Pred-ophtalene

Leaflet attached to the packaging: Information for the user

Pred-Ophtalene, 5 mg/g, eye ointment

Prednisolone pivalate

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• 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 symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Pred-Ophtalene and what is it used for
• 2. Important information before using Pred-Ophtalene
• 3. How to use Pred-Ophtalene
• 4. Possible side effects
• 5. How to store Pred-Ophtalene
• 6. Contents of the pack and other information

1. What is Pred-Ophtalene and what is it used for

Pred-Ophtalene is intended for use in adults to treat severe inflammatory conditions in the front part of the eye, which are not caused by infection. Pred-Ophtalene contains the active substance prednisolone pivalate. The active substance prednisolone pivalate is a glucocorticosteroid (steroid) with strong anti-inflammatory effects. It inhibits the release of inflammatory mediators in the body, thereby preventing the occurrence of inflammation symptoms, such as swelling, vasodilation, and scarring.

2. Important information before using Pred-Ophtalene

When not to use Pred-Ophtalene:

• If you are allergic to the active substance prednisolone pivalate, other glucocorticosteroids, or any of the other ingredients of this medicine (listed in section 6).
• If you have a viral eye infection, such as herpes simplex (dendritic keratitis) or any other viral eye infection.
• If you have an untreated bacterial or viral eye infection.
• If you have narrow-angle glaucoma or advanced glaucoma and the use of eye drops alone is not sufficient.

Warnings and precautions

Before starting to use Pred-Ophtalene eye ointment, you should consult your doctor or pharmacist if:

• You have or have had eye ulcers or thinning of the eye tissues due to disease or previous eye treatment.
• You have had cataract surgery.
• You have or have had bacterial, viral (e.g., herpes simplex), or fungal eye infections.
• You have cataracts or are being treated for increased eye pressure.
• You have recently used or are currently using other eye medicines that contain glucocorticosteroids. Frequent or prolonged use of glucocorticosteroids may lead to additional side effects.

Pred-Ophtalene and other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines. No interactions with other medicines have been observed. If you are using other eye medicines that may increase eye pressure, this effect may be more pronounced.

Pregnancy and breastfeeding

Pregnancy: The effect of the medicine on the fetus is not known. If you are pregnant, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before using this medicine. Breastfeeding: Pred-Ophtalene passes into breast milk, but it is unlikely to affect breastfed babies. Pred-Ophtalene can be used during breastfeeding.

Driving and using machines

Pred-Ophtalene may cause blurred vision, which is a temporary side effect. In this case, do not drive or operate machinery until your vision is back to normal.

Pred-Ophtalene contains lanolin and cetyl stearyl alcohol

Lanolin and cetyl stearyl alcohol may cause local skin irritation (e.g., contact dermatitis).

3. How to use Pred-Ophtalene

Always use this medicine exactly as your doctor has told you. If you are not sure, ask your doctor. Recommended dose:Unless your doctor has told you otherwise, apply a 3-5 mm long strip of ointment to the affected eye 2-4 times a day. The maximum daily dose of ointment is a 5 mm long strip, applied 4 times a day. The duration of treatment is determined by your doctor. If symptoms do not improve after 2 days, consult your doctor. If you need to use the medicine for more than 10 days, your ophthalmologist should regularly check your cornea and eye pressure. In the following days and weeks, you should then gradually reduce the use of the medicine. Instructions for use

• Do not use the medicine if the protective cap on the tube is damaged before the first opening.
• Wash your hands.
• To avoid contamination of the medicine and injuries, make sure the nozzle does not touch the eye, eyelid, or area around the eye, or any other objects.
• Remove contact lenses before applying the medicine and do not put them back for at least 15 minutes after using the ointment.
• Tilt your head back.
• Take the open tube in one hand and gently pull down the lower eyelid with your index finger of the other hand to form a "pocket" between the eyelid and the eyeball.
• Hold the tube close to the eye.
• Gently squeeze the tube to place a 3-5 mm long strip of ointment in the "pocket" between the eyelid and the eyeball.
• Blink 2-3 times. The ointment will then form a thin layer on the surface of the eye.
• If the medicine is to be used in both eyes, repeat the same procedure for the second eye.
• Close the tube immediately after using the medicine to avoid contamination.
• If you are using other eye medicines, wait at least 5 minutes before using the next medicine.
• If you are using several different eye medicines, apply the eye ointment last.
• Pressure on the tear duct should last for 1 minute.
• Close your eye and press the corner of your eye next to your nose for 1 minute. Immediately remove any excess ointment from your face. This will help prevent the medicine from entering the rest of your body through the tear ducts and skin.

Using more Pred-Ophtalene than recommended

Accidentally putting too much ointment in the eye is unlikely to cause side effects. In this case, blink several times to spread the ointment across the eyelashes, and then gently remove it.

Missing a dose of Pred-Ophtalene

If you miss a dose of Pred-Ophtalene, use it as soon as you remember. Take the next doses at the usual time. If you use Pred-Ophtalene irregularly or miss doses, the effectiveness of the treatment may be lower.

Stopping the use of Pred-Ophtalene

Use Pred-Ophtalene regularly, as advised by your doctor. Use Pred-Ophtalene for the duration recommended by your doctor. If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Pred-Ophtalene eye ointment can cause side effects, although not everybody gets them. If you experience eye pain, contact your doctor immediately, as it may be caused by corneal ulcers or eye surface damage. This is a rare side effect (may affect up to 1 in 1,000 people). Other side effects that may occur: Common (may affect up to 1 in 10 people):Increased eye pressure during prolonged treatment, burning sensation, tingling, eye irritation, foreign body sensation in the eye. Uncommon (may affect up to 1 in 100 people):Blurred vision Rare (may affect up to 1 in 1,000 people):Allergic reactions in the eye, cataracts. Frequency not known; frequency cannot be estimated from the available data:Hypersensitivity, hives, headache, pupil dilation, rash or itching, taste disturbance, bacterial, fungal, or viral eye infections. With the use of other glucocorticosteroids in eye treatment, the following side effects have been observed: Rare (may affect up to 1 in 1,000 people):Eye inflammation, drooping eyelids, focusing problems.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. You can also report side effects directly to the Department of Drug Adverse Reaction Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. You can also report side effects to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Pred-Ophtalene

Keep this medicine out of the sight and reach of children. This medicinal product does not require any special storage conditions. Do not use this medicine after the expiry date stated on the label. The expiry date refers to the last day of the month stated. Do not use this medicine if the tube seal is damaged. Use within 4 weeks of first opening the package. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Pred-Ophtalene contains

The active substance is prednisolone pivalate. 1 g of ointment contains 5 mg of prednisolone pivalate. A 1 cm long strip of ointment contains approximately 0.1 mg of prednisolone pivalate. The other ingredients are: cetyl stearyl alcohol, liquid paraffin, white petrolatum, lanolin, purified water.

What Pred-Ophtalene looks like and contents of the pack

5 g of white to slightly yellowish, odorless ointment in a closed aluminum tube with a white nozzle and a white protective ring, in a cardboard box.

Marketing authorization holder and manufacturer

AGEPHA Pharma s.r.o, Diaľničná cesta 5, 903 01 Senec, Slovakia, Email: [email protected]

Date of last revision of the leaflet: