Label: information for the user

Ibuprofeno Farmasierra 50 mg/g gel

This medication is a topical gel for use on the skin.

The active ingredient ibuprofen acts as a local analgesic and anti-inflammatory.

It is indicated for adults and adolescents to relieve local pain and inflammation caused by: minor bruises, blows, muscle strains, torticollis, or other muscle contractions, lower back pain, and mild sprains resulting from a twist.

Consult a doctor if symptoms persist or worsen after 7 days.

Do not use Ibuprofeno Farmasierra :

• if you are allergic (hypersensitive) to ibuprofen or to any of the other components of this medication (listed in section 6).
• if you have a sunburn on the affected area.
• if you have had allergic reactions (rhinitis, difficulty breathing or asthma, urticaria, itching or others) caused by acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs.
• if you are in the last 3 months of pregnancy.

Warnings and precautions:

Consult your doctor, pharmacist or nurse before using this medication.

• If you are asthmatic or allergic to any coloring agents used in food or medications (such as yellow-orange, tartrazine, etc…), consult your doctor before using this medication.
• Do not use on mucous membranes, or on skin with wounds or eczema.
• Avoid contact with the eyes.
• Do not expose the treated area to the sun, or use with bandages or on large areas.
• Do not apply Ibuprofeno Farmasierra simultaneously in the same area where other medications have been applied.
• 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 ibuprofen treatment. Discontinue Ibuprofeno Farmasierra treatment and seek medical attention immediately if you notice any of the symptoms related to these severe skin reactions described in section 4.

Special caution is recommended with Ibuprofeno Farmasierra 50 mg/g gel.

Severe skin reactions

Severe skin reactions have been reported associated with Ibuprofeno Farmasierra 50 mg/g gel treatment. Stop using Ibuprofeno Farmasierra 50 mg/g gel 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

This medication should not be used in children under 12 years old.

Use of Ibuprofeno Farmasierra with other medications

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

Pregnancy, breastfeeding and fertility:

If you are pregnant or breastfeeding, suspect you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medication.

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

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

Driving and operating machinery

No effects on the ability to drive vehicles and operate machinery have been described when using externally on the skin.

Follow these instructions exactly, or the indications that your doctor, pharmacist, or nurse has advised you. Consult your doctor, pharmacist, or nurse if you have any doubts.

This medication is for external use only on the skin.

The recommended dose is:

Over 12 years old: Apply a thin layer of the product to the painful area 3 to 4 times a day and gently massage it in to facilitate its penetration.

Do not use for more than 7 consecutive days.

If symptoms worsen or persist after 7 days of treatment, you must consult your doctor.

If you use more Ibuprofeno Farmasierra than you should:

Due to its external use, cases of overdose are unlikely. In case of accidental ingestion, go immediately to a medical center or call the Toxicological Information Service (Tel: 915 620 420), indicating the medication and the amount ingested, as it may cause: nausea, vomiting, abdominal pain, drowsiness, dizziness, muscle spasms, and low blood pressure.

If you forgot to use Ibuprofeno Farmasierra

Do not apply a double dose to compensate for missed applications.

If you interrupt treatment with Ibuprofeno Farmasierra

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

Like all medications, Ibuprofeno Farmasierra50 mg/ggel may have adverse effects, although not everyone will experience them.

• Rare (may affect up to 1 in 100 people): redness, itching, and burning sensation on the skin at the application site, which disappear when treatment is discontinued.
• Uncommon (may affect up to 1 in 1000 people): dermatitis (skin inflammation) caused by the sun.
• Frequency «unknown» Generalized red scaly rash, with bumps under the skin and localized blisters, mainly on the skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (generalized acute pustular exanthema).

Stop using Ibuprofeno Farmasierra50 mg/ggel if you experience these symptoms and seek medical attention immediately. See also section 2.

The skin becomes sensitive to light

Discontinue treatment with ibuprofen and seek immediate medical attention if you notice any of the following symptoms:

• 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 rash, elevated body temperature, and hypertrophied 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 (generalized acute pustular exanthema).

If you consider any of the adverse effects you are experiencing to be severe, or if you notice any adverse effect not mentioned in this leaflet, inform your doctor or pharmacist.

Adverse Reaction Report

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines 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 out of the sight and reach of children.

No special storage conditions are required.

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

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at 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 of Ibuprofeno Farmasierra 50 mg/g gel

The active ingredient is ibuprofen. Each gram of gel contains 50 mg of ibuprofen.

The other components (excipients) are: hyetelose, benzyl alcohol, isopropyl alcohol, sodium hydroxide and purified water.

Appearance of the product and contents of the packaging

This medicine is a transparent and colourless gel.

It is presented in an aluminium tube with a white polyethylene stopper containing 50 grams of gel.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Farmasierra Laboratorios, S.L

Ctra. de Irún km 26,200

San Sebastián de los Reyes 28700 (Madrid)

Spain

Responsible for manufacturing:

Farmasierra Manufacturing, S.L.

Ctra. de Irún km 26,200

San Sebastián de los Reyes 28700 (Madrid)

Spain

Last review date of this leaflet: December 2023

Other sources of information

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