Pirobec

Package leaflet: Information for the user

Pirobec 10 mg/g cutaneous foam

Piroxicam
Please read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you to.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Contact your doctor if you do not notice any improvement or if your symptoms worsen after 7–10 days.

Contents of this leaflet:

1. What Pirobec is and what it is used for
2. What you need to know before using Pirobec
3. How to use Pirobec
4. Possible side effects
5. How to store Pirobec
6. Contents of the pack and other information

1. What Pirobec is and what it is used for

Pirobec is a topical medicine containing the active substance piroxicam, which belongs to the class of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs).
Pirobec is indicated in adults for the local treatment of pain and inflammation of joints, muscles, tendons (the structures that allow muscles to attach to a bone) and ligaments (the structures that connect two bones or two parts of the same bone).
If you do not feel better or if you feel worse after 7 to 10 days, consult your doctor.

2. What you need to know before using Pirobec

If you develop a skin rash or skin symptoms, you must stop using Pirobec immediately, contact a doctor immediately and inform them that you are using this medicine.
Do not use Pirobec

• 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 Pirobec.
In particular, inform your doctor:

• if you suffer from asthma (inflammation of the airways, making breathing difficult)
• if you suffer from chronic obstructive bronchial disease (a chronic lung disease characterized by obstruction of the bronchi)
• if you suffer from allergic rhinitis (allergic inflammation of the nasal mucosa)
• if you suffer from nasal polyps (presence of small nodules inside the nasal cavity).

During the use of this medicine, you may experience allergic reactions,
especially after prolonged use (see section “Possible side effects”). If this occurs, stop using
Pirobec immediately and contact your doctor immediately.
Children and adolescents
Avoid giving this medicine to children and adolescents aged between 0 and 18 years, as the safety and efficacy of this medicine have not yet been established.
Other medicines and Pirobec
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
The use of Pirobec during pregnancy and breastfeeding is not recommended; use it only if strictly necessary and under medical supervision.
Driving and using machines
The effects of Pirobec on the ability to drive or operate machinery are unknown.
However, it is unlikely that this medicine affects the ability to drive or operate machinery.
Pirobec contains propylene glycol
May cause skin irritation.
Pirobec contains parahydroxybenzoates
May cause allergic reactions (including delayed reactions).
Pirobec contains alcohol (ethanol)
Pirobec contains 38.4 mg of alcohol (ethanol) per maximum administered dose. It may cause a burning sensation on damaged skin.

3. How to use Pirobec

Use this medicine exactly as described in this leaflet or as instructed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.
Adults
Apply a thin layer of foam 2–3 times daily to the affected area of skin. The amount to apply depends on the size of the area to be treated.
Caution: Do not exceed the recommended doses without medical advice.
Instructions for use

1. Shake the container upside down before use.
2. Press the valve for a few seconds to dispense the foam.
3. Gently massage the skin to promote absorption of the foam.
   Important: Do not spray the foam onto a flame or hot surface. Do not smoke during application, as the foam contains flammable gas.
   Use in children and adolescents
   Do not administer this medicine to children and adolescents aged 0 to 18 years, as the safety and efficacy of this medicine have not yet been established in this age group.
   Duration of treatment
   Use Pirobec only for short-term treatment periods.
   If you use more Pirobec than you should
   There have been no reported cases of overdose with piroxicam when applied topically.
   However, if you accidentally ingest this medicine, consult your doctor immediately or go to the nearest hospital, taking the medicine pack with you.
   If you forget to use Pirobec
   Do not apply a double dose to make up for a missed dose.
   If you stop using Pirobec
   If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
If you experience any of the following adverse reactions during treatment with Pirobec, STOP treatment immediately and contact your doctor without delay:

• allergic reactions
• local irritation
• urticaria (skin redness accompanied by itching)
• bronchospasm (narrowing of the airways causing severe breathing difficulty due to reduced airflow)
• asthma (inflammation of the airways, making breathing difficult).

In addition, the following adverse reactions may occur:
Skin-related effects

• contact dermatitis (skin inflammation of allergic origin)
• eczema (skin inflammation associated with itching, non-contagious)
• photosensitivity skin reactions (skin reaction following exposure to sunlight)
• Quincke's edema (localized swelling of the skin or mucosa).

Adverse reactions with unknown frequency
Drug-induced fixed eruption (may appear as round or oval patches of redness and swelling of the skin), blisters (urticaria), itching.
Generally, there is no risk of systemic adverse reactions (reactions affecting multiple parts of the body).
Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. You may also report adverse reactions directly via the national reporting system on the website of the Italian Medicines Agency: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. How to store Pirobec

Keep this medicine out of the sight and reach of children.
Store below 25°C.
PIROBEC 10 mg/g cutaneous foam contains flammable propellant. Do not expose to
temperatures above 50°C. The pressurised container must not be pierced, and must not be
exposed, even when empty, to heat sources or direct sunlight, and must not be frozen.
Do not use this medicine after the expiry date stated on the packaging after "Exp."
The expiry date refers to the last day of that month.
Do not use this medicine if you notice any signs of deterioration in the foam, which should be soft and white-cream in colour.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.
Do not burn the container after use and do not discard it in the environment.

6. Package contents and other information

What Pirobec contains

• The active substance is: piroxicam (100 g of cutaneous foam contain 1 g of piroxicam)
• The other components are: propylene glycol (see section “Pirobec contains propylene glycol”), methyl parahydroxybenzoate, propyl parahydroxybenzoate (see section “Pirobec contains parahydroxybenzoates”), polysorbate 80, xanthan gum, menthol, citric acid monohydrate, sodium hydroxide drops, titanium dioxide, ethanol 96% (see section “Pirobec contains alcohol (ethanol)”), purified water. Propellant: propane-butane isobutane.

Description of the appearance of Pirobec and contents of the pack
Pirobec is a white-cream coloured foam for application to the skin.
It is supplied in a pressurised container holding 50 g of foam, equipped with a valve for dispensing the foam and a cap.
Marketing Authorisation Holder
Neopharmed Gentili S.p.A. – Via San Giuseppe Cottolengo, 15 - Milan
Manufacturer
Farmol Health Care S.r.l. - via del Maglio 6 - 23868 Valmadrera (Lecco)