IBUFEN 50 mg/g GEL

2. What you need to know before using IBUFEN

Do not useIBUFEN

• If you are allergic to ibuprofen or any of the other components of this medicine (listed in section 6).
• If you have experienced allergic reactions of an asthmatic type (difficulty breathing, shortness of breath, bronchospasm, and in some cases cough or wheezing when breathing) when taking acetylsalicylic acid, other analgesics, or anti-inflammatory drugs. If you have or have had asthma, rhinitis, edema, or urticaria.
• On 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 use IBUFEN.

• This medicine is for cutaneous use only, do not ingest.
• Apply only to intact skin, without wounds.
• You should avoid contact with mucous membranes (nose, mouth) and eyes.
• Do not apply the gel to very large areas of skin, or for prolonged periods.
• Do not use with tight bandages, or apply heat to the area where it is used. If you cover the area where you have used this medicine, do so in a way that the garment covering the treated area is slightly loose.
• The treated areas should not be exposed to the sun (even if cloudy), or to 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), acute generalized exanthematous pustulosis (AGEP), have been reported in association with IBUFEN treatment. Discontinue IBUFEN treatment and seek immediate medical attention if you notice any of the symptoms related to these severe skin reactions described in section 4.

Stop using IBUFEN and go to the doctor immediately if you experience any skin rash, lesions on the mucous membranes, blisters, or other signs of allergy, as these may be the first signs of a very severe skin reaction. See section 4.

Children and adolescents

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

Using IBUFEN with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicine.

Do not apply other cutaneous 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 plan to become pregnant, consult your doctor or pharmacist before using this medicine.

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

Oral forms (e.g., tablets) of IBUFEN gel may cause adverse reactions in the fetus. It is not known if the same risk applies to IBUFEN gel when used on the skin.

Driving and using machines

No effects on the ability to drive vehicles or use machinery have been described when used externally on the skin.

3. How to use IBUFEN

Follow the administration instructions of the medicine contained in this package leaflet or as indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

If you think the effect of IBUFEN is too strong or too weak, tell your doctor or pharmacist.

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

How to use:

This medicine is for external cutaneous use only, on intact skin. When first using, you can use the cap to pierce the tube.

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

Do not apply for more than 7 consecutive days.

If you use moreIBUFENthan you should

Due to its external use, it is unlikely that cases of intoxication will occur.

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

If you forget to useIBUFEN

Do not use a double dose to make up for forgotten doses.

If you stop usingIBUFEN

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

• Rare (may affect up to 1 in 1,000 patients): sun-induced dermatitis.

• Frequency not known (cannot be estimated from the available data): generalized red scaly rash, with bumps under the skin and blisters, mainly located in skin folds, trunk, and upper limbs, accompanied by fever at the start of treatment (acute generalized exanthematous pustulosis). The skin becomes sensitive to light. Stop using IBUFEN if you experience these symptoms and seek immediate medical attention. See also section 2.

If you experience any of the following side effects, discontinue treatment and go to your doctor immediately:

• Red patches, not raised, in a target or circular shape on the trunk, often with blisters in the center, skin peeling, mouth, throat, nose, genital, and eye ulcers. These severe skin rashes can be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].
• Generalized skin rash, elevated body temperature, and swollen lymph nodes (DRESS syndrome).
• Generalized red scaly rash, with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the start of treatment (acute generalized exanthematous pustulosis).

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medicines Monitoring System: https://www.notificaram.es/. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of IBUFEN

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

This medicine does not require special storage conditions.

Do not use this medicine after the expiry date stated on the packaging after CAD. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicines in the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Contents of the pack and further information

Composition ofIBUFEN

• The active ingredient is ibuprofen, each gram of IBUFEN contains 50 mg of ibuprofen.
• The other ingredients are levomenthol, carbomers, diisopropanolamine 90%, isopropyl alcohol, glycerol (E-422), and purified water.

Appearance of the product and pack contents

IBUFEN is a colorless or slightly yellowish transparent gel with a mentholated odor.

IBUFEN is presented in an aluminum tube containing 50 grams of gel.

Marketing authorization holder and manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Date of the last revision of this package leaflet: January 2024

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) www.aemps.gob.es