PRED FORTE 10 mg/ml EYE DROPS IN SUSPENSION

Introduction

Package Leaflet: Information for the User

Pred Forte 10 mg/ml eye drops, suspension

prednisolone acetate

Read this package leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this package 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.

Contents of the package leaflet

1. What is Pred Forte and what is it used for
2. What you need to know before you use Pred Forte
3. How to use Pred Forte
4. Possible side effects
   1. Storage of Pred Forte

1. Contents of the pack and other information

1. What is Pred Forte and what is it used for

Pred Forte is used for the treatment in adults of the inflammation of the bulbar conjunctiva, cornea and anterior segment of the eyeball, which responds to steroids.

2. What you need to know before you use Pred Forte

Do not use Pred Forte:

1. - if you are allergic to prednisolone acetate or any of the other ingredients of this medicine (listed in section 6).

1. - in case of acute untreated purulent eye infections, superficial herpes simplex (or epithelial) keratitis, dendritic keratitis, vaccinia, varicella, and most viral infections of the cornea and conjunctiva, mycobacterial infections such as ocular tuberculosis, fungal eye infections.

Warnings and precautions

Consult your doctor before starting to use Pred Forte:

• In the case of patients with a history of herpes simplex, treatment with topical steroids should be carried out with caution.
• In the case of purulent conditions, the use of corticosteroids may mask the infection.
• If after prolonged use of the preparation, the symptoms of inflammation persist, the possibility of fungal infection should be considered.
• Once therapy has been established, caution should be exercised not to discontinue it prematurely.
• Use with caution in lesions that occur with thinning of the cornea or sclera.
• You should inform your doctor before using this medicine if you have glaucoma or are being treated for high pressure in the eye. You should also inform him if you have had cataract surgery.
• Contact your doctor if you experience blurred vision or other visual disturbances.

Children and adolescents

This medicine is not recommended for children under 18 years of age. There is not enough information.

Using Pred Forte with other medicines

• Tell your doctor if you are taking or have recently taken any other medicines, including those obtained without a prescription.
• Some medicines may increase the effects of Pred Forte, so your doctor will monitor you closely if you are taking these medicines (including some for HIV: ritonavir, cobicistat).

Pregnancy, breastfeeding, and fertility

If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine, as steroids may be harmful to the baby.

If you are pregnant, consult your doctor before taking this medicine, as it may be harmful to your baby due to its boron content. (See section Pred Forte contains boric acid for more information).

If you are breastfeeding, the use of Pred Forte is not recommended.

Driving and using machines

Pred Forte may cause temporary blurred vision. Do not drive or operate tools or machines until the symptoms have disappeared.

Pred Forte contains benzalkonium chloride

This medicine contains 0.0024 mg of benzalkonium chloride per drop, equivalent to 0.06 mg/ml.

Benzalkonium chloride can be absorbed by soft contact lenses, altering their color. Remove contact lenses before using this medicine and wait 15 minutes before putting them back.

Benzalkonium chloride may cause eye irritation, especially if you have dry eye or other corneal diseases (the transparent layer of the front of the eye). Consult your doctor if you feel any strange sensation, itching, or pain in the eye after using this medicine.

Pred Forte contains boric acid

At doses equal to or less than the maximum recommended dose (2 drops in each eye 4 times a day), it should not be administered to children under 12 years of age without consulting a doctor first, as this medicine contains boron and may affect future fertility. For the same reason, at doses above the maximum recommended dose (2 drops in each eye 4 times a day), it should not be administered to children under 18 years of age without consulting a doctor first.

For information on pregnancy, see section Pregnancy, breastfeeding, and fertility.

3. How to use Pred Forte

Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is: one or two drops instilled into the affected eye(s), two to four times a day. If necessary and under medical criteria, the frequency of the dose may be increased. Maintain therapy during the treatment period established by the doctor.

Method of administration

Do not use the product if the security seal on the neck of the container is broken before the first use.

1. 2. 3. 4.

1. Wash your hands and shake the container before use. Tilt your head back and look up.
2. Gently pull down the lower eyelid until a small pocket is formed.
3. Invert the bottle and squeeze it so that one or two drops fall into each eye.
4. Release the eyelid and close the eye. Press the lacrimal area (the area of the eye closest to the nose) with your finger for 1 minute.
5. Repeat steps 2, 3, and 4 for the other eye if it also needs treatment.

To avoid contaminating the product and causing eye injuries, avoid touching the dropper tip to the eye or any other surface.

Close the container tightly after each application.

Wipe away any excess liquid from your cheek with a clean cloth.

Wait at least 5 minutes before using other eye drops.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

If you use more Pred Forte than you should

In case of necessity, wash the eye with plenty of water or saline solution.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you notice any of the following side effects, please contact your doctor immediately:

• Ulcers on the surface of the eye
• Severe eye pain

You should also contact your doctor if any of the following side effects cause you problems or if they last longer than expected:

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

• Allergic reaction
• Headache
• Increased pressure in the eye
• Clouding of vision in the center of the eye (cataract)
• Feeling of a foreign body in the eye
• Eye infection (bacterial, fungal, or viral)
• Itching or irritation
• Redness of the eye
• Blurred or defective vision
• Pupil dilation
• Drooping eyelid*
• Drooping eyelid
• Change in taste
• Rash or itching

*prolonged use

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Pred Forte

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the container after EXP. The expiry date is the last day of the month shown.

Discard the container 4 weeks after opening.

Do not freeze.

Do not use this medicine if you notice a change in color or if the contents become cloudy.

Medicines should not be disposed of via wastewater or household waste. Place the container and any unused medicine in the SIGRE collection point at your pharmacy. If you have any further questions on how to dispose of the container and any unused medicine, ask your pharmacist. This will help protect the environment.

6. Contents of the pack and other information

Composition of Pred Forte

• The active substance is prednisolone acetate.
• The other ingredients are: benzalkonium chloride 0.06 mg, polysorbate 80, boric acid, sodium citrate dihydrate, sodium chloride, disodium edetate, hydroxypropylmethylcellulose, purified water, sodium hydroxide or hydrochloric acid (for pH adjustment). …

Appearance and pack contents

Pred Forte is a sterile eye suspension.

Each container contains 5 ml of suspension and is filled approximately to the middle.

Marketing authorisation holder and manufacturer

Marketing authorisation holder:

AbbVie Spain, S.L.U.

Avenida de Burgos 91,

28050 Madrid,

Spain

Manufacturer:

Allergan Pharmaceuticals Ireland

Castlebar Road, Co. Mayo

Westport,

Ireland

Date of last revision of this leaflet:

November 2024

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/