Active ingredients: Piroxicam
Pirobec 10mg / 1g skin foam
Indications Why is Pirobec used? What is it 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 adults in 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 together. ).
Talk to your doctor if you don't feel better or if you feel worse after 7/10 days.
Contraindications When Pirobec should not be used
Do not use Pirobec
- if you are allergic to piroxicam or any of the other ingredients of this medicine.
Precautions for use What you need to know before taking Pirobec
Talk to your doctor or pharmacist before using Pirobec.
In particular, tell your doctor:
- if you have asthma (inflammation of the airways, which makes it difficult to breathe)
- if you suffer from chronic obstructive diseases of the bronchi (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).
You may experience allergic reactions while using this medicine, especially after prolonged use (see section "Possible side effects"). If this happens, stop using Pirobec immediately and contact your doctor immediately.
Children and adolescents
Avoid giving 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.
Interactions Which drugs or foods can modify the effect of Pirobec
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Warnings It is important to know that:
Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
The use of Pirobec in pregnancy and during breastfeeding is not recommended; use it only when absolutely necessary and under the supervision of your doctor.
Driving and using machines
The effects of Pirobec on the ability to drive and use machines are not known. However, the medicine is unlikely to interfere with your ability to drive and / or use machines.
Pirobec contains propylene glycol
It can cause skin irritation.
Pirobec contains parahydroxybenzoates
It can cause allergic reactions (even delayed).
Dose, Method and Time of Administration How to use Pirobec: Posology
Always use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Adults
Apply a thin layer of foam 2-3 times a day to the area of the skin to be treated. The quantity to be applied depends on the extension of the area to be treated.
Warning: do not exceed the indicated doses without the advice of your doctor.
Instructions for Use
- Shake the container upside down before use.
- Press the valve for a few seconds to dispense the foam.
- Gently massage the skin to help absorb the foam.
Important: do not vaporize the foam on a flame or on an incandescent body, do not smoke during delivery as the foam contains flammable gas.
Use in children and adolescents
Avoid giving 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
Only use Pirobec for short periods of treatment.
If you forget to use Pirobec
Do not use a double dose to make up for a forgotten dose.
If you stop taking Pirobec
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Overdose What to do if you have taken too much Pirobec
There are so far no cases of using an overdose of piroxicam when applied topically.
However, if you accidentally swallow this medicine, consult your doctor immediately or go to the nearest hospital and take the medicine pack with you.
Side Effects What are the side effects of Pirobec
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If during treatment with Pirobec you experience the following side effects, STOP the treatment and contact your doctor immediately:
- allergic reactions
- local irritation
- hives (redness of the skin accompanied by itching)
- bronchospasm (narrowing of the bronchi which causes severe breathing difficulties due to a reduced passage of air)
- asthma (inflammation of the airways, which makes it difficult to breathe).
In addition, the following side effects may occur:
Effects affecting the skin
- contact dermatitis (inflammation of the skin of allergic origin)
- eczema (inflammation of the skin associated with itching, not contagious)
- photosensitivity skin reactions (skin reaction following exposure to the sun) • Quincke's edema (local inflammation of the skin or mucosa).
Generally, there is no risk of systemic side effects (effects affecting different parts of the body).
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system on the website of the Italian Medicines Agency: www.agenziafarmaco.it/it/responsabili.
By reporting side effects you can help provide more information on the safety of this medicine.
Expiry and Retention
Keep this medicine out of the sight and reach of children.
Do not expose to temperatures exceeding 50 ° C. The container under pressure must not be pierced, it must not be approached, even if empty, to heat sources and direct sunlight, do not freeze.
Do not use this medicine if you notice any signs of deterioration in the foam which should be soft and creamy-white in color.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.
Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
Do not burn the container after use and do not disperse it in the environment.
Other information
What Pirobec contains
- The active ingredient is: piroxicam (100 g of skin foam contain 1 g of piroxicam)
- The other ingredients 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, 96% ethanol, purified water. Propellant: propane-butane isobutane.
Description of the appearance of Pirobec and contents of the pack
Pirobec comes in the form of a cream-white foam, to be applied on the skin, packaged in a pressurized container containing 50 g of foam, and equipped with a valve to dispense the foam and a cap.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
PIROBEC 10 MG / G SKIN FOAM
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
10 mg / g cutaneous foam
100 g of skin foam contain 1 g of piroxicam.
Excipients: propylene glycol, methyl p-hydroxybenzoate, propyl p-hydroxybenzoate
For the full list of excipients, see section 6.1
03.0 PHARMACEUTICAL FORM
Skin foam
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Painful and inflammatory states of a rheumatic or traumatic nature of the joints, muscles, tendons and ligaments.
04.2 Posology and method of administration
Adults:
Apply PIROBEC 10 mg / g foam 2-3 times a day, massaging gently to favor its absorption.
To dispense the foam, shake the container upside down before use, then press the valve for a few seconds: the valve delivers 1-2 g / sec, sufficient for a surface of about 40 cm2.
Pediatric population:
The safety and efficacy of PIROBEC 10 mg / g cutaneous foam in children have not yet been established. There are no data available.
04.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients.
04.4 Special warnings and appropriate precautions for use
The quantity of active ingredient absorbed through the skin does not normally reach concentrations in circulation such as to make the warnings valid and expose to the risk of side effects related to the administration of the drug systemically.
