Flogoprofen 50 mg/ml solution for cutaneous spray
Spain
Table of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
Flogoprofen 50 mg/ml cutaneous spray solution
Etofenamate
Read all of this leaflet carefully before you start using this medicine, because it contains important information for you.
Follow exactly the instructions for administering this medicine provided in this leaflet or as directed by your doctor or pharmacist.
- Keep this leaflet. You may need to read it again.
- If you need advice or more information, consult your pharmacist.
- If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.
- You should consult a doctor if your condition worsens or if you do not improve after 7 days.
Contents of this leaflet
- What Flogoprofen is and what it is used for
- What you need to know before using Flogoprofen
- How to use Flogoprofen
- Possible side effects
- How to store Flogoprofen
- Contents of the pack and other 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 conditions.
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: minor bruises, blows, strains, torticollis or other muscle spasms, lumbago, and mild sprains resulting from twisting injuries.
2. What you need to know before using Flogoprofen
Do not use Flogoprofen
- If you are allergic to etofenamate or to any of the other ingredients of this medicine (listed in section 6).
- If the area where the gel is to be applied is irritated, has wounds, or presents any skin disease.
- On mucous membranes or eyes.
- If you have previously experienced an allergic reaction to acetylsalicylic acid or other anti-inflammatory drugs.
Warnings and precautions
Consult your doctor or pharmacist before starting to use Flogoprofen
- Use only on intact skin, not on open wounds, mucous membranes, or irritated skin.
- Avoid contact with the eyes; if contact occurs, rinse thoroughly with plenty of water.
- Do not use the product over large areas or for prolonged periods. This may cause skin irritation and dryness.
- Do not use occlusive dressings.
- Avoid applying it in the same area as other topical preparations.
- Avoid exposing treated areas to sunlight to reduce the risk of photosensitivity allergic reactions.
- Take special care if you suffer from: gastroduodenal ulcer, ulcerative colitis, coagulation disorders, high blood pressure, heart failure, renal or hepatic insufficiency.
- Do not use near open flames or incandescent sources, and do not spray near fire. Keep the container protected from excessive heat.
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.
Use of Flogoprofen with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, especially other analgesics, including those obtained without a prescription.
- Avoid applying Flogoprofen to the same area as other topical preparations.
- Simultaneous use with topical anti-infective medicines is not recommended.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you might be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Flogoprofen must not be used during pregnancy unless clearly considered necessary by your doctor.
During breastfeeding, this medicine should only be applied to small areas and for a short period of time.
Driving and using machines
Flogoprofen has no influence on the ability to drive or operate machinery.
Flogoprofen contains dimethyl sulfoxide and propylene glycol
This medicine may cause skin irritation because it contains dimethyl sulfoxide and propylene glycol.
This medicine contains 100 mg of propylene glycol per milliliter of solution. Do not use on open wounds or large damaged skin areas (such as burns) without consulting your doctor or pharmacist first.
3. How to use Flogoprofen
Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
The recommended dose is:
Adults and adolescents (over 12 years of age): Apply a thin layer of the solution to the affected area 3 or 4 times a day and gently rub in until absorbed.
Wash hands after each application.
Use in children and adolescents
Do not administer to children under 12 years of age due to lack of safety and efficacy data in this population.
If you use more Flogoprofen than you should
Because of its topical use, poisoning is unlikely. However, if you have used more of this medicine 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. Symptoms may include skin irritation, headache, dizziness, or abdominal pain. Remove the medicine by washing the entire affected area thoroughly with abundant water.
If you forget to use Flogoprofen
Do not use a double dose to make up for the missed dose.
If you have any other questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, Flogoprofen may cause adverse effects, although not everyone will experience them.
These adverse effects include, in order from most to least frequent:
- Disorders of the skin and subcutaneous tissue: skin redness; allergic skin reactions (pruritus, rashes, redness, swelling, or blisters), which usually disappear quickly once treatment is discontinued; allergic skin reactions due to exposure to sunlight.
Reporting of 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 leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: http://www.notificaram.es.
By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Flogoprofen
No special storage conditions are required.
Flammable liquid; keep away from flames and excessive sources of heat.
Keep out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Flogoprofen
- The active substance is etofenamate. Each millilitre of solution contains 50 mg of etofenamate.
- The other components are dimethyl sulfoxide, turpentine oil, levomenthol, propylene glycol (E-1520), and 96 percent ethanol.
Nature of the product and pack contents
Flogoprofen is a slightly yellowish, transparent solution with a turpentine oil odour, contained in a polyethylene spray bottle. Each bottle contains 100 ml of solution for cutaneous spray.
Marketing Authorisation Holder
CHIESI ESPAÑA, S.A.U.
Plaça d’Europa, 41-43, Planta 10
08908 L’Hospitalet de Llobregat
Barcelona (Spain)
Manufacturer
ITALFARMACO S.A.
San Rafael, 3
28108 Alcobendas
Madrid (Spain)
Date of the most recent revision of this leaflet: February 2019.
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es.