Prattack

Package Leaflet: Information for the User

PRATTACK

1 mg/ml, eye drops, solution

Pranoprofen

Read the package 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.
• The medicine 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 PRATTACK and what is it used for
• 2. Important information before using PRATTACK
• 3. How to use PRATTACK
• 4. Possible side effects
• 5. How to store PRATTACK
• 6. Contents of the pack and other information

1. What is PRATTACK and what is it used for

PRATTACK is an eye drop solution containing pranoprofen as the active substance, a medicine with anti-inflammatory properties. PRATTACK is indicated for the treatment of acute and chronic non-infectious inflammatory eye diseases (blepharitis, conjunctivitis, blepharoconjunctivitis, anterior uveitis) and post-operative anti-inflammatory treatment after surgeries in the anterior segment of the eye (after cataract removal).

2. Important information before using PRATTACK

When not to use PRATTACK

If you are allergic to pranoprofen or any of the other ingredients of this medicine (listed in section 6). In children under 2 years of age (see "PRATTACK contains boron").

Warnings and precautions

Before starting to use PRATTACK, discuss it with your doctor or pharmacist. Wait at least 5 minutes after administering PRATTACK before administering another eye medicine.

PRATTACK and other medicines

No adverse interactions between PRATTACK and other medicines have been reported so far, however, you should tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine. Pregnancy The safety of PRATTACK in pregnancy has not been established. PRATTACK should only be used during pregnancy under close medical supervision and only if the doctor considers it necessary. Breastfeeding No controlled clinical studies have been conducted on the use of PRATTACK in breastfeeding women. PRATTACK should only be used during breastfeeding under close medical supervision and only if the doctor considers it necessary.

Driving and using machines

Using PRATTACK has no effect on the ability to drive or operate machinery. However, remember that putting any eye drops into your eyes may cause temporary blurred vision. Additionally, the diseases for which PRATTACK is indicated may impair vision and thus affect the ability to drive or operate machinery. PRATTACK contains benzalkonium chloride(a preservative) The medicine contains 0.07 mg of benzalkonium chloride per milliliter of solution. Benzalkonium chloride may be absorbed by soft contact lenses and change their color. Remove contact lenses before administering the drops and wait at least 15 minutes before putting them back. Benzalkonium chloride may also cause eye irritation, especially in people with dry eye syndrome or corneal disorders (the transparent layer at the front of the eye). If you experience any abnormal sensations in the eye, stinging, or eye pain after using the medicine, contact your doctor.

PRATTACK contains boron

Do not use in children under 2 years of age due to the presence of boron, which may cause fertility disorders (see "When not to use PRATTACK").

3. How to use PRATTACK

Dosage PRATTACK should always be used exactly as your doctor has instructed. If you are unsure, ask your doctor. The usual dose is 2 drops into the affected eye(s) every 6 hours. The duration of treatment is determined by your doctor. Method of administration:

• 1. Prepare the bottle with the medicine and a mirror.
• 2. Wash your hands.
• 3. Remove the cap.

• 4. Hold the bottle in your hand, with the cap facing upwards, and hold it between your thumb and middle finger.
• 5. Tilt your head back. With a clean finger, gently pull the lower eyelid down to create a "pocket" between the eye and the eyelid; the drop should fall into this pocket.
• 6. Bring the tip of the bottle close to the eye. You can use a mirror to help you.
• 7. Do not touch the dropper to the eye, eyelid, or surrounding areas.This may cause contamination of the drops. Using contaminated drops can lead to serious complications, even vision loss.
• 8. To release one drop, gently squeeze the bottom of the bottle.
• 9. If the drop does not fall into the eye, repeat the attempt.
• 10. After administering the drop, gently close your eye and press the corner of your eye near your nose for at least one minute. This will help prevent the medicine from spreading to the rest of your body.
• 11. If you need to administer drops to both eyes, repeat the steps for the second eye.
• 12. Immediately after use, replace the cap on the bottle.

The product should not be used by more than one person. It should be administered under the best possible hygiene conditions. Any other eye medicine can be administered only after waiting at least 5 minutes after administering PRATTACK.

Using more than the recommended dose of PRATTACK

Given the nature of the medicine, which is intended for local administration to the eyes, it is unlikely to expect toxic effects associated with its use in recommended doses or in case of accidental ingestion. Nevertheless, if you have taken more than the recommended dose of PRATTACK or if you have accidentally ingested it, contact your doctor or pharmacist.

Missing a dose of PRATTACK

If you miss a dose, resume your normal dosing schedule as soon as possible. Do not take a double dose to make up for a missed dose.

4. Possible side effects

Like all medicines, PRATTACK can cause side effects, although not everybody gets them. Some patients have experienced: conjunctival hyperemia, itching, eyelid edema, foreign body sensation, irritation, or tearing. The frequency of these side effects is unknown (cannot be estimated from the available data). Reporting side effects If you experience any side effects, including any not listed in this leaflet, please tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Pharmacovigilance of the 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, e-mail: [email protected] Side effects can also be reported 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 PRATTACK

Keep the medicine out of the sight and reach of children. Do not use this medicine after the expiry date stated on the packaging. Shelf-life after first opening the bottle: 4 weeks. Store in a temperature below 25°C. Protect from light.

6. Contents of the pack and other information

What PRATTACK contains

• The active substance is pranoprofen (1 ml of the medicine contains 1 mg of pranoprofen).
• The other ingredients are: benzalkonium chloride, boric acid, polysorbate 80, borax, disodium edetate, purified water to 1 ml.

What PRATTACK looks like and contents of the pack

PRATTACK is a clear, colorless solution. The pack contains one bottle of PRATTACK containing 5 ml of solution.

Marketing authorization holder

Senju Poland Sp. z o.o. Rondo Ignacego Daszyńskiego 2B, 00-843 Warsaw tel.: +48 22 236 05 05 e-mail: [email protected]

Name and address of the importer responsible for the release of the series

PROFARM PS Sp. z o.o. ul. Słoneczna 96 05-500 Stara Iwiczna Poland Synoptis Industrial Sp. z o.o. ul. Rabowicka 15 62-020 Swarzędz Date of last revision of the leaflet:07/2024