DICLOREUM ACTIGEL*GEL 50G 1%

Dicloreum Actigel 1% Gel
Diclofenac

What it is and what it is used for
Dicloreum Actigel is a gel for topical application containing the active ingredient diclofenac hydroxyethylpyrrolidine, which belongs to a class of medicines called non-steroidal 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 paragraph 6).
• if you have had previous asthma attacks, rash (hives) or cold (acute rhinitis) 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 foetus (see paragraph 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-inflammatories, especially if prolonged and on extensive skin surfaces, could lead to undesirable effects on the body and allergies. In such a case, it is necessary to stop the treatment and consult your doctor.

Use Dicloreum Actigel:
• only on intact, unbroken skin, which does not have open wounds or lesions.
• only with air-permeable bandages (non-tight bandages).

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

Do not swallow the gel.

Use Dicloreum Actigel with particular caution:
• if you suffer from asthma, chronic obstructive bronchial diseases, allergic rhinitis or inflammation of the nasal mucosa (nasal polyps) because you may more easily, compared to other patients, experience asthma attacks, local inflammation of the skin or mucous membranes (Quincke's oedema) and skin rash (hives).

Possible side effects
Like all medicines, Dicloreum Actigel can cause side effects, although not everyone experiences them.

Common side effects (may affect up to 1 in 10 people):
• skin rash
• intense skin redness (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 (angioneurotic oedema)
• skin eruption (rash) with pustules
• shortness of breath or difficulty breathing (asthma)
• skin reactions to sunlight (photosensitivity)

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

Reporting of side effects
If you get any side effects, including any not listed in this leaflet, tell 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.