FLECTOR UNIDIE*8PLAS MED 14MG

FLECTOR UNIDIE 14 mg, medicated plaster
Piroxicam

What it is and what it is used for
FLECTOR UNIDIE is a medicine containing piroxicam, an active ingredient belonging to the class of non-steroidal anti-inflammatory drugs (NSAIDs) that act against pain, fever, and inflammation.

FLECTOR UNIDIE plaster is applied to the skin and is used to reduce pain and inflammation of joints, muscles, tendons, and ligaments, due to trauma or rheumatic diseases.

Consult your doctor if you do not feel better or if you feel worse after a short period of treatment.

What you need to know before taking the medicine
Do not use FLECTOR UNIDIE if:
• you are allergic (hypersensitive) to the active ingredient or to any of the other ingredients of this medicine (listed in paragraph 6);
• you have had an allergic reaction after taking other pain and inflammation medications (NSAIDs);
• you have asthma;
• you have a stomach and/or duodenal ulcer (peptic);
• you have had episodes of stomach or intestinal bleeding (including blood in vomit or during defecation or black and tarry stools) after taking other pain and inflammation medications (NSAIDs);
• you are using blood thinners (anticoagulants);
• you are pregnant or breastfeeding (see Pregnancy, breastfeeding and fertility).

FLECTOR UNIDIE should not be used in children under 12 years of age.

Warnings and precautions
Consult your doctor before using FLECTOR UNIDIE if:
• you have heart problems;
• you have severe kidney problems;
• you have severe liver problems;
• you have had a stomach or duodenal ulcer (peptic);
• you suffer from intestinal diseases, such as ulcerative colitis or Crohn's disease;
• you have had episodes of stomach or intestinal bleeding (including blood in vomit or during defecation or black and tarry stools);
• you are prone to bleeding (bleeding disorders);
• you have respiratory problems such as nasal inflammation due to allergy (allergic rhinitis), nasal polyps, bronchial diseases (chronic bronchitis);
• you are elderly as you are more likely to develop side effects from this medicine.

If you develop a skin rash or skin symptoms, you must immediately stop taking FLECTOR UNIDIE, contact a doctor immediately and inform them that you are taking this medicine.

PAY ATTENTION
• Do not expose yourself to direct sunlight after applying FLECTOR UNIDIE. This will reduce the risk of adverse light reaction (photosensitivity).
• Like other topical medicines, FLECTOR UNIDIE can cause redness and itching (sensitization phenomena), especially in case of prolonged or repeated therapy.
STOP TREATMENT AND CONSULT YOUR DOCTOR OR PHARMACIST IF YOU NOTICE SKIN REACTIONS AT THE APPLICATION SITE WHILE USING THIS PLASTER (see paragraph 4).

Possible side effects
Like all medicines, FLECTOR UNIDIE can cause side effects, although not everybody gets them. Following the instructions in this leaflet reduces the risk of side effects.

Stop using FLECTOR UNIDIE immediately and consult your doctor if you experience any of the following:
• allergic reactions such as: sudden appearance of skin lesions, for example spotty or widespread color changes (erythema), itching, burning, skin inflammation (contact dermatitis), numbness or tingling at the site where you applied the plaster;
• extensive and severe skin reactions, even after sun exposure (photosensitivity), such as urticaria, swelling (angioedema) of the face, eyes, lips, tongue and throat with difficulty breathing, erythema multiforme;
• severe breathing difficulties (asthma attacks).

Since FLECTOR UNIDIE plaster is applied directly to the affected area, the risk of having side effects that affect the whole body (systemic), such as stomach or intestinal problems, is lower compared to taking piroxicam by mouth.

If the medicated plasters are not used correctly, are used on large areas of skin and/or for a very long period of time, such effects can still occur (see paragraph 3, If you use more FLECTOR UNIDIE than you should).

Cases of fixed drug eruption (which may appear as round or oval patches of redness and swelling of the skin), blisters (urticaria), itching, with unknown frequency (frequency cannot be estimated from the available data) may occur.

Reporting of side effects
If you get any side effects, including any not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazionireazioni-avverse.
By reporting side effects you can help provide more information on the safety of this medicine.