BREXIDOL UNIDIE*4CER MED 14MG

BREXIDOL Unidie 14 mg, medicated patch
Piroxicam

What it is and what it is used for
BREXIDOL Unidie contains the active ingredient piroxicam, which belongs to the class of non-steroidal anti-inflammatory drugs (NSAIDs) that act against pain, fever, and inflammation.

BREXIDOL Unidie patch 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.

What you need to know before taking the medicine
Do not use BREXIDOL Unidie if:
• you are allergic (hypersensitive) to the active ingredient or to any of the other ingredients of this medicine (listed in section 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 bleeding in the stomach or intestines (including blood in vomit or during bowel movements or black and tarry stools) after taking other pain and inflammation medications (NSAIDs);
• you are taking blood-thinning medications (anticoagulants);
• you are pregnant or breastfeeding.

BREXIDOL Unidie should not be used in children under 12 years of age.

Warnings and precautions
Talk to your doctor before using BREXIDOL 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 bleeding in the stomach or intestines (including blood in vomit or during bowel movements 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 prone to localized inflammatory reactions of the skin or mucous membrane (Quincke's edema);
• you are elderly as you are more likely to develop side effects to this medicine.

BE CAREFUL not to expose yourself to direct sunlight. This will reduce the risk of adverse reaction to light (photosensitivity).

Like other local (topical) medicines, especially in case of prolonged or repeated therapy, BREXIDOL Unidie can cause redness and itching (sensitization phenomena). Stop treatment and consult your doctor or pharmacist if skin reactions occur at the application site while using this patch.

If you develop a rash or skin symptoms, you must stop taking BREXIDOL Unidie immediately, seek medical attention immediately, and inform them that you are taking this medicine.

Children and adolescents
Do not use BREXIDOL Unidie in children under 12 years of age.

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

Stop using BREXIDOL Unidie immediately and contact your doctor if you experience any of the following:
• allergic reactions such as: more or less sudden appearance of skin lesions, for example, patchy or widespread color changes (erythema), itching, burning, skin inflammation (contact dermatitis), numbness or tingling at the site where you applied the patch;
• widespread and severe skin reactions, even after sun exposure (photosensitivity), such as hives, swelling (angioedema) of the face, eyes, lips, tongue, and throat with breathing difficulties, erythema multiforme;
• severe breathing difficulties (asthma attacks);
• fixed drug eruption (may manifest as round or oval patches of redness and swelling of the skin), blisters (hives), itching.

Since BREXIDOL Unidie patch is applied directly to the affected area, the risk of systemic side effects, such as stomach or intestinal problems, is lower compared to taking piroxicam orally. If systemic side effects occur during use, consult your doctor for more information and discontinue treatment.

If the medicated patches are not used correctly, are used on large areas of skin, and/or for a very long period of time, such effects may still 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.