BREXIADVANCE*SPRAY30ML/125DOSES

BrexiAdvance 40 mg/ml cutaneous spray, solution
Diclofenac sodium

What it is and what it is used for
BrexiAdvance contains the active ingredient diclofenac sodium, which belongs to the class of non-steroidal anti-inflammatory drugs (NSAIDs) and should be applied to the skin of the affected area.

This medicine is indicated in adults and adolescents over 14 years of age for the medium-term local symptomatic treatment of mild to moderate pain and inflammatory conditions secondary to acute blunt trauma to small and medium joints and their associated structures.

Consult your doctor if you do not feel better or if you feel worse after 3 days.

What you need to know before taking the medicine
Do not use BrexiAdvance
• If you are allergic to diclofenac or any of the other ingredients of this medicine (listed in section 6).
• If you are allergic to peanuts or soy, as the medicine contains soy lecithin.
• If you have previously had allergic reactions with difficulty breathing (asthma), skin rash, runny nose, or swelling of the face or tongue after taking any other medicine to relieve pain, fever, or inflammation, such as ibuprofen or acetylsalicylic acid (also used as an anticoagulant).
• On mucous membranes or on skin with open wounds, infections, inflammations, or eczema.
• In the third trimester of pregnancy (see the section Pregnancy and breastfeeding).

Warnings and precautions
Talk to your doctor or pharmacist before using BrexiAdvance.
• Pay particular attention if you have a history of bronchial asthma or allergies.
• Avoid contact of the spray content with the eyes; if this occurs, wash them immediately with running water and contact your doctor.
• Do not swallow BrexiAdvance.
• Discontinue treatment with BrexiAdvance if skin rashes appear after applying the product.
• Do not cover the treated area with occlusive bandages or dressings (waterproof or non-breathable).
• Do not expose the treated area to the sun and do not use sunbeds.
If BrexiAdvance is used on large areas of skin and for long periods of time, side effects affecting the whole body may occur. Side effects can be minimized by using the lowest effective dose for the shortest duration of treatment necessary to control symptoms.

Danger: flammable. Keep the product away from heat sources, heated surfaces, sparks, open flames, or other ignition sources.

Children and adolescents
Do not use this medicine in children and adolescents under 14 years of age.

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

Discontinue use of BrexiAdvance if a skin rash appears. After topical (cutaneous) use of diclofenac preparations, reactions at the application site, such as skin rashes, itching, redness, burning sensation or skin peeling, have been frequently reported.

Some rare or very rare side effects can be serious:
If you experience any of the signs of allergy listed below, stop using BrexiAdvance and contact your doctor immediately.
- Rare (may affect up to 1 in 1,000 people): rash with blisters.
- Very rare (may affect up to 1 in 10,000 people): wheezing, shortness of breath or tightness in the chest (asthma); hypersensitivity reactions, including urticaria (raised red wheals, often accompanied by itching and burning); swelling of the face, lips, tongue or throat. Other side effects may also occur, which are often mild and transient. If you get any side effects, talk to your doctor or pharmacist.
- Common (may affect 1 in 10 people): rash, itching, redness or tingling of the skin after using the medicine.
- Uncommon (may affect 1 in 100 people): dandruff, dry skin, edema.
- Very rare (may affect up to 1 in 10,000 people): the skin may become more sensitive to sunlight (photosensitivity) with possible sunburn accompanied by itching, swelling and blistering; rash with pustules; gastrointestinal disorders.
- If the medicine is used for a long period of time and/or on large areas of skin, side effects involving the entire body may occur, such as stomach upset and pain, heartburn, liver and kidney disorders, hypersensitivity reactions.

Reporting of side effects
If you get 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.