FLECTOR 14 mg Plaster Transdermalny

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1. FLECTOR UNIDIE 14 mg, medicated patch
   1. What is FLECTOR UNIDIE and what is it used for
   2. WHAT YOU NEED TO KNOW BEFORE USING FLECTOR UNIDIE
   3. HOW TO USE FLECTOR UNIDIE
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE FLECTOR UNIDIE
   6. PACKAGE CONTENTS AND OTHER INFORMATION

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

1. What is FLECTOR UNIDIE and what is it used for

FLECTOR UNIDIE is a medicine that contains 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 of
joints, muscles, tendons and ligaments, due to trauma 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 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 vomit or during evacuation 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 (see “Pregnancy, breastfeeding and fertility”).

FLECTOR UNIDIE should not be used in children under 12 years of age.

Warnings and precautions
Consult 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 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 vomit or during evacuation 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, bronchial diseases (chronic bronchitis);
• you are elderly as you have a greater likelihood of developing undesirable effects with this medicine.

If you develop a skin rash or skin symptoms, you should immediately stop taking
FLECTOR UNIDIE, immediately consult a doctor and inform them that you are taking this
medicine
PAY ATTENTION

• Do not expose yourself to direct sunlight after applying FLECTOR UNIDIE. This will reduce the risk of adverse reaction to light (photosensitivity).
• Like other medicines for topical use, FLECTOR UNIDIE may cause redness and itching (sensitization phenomena), especially in case of prolonged or repeated therapy. STOP TREATMENT AND CONSULT YOUR DOCTOR OR PHARMACIST IF YOU NOTICE SKIN REACTIONS AT THE SITE OF APPLICATION 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 may take any
other medicine, as some medicines can interact with FLECTOR UNIDIE or increase the risk of
side effects, even serious ones. This is particularly important if you are taking other medicines
containing piroxicam or other medicines for pain and inflammation (NSAIDs).

Pregnancy, breastfeeding and fertility
Do not use FLECTOR UNIDIE if you are pregnant or if you are breastfeeding.
If you have problems conceiving and are using FLECTOR UNIDIE, discontinue treatment.
If you want to become pregnant, this medicine should only be used in cases of actual
need and under direct medical supervision. Consult your doctor before using FLECTOR UNIDIE.

Driving and operating machinery
FLECTOR UNIDIE does not impair the ability to drive vehicles or operate machinery.

3. HOW TO USE FLECTOR UNIDIE

Use this medicine following exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.
Adults and children over 12 years of age
The usual dose is 1 patchper day, for a maximum period of 8 days. Apply the patch to the affected part
of the body. Replace the used patch every 24 hours.
Do not apply FLECTOR UNIDIE to open wounds or sores (e.g., burns); avoid contact with the
eyes or mucous membranes. The medicated patch should not be wet: it is recommended to bathe or shower
between two successive applications.
Do not exceed the dose of FLECTOR UNIDIE and do not apply it to extensive areas of skin. Use FLECTOR
UNIDIE for the shortest possible time. See your doctor if you do not notice any improvement or if you notice a
worsening of symptoms.

Instructions for applying the patch

• Wash and dry the painful area thoroughly.
• 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 dressing (occlusive).
• Carefully reseal the sachet with the sliding closure.

If you use more FLECTOR UNIDIE than you should, for example if you use the patches incorrectly or on extensive
areas of skin or for a very long time, undesirable effects that
affect 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 FLECTOR UNIDIE
Do not apply an extra patch to make up for the forgotten one.

4. POSSIBLE SIDE EFFECTS

Like all medicines, FLECTOR UNIDIE can cause side effects, although not everybody gets them.
side effects.
Stop using FLECTOR UNIDIE immediately and see a doctor if any of the following conditions occur:

• allergic reactions such as: more or less sudden appearance of skin lesions, for example color changes in patches or widespread (erythema), itching, burning, skin inflammation (contact dermatitis), numbness or tingling at the site where you applied the patch;
• extensive and serious 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;
• serious breathing difficulties (asthma attacks).

Because FLECTOR 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 by mouth.
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 can still occur (see paragraph 3, “If you use more
FLECTOR UNIDIE than you should”).
Cases of fixed drug eruption may occur (it may manifest as round or
oval patches of redness and swelling of the skin), blisters (urticaria), itching, with frequency unknown (the
frequency cannot be defined based on available data).

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

6. PACKAGE CONTENTS AND OTHER INFORMATION

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

Description of the appearance of FLECTOR UNIDIE and package contents
This medicine is a self-adhesive medicated patch with a 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
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)