Flogoprofen is an anti-inflammatory drug with analgesic properties that is used for the topical treatment of painful and inflammatory processes.

Flogoprofen is indicated in adults and adolescents (over 12 years of age) for the local relief of mild and occasional pain and inflammation caused by: small contusions, bumps, strains, torticollis or other contractures, low back pain and minor sprains produced as a result of a twist.

Do not use Flogoprofen

• If you are allergic to etofenamate or any of the other ingredients of this medicine (listed in section 6).
• If the area where the gel should be applied is irritated, with wounds or has a skin disease.
• In mucous membranes or eyes.
• If you have had an allergic reaction caused by acetylsalicylic acid or another anti-inflammatory.

Warnings and cautions

Talk to your doctor or pharmacist before using Flogoprofen.

• Use only on intact skin, not on open wounds, mucous membranes or irritated skin.
• Avoid contact with the eyes, if it occurs, wash with plenty of water.
• Do not use the product in large areas or for a long time. May cause irritation and dryness to the skin.
• Do not use occlusive bandages.
• Avoid applying it to the same area as other topical preparations.
• Do not expose the treated area to the sun to reduce the risk of an allergic reaction due to photosensitivity.
• Take special care if you suffer from: gastroduodenal ulcer, ulcerative colitis, coagulation disorders, high blood pressure, heart failure, kidney failure or liver failure.

If symptoms persist for more than 7 days or irritation or worsening occurs, you should consult your doctor.

Children and adolescents

Do not use in children under 12 years of age.

Using Flogoprofen with other medicines

Tell your doctor or pharmacist if you are using, have recently used or might take any other medicines, especially other pain relievers, even those obtained without a prescription.

• Avoid applying Flogoprofen to the same area as other topical preparations.
• Simultaneous use with topical anti-infective medications is not recommended.

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, think you might be pregnant or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Flogoprofen should not be used during pregnancy unless your doctor considers it clearly necessary.

During breastfeeding, this medicine should only be applied to small areas and for a short period of time.

Driving and using machines

The influence of Flogoprofen on the ability to drive and use machines is zero.

Flogoprofen contains dimethylsulfoxide

This medicine may cause skin irritation because it contains dimethyl sulfoxide.

Follow exactly the instructions of administration of this medicine indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist again.

The recommended dose is:

Adults and adolescents (over 12 years): Apply 3 or 4 times a day a light layer of gel on the affected area and rub lightly to absorb it.

Wash your hands after each application.

Use in children and adolescents

Do not administer in children under 12 years of age due to the lack of data on safety and efficacy in this population.

If you use more Flogoprofen than you should

Due to its cutaneous use, it is not probable that poisoning will occur. However, if you have used this medicine more than you should, or in case of accidental ingestion, go immediately to a medical center or call the Toxicology Information Service (Tel: 915620420), indicating the medicine and the amount ingested; skin irritation, headache, dizziness, or abdominal pain may occur. Remove the medicine by washing the entire affected surface with plenty of water.

If you forget to use Flogoprofen

Do not use a double dose to make up for a forgotten dose.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Like all medicines, Flogoprofen can cause side effects, although not everyone gets them.

These side effects include, in order from most to least frequent:

• Skin and subcutaneous tissue disorders: redness of the skin; allergic skin reactions (itching, rash, redness, swelling, or blisters) that usually disappear quickly with stopping treatment; allergic skin reactions from sun exposure.

Communication of adverse effects

If you experience any kind of side effect, consult your doctor or pharmacist, even if it is about possible side effects that are not listed in this leaflet. You can also communicate them directly through the Spanish Pharmacovigilance System for Medicines for Human Use http: // www.notificaram.es. By reporting side effects you can help provide more information on the safety of this medicine.

It does not require any special storage conditions.

Keep out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiration date is the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Deposit the containers and medicines that you do not need at the SIGRE Point of the pharmacy. If in doubt, ask your pharmacist how to dispose of medicines no longer required. This way you will help to protect the environment.

Composition of Flogoprofen

• The active substance is etofenamate. Each gram of gel contains 50 mg of etofenamate.
• The other ingredients (excipients) are dimethyl sulfoxide, levomenthol, carbomers, 96 percent ethanol, essence of turpentine, triethanolamine, and purified water.

What the product looks like and contents of the pack

Flogoprofen is a clear and colorless gel that is contained in an aluminum tube. Each tube contains 60 g of gel or 100 g of gel.

Marketing authorization holder

CHIESI ESPAÑA, SAU

Plaça d'Europa, 41-43, Floor 10

08908 L'Hospitalet de Llobregat

Barcelona, Spain)

Responsible for manufacturing

ALCALA FARMA, SL

Highway M-300 Km 29,920

Alcalá de Henares (Madrid) - 28802 - Spain

B. BRAUN MEDICAL, SA

Huelma, 5. Poligono Industrial Los Olivares.

Jaén (Jaén) - 23009 - Spain

This leaflet was approved in August 2012.

Detailed and updated information on this drug is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es .