The application of topical products, especially if prolonged, can give rise to sensitization phenomena. In the presence of hypersensitivity reactions, treatment must be interrupted and appropriate therapy instituted (see also section 4.8).
Patients with asthma, chronic obstructive diseases of the bronchi, allergic rhinitis or inflammation of the nasal mucosa (nasal polyp) react with asthma attacks, local inflammation of the skin or mucosa (Quincke's edema) or urticaria to antirheumatic treatment with NSAIDs more often than others patients.
The parahydroxybenzoates present as excipients in the skin foam they can cause allergic reactions (even delayed).
The propylene glycol present as an excipient in the skin foam can cause skin irritation.
04.5 Interactions with other medicinal products and other forms of interaction
Based on bioavailability studies, piroxicam foam is extremely unlikely to displace other drugs bound to plasma proteins.
However, physicians will need to monitor patients treated with PIROBEC 10 mg / g foam and high protein binding drugs for any dose adjustments.
04.6 Pregnancy and breastfeeding
As a precaution, its use during pregnancy and breastfeeding is not recommended.
Any use is allowed only on the advice of the doctor, if he deems it absolutely necessary.
04.7 Effects on ability to drive and use machines
None known.
04.8 Undesirable effects
The use of the product, especially if prolonged, can give rise to sensitization and local irritation. Rarely, immediate reactions with urticaria and bronchospasm. In this case it is necessary to interrupt the treatment.
The following dermatological side effects have also been reported with topical use of piroxicam: contact dermatitis, eczema and photosensitivity skin reactions.
Reporting of suspected adverse reactions
Reporting of suspected adverse reactions occurring after authorization of the medicinal product is important as it allows continuous monitoring of the benefit / risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system. "address" www.agenziafarmaco.gov.it/it/responsabili ".
04.9 Overdose
No cases of overdose have been reported in the literature so far.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmaco-therapeutic category: non-steroidal anti-inflammatory drugs for topical use.
ATC code: M02AA07.
Piroxicam is an NSAID with a marked anti-inflammatory and analgesic activity which is also associated with an antipyretic effect. The mechanism of action is mainly constituted by an inhibition of the biosynthesis of prostaglandins, known mediators of inflammatory processes, through the reversible inhibition of the cyclooxygenase enzyme. Any interference of the drug on the pituitary-adrenal system is excluded.
The activity of the active principle administered percutaneously in the various models of acute and chronic inflammation appears to be very relevant, even in the presence of reduced plasma levels: this finds a convincing explanation in the marked tropism of piroxicam, conveyed percutaneously, for the inflamed site .
05.2 Pharmacokinetic properties
Studies conducted in both humans and animals have shown that the "systemic" bioavailability of epicutaneous application is about 1/10 of that by mouth (comparison of kinetics with equiponderal doses).
The serum half-life of piroxicam is approximately 50 hours.
05.3 Preclinical safety data
Toxicological tests carried out on various animal species have shown that piroxicam foam is well tolerated and has no mutagenic activity.
Acute toxicity: LD50 (mg / kg) in rats: p.o. 270; i.p. 220; in the mouse: p.o. 360; i.p. 360; in dogs: p.o. 700.
Doses between 0.3 and 25 mg / kg / day were used for subacute and chronic toxicity studies in mice, rats, dogs and monkeys; this latter dose is approximately 60 times higher than the dose indicated for humans.
The only pathological events observed at the maximum dose used were gastrointestinal lesions and renal papillary necrosis.
As with other substances that inhibit prostaglandin synthesis, piroxicam also increases the incidence of dystocia and post-term births in animals when the administration of the substance continues during pregnancy.
Administration of NSAIDs to pregnant rats may result in constriction of the fetal arterial duct. Furthermore, in the last trimester of pregnancy, gastroduodenal toxicity increases.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Pirobec 10 mg / g cutaneous foam: propylene glycol; polysorbate 80; xanthan gum; menthol; methyl p-hydroxybenzoate; propyl p-hydroxybenzoate; citric acid monohydrate; sodium hydroxide drops; titanium dioxide; 96% ethanol; purified water.
Propellant: propane-butane isobutane.
06.2 Incompatibility
None known.
06.3 Period of validity
3 years
06.4 Special precautions for storage
PIROBEC 10 mg / g cutaneous foam: Do not expose to temperatures exceeding 50 ° C. The container under pressure must not be pierced, it must not be approached, even if empty, to heat sources and direct sunlight, do not freeze.
06.5 Nature of the immediate packaging and contents of the package
PIROBEC 10 mg / g cutaneous foam: internally painted aluminum pressurized container containing 50 g of cutaneous foam, equipped with valve and cap.
06.6 Instructions for use and handling
PIROBEC 10 mg / g foam contains flammable gas, do not vaporize the contents on a flame or on an incandescent body, do not smoke while dispensing.
Do not pierce, do not burn the container after use and do not disperse it in the environment
07.0 MARKETING AUTHORIZATION HOLDER
MDM S.p.A. - Viale Papiniano, 22 / b - 20123 MILAN MI
08.0 MARKETING AUTHORIZATION NUMBER
PIROBEC 10 mg / g cutaneous foam - pressurized container 50 g - AIC n ° 035960018
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
PIROBEC 10 mg / g cutaneous foam - pressurized container 50 g: November 2006 / September 2012
10.0 DATE OF REVISION OF THE TEXT
January 2017
