Pred Forte 10 mg/ml suspension for eye drops

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Pred Forte 10 mg/ml 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 need to read it again.

• If you have any questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you. It could harm them.

  • If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4

Contents of this leaflet

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

2. What you need to know before using Pred Forte

3. How to use Pred Forte

4. Possible side effects

   1. Storage of Pred Forte

5. Contents of the pack and other information

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

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

2. What you need to know before using Pred Forte

Do not use Pred Forte:

1. • if you are allergic to prednisolone acetate or to any of the other ingredients of this medicine (listed in section 6).
2. • in case of untreated acute purulent ocular infections, acute superficial (or epithelial) herpes simplex, keratitis (dendritic keratitis), vaccinia, varicella, and most viral infections of the cornea and conjunctiva, mycobacterial infections such as ocular tuberculosis, or fungal eye infections.

Warnings and precautions

Consult your doctor before starting to use Pred Forte:

• In patients with a history of herpes simplex, treatment with topical steroids should be carried out with caution.
• In cases of purulent conditions, the use of corticosteroids may mask the infection.
• If symptoms of inflammation persist after prolonged use of the preparation, fungal infection should be considered.
• Once therapy has been initiated, care must be taken not to discontinue treatment prematurely.
• Use with caution in conditions associated with thinning of the cornea or sclera.
• You must inform your doctor before using this medicine if you have glaucoma or are being treated for elevated eye pressure. You should also inform your doctor if you have had surgery to treat cataracts.
• Contact your doctor if you experience blurred vision or other visual disturbances.

Children and adolescents

This medicine is not recommended for patients under 18 years of age. There is insufficient information.

Use of Pred Forte with other medicines

• Inform 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 closely monitor you if you are taking these medicines (including some used for HIV: ritonavir, cobicistat).

Pregnancy, breastfeeding, and fertility

If you are pregnant, think you may be pregnant, or are planning 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 due to its boric acid content it may be harmful to your baby. (See section "Pred Forte contains boric acid" for more information.)

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

Driving and use of machines

Pred Forte may cause transient blurred vision. Do not drive or operate tools or machinery until these symptoms have resolved.

Pred Forte contains benzalkonium chloride

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

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

Benzalkonium chloride may cause eye irritation, particularly if you have dry eye or other corneal conditions (the transparent layer at the front of the eye). Consult your doctor if you experience a foreign body sensation, stinging, or eye pain 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 daily), this medicine should not be administered to children under 12 years of age without first consulting your doctor, as this medicine contains boron and may affect future fertility. For the same reason, at doses exceeding the maximum recommended dose (2 drops in each eye 4 times daily), this medicine should not be administered to children under 18 years of age without first consulting your doctor.

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

3. How to use Pred Forte

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in 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 at the physician's discretion, the dosing frequency may be increased. Continue therapy for the duration established by the physician.

Method of administration

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

2. Wash your hands and shake the container before use. Tilt your head backward and look upward.

3. Gently pull down the lower eyelid until a small pocket is formed.

4. Invert the bottle and squeeze it to instill one or two drops into each eye.

5. Release the eyelid and close the eye. Press with your finger on the tear duct area (the area of the eye near the nose) for one minute.

6. Repeat steps 2, 3, and 4 for the other eye if treatment is also required.

To avoid contamination of the product and prevent eye injury, avoid allowing the dropper tip to touch the eye or any other surface.

Close the container tightly after each use.

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

Wait at least 5 minutes before using any other eye drops.

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

If you use more Pred Forte than you should

If necessary, rinse the eye with copious amounts of water or saline solution.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

If you notice any of the following adverse 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 adverse effects bother you or if they persist for a long time:

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

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

*prolonged use

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaRAM.es. By reporting adverse 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 stated on the container after EXP. The expiry date refers to the last day of the month indicated. Discard the container 4 weeks after opening.

Do not freeze.

Do not use this medicine if there is a change in color or if the solution becomes cloudy.

Medicines must not be disposed of via wastewater or household waste. Return unused containers and unwanted medicines to the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. 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 components are: benzalkonium chloride 0.06 mg, polysorbate 80, boric acid, sodium citrate dihydrate, sodium chloride, disodium edetate, hypromellose, purified water, sodium hydroxide or hydrochloric acid (for pH adjustment). …

Appearance of the medicine and contents of the pack

Pred Forte is a sterile ophthalmic suspension.

Each container holds 5 ml of suspension and is approximately half-filled.

Marketing Authorization Holder and Manufacturer

Marketing Authorization 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 the most recent revision of this leaflet:

November 2024

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/