Package leaflet: Information for the user

PIROFTAL 0.5% eye drops, solution

Piroxicam
Please read this leaflet carefully before 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. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

What PIROFTAL is and what it is used for
What you need to know before using PIROFTAL
How to use PIROFTAL
Possible side effects
How to store PIROFTAL
Contents of the pack and other information

1. What PIROFTAL is and what it is used for

PIROFTAL contains the active substance piroxicam, which belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs) that work by relieving pain and symptoms of inflammation.
PIROFTAL is indicated to reduce inflammations, possibly accompanied by pain, not caused by infection, in the front part of the eye (anterior segment), particularly following eye surgery (cataract surgery).

2. What you need to know before using PIROFTAL

Do not use PIROFTAL

if you are allergic to piroxicam or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before using PIROFTAL.
During treatment with this medicine, you may experience allergic reactions (sensitization reactions), as with all topical medicines, especially when used for prolonged periods. If this occurs, stop treatment and inform your doctor, who will prescribe appropriate therapy.

Elderly patients
If you are an elderly patient, use PIROFTAL with great caution.

Other medicines and PIROFTAL
Tell your doctor or pharmacist if you are currently using, have recently used, or might use any other medicines.
No interactions between PIROFTAL and other medicines are known.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before using this medicine.
Use PIROFTAL only if clearly needed and under strict medical supervision.

Driving and operating machinery
The effects of this medicine on the ability to drive vehicles or operate machinery are unknown.

PIROFTAL contains parahydroxybenzoate esters
This medicine contains methyl parahydroxybenzoate and propyl hydroxybenzoate, which may cause allergic reactions (including delayed reactions).

PIROFTAL contains phosphates
This medicine contains approximately 0.099 mg of phosphates per drop, equivalent to 3.3 mg/ml.
If you have severe damage to the outer transparent layer of the eye (the cornea), phosphates may very rarely cause calcium deposits leading to opaque corneal spots during treatment.

3. How to use PIROFTAL

Use this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is 1-2 drops, 3 times daily.
The duration of treatment ranges from 4 to 10 days.
Instill the eye drops into the lower part of the eye (conjunctival sac).

If you use more PIROFTAL than you should
Cases of overdose are not known.
In case of accidental ingestion/overdose of an excessive amount of PIROFTAL, inform your doctor immediately or go to the nearest hospital.

If you forget to use PIROFTAL
Do not use a double dose to make up for the missed dose.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Mild and temporary eye irritations may occur.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system at the following website:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store PIROFTAL

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after "Exp.".
The expiry date refers to the last day of that month and to the product in its original packaging,
properly stored.
Do not store above 25 °C.
ONCE THE CONTAINER IS OPENED, THE EYE DROPS MUST BE USED
WITHIN 30 DAYS.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What PIROFTAL contains

The active substance is piroxicam. 100 ml of eye drops, solution contain 0.500 g of piroxicam.
The other components are: polyvinylpyrrolidone, trisodium phosphate dodecahydrate, methyl p-hydroxybenzoate, propyl p-hydroxybenzoate, purified water.

Description of the appearance of PIROFTAL and package contents
10 ml bottle.
Marketing Authorization Holder and Manufacturer
BRUSCHETTINI S.r.l. – Via Isonzo 6 – Genova – Italy