IBUDOL ROLL-ON 50 mg/g GEL with ball applicator

2. What you need to know before using Ibudol Roll-On

Do not use Ibudol Roll-On:

• If you are allergic (hypersensitive) to ibuprofen or any of the other components of this medication.
• If you have a sunburn in the affected area.
• If you have had allergic reactions caused by acetylsalicylic acid or other non-steroidal anti-inflammatory drugs, such as:
• • Asthma-like allergic reactions (difficulty breathing, shortness of breath, chest tightness, and in some cases coughing or wheezing).
  • Swelling of the face, lips, mouth, tongue, or throat that can cause difficulty swallowing or breathing (angioedema).
  • Other allergic reactions such as rhinitis, itching, or hives.

• If you are in the last 3 months of pregnancy.

Be careful with Ibudol Roll-On:

• Do not use it on mucous membranes or on skin with wounds or eczema.
• Apply this medication only to intact skin.
• 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 medication.
• Avoid contact with eyes and mucous membranes.
• Treated areas should not be exposed to the sun (even on cloudy days) or to ultraviolet lamps (UVA).
• Do not use with occlusive dressings.
• Do not apply the gel to large areas or for extended periods. Use exclusively on the affected area.
• Do not apply Ibudol Roll-On simultaneously to the same skin area where other medications have been applied.

Skin Reactions

Be careful with Ibudol Roll-On:

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 Ibudol Roll-On and seek immediate medical attention if you notice any of the symptoms related to these severe skin reactions described in section 4.

Use of Other Medications

Inform 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, Breastfeeding, and Fertility

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 medication.

Do not use Ibudol Roll-On if you are in the last 3 months of pregnancy. Do not use Ibudol Roll-On 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 Ibudol may cause adverse reactions in the fetus. It is unknown if the same risk applies to Ibudol Roll-On when used on the skin.

Use in Children

Do not use this medication in children under 12 years of age due to the lack of data in this population.

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 Ibudol Roll-On

Follow the administration instructions exactly as indicated, unless your doctor has given you different instructions. Consult your doctor or pharmacist if you have doubts.

This medication is for cutaneous use only (to be applied only to the skin).

The normal dose is:

Adults and children over 12 years: apply a thin layer of the gel to the painful area 3 to 4 times a day and perform a gentle massage with the ball applicator to facilitate penetration.

Wash your hands after each application. Do not use for more than 7 consecutive days.

If symptoms worsen or persist after 7 days of treatment, or if irritation or redness of the area occurs, consult a doctor.

If you use more Ibudol Roll-On than you should:

Due to its cutaneous use, it is unlikely that cases of intoxication will occur. However, if you have used this medication more than you should, or in case of accidental ingestion, go immediately to a medical center or call the Toxicology Information Service (Tel: 915620420), indicating the medication and the amount ingested, as it may cause: nausea, vomiting, abdominal pain, drowsiness, dizziness, spasms (cramps), and low blood pressure.

4. Possible Side Effects

Like all medications, Ibudol Roll-On can have side effects, although not everyone will experience them.

Discontinue treatment with Ibudol Roll-On 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].
• Widespread rash, elevated body temperature, and swollen lymph nodes (DRESS syndrome).
• Widespread, red, and scaly rash, with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the start of treatment (acute generalized exanthematous pustulosis).

You may experience the following side effects:

• 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: widespread, red, scaly rash, with bumps under the skin and blisters, mainly in skin folds, trunk, and upper limbs, accompanied by fever at the start of treatment (acute generalized exanthematous pustulosis). Stop using Ibudol Roll-On if you experience these symptoms and seek immediate medical attention. See also section 2, skin becomes sensitive to light.

If you consider any of the side effects you are experiencing to be 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 Medicines and Healthcare Products Agency's website: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Ibudol Roll-On

Keep out of the reach and sight of children.

No special storage conditions are required.

Do not use this medication after the expiration date stated on the packaging, after CAD:

The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Ibudol Roll-On

Each gram of gel contains 50 mg of ibuprofen as the active ingredient.

The other components (excipients) are: ethanol 96%, isopropyl alcohol, hydroxyethylcellulose, diethylene glycol monoethyl ether, macrogolglycerides of capric/caprylic acid, glycerol (E-422), sodium hydroxide (E-524) (15% aqueous solution), levomenthol, reflex aroma (camphor, iso-menthone, L-menthone, borneol, methyl salicylate, BHT (E-321)), and purified water.

Appearance of the Product and Package Contents

This medication is a clear, colorless gel with a reflex aroma.

It is available in packages with a ball applicator containing 30 or 60 grams of gel.

Only some package sizes may be marketed.

Marketing Authorization Holder:

Kern Pharma, S.L.

Venus, 72 – Pol. Ind. Colón II

08228 Terrassa – Barcelona

Spain

Manufacturer:

Farmasierra Manufacturing, S.L.

Ctra. de Irún km 26,200

San Sebastián de los Reyes 28706 (Madrid)

Spain

This leaflet was revised in January 2024

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