LENOTAC 8CER MED 14MG

LENOTAC 14 MG MEDICAL CERTO

active ingredients

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

Excellent

Acrylic copolymer, Eudragit E 100; nonwoven fabric, silicone polyester.

Therapeutic indications

LENOTAC is indicated for the treatment of painful and phlogistic states of rheumatic and traumatic nature of joints, muscles, tendons and ligaments.

Contraindications

Hypersensitivity to the active ingredient (piroxicam) or to any of the excipients. Patients in which substances with a similar mechanism of action (FANS) have caused hypersensitivity reactions (see section 4.4) LENOTAC is contraindicated in patients with active peptic ulcer, patients with bronchial asthma, amnesi of gastrointestinal hemorrhage by FANS. Patients in anticoagulant therapy. Pregnancy and nursing (see section 4.6). Children under 12 years old LENOTAC plaster should not be used on open wounds or lesions, but only on integral skin. Avoid contact with eyes and mucosa.

Population

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 during the same day. LENOTAC is used exclusively on the skin. After carefully washed and dried the sore area, rub between your fingers one of the corners of LENOTAC to remove the protective film and apply the adhesive part directly on the skin. In case LENOTAC should be applied to greater mobility joints, such as elbow or knee, it is advisable to use a retention bandage to be applied to flexural joints, in order to keep the patch in place. Do not exceed the recommended doses.

Conservation

This medicine does not require any special condition for conservation.

Warnings

The serum levels reached with LENOTAC have been significantly lower than those obtained by oral administration but with a strong individual variability so the occurrence of systemic undesirable effects can not be excluded especially at gastroenteric level. Analgesics, antipyretics, non-steroidal anti-inflammatory drugs, including piroxicam, can cause hypersensitivity reactions, potentially serious even in individuals not previously exposed to this type of medication. These include asthma attacks, skin rashes, allergic rhinitis and anaphylactic type reactions. LENOTAC must be used with caution in subjects with chronic obstructive diseases of bronchi, allergic rhinitis or nasal mucosa inflammation ( nasal polyps) in which asthmatic attacks or localized inflammatory reactions of the skin and mucosa (Quincke edema). Use caution in patients with peptic ulcer anamnesis, in patients with gastrointestinal hemorrhage no secondary to administration of NSAIDs or other hemorrhagic disorders, in patients with Crohn disease or ulcerative colitis, with severe liver or kidney dysfunctions or with heart failure. Prolonged or repeated use of skin products can give rise to sensitization phenomena. In the presence of hypersensitivity reactions it is necessary to interrupt therapy. You should use caution in the treatment of elderly patients who are generally more predisposed to adverse events. After short therapy without results consult your doctor. To avoid any hypersensitivity or photosensitization phenomena avoid exposure to direct sunlight. Piroxicam has 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. Keep the medicine out of reach and view of children.

Interactions

It is unlikely that the use of pyroxicam-based patches has interactions with other medicines. It is not however to exclude the possibility of competition between the absorbed pyroxicam and other high-linked drugs with plasma proteins. Do not use the product along with other oral or local medicines, containing piroxicam or other NSAIDs.

Effects

The use of the product can cause local irritative or allergic skin reactions such as erythema, itching, burning, contact dermatitis, numbness and formicolii on the application site; with this type of medicines have been reported cases of extensive and severe dermatological lesions such as hives, edema of Quincke, multiform erythema. Photosensitivity reactions and skin and mucosa reactions are possible more extensive and more severe, including asthma attacks. Systemic undesirable reactions as a result of 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 prolonged therapies beyond the recommended term and non-observance of contraindications and warnings, the appearance of undesirable systemic effects, especially at gastroenteric level (see sections 4.4 and 5.2). Not known frequency: fixed eruption by drugs (see paragraph 4.4). Any appearance of general side effects or at the point of application requires suspension of therapy. Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions occurring 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 www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.

Overdosing

No known overdose cases. In case of overdose with obvious clinical manifestations, immediately establish symptomatic therapy and apply the common emergency measures of the case.

LENOTAC is contraindicated during pregnancy and nursing and is not recommended in women who intend to start a pregnancy. The administration must be suspended in women with fertility problems or who are subject to fertility investigations.

Source: Farmadati