BREXIDOL 14 mg Transdermal Patch

Зміст інструкції

1. BREXIDOL UNIDIE 14 mg, medicated patch
   1. What is BREXIDOL UNIDIE and what is it used for
   2. What you need to know before using BREXIDOL UNIDIE
   3. How to use BREXIDOL UNIDIE
   4. Possible side effects
   5. How to store BREXIDOL UNIDIE
   6. Contents of the pack and other information

BREXIDOL UNIDIE 14 mg, medicated patch

Piroxicam

Read this leaflet carefully before using this medicine as it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms worsen after a short period of treatment.

Contents of this leaflet:

• 1. What BREXIDOL UNIDIE is and what it is used for
• 2. What you need to know before you take BREXIDOL UNIDIE
• 3. How to take BREXIDOL UNIDIE
• 4. Possible side effects
• 5. How to store BREXIDOL UNIDIE
• 6. Contents of the pack and other information

1. What is BREXIDOL UNIDIE and what is it 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.

2. What you need to know before using BREXIDOL UNIDIE

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 medicines for pain and inflammation (NSAIDs);
• you have asthma;
• you have a stomach and/or duodenal ulcer (peptic);
• you have had episodes of bleeding in the stomach or intestine (including blood in the vomit or during bowel movements or black, tarry stools) after taking other medicines for pain and inflammation (NSAIDs);
• you are using medicines that thin the blood (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 intestine (including blood in the vomit or during bowel movements or black, tarry stools);
• you are prone to bleeding (bleeding disorders);
• you have respiratory problems such as inflammation of the nose due to allergies (allergic rhinitis), nasal polyps, bronchial diseases (chronic bronchitis);
• you are subject to localized inflammatory reactions of the skin or mucous membranes (angioedema);
• you are elderly as you have a greater likelihood of developing undesirable effects with this medicine

BE CAREFUL not to expose yourself to direct sunlight. This will reduce the risk of adverse reaction to light (photosensitization).
Like other medicines for topical use, especially in case of prolonged or repeated therapy,
BREXIDOL UNIDIE may cause redness and itching (sensitization phenomena). Stop the
treatment and consult your doctor or pharmacist if, when using this patch, skin reactions occur
at the application site.
If you develop a rash or skin symptoms, you should immediately stop taking
BREXIDOL UNIDIE, immediately consult a doctor 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

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

Pregnancy and breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding
ask your doctor or pharmacist for advice before taking this
medicine.
Pregnancy
Do not use BREXIDOL UNIDIE if you are pregnant.
Oral forms (e.g., tablets) of piroxicam can cause adverse effects in the fetus.
It is not known if the same risk applies to BREXIDOL UNIDIE.
Breastfeeding
Do not use BREXIDOL UNIDIE if you are breastfeeding.
Fertility
If you have problems conceiving and are using BREXIDOL UNIDIE, stop treatment.
This medicine is not recommended if you want to become pregnant.

Driving and using machines
BREXIDOL UNIDIE does not impair the ability to drive vehicles or operate machinery.

3. How to use BREXIDOL UNIDIE

Use this medicine following the instructions of your doctor exactly. If you have any doubts, consult your doctor
or pharmacist.
The usual dose is 1 patchper 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.

How to apply the patch

• Wash and thoroughly dry the painful area.
• Take a medicated patch from the sachet.
• Rub one of the corners of the patch between your fingers and remove the protective film that protects the adhesive part of the patch.
• Apply the patch to the affected area. If you apply the patch to a very mobile joint (e.g. the knee or elbow) you may need to secure the patch with an elastic bandage, bend the joint and apply the bandage. Do not cover the medicated area with plastic or non-breathable (occlusive) dressings.
• Carefully reseal the sachet with the sliding closure.

Do not apply BREXIDOL UNIDIE to lesions or open wounds (e.g. burns); avoid contact with the
eyes or mucous membranes. The medicated patch should not be wetted: it is advisable to bathe or shower
between two
subsequent applications.
Do not exceed the dose of BREXIDOL UNIDIE and do not apply it to large areas of skin. Use BREXIDOL
UNIDIE for the shortest possible time. See your doctor if you do not notice any improvement or if you notice a
worsening of symptoms.

If you use more BREXIDOL UNIDIE than you should,for example if you use the patches incorrectly or on large
areas of skin or for a very long time, adverse effects affecting the whole body (systemic) may occur, such as problems with the stomach or intestines. In this case, inform
your doctor or go to the nearest hospital, as appropriate measures may be necessary.

If you forget to use BREXIDOL UNIDIE
Do not apply an extra patch to make up for the forgotten one.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Stop using BREXIDOL UNIDIE immediately and contact your doctor if any of the following conditions occur:

• allergic reactions such as: more or less sudden appearance of skin lesions, for example changes in color in patches or widespread (erythema), itching, burning, skin inflammation (contact dermatitis), numbness or tingling at the site where you applied the patch;
• extensive and severe skin reaction, even after exposure to sunlight (photosensitivity), such as hives, swelling (angioedema) of the face, eyes, lips, tongue and throat with difficulty breathing, erythema multiforme;
• severe difficulty breathing (asthma attacks)
• fixed drug eruption (can manifest as round or oval patches of redness and swelling of the skin), blisters (urticaria), itching

Because BREXIDOL UNIDIE patch 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 than taking piroxicam orally. If systemic side effects occur during use, contact your doctor for more information and discontinue therapy. If the medicated patches are not used correctly, are used on large areas of skin and/or for a very long period of time, these effects may still occur.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at “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 which is stated on the pack after the wording EXP. The
expiry date refers to the last day of that month.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

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

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