BREXIADVANCE 40 mg /Ml Cutaneous Spray, Solution

Зміст інструкції

1. BrexiAdvance 40 mg/ml cutaneous spray, solution
   1. What is BrexiAdvance and what is it used for
   2. What you need to know before using BrexiAdvance
   3. How to use BrexiAdvance
   4. Possible side effects
   5. Contents of the pack and other information

BrexiAdvance 40 mg/ml cutaneous spray, solution

diclofenac sodico

Read this leaflet carefully before using this medicine as it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.

• Keep this leaflet. You may need to read it again.
• If you would like more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better 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 is BrexiAdvance and what is it 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 symptomatic local treatment of mild to moderate pain and inflammatory conditions secondary to acute contusion injuries of small and medium joints and their related appendages.
See a 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 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 breathing difficulties (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 a blood thinner).
• On mucous membranes or skin with open wounds, infections, inflammation or eczema.
• In the third trimester of pregnancy (see section “Pregnancy and breastfeeding”).

Warnings and precautions
Consult your doctor or pharmacist before using BrexiAdvance.

• Pay particular attention if you have suffered from bronchial asthma or allergies in the past.
• Avoid contact of the spray contents with your eyes; if this occurs, wash them immediately with running water and contact your doctor.
• Do not ingest BrexiAdvance.
• Stop treatment with BrexiAdvance if skin rashes develop after application of the product.
• Do not cover the treated area with occlusive (waterproof or non-breathable) bandages or dressings.
• 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 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 the symptoms.
Danger: flammable. Keep the product 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
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicine.

Consult your doctor before using BrexiAdvance:

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

Taking other NSAIDs (including acetylsalicylic acid or ibuprofen) together with BrexiAdvance can increase the risk of side effects.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning a pregnancy or are breastfeeding, ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
BrexiAdvance should not be used during the third trimester of pregnancy, as it may increase the risk of complications for the mother and the unborn child.
BrexiAdvance should only be used under the direct control of a doctor during the first and second trimester of pregnancy, limiting use to the lowest dose for the shortest possible duration of treatment.
Oral forms (e.g. tablets) of BrexiAdvance can cause adverse effects in the unborn child.
It is not known whether the same risk applies when BrexiAdvance is used on 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 needs to be treated for a long period of time.

Driving and using machines
The cutaneous application of BrexiAdvance does not impair the ability to drive and use machines.

BrexiAdvance contains propylene glycol (E1520), ethanol and soy lecithin:
This medicine contains 30 mg of propylene glycol (E1520) per spray.
This medicine contains 6.65 mg of alcohol (ethanol) per spray.
This medicine contains soy oil. If you are allergic to peanuts or soy, do not use this medicine.

3. How to use BrexiAdvance

Use this medicine following exactly as described in this leaflet or as instructed 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 extent of the area to be treated. The maximum dose per application should not exceed 5 sprays. The maximum daily dose is 15 sprays.
Treatment may be discontinued when symptoms disappear (pain and swelling).
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 external use only. Follow the instructions carefully:

• Remove the transparent protective cap from the applicator.
• Before first use, press the applicator four times to activate it, discarding the contents. If you are unable to prime the applicator correctly, it is possible that the first dose dispensed may be lower than necessary.
• Wash and dry the painful area. Apply the spray to the affected parts of the body and gently rub it into the skin. Afterwards, wipe your hands with a paper towel and then wash them, unless the area being treated is your hands.
• If an excessive amount of spray is applied accidentally, remove the excess spray with a paper towel.
• Dispose of the paper towel in household waste to prevent unused product from reaching the aquatic environment.
• Before applying a bandage, allow the spray to dry on the skin for a few minutes.

Wash and dry the area. Apply to the
area to be treated.
Massage gently
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 contents of the spray, inform your doctor immediately or go to the

If you forget to use BrexiAdvance
If you forget to use this medicine as prescribed, apply the solution as soon as possible and continue treatment as before. Do not use a double dose to make up for a missed dose.
If you have any doubts about using this medicine, ask your doctor or pharmacist.

4. 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
preparations based on diclofenac, reactions at the application site have been frequently reported,
such as rashes, itching, redness, burning sensation or
skin peeling.
painful.

Some rare or very rare side effects can be serious:
If you experience any signs of allergy from those listed below, stop using BrexiAdvance
and consult 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 a feeling of tightness in the chest (asthma); hypersensitivity reactions, including urticaria (raised, itchy, red bumps); swelling of the face, lips, tongue or throat. Other side effects may also occur, but these are often mild and transient. If you experience any side effect, consult 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 blisters; rash with pustules; gastrointestinal disorders.
• If the medicine is used for a long time and/or on large areas of skin, side effects involving the whole body may occur, such as stomach discomfort and pain, heartburn, liver and kidney disorders, hypersensitivity reactions.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your
doctor or pharmacist or nurse. You can also report side effects directly
through 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.
Keep this medicine out of the sight and reach of children.
Keep the medicine in its original packaging protected from light.
Do not use this medicine after the expiry date which is stated on the pack and the bottle after
“EXP.”. The expiry date refers to the last day of that month.
Do not use this medicine after 6 months from first opening.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What BrexiAdvance contains

• The active ingredient is diclofenac sodium. Each ml of cutaneous spray, solution (equivalent to 5 applications) contains 40 mg of diclofenac sodium. Each application of the spray (0.2 ml of solution) contains 8 mg of diclofenac sodium.
• The other components are: propylene glycol (E1520), isopropyl alcohol, Phospholipon 90G (containing phosphatidylcholine derived from soybean lecithin, lysophosphatidylcholine, non-polar lipids and tocopherol), 96% ethanol, disodium phosphate, disodium hydrogen 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.
Yellow glass bottle of 30 ml with 25 g of cutaneous spray, solution, containing 125 applications.
The applicator consists of a polypropylene pump and a polyethylene dip tube.

Marketing Authorisation Holder
Farmalider, S.A.
C/ La Granja 1
Alcobendas, Madrid

• 28108 - Spain ManufacturerMedinfar 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