Brexiadvance

Package leaflet: Information for the patient

BrexiAdvance 40 mg/ml cutaneous spray, solution

diclofenac sodium
Please read carefully all of this leaflet before you start using this medicine because it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Contact your doctor if you do not notice any improvement or if your symptoms worsen after 3 days.

Contents of this leaflet:

1. What BrexiAdvance is and what it is used for
2. What you need to know before using BrexiAdvance
3. How to use BrexiAdvance
4. Possible side effects
5. How to store BrexiAdvance
6. Contents of the pack and other information

1. What BrexiAdvance is and what it is used for

BrexiAdvance contains the active substance sodium diclofenac, which belongs to the class of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs), and is to be applied to the skin of the area to be treated.
This medicinal product 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 injuries of small and medium joints and their associated tissues.
Consult your doctor if you do not feel better or if you feel worse after 3 days.

2. What you need to know before using BrexiAdvance

Do not use BrexiAdvance

• If you are allergic to diclofenac or to any of the other ingredients of this medicine (listed in section 6).
• If you are allergic to peanuts or soya, as the medicine contains soya lecithin.
• If in the past you have had allergic reactions with breathing difficulties (asthma), skin rash, runny nose, or swelling of the face or tongue after taking any other medicine used 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.
• During the third trimester of pregnancy (see section “Pregnancy and breastfeeding”).

Warnings and precautions
Talk to your doctor or pharmacist before using BrexiAdvance.

• Take special care if in the past you have suffered from bronchial asthma or allergies.
• Avoid contact of the spray contents with the eyes; if this occurs, rinse immediately with running water and contact your doctor.
• Do not swallow BrexiAdvance.
• Stop treatment with BrexiAdvance if skin rashes appear after application.
• Do not cover the treated area with plasters or occlusive dressings (impermeable or non-breathable).
• Do not expose the treated area to sunlight or use sunlamps.

If you use BrexiAdvance over large areas of skin and for prolonged periods of time, it is possible that
undesirable effects involving the entire organism may occur. Undesirable effects can be minimized
by using the lowest effective dose for the shortest duration necessary to control symptoms.
Warning: Flammable. Keep away from sources of 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.
Other medicines and BrexiAdvance
Inform your doctor or pharmacist if you are currently using, have recently used, or might use any
other medicines.
Talk to your doctor before using BrexiAdvance:

• If you are taking any medicine containing diclofenac or acetylsalicylic acid, or any other NSAID, such as ibuprofen.

Concomitant use of other NSAIDs (including acetylsalicylic acid or ibuprofen) together with
BrexiAdvance may increase the risk of undesirable effects.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning a pregnancy, or breastfeeding, consult
your doctor or pharmacist before using this medicine.
Pregnancy
BrexiAdvance must not be used during the third trimester of pregnancy, as it may increase the risk
of complications for both mother and unborn child.
BrexiAdvance should only be used under direct medical supervision during the first and second
trimesters of pregnancy, limited to the lowest possible dose for the shortest duration necessary.
Oral forms (e.g. tablets) of BrexiAdvance may cause adverse effects in the unborn child.
It is not known whether the same risk applies with BrexiAdvance when applied to the skin.
Breastfeeding
Do not use BrexiAdvance if you are breastfeeding, unless otherwise advised by your doctor.
In any case, if you are breastfeeding, do not apply the medicine to the breast or to other parts of the
body if the area to be treated is extensive or requires prolonged treatment.
Driving and using machines
The topical application of BrexiAdvance does not impair the ability to drive or operate machinery.
BrexiAdvance contains propylene glycol (E1520), ethanol and soya lecithin:
This medicine contains 30 mg of propylene glycol (E1520) per spray actuation.
This medicine contains 6.65 mg of alcohol (ethanol) per spray actuation.
This medicine contains soya oil. If you are allergic to peanuts or soya, do not use this medicine.

