FLECTOR "180 MG MEDICATED PATCH" 5 MEDICATED PATCHES"

Name
FLECTOR 180 mg medicated plaster
Diclofenac hydroxyethylpyrrolidine


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

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

Talk to your doctor if you do not feel better when using FLECTOR 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 section 6);
• during the last three months of pregnancy (see “Pregnancy, breastfeeding and fertility”);
• if you have a stomach or duodenal (peptic) ulcer;
• if the skin where you want to apply the patch 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
Talk to your doctor or pharmacist before using FLECTOR if:
• has respiratory problems such as asthma, inflammation of the nose due to allergies (allergic rhinitis), nasal polyps, bronchial diseases;
• have heart, liver or kidney problems;
• have had a stomach or duodenal (peptic) ulcer;
• has suffered from inflammatory bowel disease;
• is predisposed to blood loss (hemorrhagic diathesis);
• is elderly, as he or she is more likely to experience side effects.

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

Like other topical medications, especially with prolonged use, FLECTOR may cause redness and itching (sensitization reactions). Stop treatment and contact your doctor or pharmacist if you experience skin reactions at the application site while using this patch.

Side effects can be minimized by using the lowest effective dose for the shortest duration necessary. Do not exceed the recommended 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 everybody gets them.

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

Rare side effects (may affect up to 1 in 1,000 people)
• Inflammation of the skin 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 exposure to the sun (photosensitivity reaction).
• Asthma.
• Inflammation of the skin with the presence of pus (rash with pustules).

Because the FLECTOR patch is applied directly to the affected area, the risk of systemic side effects, such as stomach or intestinal problems, is lower than when taking diclofenac by mouth. If medicated patches are used incorrectly, or if they are applied to large areas of skin for a very long time, these side effects may still occur.

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

Reporting of side effects
If you experience any side effects, including any not listed in this leaflet, talk to 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.