Package Leaflet: Information for the User

Pred Forte 10 mg/ml Eye Drops Suspension

prednisolone acetate

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

• Keep this leaflet, as 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. Do not give it to others even if they have the same symptoms as you, as it may harm them.

• If you experience any side effects, consult your doctor or pharmacist, even if they are 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 using Pred Forte

3.How to use Pred Forte

4.Possible side effects

1. Storage of Pred Forte

6.Contents of the pack and additional information

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

No use Pred Forte:

1. -If you are allergic to prednisolone acetate or any of the other components of this medication (listed in section 6).

1. -In case of acute, untreated purulent eye infections, superficial (or epithelial) acute herpes simplex, acute dendritic keratitis, vaccinia, varicella, and most viral corneal and conjunctival conditions, mycobacterial infections such as ocular tuberculosis, fungal eye infections.

Warnings and Precautions

Consult your doctor before starting to use Pred Forte:

• Patients with a history of herpes simplex should be treated with caution when using topical steroids.
• In case of purulent conditions, the use of corticosteroids may mask the infection.
• If symptoms of inflammation persist after prolonged use, consider the possibility of fungal infection.
• Once therapy is initiated, be cautious not to discontinue it prematurely.
• Use with caution in cases where the cornea or sclera is thinning.
• Inform your doctor before using this medication if you have glaucoma or are being treated for high eye pressure. Also inform them if you have undergone surgery to treat cataracts.
• Contact your doctor if you experience blurry vision or other visual disturbances.

Children and Adolescents

This medication is not recommended for children under 18 years of age. There is insufficient information.

Using Pred Forte with Other Medications

• Inform your doctor if you are taking or have recently taken other medications, including those obtained without a prescription.
• Some medications may increase the effects of Pred Forte, so your doctor will perform close monitoring if you are taking these medications (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 medication, as steroids may be harmful to the baby.

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

Do not use Pred Forte while breastfeeding.

Driving and Operating Machines

Pred Forte may cause temporary blurry vision. Do not drive or operate tools or machines until symptoms have resolved.

Pred Forte contains benzalkonium chloride

This medication contains 0.0024 mg of benzalkonium chloride in each 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 medication and wait 15 minutes before reinserting them.

Benzalkonium chloride may cause eye irritation, especially if you have dry eye or other corneal conditions (the transparent layer at the front of the eye). Consult your doctor if you experience unusual sensations, stinging, or eye pain after using this medication.

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), do not administer to children under 12 years of age without consulting your doctor, as this medication contains boron and may affect future fertility. At doses above the maximum recommended dose (2 drops in each eye 4 times a day), do not administer to children under 18 years of age without consulting your doctor.

For information on pregnancy, see epigraph Pregnancy, Breastfeeding, and Fertility.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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

Administration Method

Do not use the product if the safety 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 your lower eyelid until a small space is formed.
3. Invert the bottle and press it to release one or two drops into each eye.
4. Release your eyelid and close your eye. Press the lacrimal area (the area near your nose) with your finger for 1 minute.
5. Repeat steps 2, 3, and 4 for the other eye if also in need of treatment.

To avoid product contamination and eye injuries, avoid letting the dropper tip come into contact with your eye or any other surface.

Close the container tightly after each application.

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

Wait at least 5 minutes before using other eye drops.

If you have any other questions about using this product, ask your doctor or pharmacist.

If you use more Pred Forte than you should

In case of need, rinse your eye with plenty of water or saline solution.

Like all medications, this medication may produce adverse effects, although not everyone will experience 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 cause you problems or if their duration is prolonged:

Unknown frequency(frequency cannot be estimated from available data)

• Allergic reaction
• Headache
• Increased eye pressure
• Clouding of vision in the center of the eye (cataract)
• Sensation of a foreign body in the eye
• Eye infection (bacterial, fungal, or viral)
• Burning or irritation
• Ocular redness
• Blurred or defective vision
• Pupil dilation
• Ptosis*
• Ptosis
• Change in sense of taste
• Rash or pruritus

*Prolonged use

Reporting Adverse Effects

If you experienceany type of adverse effect, consult your doctor or pharmacist, even if it is apossibleadverse effect not listed in this prospectus.You can also report them directly to the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

Do not use this medication after the expiration date that appears on the packaging after CAD.The expiration date is the last day of the month indicated.Dispose of the packaging 4 weeks after opening.

Do not freeze.

Do not use this medication if you observe a change in color or if cloudiness occurs in its contents.

Medications should not be thrown into the drains or trash. Deposit the packaging and medications you no longer need at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Pred Forte

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

Appearance of the product and contents of the packaging

Pred Forte is a sterile ophthalmic suspension.

Each package contains 5 ml of suspension and is approximately half full.

Holder of the marketing authorization and manufacturer responsible

Holder of the marketing authorization:

AbbVie Spain, S.L.U.

Avenida de Burgos 91,

28050 Madrid,

Spain

Manufacturer responsible:

Allergan Pharmaceuticals Ireland

Castlebar Road, Co. Mayo

Westport,

Ireland

Date of the last review of this leaflet:

November 2024

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/