Dolaut Mono 14 mg Piroxicam 8 Medicated Patches

Painkiller and anti-inflammatory medicated plaster based on piroxicam.

Therapeutic indications

Dolaut Mono is indicated for the treatment of painful and inflammatory conditions of a rheumatic and traumatic nature of the joints, muscles, tendons and ligaments.

Dosage and posology

It is recommended to use only one medicated plaster at a time and to replace it every 24 hours for a period not exceeding 8 days. Do not apply two patches in the same day. Dolaut Mono is to be used only on intact skin. After having thoroughly washed and dried the painful area, rub one of the corners of Dolaut Mono between your fingers to remove the protective film and apply the adhesive part directly on the skin. In the event that Dolaut Mono is to be applied to joints with greater mobility, such as the elbow or knee, it is advisable to use a retention bandage to be applied to the flexed joint, in order to keep the patch in place. Do not exceed the recommended doses.

Overdose

There are no known cases of overdose. In the event of an overdose with evident clinical manifestations, immediately institute symptomatic therapy and apply common emergency measures as appropriate.

Contraindications

• Hypersensitivity to the active substance (piroxicam) or to any of the excipients.
• Patients in whom substances with a similar mechanism of action (NSAIDs) have caused hypersensitivity reactions
• In patients with active peptic ulcer, patients with bronchial asthma, history of NSAID gastrointestinal bleeding.
• Patients on anticoagulant therapy.
• Pregnancy and breastfeeding
• Children under the age of 12
• Dolaut Mono Medicated Patch should not be used on open wounds or lesions, but only on intact skin.
• Avoid contact with eyes and mucous membranes.

Side effects

The use of the product can cause local irritative or allergic skin reactions such as erythema, itching, burning, contact dermatitis, numbness and tingling at the application site; cases of extensive and severe dermatological lesions such as urticaria, Quincke's edema, erythema multiforme have been reported with this type of medicinal product. More extensive and more severe photosensitivity reactions and skin and mucosal reactions, including asthma attacks, are possible. Systemic undesirable reactions following the topical use of piroxicam are unlikely; since the plasma levels obtained are lower than those measured after systemic administration but very variable from individual to individual, it is not possible to exclude, especially in the case of therapies prolonged beyond the recommended term and the non-observance of contraindications and warnings, the appearance of undesirable effects systemic, especially at the gastrointestinal level. Any appearance of general or application site side effects requires discontinuation of therapy.

Pregnancy and breastfeeding

Dolaut Mono is contraindicated during pregnancy and breastfeeding and is not recommended for women planning to become pregnant. Administration should be discontinued in women with fertility problems or who are undergoing fertility investigations.

Special warnings

The use of piroxicam patches is unlikely to have interactions with other medicinal products. However, the possibility of competition between absorbed piroxicam and other drugs with high plasma protein binding cannot be excluded. Do not use the product together with other drugs for oral or local use, containing piroxicam or other NSAIDs.

The serum levels achieved with Dolaut Mono were significantly lower than those obtained by oral administration but with a strong individual variability for which the onset of systemic undesirable effects, especially at the gastrointestinal level, cannot be excluded. Analgesics, antipyretics, non-steroidal anti-inflammatory drugs, including piroxicam, can cause hypersensitivity reactions, potentially serious even in subjects not previously exposed to this type of drug. These include asthma attacks, skin rashes, allergic rhinitis and anaphylactic-type reactions.

Dolaut Mono should be used with caution in people with chronic obstructive diseases of the bronchi, allergic rhinitis or inflammation of the nasal mucosa (nasal polyps) in which asthma attacks or localized inflammatory reactions of the skin and mucosa (Quincke's edema) are more frequent. . Use caution in patients with a history of peptic ulcer, in patients with a history of gastrointestinal bleeding not secondary to NSAID administration or with other bleeding disorders, in patients with Crohn's disease or ulcerative colitis, with severe liver or kidney dysfunction or heart failure. Prolonged or repeated use of products for cutaneous use can give rise to sensitization phenomena. In the presence of hypersensitivity reactions it is necessary to interrupt the therapy. Caution should be exercised when treating elderly patients who are generally more predisposed to adverse events. After a short therapy without results, consult your doctor. To avoid any hypersensitivity or photosensitization phenomena, avoid exposure to direct sunlight. Keep this medicine out of the reach and sight of children.

Expiration and retention

Check the expiration date indicated on the package. The expiry date indicated on the package refers to the product in intact packaging, correctly stored.

Warning : do not use the medicine after the expiry date indicated on the package.

Composition

A 100 x 70 mm (70 cm²) Dolaut Mono patch contains:

Active principle

14 mg of piroxicam.

Excipients

Acrylic copolymer, Eudragit E 100; non-woven fabric, silicone-coated polyester.