BREXIDOL "14 MG MEDICATED PATCH" 8 PATCHES"

Name
BREXIDOL Unidie 14 mg, medicated plaster
Piroxicam


What is it and what is it for?
BREXIDOL Unidie contains the active substance 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:
• are allergic (hypersensitive) to the active substance or to any of the other ingredients of this medicine (listed in section 6);
• have had an allergy after taking other drugs against pain and inflammation (NSAIDs);
• has asthma;
• have a stomach and/or duodenal (peptic) ulcer;
• have had episodes of bleeding in the stomach or intestines (including blood in vomiting or during bowel movements or black, tarry stools) after taking other medicines for pain and inflammation (NSAIDs);
• is using medicines that thin the blood (anticoagulants);
• is 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:
• has heart problems;
• has serious kidney problems;
• has serious liver problems;
• have had a stomach or duodenal (peptic) ulcer;
• suffer from intestinal diseases, such as ulcerative colitis or Crohn's disease;
• have had episodes of bleeding in the stomach or intestines (including blood in vomiting or during bowel movements or black, tarry stools);
• is prone to bleeding (bleeding disorders);
• has respiratory problems such as inflammation of the nose due to allergies (allergic rhinitis), nasal polyps, bronchial diseases (chronic bronchitis);
• is subject to localized inflammatory reactions of the skin or mucosa (Quincke's edema);
• are elderly as they are more likely to develop side effects from this medicine.

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

Like other topical medications, especially with prolonged or repeated use, BREXIDOL Unidie may cause redness and itching (sensitivity reactions). Stop treatment and contact your doctor or pharmacist if you experience skin reactions at the application site while using this patch.

If you develop a rash or skin symptoms, you must stop taking BREXIDOL Unidie immediately, contact a doctor immediately and tell your doctor 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 conditions:
• allergic reactions such as: more or less sudden appearance of skin lesions, for example spotty or widespread changes in colour (erythema), itching, burning, inflammation of the skin (contact dermatitis), numbness or tingling at the site where the patch was applied;
• extensive and severe skin reactions, even after exposure to the sun (photosensitivity), such as hives, swelling (angioedema) of the face, eyes, lips, tongue and throat with difficulty breathing, erythema multiforme;
• severe breathing difficulties (asthma attacks);
• fixed drug eruption (may appear as round or oval patches of redness and swelling of the skin), blisters (hives), itching.

Because BREXIDOL Unidie is applied directly to the affected area, the risk of systemic side effects, such as stomach or intestinal problems, is lower than when taking piroxicam orally. If you experience systemic side effects while using it, consult your doctor for further information and discontinue treatment.

If medicated plasters are not used correctly, are used on large areas of skin and/or for a very long period of time, these effects can still occur.

Reporting of side effects
If you experience 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.