IBUPROFEN FARMASIERRA 50 MG/G GEL

Patient Information Leaflet

Introduction

Patient Information Leaflet

Ibuprofen Farmasierra 50 mg/g gel

Contents of the leaflet:

1. What Ibuprofeno Farmasierra is and what it is used for.
2. What you need to know before using Ibuprofeno Farmasierra
3. How to use Ibuprofeno Farmasierra
4. Possible side effects.
5. Storage of Ibuprofeno Farmasierra
6. Contents of the package and additional information.

1. What Ibuprofeno Farmasierra is and what it is used for

This medicine is a gel for cutaneous use (on the skin).

Ibuprofen, the active substance in this medicine, acts as a local analgesic and anti-inflammatory.

It is indicated in adults and adolescents for the local relief of mild and occasional pain and inflammation caused by: minor bruises, injuries, sprains (muscle strains), torticollis (neck pain), or other muscle spasms, lumbago (lower back pain), and mild sprains resulting from twisting injuries.

You should consult a doctor if symptoms persist or worsen after 7 days.

2. What you need to know before using Ibuprofeno Farmasierra

Do not use Ibuprofeno Farmasierra:

• if you are allergic (hypersensitive) to ibuprofen or to any of the other ingredients of this medicine (listed in section 6).
• if you have sunburn on the affected area.
• if you have previously experienced allergic reactions (such as rhinitis, breathing difficulties 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 have asthma or are allergic to any dyes used in food or medicines (for example: orange-yellow, tartrazine, etc.), you should consult your doctor before using this medicine.
• Must not be used on mucous membranes, or on wounded or eczematous skin.
• Avoid contact with the eyes.
• Do not expose the treated area to sunlight, and do not use under bandages or on extensive areas of skin.
• Do not apply Ibuprofeno Farmasierra simultaneously to the same area where other medicines have been applied.
• Serious skin reactions have been reported in association with ibuprofen treatment, including 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). Discontinue treatment with Ibuprofeno Farmasierra and seek immediate medical attention if you notice any symptoms related to these serious skin reactions described in section 4.

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

Skin reactions

Serious skin reactions have been reported with Ibuprofeno Farmasierra 50 mg/g gel. Stop using Ibuprofeno Farmasierra 50 mg/g gel and contact your doctor immediately if you develop any skin rash, lesions of mucous membranes, blisters, or other signs of allergy, as these may be early signs of a serious skin reaction. See section 4.

Children

This medicine must not be used in children under 12 years of age.

Use of Ibuprofeno Farmasierra with other medicines

Inform your doctor or pharmacist if you are currently using, have recently used, or might need to use any other medicines.

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 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 required during this period, the lowest dose for the shortest possible duration should be used.

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

Driving and using machines

No effects on the ability to drive vehicles or operate machinery have been reported with external use on the skin.

3. How to use Ibuprofeno Farmasierra

Follow these instructions exactly, or those 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:

Adults and children over 12 years: apply a thin layer of the product to the painful area 3 to 4 times daily and gently massage to enhance penetration.

Do not use for more than 7 consecutive days.

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

If you use more Ibuprofeno Farmasierra than you should:

Due to its external use, poisoning is 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 the following may occur: nausea, vomiting, abdominal pain, somnolence, dizziness, spasms (cramps), and low blood pressure.

If you forget to use Ibuprofeno Farmasierra

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

If you stop using Ibuprofeno Farmasierra

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

4. Possible adverse effects

Like all medicines, Ibuprofeno Farmasierra 50 mg/g gel may have adverse effects, although not everyone experiences them.

• Uncommon (may affect up to 1 in 100 people): redness, itching, and burning sensation of the skin at the application site, which disappear when treatment is discontinued.
• Rare (may affect up to 1 in 1,000 people): sun-induced dermatitis (skin inflammation).
• Frequency not known: 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 beginning of treatment (acute generalized exanthematous pustulosis).

Stop using Ibuprofeno Farmasierra 50 mg/g gel if you experience these symptoms and seek immediate medical attention. See also section 2.

Skin becomes sensitive to light

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

• Flat reddish spots, target-like or circular rashes on the trunk, often with blisters in the center, peeling skin, mouth, throat, nose, genital, or eye ulcers. These serious skin rashes may be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].
• Generalized skin rash, high 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 beginning of treatment (acute generalized exanthematous pustulosis).

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

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor, pharmacist, or nurse, even if it is a possible adverse reaction not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse reactions, 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, following EXP:. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater drains or in household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This helps protect the environment.

6. Contents of the pack and other information

Composition of Ibuprofeno Farmasierra 50 mg/g gel

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

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

Appearance of the product and contents of the container

This medicine is a clear, colourless gel.

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

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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 the most recent review of this leaflet: December 2023

Other sources of information

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