DICLOREUM ACTIGEL "1% GEL"100 G TUBE"

Name
Dicloreum Actigel 1% Gel
Diclofenac


What is it and what is it for?
Dicloreum Actigel is a gel 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 Actigel 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 Dicloreum Actigel
• if you are allergic to diclofenac or any of the other ingredients of this medicine (listed in section 6).
• if you have had a history of asthma attacks, skin rash (hives) or cold (acute rhinitis) following the use of 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 can cause damage to the heart, lungs and kidneys of the fetus (see section "Pregnancy, breastfeeding 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 of topical anti-inflammatory medications, especially if prolonged and on large areas of skin, may cause side effects and allergies. In this case, discontinue treatment and consult your doctor.

Uses of Dicloreum Actigel:
• only on intact, non-diseased skin that does not have wounds or open lesions.
• only with bandages that allow air to pass through (loose bandages).

Be careful not to let the gel come into contact with your eyes or mucous membranes (e.g. mouth or vagina): if this happens, rinse immediately with running water and contact your doctor.

Do not ingest the gel.

Use Dicloreum Actigel with particular caution:
• 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.


Possible side effects
Like all medicines, Dicloreum Actigel 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 (erythema) and appearance of blisters (eczema)
• 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
• shortness of breath or difficulty breathing (asthma)
• skin reactions to sunlight (photosensitivity)

Dicloreum Actigel in combination with other medicines containing diclofenac may cause the following side effects:
• hypersensitivity to light
• intense redness of the skin (erythema) and appearance of blisters (eczema)
• severe skin reactions (Stevens-Johnson syndrome, Lyell 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.