Leaflet: information for the patient

Ibudol roll-on 50 mg/g gel container with ball applicator

Ibuprofen

Read this leaflet carefully because it contains important information for you.

Follow exactly the administration instructions of the medicine contained in this leaflet or those indicated by your doctor, pharmacist or nurse.

• Keep this leaflet as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet.See section 4
• You should consult a doctor if it worsens or does not improve after 7 days.

1. What isIbudol roll-onand what it is used for

2. What you need to know before starting to useIbudol roll-on

3. How to useIbudolroll-on

4. Possible side effects

5. Storage ofIbudolroll-on

6. Contents of the container and additional information

The ibuprofen, active ingredient of this medication, acts as a local analgesic and anti-inflammatory.

This medication is indicated in adults and adolescents from 12 years of age for the relief of mild and occasional pain and inflammation caused by: small bruises, blows, muscle strains (muscle pulls), torticollis (neck pain and stiffness) or other contractures, lower back pain and mild sprains resulting from a twist.

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 on the affected area.
• If you have had allergic reactions caused by acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs, such as:
• • Asthmatic allergic reactions (difficulty breathing, choking, chest tightness, and in some cases, coughing or wheezing).
  • Swelling of the face, lips, mouth, tongue, or throat that may cause difficulty swallowing or breathing (angioedema).
  • Other allergic reactions such as: rhinitis, itching, or urticaria.

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

Be especially careful with Ibudol roll-onroll-on

• Do not use it on mucous membranes, or on skin with wounds or eczema.
• Apply this medication only on intact skin.
• If you are asthmatic or allergic to any food colorant or medication (such as yellow-orange, tartrazine, etc.), consult your doctor before using this medication.
• Avoid contact with the eyes and mucous membranes.
• The treated areas should not be exposed to the sun (even on cloudy days), or to ultraviolet A (UVA) lamps.
• Do not use with occlusive dressings.
• Do not apply the gel to extensive areas, or for a prolonged period. Use it exclusively on the affected area.
• Do not apply Ibudol roll-on simultaneously in the same skin area where other medications have been applied.

Skin Reactions

Be especially 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), generalized acute pustular psoriasis (PEGA), have been reported in association with ibuprofen treatment. Discontinue treatment with Ibudol roll-on and seek medical attention immediately 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 analgesics, even those purchased without a prescription.

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 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 your doctor advises you to do so. If you need treatment during this period, use the lowest dose for the shortest possible time.

Oral forms of Ibudol (e.g., tablets) may cause adverse reactions in the fetus. It is unknown whether 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 old, due to the scarcity of data in this population.

Driving and operating machinery

No effects on the ability to drive vehicles and use machinery have been described when using Ibudol roll-on externally on the skin.

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

This medication is only for topical use (only to be applied on 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 applicator ball itself, to facilitate its 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 occurs, you must consult your doctor

If you use more Ibudol roll-on than you should:

Due to its topical use, cases of poisoning are unlikely. 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 Toxicological Information Service (Tel: 915620420), indicating the medication and the amount ingested, as it may cause: nausea, vomiting, abdominal pain, drowsiness, dizziness, spasms (cramps) and a drop in blood pressure.

Like all medicines,Ibudol roll-onmay cause side effects, although not everyone will experience them.

Like all medicines,Ibudol roll-onmay cause side effects, although not everyone will experience them.

Stop using Ibudol roll-on and seek medical attention immediately 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 ulcers, throat, nose, genital, and eye ulcers. These severe skin eruptions may be preceded by fever and similar symptoms to the flu [dermatitis exfoliativa, eritema poliforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].
• Generalized skin eruption, elevated body temperature, and swollen lymph nodes (DRESS syndrome).
• Generalized, red, scaly eruption, with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized pustular psoriasis).

You may experience the following side effects:

• Rare (may affect up to 1 in 100 people): redness, itching, and burning sensation on the skin in the application area, which disappear when treatment is stopped.
• Uncommon (may affect up to 1 in 1000 people): sun-induced dermatitis (inflammation of the skin).
• Unknown frequency: generalized, red, scaly eruption, 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 pustular psoriasis). Stop using Ibudol roll-on if you experience these symptoms and seek medical attention immediately. See section 2, skin becomes sensitive to light.

If you consider any of the side effects you experience to be severe, 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 to the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep out of reach and sight of children.

No special storage conditions are required.

Do not use this medicine after the expiration date shown 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. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

the environment.

Composition ofIbudolroll-on

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

The other components (excipients) are: ethanol at 96 percent, isopropyl alcohol, hydroxyethylcellulose, diethylene glycol monoethyl ether, caproilocaproyl macrogolglycerides, glycerol (E-422), sodium hydroxide (E-524) (15% aqueous solution), levo menthol, reflex aroma (camphor, menthone-iso, menthone-L, borneol, methyl salicylate, B.H.T (E-321) and purified water.

Appearance of the product and contents of the packaging

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

It is presented in containers with a ball applicator that contain 30 or 60 grams of gel.

Only some sizes of containers may be commercially available.

Holder of the marketing authorization:

Kern Pharma, S.L.

Venus, 72 – Pol. Ind.Colón II

08228 Terrassa – Barcelona

Spain

Responsible for manufacturing:

Farmasierra Manufacturing, S.L.

Ctra. de Irún km 26,200

San Sebastián de los Reyes 28709 (Madrid)

Spain

This prospectus has been reviewed in January 2024

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