LENOTAC 14 mg Plaster Transdermalny

NAMEOFTHEMEDICINE
LENOTAC14 mg medicated patch
WHAT IT IS
LENOTAC is a medicated patch based on piroxicam, a non-steroidal anti-inflammatory drug with
a pronounced anti-inflammatory and analgesic action. The pharmacological effects are due
mainly to the inhibition of prostaglandin synthesis.
The activity of the active ingredient administered topically in various models of acute
and chronic inflammation manifests even in the presence of reduced plasma levels.

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

WHEN IT SHOULD NOT BE USED

• hypersensitivity to the active ingredient or to any of the excipients
• on open wounds or lesions
• Avoid contact with eyes and mucous membranes.
• in case of a history of hypersensitivity reaction (asthma, allergic rhinitis, skin rashes and anaphylactic reactions) or gastrointestinal bleeding from anti-inflammatory drugs;
• in the presence of an active peptic ulcer, in patients with bronchial asthma or undergoing anticoagulant therapy.
• Pregnancy and breastfeeding
• Children under 12 years of age

PRECAUTIONS FOR USE
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.
LENOTAC must be used with great caution and on the doctor's prescription in the elderly, in
subjects with chronic bronchitis, allergic rhinitis or inflammation of the nasal mucosa (in which
asthmatic attacks or serious inflammatory reactions of the skin and mucous membranes are more frequent), in
patients with a history of gastrointestinal diseases (such as gastrointestinal ulcer, ulcerative colitis or
Crohn's disease), in patients with a history of gastrointestinal bleeding not secondary to
the administration of NSAIDs or with other bleeding disorders, with hepatic or renal dysfunction or with
heart failure.
To avoid any hypersensitivity or photosensitization phenomena, avoid exposure to
direct sunlight

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

IT IS IMPORTANT TO KNOW THAT
When it can be used only after consulting a doctor

• in case of a history of hypersensitivity reaction (asthma, allergic rhinitis, skin rashes and anaphylactic reactions) or gastrointestinal bleeding from anti-inflammatory drugs;
• in the presence of an active peptic ulcer, in patients with bronchial asthma or undergoing anticoagulant therapy.

It is advisable to consult a doctor even in cases where these disorders 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
who intend to become pregnant. Administration should be discontinued in women with
fertility problems or who are undergoing fertility investigations.

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

Important information on some excipients
Not applicable

Doping warning
Not applicable

HOW TO USE THIS MEDICINE
HOW MUCH
One patch once a day
Caution: do not exceed the indicated doses.

WHEN AND FOR HOW LONG
The patch can be applied at any time of the day, once a day.
Do not use for a period longer than 8 days.
Do not apply two patches within the same day.
Consult your doctor if the disorder recurs or if you notice any
recent change in its characteristics.

HOW
LENOTAC is to be used exclusively on intact skin. After thoroughly 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 be applied
to the flexed joint, in order to keep the patch in place.

WHATTODOIFYOUHAVETAKENTOOMUCHMEDICINE
In case of accidental administration of an excessive dose of LENOTAC, immediately warn
your doctor or go to the nearest hospital.

WHAT TO DO IF YOU FORGET TO TAKE A DOSE OR MORE
Apply the patch you forgot as soon as you remember.
However, if it is almost time to apply the next patch, apply only the next
regularly scheduled patch.
Do not apply two patches within the same day.

IF YOU HAVE ANY DOUBTS ABOUT THE USE OF LENOTAC, ASK YOUR DOCTOR OR PHARMACIST
UNDESIRABLE EFFECTS
Like all medicines, LENOTAC medicated patch can cause side effects, although
not everyone will experience them.
The use of LENOTAC may lead to the appearance of allergic skin reactions, erythema, itching,
irritation, burning, contact dermatitis, numbness and tingling at the application site;
cases of extensive and serious skin lesions such as urticaria, angioedema, erythema multiforme have been reported with this type of medicine.
Photosensitivity skin reactions and more extensive and more serious reactions, including
asthma attacks, are possible.
Systemic adverse reactions following topical application of piroxicam are unlikely;
as the plasma levels obtained are lower than those measured after systemic administration
but variable from individual to individual, it is not possible to exclude, especially in the case of therapies
prolonged beyond the recommended period and non-observance of contraindications and warnings, the
appearance of systemic adverse effects, especially at the gastrointestinal level.
In case of local or general adverse effects, it is necessary to interrupt the treatment and
consult your doctor to establish suitable therapy.
undesirable.
The side effects described are generally transient. When they occur, however, it is
advisable to consult your Doctor or Pharmacist.
If any of the side effects worsen, or if you notice the appearance of any side effect

EXPIRY AND STORAGE
Expiry date: see the expiry date printed on the packaging.
The expiry date refers to the product in intact packaging, stored correctly.
Caution: do not use the medicine after the expiry date printed on the packaging.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help protect
the environment.
KEEP LENOTAC OUT OF THE SIGHT AND REACH OF CHILDREN
It is important to always have information about the medicine available, so keep both

COMPOSITION
One patch measuring 100 x 70 mm (70 cm) contains 14 mg of piroxicam.
The excipients are: Acrylic copolymer, Eudragit E 100, non-woven fabric, siliconized polyester.

HOW IT IS PRESENTED
Pack containing 8 laminated sachets: each sachet contains 1 medicated patch of 14 mg.
Pack containing 4 laminated sachets: each sachet contains 1 medicated patch of 14 mg.

Marketing Authorisation 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)