Patient Information Leaflet

BREXIDOL UNIDIE 14 mg, medicated patch

Piroxicam
Please read all of this leaflet carefully before you start using this medicine, as it contains important information for you.
Use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.

Keep this leaflet. You may need to read it again.
If you need more information or advice, consult your pharmacist.
If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.
Consult your doctor if you do not notice improvement or if you notice worsening of symptoms after a short period of treatment.

Contents of this leaflet:

What BREXIDOL UNIDIE is and what it is used for
What you need to know before using BREXIDOL UNIDIE
How to use BREXIDOL UNIDIE
Possible side effects
How to store BREXIDOL UNIDIE
Contents of the pack and other information

1. What BREXIDOL UNIDIE is and what it is used 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.
The BREXIDOL UNIDIE patch is applied to the skin and is used to reduce pain and inflammation of joints, muscles, tendons and ligaments, caused by injuries or rheumatic diseases.

2. What you need to know before using BREXIDOL UNIDIE

Do not use BREXIDOL UNIDIE if:

you are allergic (hypersensitive) to the active substance 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 anti-inflammatory medicines (NSAIDs);
you have asthma;
you have a stomach and/or duodenal (peptic) ulcer;
you have experienced episodes of stomach or intestinal bleeding (including blood in vomit or during bowel movements, or black, tarry stools) after taking other pain and anti-inflammatory medicines (NSAIDs);
you are taking blood-thinning medicines (anticoagulants);
you are pregnant or breastfeeding;

BREXIDOL UNIDIE must 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 (peptic) ulcer;
you suffer from bowel diseases such as ulcerative colitis or Crohn's disease;
you have experienced episodes of stomach or intestinal bleeding (including blood in vomit or during bowel movements, or black, tarry stools);
you are prone to bleeding (bleeding disorders);
you have respiratory problems such as nasal inflammation due to allergy (allergic rhinitis), nasal polyps, or bronchial diseases (chronic bronchitis);
you are prone to localized inflammatory reactions of the skin or mucous membranes (Quincke's edema);
you are elderly, as you have a higher risk of developing adverse effects with this medicine.

TAKE CARE to avoid exposure to direct sunlight. This will reduce the risk of an adverse reaction to light (photosensitization).
Like other topical medicines, especially with prolonged or repeated treatment, BREXIDOL UNIDIE may 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 skin rash or skin symptoms, you must stop using BREXIDOL UNIDIE immediately, contact a doctor 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.
Other medicines and BREXIDOL UNIDIE

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, as some medicines may interact with BREXIDOL UNIDIE or increase the risk of adverse effects, even serious ones. Do not use BREXIDOL UNIDIE if you are taking other oral or topical medicines containing piroxicam or other non-steroidal anti-inflammatory drugs (NSAIDs).

Pregnancy, breastfeeding, and fertility
If you are pregnant, think you might be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Do not use BREXIDOL UNIDIE if you are pregnant.
Oral forms (e.g., tablets) of piroxicam may cause adverse effects in the fetus.
It is not known whether the same risk applies to BREXIDOL UNIDIE.
Breastfeeding
Do not use BREXIDOL UNIDIE if you are breastfeeding.
Fertility
If you have fertility problems and are using BREXIDOL UNIDIE, discontinue treatment.
This medicine is not recommended if you are planning to become pregnant.
Driving and using machines
BREXIDOL UNIDIE does not impair the ability to drive or operate machinery.

3. How to use BREXIDOL UNIDIE

Use this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
The usual dose is 1 patch per day, for a maximum period of 8 days. Replace the patch every 24 hours.
Children under 12 years of age
Do not use BREXIDOL UNIDIE patch.

Instructions for applying the patch

Wash and dry the painful area thoroughly.
Take one medicated patch from the pouch.
Rub one of the corners of the patch between your fingers and remove the protective film covering the adhesive side of the patch.
Apply the patch to the affected area. If applying the patch to a highly mobile joint (e.g. knee or elbow), it may be necessary to secure the patch with an elastic bandage; bend the joint and apply the bandage. Do not cover the medicated area with plastic material or an airtight (occlusive) dressing that does not allow air passage.
Close the pouch carefully using the resealable closure.

Do not apply BREXIDOL UNIDIE to damaged or open wounds (e.g. burns); avoid contact with eyes or mucous membranes. The medicated patch should not get wet: it is advisable to take a bath or shower between successive applications.
Do not exceed the recommended dose of BREXIDOL UNIDIE and do not apply it to large areas of skin. Use BREXIDOL UNIDIE for the shortest possible duration. Contact your doctor if you do not notice any improvement or if you experience worsening of symptoms.

If you use more BREXIDOL UNIDIE than you should, for example if you use the patches incorrectly, on large areas of skin, or for a prolonged period of time, systemic adverse effects may occur, such as stomach or intestinal problems. In such cases, inform your doctor or go to the nearest hospital, as appropriate measures may be required.

If you forget to use BREXIDOL UNIDIE
Do not apply an additional patch to make up for the missed application.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Following the instructions contained 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 discolouration in spots or widespread areas (erythema), itching, burning, skin inflammation (contact dermatitis), numbness or tingling at the site where the patch was applied;
severe skin reactions, even after sun exposure (photosensitivity), such as urticaria, swelling (angioedema) of the face, eyes, lips, tongue, and throat with breathing difficulties, erythema multiforme;
severe breathing difficulties (asthma attacks);
fixed drug eruption (may appear as round or oval-shaped red patches with swelling of the skin), blisters (urticaria), itching.

Since BREXIDOL UNIDIE patch is applied directly to the affected area, the risk of experiencing side effects affecting the whole body (systemic effects), such as stomach or intestinal problems, is lower compared to taking oral piroxicam. However, if systemic side effects occur during use, consult your doctor for further advice and discontinue treatment.
If medicated patches are not used correctly, are applied to large skin areas and/or for a prolonged period of time, such systemic effects may still occur.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist. You may also report side effects directly via the national reporting system at the website: “https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse”. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store BREXIDOL UNIDIE

Keep this medicine out of the sight and reach of children. No special storage conditions are required.
Do not use this medicine after the expiry date stated on the packaging after the word "EXP". The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What BREXIDOL UNIDIE contains
The active substance is piroxicam.
One medicated patch contains: 14 mg of piroxicam.
The other components are: acrylic copolymer, eudragit E100, non-woven fabric, silicone-coated polyester.

Description of the appearance of BREXIDOL UNIDIE and pack contents
This medicine is a self-adhesive medicated patch with a protective film, measuring 100 x 70 mm (70 cm²), available in packs of:

4 patches, each contained in a sachet;
8 patches, each contained in a sachet.

Marketing Authorisation Holder
PROMEDICA S.r.l., Via Palermo, 26/A - Parma

Manufacturer
IBSA Farmaceutici Italia S.r.l.
S.S. n. 11 Padana Superiore Km 160
20051 Cassina de’ Pecchi (MI)
or alternatively:
Altergon Italia S.r.l.
Zona Industriale
83040 – Morra De Sanctis (AV)
ITALY