Package Insert: Information for the User

Flogoprofen 50 mg/g Gel

Etofenamate

Read this entire package insert carefully before starting to use this medication, as it contains important information for you.

Follow exactly the medication administration instructions contained in this package insert or those provided by your doctor or pharmacist.

• Keep this package insert, as you may need to refer to it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.
• You should consult a doctor if your condition worsens or does not improve after 7 days.

Flogoprofen is an anti-inflammatory medication 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) for local relief of mild and occasional pain and inflammation caused by: small bruises, blows, strains, torticollis or other contractures, lower back pain, and mild sprains resulting from a twist.

Do not use Flogoprofen

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

Warnings and precautions

Consult your doctor or pharmacist before starting to use Flogoprofen

• Use it only on intact skin, not on open wounds, mucous membranes, or irritated skin.
• Avoid contact with the eyes; if this occurs, wash abundantly with water.
• Do not use the product on extensive areas or for a prolonged period. It may cause skin irritation and dryness.
• Do not use occlusive dressings.
• 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 allergic reaction by photosensitivity.
• Be especially careful if you have: gastric or duodenal ulcer, ulcerative colitis, coagulation disorders, high blood pressure, heart failure, renal insufficiency, or liver insufficiency.

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.

Use of Flogoprofen with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication, especially if it is another analgesic, even those acquired without a prescription.

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

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

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

Driving and operating machines

The influence of Flogoprofen on the ability to drive and operate machines is nil.

Flogoprofen contains dimethylsulfoxide

This medication may cause skin irritation because it contains dimethylsulfoxide.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose is:

Adults and adolescents (over 12 years): Apply a light layer of gel 3 or 4 times a day to the affected area and gently rub it in for absorption.

Wash your hands after each application.

Use in children and adolescents

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

If you use more Flogoprofen than you should

Due to its topical use, poisoning is unlikely. However, if you have used this medication more than you should, or in case of accidental ingestion, go immediately to a medical center or call the Toxicological Information Service (Tel: 915620420), indicating the medication and the amount ingested; skin irritation, headache, dizziness, or abdominal pain may occur. Remove the medication by washing the affected area thoroughly with plenty of water.

If you forgot to use Flogoprofen

Do not use a double dose to compensate for the missed dose.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, Flogoprofen may cause adverse effects, although not everyone will experience them.

Among these adverse effects, listed in order from most frequent to least frequent:

• Dermatological and subcutaneous tissue disorders: skin redness; skin allergic reactions (pruritus, rashes, redness, swelling, or blisters) that generally disappear quickly with treatment interruption; skin allergic reactions due to sun exposure.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use http://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

No special storage conditions are required.

Keep out of sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medicines at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medicines. By doing so, you will help protect the environment.

Composition of Flogoprofen

• The active principle is etofenamate. Each gram of gel contains 50 mg of etofenamate.
• The other components (excipients) are dimethylsulfoxide, levomenthol, carboxymers, ethanol at 96 percent, menthol essence, triethanolamine, and purified water.

Appearance of the product and contents of the packaging

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

Holder of the marketing authorization

CHIESI ESPAÑA, S.A.U.

Plaça d’Europa, 41-43, 10th floor

08908 L’Hospitalet de Llobregat

Barcelona (Spain)

Responsible for manufacturing

ALCALA FARMA, S.L

Carretera M-300 Km 29,920

Alcalá de Henares (Madrid) - 28802 - Spain

B. BRAUN MEDICAL, S.A.

Huelma, 5. Industrial Park Los Olivares.

Jaén (Jaén) - 23009 – Spain

This prospectus was approved in August 2012.

The detailed and updated information on this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es.