Monday, September 26, 2016

Pred Forte






PRED FORTE



1% w/v Eye Drops, Suspension


(Prednisolone acetate)



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 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 gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.




In this leaflet:


  • 1. What PRED FORTE is and what it is used for

  • 2. Before you use PRED FORTE

  • 3. How to use PRED FORTE

  • 4. Possible side effects

  • 5 How to store PRED FORTE

  • 6. Further information




What PRED FORTE is and what it is used for


PRED FORTE belongs to a group of medicines known as steroidal anti-inflammatory drugs. 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.




Before you use PRED FORTE



Do not use PRED FORTE


  • If you are allergic (hypersensitive) to:

    prednisolone acetate, benzalkonium chloride or other ingredients 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 suffer from glaucoma

  • If you have previously had herpes simplex



Take special care with PRED FORTE


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

  • You have had surgery for cataracts.

  • Bacterial, viral or fungal eye infections



Using other medicines


Please tell your doctor or pharmacist if you are using or have recently used any other medicine, including medicines obtained without a prescription.




Tell your doctor before using PRED FORTE, if you are:


Using or have used other steroid eye drops, as frequent or long-term use of steroids can result in additional side effects.




Pregnancy and breast-feeding


Tell your doctor before you start using PRED FORTE if you are pregnant or if you are breast-feeding as steroids may be harmful to the baby.


Ask your doctor or pharmacist for advice before using any medicine.




Driving and using machines


PRED FORTE may cause temporary blurred vision. Do not drive or use machinery until the symptoms have cleared.




Important information about some of the ingredients of PRED FORTE



Contact lenses


  • Do not use the drops while your contact lenses are in your eyes. Wait at least 15 minutes after using the eye drops before putting your lenses back in your eyes

  • A preservative in PRED FORTE (benzalkonium chloride) may cause eye irritation. PRED FORTE should not be used whilst soft contact lenses are in place, as it may discolour them.




How to use PRED FORTE


Always use PRED FORTE exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.


The usual dose of PRED FORTE 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 your head back and look at the ceiling.

  • 2. Gently pull the lower eyelid down until there is a small pocket.

  • 3. Turn the bottle upside down and squeeze it to release one or two drops into each eye that needs treatment.

  • 4. Let go of the lower lid, and close your eye. Press your finger against the corner of your eye (the side where your eye meets your nose) for one minute.

If a drop misses your eye, try again.


To avoid contamination, do not let the tip of the dropper touch your eye or anything else.


Replace and tighten the cap straight after use.


Wipe off any excess liquid from your cheek with a clean tissue.


If you use this medicine for more than 10 days, your doctor may ask you to have check-ups. These are to make sure that your medicine is working properly and that the dose 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 doctor or pharmacist.




If you use more PRED FORTE than you should


Putting too many drops in your eye(s) is unlikely to lead to unwanted side-effects. If you have placed too many drops in your eye(s), wash your eye(s) with clean water. Apply your next dose at the normal time.


If, by accident, anyone drinks this medicine, contact your doctor straight away.




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 apply your next dose as usual and continue with your normal routine.


Do not use a double dose to make up for a forgotten dose.




If you stop using PRED FORTE


PRED FORTE should be used as advised by your doctor. Do not stop using PRED FORTE until your doctor has told you to. If you have any further questions on the use of this product, ask your doctor or pharmacist.





Pred Forte Side Effects


Like all medicines, PRED FORTE can cause side effects. but not everyone gets them.



You should see your doctor immediately if you experience:


  • ulcers on the surface of the eye

  • severe pain in the eye



You should see your doctor if any of the following effects prove troublesome or if they are long-lasting:


  • allergic reaction

  • headache

  • increased pressure within the eye

  • centre of the eye becomes cloudy (cataracts)

  • eye infections

  • mild stinging or irritation

  • blurred or poor vision

  • pupil dilation

  • change in sense of taste

  • rash or itching


If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.




How to store PRED FORTE


Keep out of the reach and sight of children.


Discard the bottle 28 days after opening, even if there is solution remaining.


Do not use PRED FORTE after the expiry 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 that month for an unopened bottle.


Do not store above 25°C (room temperature). Do not freeze.


Do not use PRED FORTE if you notice the tamper-proof seal is broken.


Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.




Further information



What PRED FORTE contains


  • The active substance is Prednisolone acetate 1.0% w/v

  • The other ingredients are benzalkonium chloride, disodium edetate, hydroxypropylmethylcellulose, polysorbate 80, boric acid, sodium citrate, sodium chloride and purified water.



What PRED FORTE looks like and contents of the pack


PRED FORTE is a sterile eye drop suspension in a plastic bottle.


Each carton contains 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 International

The Parkway

Marlow

Bucks

SL7 1YL




If you would like further information, please contact Medical Information at Allergan Ltd. Tel: 01628 494026 or Email: uk_medinfo@allergan.com


Manufacturer:



Allergan Pharmaceuticals Ireland

Westport

Co Mayo

Ireland



This leaflet was last approved in May 2010.



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 only).



Please be ready to give the following information: Prednisolone 1% reference number PL 00426/0051.



This is a service provided by the Royal National Institute of Blind People.


UK-PIL-2010-05-04





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