FLOGOPROFEN 50 mg/g Gel

Introduction

Package Leaflet: Information for the User

Flogoprofen 50 mg/g Gel

Etofenamate

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

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist.

• Keep this package leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.
• You should consult a doctor if your symptoms worsen or do not improve after 7 days.

Contents of the Package Leaflet

1. What Flogoprofen is and what it is used for
2. What you need to know before using Flogoprofen
3. How to use Flogoprofen
4. Possible side effects
5. Storage of Flogoprofen
6. Package contents and additional information

1. What Flogoprofen is and what it is used for

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

Flogoprofen is indicated in adults and adolescents (over 12 years) for the local relief of mild and occasional pain and inflammation caused by: minor bruises, blows, sprains, torticollis, or other contractures, mild lumbar and ankle sprains resulting from a twist.

2. What you need to know before using Flogoprofen

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.
• On mucous membranes or eyes.
• If you have had an allergic reaction caused by acetylsalicylic acid or another anti-inflammatory medication.

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; in case of contact, rinse thoroughly with water.
• Do not use the product on large areas or for prolonged periods. It may cause skin irritation and dryness.
• Do not use occlusive dressings.
• Avoid applying it to the same area as other topical preparations.
• Avoid exposing the treated area to the sun to reduce the risk of allergic reactions due to photosensitivity.
• Be especially careful if you have: gastroduodenal ulcer, ulcerative colitis, coagulation disorders, high blood pressure, heart failure, renal insufficiency, or hepatic insufficiency.

If symptoms persist for more than 7 days or if 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 medications

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

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

Pregnancy and breastfeeding

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

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

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

Driving and using machines

Flogoprofen has no influence on the ability to drive and use machines.

Flogoprofen contains dimethyl sulfoxide

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

3. How to use Flogoprofen

Follow 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 3 or 4 times a day a thin layer of gel to the affected area and gently rub it in.

Wash your hands after each application.

Use in children and adolescents

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

If you use more Flogoprofen than you should

Due to its topical use, overdose 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 Toxicology Information Service (Tel: 915620420), indicating the medication and the amount ingested; you may experience skin irritation, headache, dizziness, or abdominal pain. Remove the medication by washing the entire affected area with plenty of water.

If you forget to use Flogoprofen

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

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

4. Possible side effects

Like all medications, Flogoprofen can cause side effects, although not everyone will experience them.

These side effects include, in order of frequency:

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

Reporting side effects

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

5. Storage of Flogoprofen

No special storage conditions are required.

Keep out of sight and reach of children.

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

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Flogoprofen composition

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

Appearance of the product and package contents

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

Marketing authorization holder

CHIESI ESPAÑA, S.A.U.

Plaça d’Europa, 41-43, 10th floor

08908 L’Hospitalet de Llobregat

Barcelona (Spain)

Manufacturer

ALCALA FARMA, S.L

Carretera M-300 Km 29,920

Alcalá de Henares (Madrid) - 28802 - Spain

• BRAUN MEDICAL, S.A.

Huelma, 5. Poligono Industrial Los Olivares.

Jaén (Jaén) - 23009 – Spain

This package leaflet was approved in August 2012.

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