Package leaflet: Information for the patient

FLECTOR UNIDIE 14 mg, medicated patch

Piroxicam
Please read all of this leaflet carefully before using this medicine because 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 to.

Keep this leaflet. You may need to read it again.
If you need more information or advice, consult your pharmacist.
If you experience any of the side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contact 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 FLECTOR UNIDIE is and what it is used for
What you need to know before using FLECTOR UNIDIE
How to use FLECTOR UNIDIE
Possible side effects
How to store FLECTOR UNIDIE
Contents of the pack and other information

1. What FLECTOR UNIDIE 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 patch is applied to the skin and is used to reduce pain and inflammation in joints, muscles, tendons, and ligaments caused by injuries or rheumatic diseases.
Consult your doctor if you do not feel better or if you feel worse after a short period of treatment.

2. WHAT YOU NEED TO KNOW BEFORE USING FLECTOR UNIDIE

Do not use FLECTOR 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 (see "Pregnancy, breastfeeding and fertility").

FLECTOR UNIDIE must not be used in children under 12 years of age.
Warnings and precautions
Talk to 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 (peptic) ulcer;
you suffer from intestinal 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 allergies (allergic rhinitis), nasal polyps, or bronchial diseases (chronic bronchitis);
you are elderly, as you may have a higher risk of developing adverse effects from this medicine.

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

Do not expose yourself to direct sunlight after applying FLECTOR UNIDIE. This will reduce the risk of adverse skin reactions to light (photosensitivity).
Like other topical medicines, FLECTOR UNIDIE may cause redness and itching (sensitization phenomena), especially with prolonged or repeated treatment. STOP TREATMENT AND CONSULT YOUR DOCTOR OR PHARMACIST IF YOU EXPERIENCE SKIN REACTIONS AT THE APPLICATION SITE WHILE USING THIS PATCH (see section 4).

Other medicines and FLECTOR 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 FLECTOR UNIDIE or increase the risk of adverse effects, even serious ones. This is particularly important if you are taking other medicines containing piroxicam or other pain and anti-inflammatory medicines (NSAIDs).
Pregnancy, breastfeeding and fertility
Do not use FLECTOR UNIDIE if you are pregnant or breastfeeding.
If you have fertility problems and are using FLECTOR UNIDIE, discontinue treatment.
If you are planning a pregnancy, this medicine should only be used when strictly necessary and under direct medical supervision. Consult your doctor before using FLECTOR UNIDIE.
Driving and using machines
FLECTOR UNIDIE does not affect the ability to drive or operate machinery.

3. HOW TO USE FLECTOR UNIDIE

Use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

Adults and children over 12 years of age
The usual dose is 1 patch per day, for a maximum period of 8 days. Apply the patch to the affected area of the body. Replace the used patch every 24 hours.

Do not apply FLECTOR UNIDIE to damaged skin or open wounds (e.g., burns); avoid contact with eyes or mucous membranes. The medicated patch should not get wet: it is advisable to bathe or shower between successive applications.

Do not exceed the recommended dose of FLECTOR UNIDIE and do not apply it to large areas of skin. Use FLECTOR UNIDIE for the shortest possible duration. Consult your doctor if you do not notice any improvement or if your symptoms worsen.

Instructions for applying the patch

Wash and thoroughly dry the painful area.
Take one medicated patch from the sachet.
Rub one of the corners of the patch between your fingers and remove the protective liner 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 or non-breathable (occlusive) dressings.
Carefully reseal the sachet using the closure.

If you use more FLECTOR 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 FLECTOR UNIDIE
Do not apply an additional patch to make up for the missed dose.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, FLECTOR UNIDIE may cause adverse reactions, although not everyone experiences them.
Following the instructions contained in this leaflet reduces the risk of adverse reactions.
Immediately discontinue use of FLECTOR UNIDIE and consult your doctor if you experience any of the
following conditions:

allergic reactions such as: more or less sudden appearance of skin lesions, for example discolored spots or widespread rash (erythema), itching, burning, skin inflammation (contact dermatitis), numbness or tingling at the site where the patch was applied;
extensive and severe skin reactions, even after exposure to sunlight (photosensitivity), such as urticaria, swelling (angioedema) of the face, eyes, lips, tongue and throat with breathing difficulties, erythema multiforme;
severe breathing difficulties (asthma attacks).

Since the FLECTOR UNIDIE patch is applied directly to the affected area, the risk of systemic adverse reactions affecting the whole body, such as stomach or intestinal problems, is lower compared to oral administration of piroxicam.
However, if medicated patches are not used correctly, are applied over large areas of skin and/or for prolonged periods, these systemic effects may still occur (see section 3, "If you use more FLECTOR UNIDIE than you should").
Cases of drug-induced fixed eruption (which may appear as round or oval red patches with swelling of the skin), blisters (urticaria), itching may occur, with unknown frequency (frequency cannot be determined from available data).

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

5. HOW TO STORE FLECTOR 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. This date applies to the product in its original, unopened packaging, properly stored.
Do not dispose of any medicine via wastewater 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 PACKAGE AND OTHER INFORMATION

What FLECTOR UNIDIE contains
The active substance is: piroxicam.
Each medicated patch contains: 14 mg of piroxicam.
The other components are: acrylic copolymer, eudragit E 100, non-woven fabric, siliconized polyester.

Description of the appearance of FLECTOR UNIDIE and package contents
This medicinal product 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 pouch;
8 patches, each contained in a pouch.

Marketing Authorization Holder
IBSA Farmaceutici Italia Srl - Via Martiri di Cefalonia, 2 – 26900 Lodi
Manufacturer
IBSA Farmaceutici Italia S.r.l. S.S. n. 11 Padana Superiore Km 160 – 20060 Cassina de’ Pecchi (MI)
ALTERGON ITALIA S.R.L - Zona industriale 83040 – Morra De Sanctis (AV)