ROLIBFAR 50mg/g GEL with applicator ball

2. What you need to know before taking Rolibfar

Do not use Rolibfar if:

• You are allergic (hypersensitive) to ibuprofen or any of the other components of this medicine (listed in section 6).
• You have a sunburn in the affected area.
• 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.
• You are in the last 3 months of pregnancy.

Warnings and precautions

• It should not be used on mucous membranes or on skin with wounds or eczema.
• 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.
• Avoid contact with the eyes.
• Do not expose the treated area to the sun, nor use with bandages or on extensive areas.
• Do not apply Rolibfar 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), and acute generalized exanthematous pustulosis (AGEP), have been reported in association with ibuprofen treatment. Discontinue treatment with Rolibfar 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 Rolibfar 50 mg/g gel.

Skin reactions

Severe skin reactions have been reported in association with Rolibfar 50 mg/g gel. Stop using Rolibfar gel and consult a 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 severe skin reaction. See section 4.

Use of other medications

Tell your doctor or pharmacist if you are using or have recently used any other medication, especially pain relievers, including those purchased without a prescription.

Pregnancy and Breastfeeding

Consult your doctor or pharmacist before using any medication.

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before taking this medicine.

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

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

Use in children

Do not use this medicine in children under 12 years of age.

Driving and using machines

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

Rolibfar 50 mg/g contains ethanol.This medicine contains 200 mg of alcohol (ethanol) per gram of gel. It may cause a burning sensation on damaged skin.

Rolibfar 50 mg/gcontains BHT (butylhydroxytoluene) (E 321). It may cause local skin reactions (such as contact dermatitis) or irritation of the eyes and mucous membranes.

3. How to use Rolibfar

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

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

The recommended dose is:

Adults and adolescents (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 with the roll-on applicator to facilitate penetration.

Do not use for more than 7 consecutive days.

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

If you use more Rolibfar than you should:

Due to its external use, it is unlikely that overdose cases will occur. In case of accidental ingestion, go immediately to a medical center or call the Toxicology Information Service (Tel: 915620420), indicating the medicine and the amount ingested, as it may cause: nausea, vomiting, abdominal pain, drowsiness, dizziness, spasms, and low blood pressure.

4. Possible side effects

Like all medicines, Rolibfar can cause side effects, although not everyone may experience them.

• Uncommon (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.
• 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 located in skin folds, trunk, and upper limbs, accompanied by fever at the start of treatment (acute generalized exanthematous pustulosis).

Stop using Rolibfar gel if you experience these symptoms and seek immediate medical attention. 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:

• 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 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 consider that any of the side effects you are experiencing is serious, or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, 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: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Rolibfar

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

No special storage conditions are required.

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

Medicines should not be disposed of via wastewater or household waste. Deposit 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. Package contents and additional information

Rolibfar composition

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

The other components (excipients) are: ethanol 96%, isopropyl alcohol, hydroxyethylcellulose, diethylene glycol monoethyl ether, macrogolglycerides of capric and caprylic acid, glycerol (E-422), sodium hydroxide (E-524) (10% aqueous solution), levomenthol, reflex aroma (camphor, menthone-L, methyl salicylate, BHT (E-321), and purified water.

Appearance of the product and package contents

This medicine is a transparent and colorless gel with a reflex aroma.

It is presented in a package with a ball applicator containing 30 or 60 grams of gel. Only some package sizes may be marketed.

Marketing authorization holder:

Farmasierra Laboratorios, S.L.

Ctra. de Irún km 26,200

San Sebastián de los Reyes 28709 (Madrid)

Spain

Manufacturer:

Farmasierra Manufacturing, S.L.

Ctra. de Irún km 26,200

San Sebastián de los Reyes 28709 (Madrid)

Spain

Date of the 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/