Lenotac - for joint and muscular pain - 8 medicated patches 14 mg

Product Description

Patches

Composition:

One patch measuring 100 x 70 mm (70 cm²) contains 14 mg piroxicam. For the full list of excipients, see section 6.1.

Excipients

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

Therapeutic indications

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

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 (see section 4.4). LENOTAC is contraindicated in patients with active peptic ulcer, patients with bronchial asthma, a history of gastrointestinal bleeding from NSAIDs. Patients on anticoagulant therapy. Pregnancy and breastfeeding (see section 4.6). Children under 12 years of age. LENOTAC patch should not be used on open wounds or lesions, but only on intact skin. Avoid contact with eyes and mucous membranes.

Dosage

It is recommended to use only one medicated patch at a time and replace it every 24 hours for a period not exceeding 8 days. Do not apply two patches on the same day. LENOTAC is for use only on intact skin. After carefully washing and drying the painful area, rub one of the corners of LENOTAC between your fingers to remove the protective film and apply the adhesive side directly to the skin. If LENOTAC needs to be applied to more mobile joints, such as the elbow or knee, it is advisable to use a retention bandage to the flexed joint to keep the patch in place. Do not exceed the recommended doses.

Warnings and precautions

The serum levels achieved with LENOTAC were significantly lower than those obtained through oral administration, but with strong individual variability, so the onset of systemic side effects, especially at the gastrointestinal level, cannot be ruled out. Analgesics, antipyretics, and nonsteroidal 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. LENOTAC should be used with caution in patients with chronic obstructive bronchial disease, allergic rhinitis, or inflammation of the nasal mucosa (nasal polyps), in whom 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 disease, 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 with heart failure. Prolonged or repeated use of products for skin application may give rise to sensitization phenomena. If hypersensitivity reactions occur, discontinue therapy. Caution should be exercised when treating elderly patients, who are generally more predisposed to adverse events. After a short period of therapy without results, consult your doctor. To avoid possible hypersensitivity or photosensitivity phenomena, avoid exposure to direct sunlight. Keep the medicine out of the reach and sight of children.

Interactions

The use of piroxicam-based patches is unlikely to cause interactions with other medicinal products. However, the possibility of competition between absorbed piroxicam and other drugs highly bound to plasma proteins cannot be ruled out. Do not use the product together with other oral or local drugs containing piroxicam or other NSAIDs.

Side effects

The use of the product may cause local skin reactions of an irritant or allergic nature 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, and erythema multiforme have been reported with this type of medicine. Photosensitivity reactions and more extensive and more severe skin and mucosal reactions, including asthma attacks, are possible. Systemic adverse reactions following topical use of piroxicam are unlikely; since the plasma levels obtained are lower than those measured after systemic administration but vary greatly from individual to individual, the appearance of systemic adverse effects, especially at the gastrointestinal level, cannot be excluded, especially in the case of prolonged therapy beyond the recommended term and non-compliance with contraindications and warnings (see sections 4.4 and 5.2). The possible appearance of general or site-of-application adverse effects requires suspension of therapy.

Pregnancy and breastfeeding

LENOTAC is contraindicated during pregnancy and breastfeeding and is not recommended in women intending to become pregnant. Administration should be suspended in women with fertility problems or who are undergoing fertility investigations.