefully before you start using this medicine because it.

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Package leaflet : Information for the user PRED FORTE 1% w/v Eye Drops, Suspension Prednisolone acetate Read all of this leaflet carefully before you start using this medicine because it contains important information for you . Keep this leaflet. You may n eed 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. What is i n this leaflet : 1. What PRED FORTE is and what it is used for 2. What you need to know before you use PRED FORTE 3. How to use PRED FORTE 4. Possible side effects 5 How to store PRED FORTE 6. Contents of the pack and other information 1. What PRED FORTE is and what it is used for PRED FORTE belong s to a group of medicines known as steroid al anti -inflammatory drug s. PRED FORTE is used in adults for the short -term treatment of eye inflammation. It reduces the irritation, burning, redness and swelling of eye inflammation caused by chemicals, heat, radiation, allergy, or foreign objects in the eye. 2. What you need to k now b efore you use PRED FORTE Do not use PRED FORTE If you are allergic to prednisolone acetate, benzalkonium chloride or any of the other ingredients of this medicine ( listed in section 6 ) If you suffer from viral, fungal or bacterial eye infections If you suffer from tuberculosis of the eye If you have injuries to or ulcers on the cornea If you have previously had herpes simplex Warnings and precautions Talk to your doctor before using PRED FORTE if you suffer from, or have in the past suffered from: Eye ulcers or have had a disease or treatment to the eye that caused the tissue to become thin You have glaucoma or are being treated for raised pressure within the eye

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You have had surgery for cataracts Bacterial, viral or fungal eye infections Contact you r doctor if you experience blurred vision or other visual disturbances. Children Do not give to a child less than 12 years old as this medicine contains boron and may impair fertility in the future . Tell your doctor before using PRED FORTE, if yo u are: Using or have used other ste roid eye drops, as frequent or long -term use of steroids can result in additional side effects. Other medicines and Pred Forte Please t ell your doctor if you are taking or have recently taken any other medicine s, includi ng medic ines obtained without a pre scription. Some medicines may increase the effects of PRED FORTE and your doctor may wish to monito r you carefully if you are taking these medicines (including some medicines for HIV: ritonavir, cobicistat). Pregnancy a nd breas t-feeding If you are pregna nt or breast -feeding , think you may be pregnant or are planning to have a baby, ask your doctor or p harmacist for advice before taking this medicine as steroids may be harmful to the baby. Driving and using machines PRED FORTE m ay cause temporary blurred vision. Do not drive or use machinery until the symptoms have cleared. PRED FORTE contains benzalko nium chloride This medicine contains 0.06 mg benzalkonium chloride in each 1 ml. Contact lenses Benzalkonium chloride ma y be abs orbed by soft contact lense s and may change the colour of the contact lenses. You should remove contact lenses before using thi s medicine and put them back 15 minutes afterwards. Benzalkonium chloride may also cause eye irritation, especially if yo u have d ry eyes or disorders of the cornea (the clear layer at the front of the eye). If you feel abnormal eye sensation, stinging or p ain in the eye after using this medicine, talk to your doctor. 3. How to use PRED FORTE Always use this medicine exactl y as you r doctor has told you. Chec k with your doctor or pharmacist if you are not sure.

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The recommended dose is 1 or 2 drops into the affected eye(s) 2 to 4 times a day . During the first two days of treatment you may be asked to apply the drops as often as every hour. Instructions for use You must not use the bottle if the tamper -proof seal on the bottle neck is broken before you first use it. Apply your eye drops in the following way: 1. Wash your hands. Shake the bottle well before use. Tilt y our head back and look at the ceili ng. 2. Gently pull the lower eyelid down until there is a small pocket. 3. Turn the bottle upside down and s queeze it to release one or two drop s into each eye that needs treatment . 4. Let go of the lower lid, and clos e your e ye. Press your finger agai nst the corner of your eye (the side where your eye meets your nose) for one minute. If a drop miss es your eye, try again. To avoid eye injury and contamination , do not let the tip of the dropper touch your eye or anyth ing else . Replace and tighten the c ap straight after use. Wipe off any excess liquid from your cheek with a clean tissue. If you use t his medicine for more than 10 days, your doctor may ask you to have check -ups. These are to make sure that your medicine is work ing properly and that the d ose you are taking is right for you. Your doctor will check your eyes for: an increase in pressure cataracts infection The proper application of your eye drops is very important. If you have any questions ask your doct or or ph armacist. If you use more PRED FORTE than you should Putting too many drops in your eye(s) is unlikely to lead to unwanted sid e effects. If you have placed too many drops in your eye(s), wash your eye(s) with clean water. Apply your next dose at t he norma l time. If, by accident, a nyone drinks this medicine, contact your doctor straight away .

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If you forget to use PRED FORTE If you forget a dose apply it as soon as you remember, unless it is almost time for your next dose, in which case you should miss out the forgotten dose. Then a pply your next dose as usual and continue with your normal routine. Do not take a double dose to ma ke up for a forgotten dose. If you stop using PRED FORTE PRED FORTE should be used as advised by your doctor. Do not st op using PRED FORTE until your doct or has told you to. If you have any further questions on the use of this medicine , ask your doctor o r pharmacist. 4. Possible Side Effects Like all medicines, this medicine can cause side effects , although not everybod y gets them. You should see your doctor immediately if you experience: ulcers on the surface of the eye severe pain in the eye You s hould see your doctor if any of the following effects prove troublesome or if they are long -lasting: allergic reaction headache increased pressure within th e eye centre of the eye becomes cloudy (cataracts) a feeling that something is in your eye eye infec tions (bacterial, fungal or viral) mild stinging or irritation red eye blurred or poor vision pupil dilation change in se nse of t aste rash or itching Repor ting 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 : Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

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By reporting side effects you can help provide m ore information on the safety of this medicine. 5. How to store PRED FORTE Keep this medicine out of the sight and reach of c hildren. Discard the bottle 28 days after opening, even if there is solution remaining. Do not use this medicine after the exp iry date which is stated on the bottle label and the bottom of the carton after EXP. The expiry date refers to the last day of t hat month for an unopened b ottle. Do not store above 25°C (room temperature). Do not freeze. Do not use this medicine if you notice the tamper -proof seal is broken. Do not throw away a ny medicines via wastewater or household waste. Ask your phar macist h ow to throw away medicines you no longer use . These measures will help protect the environment. 6. Contents of the pack and o ther information What PRED FORTE contains Ł The active sub stance is Prednisolone acetate 1.0% w/v . Ł The other ingredi ents are benzalkonium chloride, dis odium edetate, hydroxypropylmethylcellulose, polysorbate 80, boric acid, sodium citrate, sodium chlo ride and purified water. What PRED FORTE looks like and con tents of the pack PRED FORTE is a sterile eye drop suspension in a pl astic bottle. Each carton c ontains 1 plastic bottle with a screw cap. Each bottle is about half full and contains 5 ml or 10 ml of the eye drops as written on the front of the carton. Marketing Authorisation Holder Allergan Limited Marlow Interna tional The Parkway Marlow Bucks, SL7 1YL If you would like further information, please contact Medical Information at Allergan Ltd . Tel: 01628 494026 or Email: [email protected] Manufa cturer

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Allergan Pharmaceuticals Ireland Westport Co Mayo Irel and Thi s leaflet was last revised in September 2020. Versio n 7 To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge: 0800 198 5000 (UK on ly). Please be ready to give the following informat ion: Pre dnisolon e 1% reference numb er PL 00426/0051. This is a service provided by the Royal National Institute of Blind People.

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