DICLOREUM ANT LOC*10CER MED180

Dicloreum Antinfiammatorio Locale 180 mg medicated patches
Diclofenac hydroxyethylpyrrolidine

What it is and what it is for
Dicloreum Antinfiammatorio Locale is a medicated patch for topical application containing the active ingredient diclofenac hydroxyethylpyrrolidine, which belongs to a category of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).

Dicloreum Antinfiammatorio Locale is indicated for the local treatment of pain and inflammation in joints, muscles, tendons and ligaments due to rheumatic diseases or trauma.

What you need to know before taking the medicine
Do not use Dicloreum Antinfiammatorio Locale
• if you are allergic to diclofenac or any of the other ingredients of this medicine (listed in paragraph 6);
• if you are allergic to medicines containing acetylsalicylic acid (e.g. aspirin) and other non-steroidal anti-inflammatory drugs (NSAIDs) or to a disinfectant called isopropanol;
• in case of previous asthma attacks, skin rash (urticaria) or cold (acute rhinitis) that occurred after taking medicines containing acetylsalicylic acid (e.g. aspirin) or other non-steroidal anti-inflammatory drugs (NSAIDs);
• in case of damaged skin, regardless of the type of injury: allergic reactions (exudative dermatitis, eczema), infected lesions, burns or wounds;
• if you are in the last 3 months of pregnancy and during breastfeeding (see paragraph Pregnancy, breastfeeding and fertility);
• if you suffer from digestive system lesions (active peptic ulcer);
• in children and adolescents under 16 years of age.

Warnings and precautions
The use of topical anti-inflammatories, especially if prolonged and over large areas of the skin, could lead to undesirable effects on the body.

The medicated patch must only be applied to intact, healthy skin, free from wounds or open lesions. Take care that the patches do not come into contact with the eyes or mucous membranes.

The medicated patch should not be applied with a tight, air-tight bandage or when bathing or showering.

Undesirable effects can be minimised by using the lowest effective dose for the shortest possible duration of treatment needed to control symptoms.

Use Dicloreum Antinfiammatorio Locale with particular caution:
• if you suffer from kidney, heart or liver disease, if you have a history of digestive system lesions (peptic ulcer) or inflammatory bowel disease or a predisposition to bleeding (haemorrhagic diathesis);
• if you are an elderly patient, as you are more prone to undesirable effects;

Use Dicloreum Antinfiammatorio Locale only after consulting your doctor:
• if you have or have had allergic reactions in the past, such as asthma attacks, skin rashes (urticaria) or acute allergic rhinitis, following the intake of non-steroidal anti-inflammatory drugs (NSAIDs);
• in case of damaged skin, regardless of the type of injury: allergic reactions (exudative dermatitis, eczema), infected lesions, burns or wounds;
• if you suffer or have suffered in the past from peptic ulcer.

Stop treatment immediately and contact your doctor or pharmacist:
• if a skin rash appears after applying the medicated patch.

Avoid excessive exposure to the sun while using Dicloreum Antinfiammatorio Locale for about one day after removing the medicated patch to reduce the risk of possible sensitisation to sunlight.

Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking Dicloreum Antinfiammatorio Locale and immediately inform your doctor or pharmacist if you notice any of the following side effects:

Common side effects (may affect up to 1 in 10 people):
• skin rash;
• intense skin redness (erythema) and appearance of blisters (eczema);
• inflammatory or allergic skin reactions (allergic dermatitis and contact dermatitis), itching;
• reactions at the administration site.

Rare side effects (may affect up to 1 in 1,000 people):
• skin inflammation with blisters (bullous dermatitis);
• dry skin.

Very rare side effects (may affect up to 1 in 10,000 people):
• allergic reactions, including skin rash (urticaria);
• severe allergic reaction (anaphylactoid) with symptoms such as agitation, low blood pressure, nausea, etc.;
• generalised skin swelling (angioneurotic oedema);
• skin rash with raised skin (pustules);
• shortness of breath or difficulty breathing (asthma);
• skin reactions to sunlight (photosensitivity).

Reporting of side effects
If you get any side effects, including those 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.