3. How to use BrexiAdvance

Use this medicine exactly as stated in this leaflet or as directed by your
doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is:
Adults and adolescents over 14 years of age:
Apply 4–5 sprays, 3 times a day at regular intervals. The number of sprays
depends on the size of the area to be treated. The maximum dose per application must not exceed
5 sprays. The maximum daily dose is 15 sprays.
Treatment may be discontinued once symptoms (pain and swelling) have resolved.
Do not use this medicine for more than 7 days unless otherwise advised by your doctor.
Consult your doctor if symptoms worsen or persist after 3 days of treatment.
Use in children and adolescents:
Do not use this medicine in children and adolescents under 14 years of age.
Method of administration:
BrexiAdvance is for cutaneous use only. Follow these instructions carefully:

• Remove the transparent protective cap from the spray nozzle.
• Before first use, prime the pump by pressing down four times, discarding the sprayed content. If the spray is not properly primed, the dose delivered when first using the product may be lower than required.
• Wash and dry the affected area. Apply the spray to the affected parts of the body and gently rub into the skin. Afterwards, wipe your hands with a paper towel and then wash them, unless the hands are the area being treated.
• If too much spray has been accidentally applied, remove the excess with a paper towel.
• Dispose of the paper towel in household waste to prevent unused product from entering the aquatic environment.
• Allow the spray to dry for a few minutes on the skin before applying a dressing.

Wash and dry the affected area. Apply to the area to be treated. Gently massage to promote absorption.
If you use more BrexiAdvance than you should
If you apply more medicine than you should, remove the excess product with a paper towel.
If you accidentally ingest the spray contents, contact your doctor immediately or go to the nearest hospital.
Take the container and the package leaflet with you.
If you forget to use BrexiAdvance
If you forget to use this medicine as prescribed, apply it as soon as possible and continue treatment as before.
Do not use a double dose to make up for a forgotten dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine may cause side effects, although not everyone experiences them.
Stop using BrexiAdvance if a skin rash appears. Reactions at the application site have been frequently reported after topical (skin) use of diclofenac-containing preparations, such as skin rash, itching, redness, burning sensation, or skin peeling.
Some rare or very rare side effects can be serious:
If you experience any of the allergic signs 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 tightness in the chest (asthma); hypersensitivity reactions, including urticaria (red raised welts, often accompanied by itching and burning); swelling of the face, lips, tongue, or throat. Other side effects may also occur, but are often mild and temporary. If you experience any side effect, consult your doctor or pharmacist.
• Common (may affect 1 in 10 people): skin rash, itching, redness, or stinging 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): skin may become more sensitive to sunlight (photosensitivity), possibly resulting in sunburn accompanied by itching, swelling, and blistering; skin rash with pustules; gastrointestinal disturbances.
• If the medicine is used for long periods and/or over large areas of skin, side effects affecting the whole body may occur, such as stomach discomfort and pain, heartburn, liver and kidney disorders, and hypersensitivity reactions.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system at http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store BrexiAdvance

Keep this medicine out of the sight and reach of children.
Store the medicine in its original packaging, protected from light.
Do not use this medicine after the expiry date stated on the carton and on the vial after "EXP.". The expiry date refers to the last day of that month.
Do not use this medicine more than 6 months after first opening.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What BrexiAdvance contains

• The active substance is sodium diclofenac. Each ml of cutaneous spray solution (equivalent to 5 actuations) contains 40 mg of sodium diclofenac. Each spray actuation (0.2 ml of solution) contains 8 mg of sodium diclofenac.
• The other ingredients are: propylene glycol (E1520), isopropyl alcohol, Phospholipon 90G (containing phosphatidylcholine derived from soybean lecithin, lysophosphatidylcholine, non-polar lipids and tocopherol), 96% ethanol, disodium phosphate, sodium dihydrogen phosphate dihydrate, disodium edetate, ascorbyl palmitate, peppermint oil, diluted hydrochloric acid, 10% sodium hydroxide and purified water.

Description of the appearance of BrexiAdvance and contents of the pack
BrexiAdvance is a yellowish solution.
30 ml amber glass bottle containing 25 g of cutaneous spray solution, providing 125 actuations.
The dispenser consists of a polypropylene pump and a polyethylene dip tube.

Marketing Authorization Holder
Farmalider, S.A.
C/ La Granja 1
Alcobendas, Madrid
28108 - Spain

Manufacturer
Medinfar Manufacturing, S.A.
Parque Industrial Armando Martins Tavares,
Rua Outeiro da Armada, 5,
Condeixa-a-Nova
3150-194, Portugal

FARMALIDER, S.A.
Calle Aragoneses 2,
28108, Alcobendas
Madrid, Spain