IBUPROFENO FARMASIERRA 50 mg/g GEL

2. What you need to know before using Ibuprofeno Farmasierra

Do not use Ibuprofeno Farmasierra:

• if you are allergic (hypersensitive) to ibuprofen or any of the other components of this medicine (listed in section 6).
• if you have a sunburn in the affected area.
• if you have had allergic reactions (rhinitis, difficulty breathing or asthma, urticaria, itching, or other) caused by acetylsalicylic acid or other non-steroidal 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 medicine.

• If you are asthmatic or allergic to any food coloring or medication (such as yellow-orange, tartrazine, etc...), you should consult your doctor before using this medicine.
• It should not be used on mucous membranes or on skin with wounds or eczema.
• You should avoid contact with the eyes.
• You should not expose the treated area to the sun, nor use it with bandages or on extensive areas.
• You should not apply Ibuprofeno Farmasierra simultaneously in the same area where other medicines 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), and acute generalized exanthematous pustulosis (AGEP), have been reported in association with ibuprofen treatment. Discontinue treatment with Ibuprofeno Farmasierra and seek immediate medical attention if you notice any symptoms related to these severe skin reactions described in section 4.

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

Skin reactions

Severe skin reactions have been reported in association with Ibuprofeno Farmasierra 50 mg/g gel. Stop using Ibuprofeno Farmasierra 50 mg/g gel and seek medical attention immediately if you experience any skin rash, mucous 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 medicine should not be used in children under 12 years of age.

Using Ibuprofeno Farmasierra with other medicines

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

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 Ibuprofeno Farmasierra if you are in the last 3 months of pregnancy. You should 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, the lowest dose should be used for the shortest possible time.

Oral forms (e.g., tablets) of ibuprofen may cause adverse effects in the fetus. It is unknown if the same risk applies to ibuprofen 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 Ibuprofeno Farmasierra

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

This medicine is for external cutaneous use only (on the skin).

The recommended dose is:

Over 12 years: apply a thin layer of the product to the painful area 3 to 4 times a day and perform a gentle massage to facilitate penetration.

Do not use for more than 7 consecutive days.

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

If you use more Ibuprofeno Farmasierra than you should:

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

If you forget to use Ibuprofeno Farmasierra

Do not apply a double dose to make up for forgotten applications.

If you stop using Ibuprofeno Farmasierra

If you have any further questions on the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Ibuprofeno Farmasierra 50 mg/g gel can cause side effects, although not everybody gets them.

• Uncommon (may affect up to 1 in 100 people): redness, itching, and burning sensation on the skin in the application area, which disappear upon discontinuation of treatment.
• Rare (may affect up to 1 in 1,000 people): dermatitis (skin inflammation) caused by the sun.
• Frequency "not known" Generalized red scaly rash, with bumps under the skin and blisters, mainly on skin folds, trunk, and upper limbs, accompanied by fever at the start of treatment (acute generalized exanthematous pustulosis).

Stop using Ibuprofeno Farmasierra 50 mg/g gel 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:

• Reddish 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 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).

If you think any of the side effects are serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.

Reporting of side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Ibuprofeno Farmasierra

Keep out of sight and reach of children.

No special storage conditions are required.

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 or household waste. Place the packaging and any unused medicine in the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and further information

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: hydroxyethyl cellulose, benzyl alcohol, isopropyl alcohol, sodium hydroxide, and purified water.

Appearance of the product and pack contents

This medicine is a clear and colorless gel.

It comes in an aluminum tube with a white polyethylene cap containing 50 grams of gel.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Farmasierra Laboratorios, S.L.

Ctra. de Irún km 26,200

San Sebastián de los Reyes 28700 (Madrid)

Spain

Manufacturer:

Farmasierra Manufacturing, S.L.

Ctra. de Irún km 26,200

San Sebastián de los Reyes 28700 (Madrid)

Spain

Date of last revision of this leaflet: December 2023

Other sources of information

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