DICLOREUM ANT LOC 180 MG MEDICATED PATCH, 10 PATCHES

Name
Dicloreum Local Anti-inflammatory 180 mg medicated plasters
Diclofenac hydroxyethylpyrrolidine


What it is and what it is used for
Dicloreum Local Anti-Inflammatory is a medicated patch to be applied to the skin containing the active ingredient diclofenac hydroxyethylpyrrolidine, which belongs to a category of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs).

Dicloreum Local Anti-Inflammatory is indicated for the local treatment of pain and inflammation of joints, muscles, tendons and ligaments due to rheumatic diseases or trauma.


What you need to know before taking the medicine
Do not use Local Anti-inflammatory Dicloreum
• if you are allergic to diclofenac or any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to medicines containing acetylsalicylic acid (e.g. aspirin) and to other non-steroidal anti-inflammatory drugs (NSAIDs) or to a disinfectant called isopropanol;
• if you have had previous asthma attacks, skin rash (hives) or cold (acute rhinitis) following the intake of 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 lesion: allergic reactions (exudative dermatitis, eczema), infected lesion, burns or wounds;
• if you are in the last 3 months of pregnancy and are breastfeeding (see section "Pregnancy, breastfeeding and fertility");
• if you suffer from lesions of the digestive system (active peptic ulcer);
• in children and adolescents under 16 years of age.


Warnings and precautions
The use, especially if prolonged and on large surfaces of the skin, of local anti-inflammatories could give rise to unwanted effects on the organism.

The medicated plaster should only be applied to intact, non-diseased skin that does not have wounds or open lesions. Make sure that the plaster does not come into contact with the eyes or mucous membranes.

The medicated plaster should not be applied with a tight bandage that does not allow air to pass through and when bathing or showering.

Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms.

Use Dicloreum Local Anti-Inflammatory with particular caution:
• if you suffer from kidney, heart or liver disease, if you have suffered in the past from lesions of the digestive system (peptic ulcer) or inflammatory bowel disease or predisposition to bleeding (haemorrhagic diathesis);
• if the patient is elderly, because he or she is more prone to side effects;

Use Dicloreum Local Anti-Inflammatory only after consulting your doctor:
• if you have or have had in the past allergic reactions, such as asthma attacks, skin rashes (hives) or acute allergic cold, following the taking of non-steroidal anti-inflammatory drugs (NSAIDs);
• in case of damaged skin, regardless of the type of lesion: allergic reactions (exudative dermatitis, eczema), infected lesion, 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 following application of the medicated plaster.

Avoid excessive exposure to the sun while using Dicloreum Local Anti-Inflammatory for about a day after removing the medicated plaster in order to reduce the risk of possible sensitization phenomena to sunlight.


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

Stop taking Dicloreum Local Anti-inflammatory and inform your doctor or pharmacist immediately if you notice any of the following side effects:

Common side effects (may affect up to 1 in 10 people):
• skin rash (rash);
• intense redness of the skin (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 (hives);
• severe allergic reaction (anaphylactoid) with symptoms such as agitation, low blood pressure, nausea, etc.;
• generalized swelling of the skin (angioedema);
• skin rash with raised bumps on the skin (pustules);
• shortness of breath or difficulty breathing (asthma);
• skin reactions to sunlight (photosensitivity).

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. 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.