DICLOREUM ANT LOC 3% SKIN FOAM PRESSURIZED CONTAINER 1 CONTAINER OF 50 G

Name
Dicloreum Local Anti-inflammatory 3% skin foam, pressurized container
Diclofenac


What it is and what it is used for
Dicloreum Local Anti-Inflammatory is a foam to be applied to the skin containing the active ingredient diclofenac, which belongs to a category of drugs called non-steroidal 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 a history of asthma attacks, skin rash (hives) or colds after taking medicines containing acetylsalicylic acid (e.g. aspirin), other non-steroidal anti-inflammatory drugs and isopropanol;
• if you are in the last 3 months of pregnancy as it may cause damage to the heart, lungs and kidneys of the fetus (see section "Pregnancy, breast-feeding and fertility");
• in children and adolescents under 14 years of age as data on the safety and efficacy of the medicine in this age group are unknown.


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.

Uses Dicloreum Local Anti-inflammatory:
- only on intact, non-diseased skin that does not have wounds or open lesions;
- only with bandages that allow air to pass through and not with tight bandages.

Be careful not to allow the foam to come into contact with your eyes and avoid ingesting it.

Use Dicloreum Local Anti-Inflammatory with particular caution:
- if you have had allergic reactions in the past, such as asthma attacks, skin rashes or acute allergic colds, following the taking of non-steroidal anti-inflammatory drugs or painkillers;
- if you suffer from asthma, chronic obstructive bronchial disease, allergic cold or inflammation of the nasal mucosa (nasal polyps) because you may experience asthma attacks, local inflammation of the skin or mucous membranes (Quincke's edema) and skin rash (urticaria) more easily than other patients;
- if you are an elderly patient or suffer from stomach problems, because you should avoid taking other anti-inflammatory drugs taken by mouth, suppository or injection at the same time as this medicine.

Stop treatment and contact your doctor or pharmacist:
• if a skin rash appears following application of the medicine;
• if allergic reactions occur after the application, especially if prolonged, of other medicines for local use.

Avoid excessive exposure to the sun while using Dicloreum Local Anti-Inflammatory to avoid possible sensitization to sunlight.


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

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

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

Very rare side effects (may affect up to 1 in 10,000 people):
• allergic reactions, including skin rash (hives);
• rapid swelling of the skin (angioedema);
• skin rash with pustules;
• asthma;
• skin reactions to sunlight (photosensitivity).

Dicloreum in association with other medicinal products containing diclofenac may cause the following side effects:
- hypersensitivity to light;
- skin rash with blistering;
- eczema;
- erythema;
- severe skin reactions (Stevens-Johnson syndrome, Lyell syndrome).

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.