Ibufen 50 mg/g gel
Spain
Table of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
IBUFÉN 50 mg/g gel
Read this entire leaflet carefully before you start using this medicine, as it contains important information for you.
Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist.
- Keep this leaflet, as you may need to read 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 effects not listed in this leaflet. See section 4.
- You should consult a doctor if your condition worsens or does not improve after 7 days of treatment (5 days in adolescents).
Contents of this leaflet
- What IBUFÉN is and what it is used for
- What you need to know before using IBUFÉN
- How to use IBUFÉN
- Possible adverse effects
- How to store IBUFÉN
- Contents of the pack and other information
1. What IBUFÉN is and what it is used for
IBUFÉN is a gel for topical use (on the skin).
Ibuprofen is a topical analgesic that works by relieving pain.
It is indicated for the local symptomatic relief of occasional muscular and joint pain, such as that caused by minor bruises, blows, sprains, torticollis or other muscle spasms, mild sprains resulting from twisting injuries, and lumbago.
2. What you need to know before using IBUFÉN.
Do not use IBUFÉN
- If you are allergic to ibuprofen or to any of the other ingredients of this medicine (listed in section 6).
- If you have experienced allergic reactions such as asthma attacks (difficulty breathing, suffocation, bronchospasm, and in some cases coughing or wheezing) when taking acetylsalicylic acid, other painkillers, or anti-inflammatory medicines. If you suffer or have suffered from asthma, rhinitis, edema, or urticaria.
- On open wounds, mucous membranes, or eczematous skin.
- If you have sunburn in the affected area.
- In children (under 12 years of age).
- During the last 3 months of pregnancy.
Warnings and precautions
Consult your doctor or pharmacist before starting to use IBUFÉN.
- This medicine is for topical use only; do not ingest.
- Apply only to intact, unbroken skin.
- Avoid contact with mucous membranes (nose, mouth) and eyes.
- Do not apply the gel over large areas of skin or for prolonged periods.
- Do not use with tight bandages or apply heat to the area where the product is used. If covering the treated area, ensure that the garment covering it remains slightly loose.
- Treated areas must not be exposed to sunlight (even when cloudy) or to ultraviolet lamps (UV rays).
Skin reactions
Serious skin reactions have been reported, such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), and acute generalized exanthematous pustulosis (AGEP), associated with treatment with IBUFÉN. Discontinue treatment with IBUFÉN and seek immediate medical attention if you notice any symptoms related to these serious skin reactions described in section 4.
Stop using IBUFÉN and contact your doctor immediately if you develop any skin rash, lesions on mucous membranes, blisters, or other signs of allergy, as these may be early signs of a severe skin reaction. See section 4.
Children and adolescents
Do not use this medicine in children under 12 years of age.
Use of IBUFÉN with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Do not apply other topical preparations to the same area of skin where you are using this medicine.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Do not use IBUFÉN during the last 3 months of pregnancy. You should not use IBUFÉN gel during the first 6 months of pregnancy unless clearly necessary and advised by your doctor. If treatment is required during this period, the lowest effective dose should be used for the shortest possible duration.
Oral forms (e.g., tablets) of ibuprofen may cause adverse effects in the fetus. It is unknown whether the same risk applies to IBUFÉN gel when applied to the skin.
Driving and using machines
No effects on the ability to drive or operate machinery have been reported with external use on the skin.
3. How to use IBUFÉN
Follow exactly the instructions for use provided in this leaflet or those indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
If you think that the effect of IBUFÉN is too strong or too weak, inform your doctor or pharmacist.
The recommended dose in adults and adolescents aged 12 years and older is 3 to 4 applications per day.
How to use:
This medicine is for external cutaneous use only, applied exclusively to intact skin. For the first use, you may use the cap to pierce the tube.
Apply the medicine with a gentle massage to enhance penetration, and wash your hands after each application to remove any residual medicine.
Do not apply for more than 7 consecutive days.
If you use more IBUFÉN than you should
Due to its external use, poisoning is unlikely.
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.
If you forget to use IBUFÉN
Do not use a double dose to make up for forgotten doses.
If you stop using IBUFÉN
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.
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Uncommon (may affect up to 1 in 100 patients): in the application area, redness, skin inflammation (dermatitis), local irritation and itching may occur, which disappear when treatment is stopped.
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Rare (may affect up to 1 in 1,000 patients): dermatitis (skin inflammation) caused by sunlight.
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Frequency not known (cannot be estimated from available data): widespread red scaly rash, with bumps under the skin and blisters mainly located in skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis). The skin becomes sensitive to light. Stop using IBUFÉN if you experience these symptoms and seek immediate medical attention. See also section 2.
If any of the following adverse effects occur, stop treatment immediately and consult your doctor without delay:
- Flat, non-elevated red spots, target-shaped or circular, on the trunk, often with blisters in the center, peeling of the skin, and ulcers in the mouth, throat, nose, genitals, and eyes. These serious skin rashes may be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].
- Widespread skin rash, high body temperature, and enlarged lymph nodes (DRESS syndrome).
- Generalized red and scaly rash, with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis).
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: https://www.notificaram.es/. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of IBUFÉN
Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.
Medicines should not be disposed of via wastewater drains or in household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If in doubt, 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 IBUFÉN
- The active substance is ibuprofen; each gram of IBUFÉN contains 50 mg of ibuprofen.
- The other components are levomenthol, carbomers, diisopropanolamine 90%, isopropyl alcohol, glycerol (E-422), and purified water.
Appearance of the product and contents of the pack
IBUFÉN is a colourless or slightly yellowish transparent gel with a menthol odour.
IBUFÉN is supplied in an aluminium tube containing 50 grams of gel.
Marketing Authorisation Holder and Manufacturer
Laboratorios Cinfa, S.A.
Carretera Olaz-Chipi, 10. Polígono Industrial Areta
31620 Huarte (Navarra) - Spain
Date of the most recent review of this leaflet: January 2024
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicinal Products and Health Products (AEMPS) www.aemps.gob.es