Pred Forte 1% w/v, Eye Drops Suspension

• 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 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.

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

• 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

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

Contact your doctor if you experience blurred vision or other visual disturbances.

PRED FORTE has not been tested in children under the age of 18. There are no recommendations for use in children.

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

Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Some medicines may increase the effects of PRED FORTE and your doctor may wish to monitor you carefully if you are taking these medicines (including some medicines for HIV: ritonavir, cobicistat).

If you are pregnant or think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine as steroids may be harmful to the baby. Use of PRED FORTE is not recommended if you are breast-feeding.

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

This medicine contains 0.06 mg benzalkonium chloride in each 1 ml.

Benzalkonium chloride may be absorbed by soft contact lenses and may change the colour of the contact lenses. You should remove contact lenses before using this medicine and put them back 15 minutes afterwards.

Benzalkonium chloride may also cause eye irritation, especially if you have dry eyes or disorders of the cornea (the clear layer at the front of the eye). If you feel abnormal eye sensation, stinging or pain in the eye after using this medicine, talk to your doctor.

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 eye injury and 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.

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 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 take a double dose to make up for a forgotten dose.

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 medicine, ask your doctor or pharmacist.

• ulcers on the surface of the eye
• severe pain in the eye
• allergic reaction

Frequency not known (cannot be estimated from the available data)

• headache
• increased pressure within the eye
• centre of the eye becomes cloudy (cataracts)
• a feeling that something is in your eye
• eye infections (bacterial, fungal or viral)
• mild stinging or irritation
• red eye
• blurred or poor vision
• droopy eyelids
• pupil dilation
• change in sense of taste
• rash or itching

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:

or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

• 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.

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.

If you would like further information, please contact Medical Information at AbbVie Ltd. Tel: 01628 561090 or Email: [email protected]