Package leaflet: Information for the user

PRATTACK
1 mg/ml, eye drops, solution
Pranoprofen
Read the following information carefully before using the medicine, as it contains important information for the patient.

Keep this leaflet, so that you can read it again if necessary.
If you have any questions, please consult your doctor or pharmacist. This medicine has been prescribed for a specific individual. Do not pass it on to others.
This medicine may harm another person, even if their symptoms appear identical.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist immediately. See section 4.

Table of contents:

What PRATTACK is and what it is used for
Important information before using PRATTACK
How to use PRATTACK
Possible side effects
How to store PRATTACK
Contents of the pack and other information

1. What PRATTACK is and what it is used for

PRATTACK is an eye drop solution containing pranoprofen as the active substance – a drug with anti-inflammatory properties. PRATTACK is indicated for the treatment of subacute and chronic non-infectious inflammatory eye diseases (blepharitis, conjunctivitis, blepharoconjunctivitis, anterior uveitis) and for anti-inflammatory postoperative treatment following surgical procedures on the anterior segment of the eye (e.g. cataract removal).

2. Important information before using PRATTACK medicine

When not to use PRATTACK medicine
If the patient is allergic to pranoprofen or any of the other ingredients of this medicine (listed in section 6).
In children under 2 years of age (see section "PRATTACK medicine contains boron").

Warnings and precautions
Before starting to use PRATTACK medicine, discuss it with your doctor or pharmacist.
Wait at least 5 minutes after administering PRATTACK before applying any other eye medication.

PRATTACK medicine and other medicines
No adverse interactions between PRATTACK and other medicines have been reported so far. Nevertheless, inform your doctor about all medicines currently used or recently used, as well as any medicines you plan to use.

Pregnancy and breastfeeding
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor before using this medicine.

Pregnancy
The safety of using PRATTACK during pregnancy has not been established. Use of PRATTACK in pregnant women should only occur under strict medical supervision and only if, in the opinion of the doctor, such treatment is necessary.

Breastfeeding
Controlled clinical studies on the use of PRATTACK in breastfeeding women have not been conducted. Use of PRATTACK in breastfeeding women should only occur under strict medical supervision and only if, in the opinion of the doctor, such treatment is necessary.

Driving and operating machinery
The use of PRATTACK has no effect on the ability to drive or operate machinery.
However, it should be noted that instillation of any eye drops may cause transient blurred vision. Additionally, diseases for which PRATTACK is indicated may impair vision and thereby affect the ability to drive or operate machinery.

PRATTACK medicine contains benzalkonium chloride (preservative)
The medicine contains 0.07 mg of benzalkonium chloride per millilitre of solution.
Benzalkonium chloride may be absorbed by soft contact lenses and may alter their colour. Remove contact lenses before instilling the drops and wait at least 15 minutes before reinserting them.
Benzalkonium chloride may also cause eye irritation, especially in individuals 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, such as stinging or pain after using the medicine, contact your doctor.

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

3. How to use PRATTACK medicine

Dosage
PRATTACK medicine should always be used as directed by the physician. In case of doubt, consult your doctor.
The usual dose is 2 drops into the affected eye(s) every 6 hours. The duration of treatment is determined by the physician.

Method of administration:

Prepare the medicine bottle and a mirror.
Wash your hands.
Unscrew the cap.
Hold the bottle in your hand with the bottom facing upwards, using your thumb and middle finger.
Tilt your head backwards. With a clean finger, gently pull the lower eyelid downwards to create a "pocket" between the eyeball and the eyelid; the drop should be instilled into this pocket.
Bring the tip of the bottle close to the eye. A mirror may be used to assist.
Do not touch the dropper tip to the eye, eyelid, surrounding areas, or any other surface. This may contaminate the drops. Using contaminated drops may lead to serious complications, including vision loss.
To release a single drop, gently squeeze the bottom of the bottle.
If the drop misses the eye, repeat the instillation.
After instilling the drop, gently close the eye and press with a finger on the inner corner of the eye near the nose for at least one minute. This helps prevent the medicine from draining into the rest of the body.
If drops are to be administered to both eyes, repeat the above steps for the second eye.
Immediately after use, tightly 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 hygienic conditions. Any other eye medicine should be administered only after waiting at least 5 minutes following the administration of PRATTACK.

Overdose of PRATTACK medicine
Due to the nature of the medicine, which is intended for local ocular administration, toxic effects are not expected when used at recommended doses or even if the entire contents of the bottle are accidentally ingested. Nevertheless, if an overdose occurs or the medicine is accidentally swallowed, consult a doctor or pharmacist immediately.

Missed dose of PRATTACK medicine
If a dose is missed, resume the normal dosing schedule as soon as possible. Do not use a double dose to make up for the missed dose.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
In some patients, the following have occurred during treatment with this medicine: conjunctival hyperaemia, itching, eyelid swelling, foreign body sensation, irritation or tearing. The frequency of occurrence of these adverse reactions is unknown (cannot be determined from available data).

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C,
02-222 Warszawa,
tel.: +48 22 49 21 301
fax: +48 22 49 21 309, e-mail: [email protected]
Adverse reactions can also be reported to the marketing authorization holder.
By reporting adverse reactions, it is possible to gather more information on the safety of this medicine.

5. How to store the medicine PRATTACK

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the container.
Usable period after first opening of the bottle: 4 weeks.
Store below 25°C. Protect from light.

6. Contents of the package and other information

What PRATTACK contains

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

What PRATTACK looks like and contents of the pack
The medicinal product is a clear, colourless solution.
The pack contains one bottle of PRATTACK solution with 5 ml of solution.
Marketing Authorisation 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 batch release
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