FLOGOPROFEN 50 mg/ml CUTANEOUS SPRAY SOLUTION

Introduction

Package Leaflet: Information for the User

Flogoprofen 50 mg/ml solution for cutaneous spray

Etofenamate

Read the entire 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 side effects 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 pain and inflammation of mild and occasional nature produced by: minor bruises, blows, sprains, torticollis, or other contractures, mild low back pain, and sprains caused by 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, wounded, or has a skin disease.
• On mucous membranes or eyes.
• If you have suffered any 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; in case of contact, rinse abundantly 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.
• Do not expose the treated area to the sun to reduce the risk of allergic reactions due to photosensitivity.
• Be especially careful if you suffer from: gastroduodenal ulcer, ulcerative colitis, coagulation disorders, high blood pressure, heart failure, renal failure, or hepatic failure.
• Do not use near incandescent sources or spray near fire. Keep the container protected from excessive heat sources.

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

Inform 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 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 except if 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

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

Flogoprofen contains dimethyl sulfoxide and propylene glycol

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

This medication contains 100 mg of propylene glycol per milliliter of solution; do not use on open wounds or large areas of damaged skin (such as burns) without consulting your doctor or pharmacist first.

3. How to Use Flogoprofen

Follow the administration instructions for this medication as indicated by your doctor or pharmacist. In case of 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 solution to the affected area and gently rub in.