PIROBEC CUT 50G 1%

PIROBEC 10 MG/G

active ingredients

10 mg/g foam cutaneous 100 g of skin foam contain g 1 of pyroxicam. Excipients with known effects: propyleneglycol, methyl p-hydroxybenzoate, propyl p-hydroxybenzoate, ethanol 96%. For the full list of excipients, see paragraph 6.1

Excellent

Pirobec 10 mg/g skin foam: propilenglicole; polysorbed 80; xanthan rubber; menthol; methyl p-hydroxybenzoate; propil p-hydroxybenzoate; citric acid monohydrate; sodium hydroxide drops; titanium dioxide; ethanol 96%; purified water. Propellent: propano-butano isobutano.

Therapeutic indications

Painful and phlogistic states of rheumatic or traumatic nature of joints, muscles, tendons and ligaments.

Contraindications

Hypersensitivity to the active ingredient or any of the excipients listed in paragraph 6.1.

Population

Population Adults: Apply PIROBEC 10 mg/g foam 2-3 times a day, gently massaging to promote absorption. Pediatric population: The safety and effectiveness of PIROBEC 10 mg/g skin foam in children and adolescents between 0 and 18 years of age have not yet been established. There are no available data. Method of administration To dispense the foam, shake before use the overturned container, then press the valve for a few seconds: the valve dispenses 1-2 g/sec, enough for a surface of about 40 cm2.

Conservation

Store at a temperature below 25°C. PIROBEC 10 mg/g skin foam contains flammable propellant. Do not expose at temperatures above 50°C. The container under pressure should not be drilled, it should not be approached, even if empty, to heat sources and direct sunlight, do not freeze.

Warnings

The amount of active ingredient absorbed through the skin does not normally reach concentrations in circulation such as to make warnings valid and expose at risk of side effects related to the administration of the drug by systemic means. The application of topical products, especially when protracted, can give rise to awareness-raising phenomena. In the presence of hypersensitivity reactions you will have to stop treatment and establish appropriate therapy (see also section 4.8). Asthmatic patients, with chronic obstructive diseases of bronchi, allergic rhinitis or inflammation of the nasal mucosa (nasmal polipo) react with asthmatic attacks, local inflammation of the skin or mucosa (Quincke edema) or hives to the anti-rheumatic treatment performed with NSAIDs more often than other patients. Cutaneous reactions: with pyroxicam have been reported cases of eruption fixed by drugs (FDE). Piroxicam should not be reintroduced in patients with anamnesi of FDE related to piroxicam. There may be a potential crusade reaction with other oxicams. I parahydroxybenzos present as excipients in skin foam can cause allergic reactions (also delayed). The propellations present as excipient in skin foam can cause irritation cutanea.Questo medicine contains 38.4 mg of alcohol (ethanol) for each maximum dose delivered. It can cause burning sensation on damaged skin.

Interactions

Based on bioavailability studies it is extremely unlikely that piroxicam foam will spy on other drugs related to plasma proteins. However, doctors will have to monitor patients treated with PIROBEC 10 mg/g foam and high-binding protein drugs for any dosage adjustments.

Effects

The use, especially if prolonged, of the product can give rise to phenomena of local sensitization and irritation. Rarely immediate reactions with hives and bronchospasm. In this case it is necessary to stop the treatment. With the topical use of piroxicam, the following dermatologic side effects were also reported: contact dermatitis, eczema and photosensitivity skin reactions. Effects with frequency not known: eruption fixed by drugs (see paragraph 4.4). Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at the address https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse

Overdosing

No overdose cases have been reported in literature so far.

Precautionary, we do not recommend the use during pregnancy and nursing. Any use is permitted only on indication of the doctor, if it considers it absolutely necessary.

Source: Farmadati