Lenotac

NAME OF THE MEDICINAL PRODUCT
LENOTAC 14 mg medicated patch

WHAT THIS MEDICINAL PRODUCT IS AND WHAT IT IS USED FOR
LENOTAC is a medicated patch containing piroxicam, a non-steroidal anti-inflammatory drug (NSAID) with marked anti-inflammatory and analgesic activity. Its pharmacological effects are primarily due to inhibition of prostaglandin synthetase.
The activity of the active substance administered topically in various models of acute and chronic inflammation is evident even at reduced plasma levels.

WHY IT IS USED
LENOTAC is indicated for the treatment of painful and inflammatory conditions of rheumatic or traumatic origin affecting joints, muscles, tendons, and ligaments.

WHEN IT MUST NOT BE USED

• Hypersensitivity to the active substance or to any of the excipients
• On open wounds or skin lesions
• Avoid contact with eyes and mucous membranes
• In patients with a history of hypersensitivity reactions (asthma, allergic rhinitis, skin rashes, anaphylactic reactions) or gastrointestinal bleeding related to anti-inflammatory drugs
• In presence of active peptic ulcer, in patients with bronchial asthma or undergoing anticoagulant therapy
• During pregnancy and breastfeeding
• In children under 12 years of age

PRECAUTIONS FOR USE
Analgesics, antipyretics, and non-steroidal anti-inflammatory drugs, including piroxicam, may cause hypersensitivity reactions, potentially severe, even in individuals previously unexposed to these drugs.
LENOTAC should be used with great caution and only on medical prescription in elderly patients, in subjects with chronic bronchitis, allergic rhinitis, or inflammation of the nasal mucosa (in whom asthma attacks or severe inflammatory reactions of the skin and mucosa are more frequent), in patients with a history of gastrointestinal disorders (such as gastrointestinal ulcer, ulcerative colitis, or Crohn’s disease), in patients with a history of gastrointestinal bleeding not secondary to NSAID use or with other bleeding disorders, and in patients with hepatic or renal dysfunction or heart failure.
To avoid possible hypersensitivity or photosensitization reactions, avoid exposure to direct sunlight.

WHICH MEDICINES OR FOODS CAN AFFECT THE MEDICINE’S EFFECT
Inform your doctor or pharmacist if you have recently taken any other medicine, including those without a prescription.
It is unlikely that piroxicam-containing patches interact with other medicines, foods, or beverages. However, concomitant topical or systemic use of other medicines containing piroxicam or other NSAIDs is not recommended.

IMPORTANT INFORMATION
When it should only be used after consulting a doctor

• In patients with a history of hypersensitivity reactions (asthma, allergic rhinitis, skin rashes, anaphylactic reactions) or gastrointestinal bleeding caused by anti-inflammatory drugs
• In presence of active peptic ulcer, in patients with bronchial asthma or undergoing anticoagulant therapy

It is advisable to consult a doctor also if such conditions have occurred in the past.

What to do during pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.
LENOTAC is contraindicated during pregnancy and breastfeeding and is not recommended for women planning to become pregnant. Treatment should be discontinued in women experiencing fertility problems or undergoing fertility investigations.

Effects on ability to drive vehicles and use machinery
LENOTAC does not impair the ability to drive vehicles or operate machinery.

Important information about certain excipients
Not applicable

Doping warning
Not applicable

HOW TO USE THIS MEDICINAL PRODUCT
DOSAGE
One patch once daily
Caution: Do not exceed the recommended dose.

WHEN AND FOR HOW LONG
The patch may be applied at any time of day, once daily.
Do not use for longer than 8 days.
Do not apply two patches within the same day.
Consult your doctor if symptoms recur or if you notice any recent changes in their characteristics.

HOW TO APPLY
LENOTAC is intended for use only on intact skin. After thoroughly washing and drying the painful area, gently rub one corner of the LENOTAC patch between fingers to remove the protective film and apply the adhesive side directly to the skin.
If LENOTAC must be applied to joints with greater mobility, such as the elbow or knee, it is advisable to use a retention bandage applied to the joint in a flexed position to keep the patch in place.

WHAT TO DO IF YOU HAVE TAKEN AN EXCESSIVE DOSE
In case of accidental overdose of LENOTAC, contact your doctor immediately or go to the nearest hospital.

WHAT TO DO IF YOU FORGET TO APPLY ONE OR MORE DOSES
Apply the missed patch as soon as you remember.
However, if it is almost time for the next scheduled patch, skip the missed one and apply only the next one as planned.
Do not apply two patches within the same day.

IF YOU HAVE ANY DOUBTS ABOUT THE USE OF LENOTAC, CONSULT YOUR DOCTOR OR PHARMACIST

UNDESIRABLE EFFECTS
Like all medicines, LENOTAC medicated patch may cause undesirable effects, although not everyone experiences them.
Use of LENOTAC may lead to skin allergic reactions such as erythema, pruritus, irritation, burning sensation, contact dermatitis, numbness, and tingling at the application site.
With this type of medicine, cases of extensive and severe skin reactions have been reported, including urticaria, Quincke’s edema (angioedema), and erythema multiforme.
Skin reactions due to photosensitivity and more widespread or severe reactions, including asthma attacks, are possible.
Systemic adverse reactions following topical use of piroxicam are unlikely; however, since plasma levels achieved are lower than those measured after systemic administration but highly variable between individuals, systemic adverse effects—particularly gastrointestinal—cannot be ruled out, especially with prolonged treatment beyond the recommended duration or failure to observe contraindications and warnings.
If local or systemic adverse effects occur, treatment must be discontinued and a doctor consulted for appropriate management.
Following the instructions in this leaflet reduces the risk of adverse effects.
The described adverse effects are generally transient. However, it is advisable to consult your doctor or pharmacist if they occur.
If any of the adverse effects worsens, or if you notice any adverse effect not listed in this leaflet, inform your doctor or pharmacist.

EXPIRY DATE AND STORAGE INSTRUCTIONS
Expiry date: see the date printed on the packaging.
The expiry date refers to the product in its original, unopened packaging stored under recommended conditions.
Caution: Do not use the medicine after the expiry date stated on the packaging.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This helps protect the environment.
KEEP LENOTAC OUT OF THE SIGHT AND REACH OF CHILDREN.
It is important to always have medicine information available; therefore, keep both the carton and the package leaflet.

COMPOSITION
One patch measuring 100 x 70 mm (70 cm²) contains 14 mg of piroxicam.
Excipients: Acrylic copolymer, Eudragit E 100, non-woven fabric, silicone-coated polyester.

PRESENTATION
Box containing 8 foil pouches: each pouch contains 1 medicated patch of 14 mg.
Box containing 4 foil pouches: each pouch contains 1 medicated patch of 14 mg.

Marketing Authorization Holder
I.B.N. SAVIO S.r.l., Via del Mare, 36 Pomezia (RM)

Manufacturer
Bouty S.p.A. S.S. n. 11 Padana Superiore Km 160 Cassina de’ Pecchi (MI)