Pirobec 1%

Skin Foam

Composition :

100 g of skin foam contains 1 g of piroxicam. Excipients: propylene glycol, methyl p-hydroxybenzoate, propyl p-hydroxybenzoate For a full list of excipients, see section 6.1.

Excipients

Pirobec 1% skin 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.

Therapeutic indications

Painful and inflammatory states of a rheumatic or traumatic nature of the joints, muscles, tendons and ligaments.

Contraindications

Hypersensitivity to the active substance or to any of the excipients.

Dosage

Adults Apply PIROBEC 1% foam 2-3 times a day, massaging gently to promote 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 1% cutaneous foam in children have not yet been established. No data are available.

Warnings and Precautions

The amount 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 products for topical use, especially if prolonged, can give rise to sensitization phenomena. In the presence of hypersensitivity reactions, treatment should be discontinued 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. Parahydroxybenzoates present as excipients in skin foam can cause allergic reactions (even delayed). Propylene glycol present as an excipient in skin foam can cause skin irritation.

Interactions

Based on bioavailability studies, piroxicam foam is extremely unlikely to displace other plasma protein bound drugs, however physicians will need to monitor patients treated with PIROBEC 1% foam and high protein binding drugs for dose adjustments.

Side effects

The use, especially if prolonged, of the product can give rise to sensitization phenomena and local irritation. Rarely immediate reactions with urticaria and bronchospasm. In this case, the treatment must be stopped. The following dermatological side effects have also been reported with the topical use of piroxicam: contact dermatitis, eczema and skin photosensitivity reactions.

Pregnancy and breastfeeding

As a precaution, its use during pregnancy and lactation is not recommended. Any use is allowed only on the advice of the doctor, if he deems it absolutely necessary.