FLOGOPROFEN 50 mg/ml CUTANEOUS SPRAY SOLUTION

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.

4. Possible Side Effects

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

Among these side effects, the following are included in order of higher to lower frequency:

• Disorders of the skin and subcutaneous tissue: skin redness; allergic skin reactions (pruritus, eruptions, redness, swelling, or blisters) that usually disappear quickly with treatment interruption; allergic skin 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.

Highly flammable liquid, keep away from flames and excessive heat sources.

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 point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Flogoprofen

• The active ingredient is etofenamate. Each milliliter of solution contains 50 mg of etofenamate.
• The other components are dimethyl sulfoxide, turpentine essence, levomenthol, propylene glycol (E-1520), and 96% ethanol.

Appearance of the Product and Package Contents

Flogoprofen is a slightly yellowish transparent solution with a turpentine essence odor, contained in a polyethylene spray bottle. Each bottle contains 100 ml of solution for cutaneous spray.

Marketing Authorization Holder

CHIESI ESPAÑA, S.A.U.

Plaça d’Europa, 41-43, 10th floor

08908 L’Hospitalet de Llobregat

Barcelona (Spain)

Manufacturer

ITALFARMACO S.A.

San Rafael, 3

28108 Alcobendas

Madrid (Spain)

Date of the Last Revision of this Package Leaflet: February 2019.

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.