FLECTOR*5MED PATCH 180MG

FLECTOR 180 mg medicated plaster
Diclofenac hydroxyethylpyrrolidine

What it is and what it is used for
FLECTOR contains the active ingredient diclofenac hydroxyethylpyrrolidine and belongs to a group of medicines that reduce pain and inflammation called non-steroidal anti-inflammatory drugs (NSAIDs).

FLECTOR plaster is applied to the skin and acts against pain and inflammation of joints, muscles, tendons and ligaments, due to trauma or rheumatic diseases.

Consult your doctor if, when using FLECTOR, you do not feel better or if you feel worse after a short period of treatment.

What you need to know before taking the medicine
Do not use FLECTOR:
• if you are allergic to diclofenac hydroxyethylpyrrolidine, acetylsalicylic acid or other NSAIDs;
• if you are allergic to any of the other ingredients of this medicine (listed in paragraph 6);
• during the last three months of pregnancy (see “Pregnancy, breastfeeding and fertility”);
• if you have a stomach or duodenal ulcer (peptic);
• if the skin where you want to apply the plaster is damaged or has lesions (exudative dermatitis, eczema, infections, burns or wounds);
• if you have had asthma, hives or inflammation of the nose (acute rhinitis) after using medicines containing acetylsalicylic acid or other NSAIDs.

Do not use FLECTOR in children and adolescents under 16 years of age.

Warnings and precautions
Consult your doctor or pharmacist before using FLECTOR if:
• you have respiratory problems such as asthma, nasal inflammation due to allergy (allergic rhinitis), nasal polyps, bronchial diseases;
• you have heart, liver or kidney problems;
• you have had a stomach or duodenal ulcer (peptic);
• you have suffered from inflammatory bowel diseases;
• you are prone to bleeding (hemorrhagic diathesis);
• you are elderly, as you are more likely to experience side effects.

Do not expose yourself to direct sunlight or sunlamps (tanning lamps) for at least one day after removing the plaster; this will reduce the risk of an adverse reaction to light (photosensitivity).

Like other medicines for local (topical) use, especially in case of prolonged therapy, FLECTOR can cause redness and itching (sensitization phenomena). Stop treatment and consult your doctor or pharmacist if skin reactions occur at the application site when using this plaster.

Side effects can be minimized by using the lowest effective dose for the shortest necessary duration. Do not exceed the dose of FLECTOR, do not apply it to large areas of skin and do not take it for long periods.

Possible side effects
Like all medicines, FLECTOR can cause side effects, although not everyone gets them.

Common side effects (may affect up to 1 in 10 people)
• Rashes and redness of the skin (rash, eczema, erythema), inflammation of the skin (dermatitis, including allergic and contact dermatitis), itching at the site where you applied the plaster.

Rare side effects (may affect up to 1 in 1,000 people)
• Skin inflammation with blistering (bullous dermatitis).
• Dry skin.

Very rare side effects (may affect up to 1 in 10,000 people)
• Symptoms due to allergic reactions: hives, swelling (angioedema) of the face, eyes, lips and throat with difficulty breathing.
• Skin lesions after sun exposure (photosensitivity reaction).
• Asthma.
• Skin inflammation with pus (pustular rash).

Since FLECTOR plaster 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 compared to taking diclofenac by mouth. If the medicated plasters are not used correctly, are used on large areas of skin and for a very long period of time, such effects can still occur.

If the medicated plasters are used in combination with other medicines containing diclofenac, the likelihood of skin reactions, even after sun exposure, such as blistering, erythema and eczema, increases. In rare cases, even serious reactions can occur, such as skin rashes with redness, blistering and peeling (e.g. Stevens-Johnson syndrome, Lyell's syndrome).

Reporting of side effects
If you get any side effects, including any not listed in this leaflet, tell 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.