BREXIADVANCE*SPRAY30ML/125ERG

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 must be applied to the skin of the area to be treated.

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 of small and medium joints and their appendages.

Talk to 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 had allergic reactions in the past with difficulty breathing (asthma), skin rash, runny nose or swelling of the face or tongue after taking any other medicines to relieve pain, fever or inflammation, such as ibuprofen or acetylsalicylic acid (also used as an anticoagulant).
• On mucous membranes or skin with open wounds, infections, inflammation or eczema.
• In the third trimester of pregnancy (see the paragraph "Pregnancy and breastfeeding").

Warnings and precautions
Talk to your doctor or pharmacist before using BrexiAdvance.
• Take particular care if you have suffered from bronchial asthma or allergies in the past.
• Avoid letting the contents of the spray come into contact with your eyes; if this occurs, wash them immediately with running water and contact your doctor.
• Do not swallow BrexiAdvance.
• Stop treatment with BrexiAdvance if skin rashes appear after applying the product.
• Do not cover the treated area with plasters or occlusive bandages (waterproof or non-breathable).
• Do not expose the treated area to the sun and do not use tanning lamps.
If you use BrexiAdvance on large areas of skin and for long periods of time, it is possible that you may experience side effects that affect the entire body. Side effects can be minimized by use of the lowest effective dose for the shortest duration of treatment needed to control symptoms.

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

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.

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

Some rare or very rare side effects can be serious:
If you experience any signs of allergy listed below, stop using BrexiAdvance and contact your doctor immediately.
- Rare (may affect up to 1 in 1,000 people): skin rash with blistering.
- Very rare (may affect up to 1 in 10,000 people): wheezing, shortness of breath or feeling of chest tightness (asthma); hypersensitivity reactions, including urticaria (raised red bumps, often accompanied by itching and burning); swelling of the face, lips, tongue or throat.

Other side effects may also occur, but they are often mild and transient. If you experience any side effects, contact 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 the appearance of blisters; skin rash with the appearance of pustules; gastrointestinal disorders.
- If the medicine is used for a long period of time and/or on large areas of skin, side effects may occur which involve the whole body, such as stomach discomfort and pain, heartburn, liver and kidney disorders, hypersensitivity reactions.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist, including any 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.