BRUFEN ANTI-INFLAMMATORY GEL 40G 5%

Brufen Topical Anti-inflammatory 5% gel
Etofenamate

What it is and what it is used for
Brufen Topical Anti-inflammatory 5% gel is a medicine containing etofenamate, a topical anti-inflammatory.

Brufen Topical Anti-inflammatory is indicated in adults:
• for the topical treatment of pain and inflammation of joints, muscles, tendons and ligaments.

Consult your doctor if you do not feel better or if you feel worse after 1-2 weeks.

What you need to know before taking the medicine
Do not use Brufen Topical Anti-inflammatory • if you are allergic to etofenamate or any of the other ingredients of this medicine (listed in paragraph 6).
• if you are allergic to flufenamic acid or other non-steroidal anti-inflammatory drugs (NSAIDs).
• if you are in your third trimester of pregnancy.
• if you are breastfeeding.
• if you are under 18 years of age.

Warnings and precautions
Consult your doctor or pharmacist before using Brufen Topical Anti-inflammatory.

Avoid applying Brufen Topical Anti-inflammatory 5% gel:
• on open wounds
• on inflamed skin with red patches, itching.

Avoid contact of Brufen Topical Anti-inflammatory 5% gel:
• with eyes and mucous membranes (e.g. mouth, nose).

You must wash your hands after applying the product and avoid contact with these parts of the body.

Do not expose the treated area to the sun and/or sunlamp during treatment and for the following two weeks.
If you suffer from asthma, chronic obstructive respiratory diseases, hay fever or chronic swelling of the nasal mucous membranes (so-called nasal polyps) or chronic obstructive airway diseases or chronic airway infections, especially if combined with hay fever symptoms, use Brufen Topical Anti-inflammatory only after taking certain precautions and under strict medical supervision.
Children must not come into contact with the skin areas treated with the medicine.

The use, especially prolonged, of products to be applied to the skin can lead to allergies. In this case, stop the treatment and ask your doctor for advice (see paragraph "Possible side effects").

Do not take this medicine orally.

If you have previously experienced allergies, use Brufen Topical Anti-inflammatory with due caution.

Children and adolescents
Use in children and adolescents under 18 years of age is not recommended, as safety and efficacy have not been established.

Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone experiences them.

During treatment with Brufen Topical Anti-inflammatory, especially if prolonged, as with other topical products, you may experience an allergy. In this case, STOP the treatment and ask your doctor for advice.

In addition, the following side effects have been observed and reported, the frequency of which cannot be established:

Effects concerning the skin
• skin redness
• irritation
• itching
• skin rash
• swelling (oedema)
• formation of blisters on the skin

The possible side effects reported above generally occur on the treated skin and disappear if the application of the cream is stopped.
• skin inflammation (allergic contact dermatitis)
• skin redness with appearance of hives and itching (urticaria)
• diffuse swelling of the skin

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.