PIROBEC 10 mg /G Pianka Skórna

Treść ulotki

1. Pirobec 10 mg/g cutaneous foam
   1. What is Pirobec and what is it 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

Pirobec 10 mg/g cutaneous foam

Piroxicam

Read this leaflet carefully before using this medicine as it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• Talk to your doctor if you do not feel better 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 is Pirobec and what is it used for

Pirobec is a medicine for local use and contains the active ingredient piroxicam, belonging to the class of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs).
Pirobec is indicated in adultsfor 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).
See your doctor if you do not feel better or if you feel worse after 7/10 days.

2. What you need to know before using Pirobec

If you develop a rash or skin symptoms, you should immediately stop using Pirobec, contact a doctor immediately and inform them that you are using this medicine.

Do not use Pirobec

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

Warnings and precautions
Consult your doctor or pharmacist before using Pirobec.
In particular, tell your doctor:

• if you suffer from asthma (inflammation of the airways, which makes breathing difficult)
• if you suffer from chronic obstructive pulmonary disease (chronic lung disease characterized by obstruction of the bronchi)
• if you suffer from allergic rhinitis (inflammation of the nasal mucosa of an allergic nature)
• 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 should occur, immediately stop using Pirobec and contact your doctor immediately.
Children and adolescents
Avoidgiving this medicine to children and adolescents between 0 and 18 years of age, as the safety and efficacy of this medicine have not yet been established.

Other medicines and Pirobec
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Pregnancy and breastfeeding
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before using this medicine.
The use of Pirobec during pregnancy and breastfeeding is not recommended; use it only if absolutely necessary and under the control of your doctor.

Driving and operating machinery
The effects of Pirobec on the ability to drive vehicles and operate machinery are not known.
However, it is unlikely that the medicine will interfere with the ability to drive vehicles and/or operate machinery.

Pirobec contains propylene glycol
It may cause skin irritation.

Pirobec contains parabens
It may cause allergic reactions (including delayed ones).

Pirobec contains alcohol (ethanol)
Pirobec contains 38.4 mg of alcohol (ethanol) per each maximum delivered dose. It may cause a burning sensation on damaged skin.

3. How to use Pirobec

Use this medicine following exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

Adults
Apply a thin layer of foam 2-3 times a day to the skin area to be treated. The amount to be applied depends on the extent of the area to be treated.
Caution: do not exceed the indicated doses without the advice of your doctor.

Instructions for use

• 1) Shake the inverted container 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 incandescent body, do not smoke during dispensing as the foam contains flammable gas.

Use in children and adolescents
Avoidadministering this medicine to children and adolescents between 0 and 18 years of age, as the safety and efficacy of this medicine have not yet been established.

Duration of treatment
Use Pirobec only for short periods of treatment.

If you use more Pirobec than you should
There have been no cases so far of overdose of piroxicam when applied locally.
However, if you should accidentally ingest this medicine, consult your doctor immediately or go to the nearest hospital bringing with you the packaging of the medicine.

If you forget to use Pirobec
Do not use a double dose to make up for a missed dose.

If you stop using Pirobec
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 gets them.
If you experience the following side effects during treatment with Pirobec,

STOPtreatment and contact your doctor immediately:

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

In addition, the following side effects may occur:

Effects affecting the skin

• contact dermatitis (skin inflammation of allergic origin)
• eczema (skin inflammation associated with itching, not contagious)
• photosensitivity skin reactions (skin reaction following exposure to sunlight)
• angioedema (local inflammation of the skin or mucous membranes).

Side effects with unknown frequency
Fixed drug eruption (may appear as round or oval patches of
skin redness and swelling), blisters (urticaria), itching.
Generally, there is no risk of systemic side effects (effects that
affect different parts of the body).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet,
tell your doctor or pharmacist. You can also report side effects
directly through the national reporting system at the website of the Italian Medicines Agency:
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 Pirobec

Keep this medicine out of the sight and reach of children.
Store at a temperature below 25°C.
PIROBEC 10 mg/g cutaneous foam contains a flammable propellant. Do not expose to
temperatures above 50°C. The pressurised container must not be punctured, and must not be
brought near, even if empty, to sources of heat and direct sunlight, do not freeze.
Do not use this medicine after the expiry date which is stated on the pack 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 off-white in colour.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.
Do not burn the container after use and do not disperse it into the environment.

6. Contents of the pack and other information

What Pirobec contains

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

Description of the appearance of Pirobec and contents of the pack
Pirobec is presented in the form of a white-cream colored foam, for application to the skin,
packaged in a pressurized container containing 50 g of foam, and 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)