Leaflet: information for the user

IBUFÉN 50 mg/g gel

Read this leaflet carefully before you start using this medicine, because it contains important information for you.

Follow exactly the administration instructions of the medicine contained in this leaflet or those indicated 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 side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

- You should consult a doctor if you get worse or do not improve after 7 days of treatment (5 days in the case of adolescents).

1.What IBUFÉN is and for what it is used

2.What you need to know before starting to use IBUFÉN

3.How to use IBUFÉN

4.Possible side effects

5.Storage of IBUFÉN

6.Contents of the pack and additional information

IBUFÉNis a topical gel (for use on the skin).

Ibuprofen is an external analgesic that acts by relieving pain.

It is indicated for the local symptomatic relief of occasional aches and pains of a muscular and articular nature such as those caused by: small contusions, blows, strains, torticollis or other contractures, mild sprains resulting from a twist and lower back pain.

No useIBUFÉN

• If you are allergic to ibuprofen or any of the other components of this medication (listed in section 6).
• If you have had an allergic reaction of the asthmatic type (difficulty breathing, choking, bronchospasm, and in some cases, coughing or wheezing) when taking acetylsalicylic acid, other analgesics, or anti-inflammatory medications. If you have or have had asthma, rhinitis, edema, or urticaria.
• Over open wounds, mucous membranes, or eczematous skin.
• If you have a sunburn in the affected area.
• In children (under 12 years old).
• If you are in the last 3 months of pregnancy.

Warnings and precautions

Consult your doctor or pharmacist before starting to useIBUFÉN.

• This medication is for topical use only, do not ingest.
• Apply only to intact skin, without wounds.
• Avoid contact with mucous membranes (nose, mouth) and eyes.
• Do not apply the gel to large areas of the skin, or for an extended period.
• Do not use with tight bandages, or apply heat to the area where the medication is used. If you need to cover the area where you have used this medication, do so in a way that the covering garment is slightly loose.
• The treated areas should not be exposed to the sun (even on cloudy days), or ultraviolet lamps (UVA rays).

Skin reactions

Severe skin reactions, such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), generalized acute pustular exanthema (PEGA), have been reported in association with treatment with IBUFÉN. Discontinue treatment with IBUFÉN and seek medical attention immediately if you notice any of the symptoms related to these severe skin reactions described in section 4.

Stop using IBUFÉN and seek medical attention immediately if you experience any skin rash, membrane lesions, blisters, or other signs of allergy, as these may be the first signs of a severe skin reaction. See section 4.

Children and adolescents

Do not use this medication in children under 12 years old.

Use of IBUFÉN with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Do not apply other topical preparations to the same area of the skin where you are using this medication.

Pregnancy, breastfeeding, and fertility

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

Do not use Ibufén if you are in the last 3 months of pregnancy. Do not use Ibufén gel during the first 6 months of pregnancy unless it is clearly necessary and your doctor advises you to do so. If you need treatment during this period, use the lowest dose for the shortest time possible.

Oral forms (e.g., tablets) of Ibufén gel may cause adverse reactions in the fetus. It is unknown whether the same risk applies to Ibufén gel when used on the skin.

Driving and operating machinery

No effects on the ability to drive vehicles and use machineryhave been described when using IBUFÉN externally on the skin.

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist.In case of doubt, ask your doctor or pharmacist.

If you think the effect ofIBUFÉNis too strong or too weak, inform your doctor or pharmacist.

The recommended dose in adults and adolescents 12 years and older is 3 to 4 applications per day.

How to use:

This medication is for external use on the skin only, exclusively on intact skin. In the first administration, you may use the plug to pierce the tube.

Apply the medication by gently massaging it to facilitate penetration and wash your hands after each application to remove any remaining medication.

Do not apply more than 7 consecutive days.

If you use moreIBUFÉNthan you should

Due to its external use, cases of intoxication are unlikely.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to useIBUFÉN

Do not use a double dose to compensate for the missed doses.

If you interrupt treatment withIBUFÉN

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

Like all medications,this medicationmay cause adverse effects, although not all people will experience them.

• Rare (may affect up to 1 in 100 patients): redness, inflammation of the skin (dermatitis), local irritation, and itching at the application site, which disappear when treatment is discontinued.

• Uncommon (may affect up to 1 in 1,000 patients): sun-induced dermatitis (inflammation of the skin).

• Unknown frequency (cannot be estimated from available data): generalized red scaly rash, with bumps under the skin and localized blisters, mainly on skin folds, trunk, and upper limbs, accompanied by fever at the start of treatment (generalized acute pustular exanthema). The skin becomes sensitive to light. Stop usingIBUFÉNif you experience these symptoms and seek medical attention immediately. See also section 2.

If any of the following adverse effects appear, discontinue treatment and seek immediate medical attention:

• Flat red spots, in the shape of a target or circles on the trunk, often with blisters in the center, skin peeling, mouth, throat, nose, genital, and eye ulcers. These severe skin eruptions may be preceded by fever and flu-like symptoms [dermatitis exfoliativa, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].
• Generalized skin eruption, elevated body temperature, and swollen lymph nodes (DRESS syndrome).
• Generalized red and scaly rash, with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the start of treatment (generalized acute pustular exanthema).

Reporting 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es/. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

This medication does not require special storage conditions.

Do not use this medication after the expiration date that appears on the packagingafter CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition ofIBUFÉN

• The active ingredient is ibuprofen, each gram ofIBUFÉNcontains 50 mg of ibuprofen.
• The other components arelevomentol, carbomers, diisopropanolamine 90%, isopropyl alcohol, glycerol (E-422) and purified water.

Appearance of the product and contents of the packaging

IBUFÉNis a transparent, colorless or slightly yellowish gel with a menthol odor.

IBUFÉNis presented in an aluminum tube with50 gramsof gel.

Title of the marketing authorization and responsible manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Industrial Estate Areta

31620 Huarte (Navarra) - Spain

Date of the last review of this leaflet: January 2024

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) www.aemps.gob.es