Leaflet: Information for the user

Ibudol 50 mg/g gel

Ibuprofen

Read this leaflet carefully before you start using this medicine because it contains important information for you.

Follow exactly the administration instructions for 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 or pharmacist, even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if you get worse or do not improve after 7 days (5 days in case of adolescents) of treatment.

Ibudol is presented in gel form for topical use. This medication belongs to the group of topical anti-inflammatory agents.

This medication is indicated for adults and adolescents 12 years of age and older for the symptomatic relief of mild, occasional aches and pains of a muscular and joint nature, such as those caused by: small contusions, blows, strains, torticollis, or other contractures, backache, and mild sprains resulting from twists.

Do not use Ibudol

• If you are allergic to ibuprofen or any of the other components of this medication (listed in section 6).
• If you are allergic to acetylsalicylic acid or any other analgesic or nonsteroidal anti-inflammatory.
• On open wounds, mucous membranes, or eczematous skin.
• On sunburned skin in the affected area.
• In children (under 12 years old).
• If you are in the last 3 months of pregnancy.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Ibudol.

• This medication is for exclusive topical use, do not ingest.
• Apply only to intact skin, without wounds.
• Avoid contact with mucous membranes (nose, mouth) and eyes.
• Do not apply the gel to large areas of the skin, or for a prolonged period.
• Do not use with tight bandages, or apply heat to the area where it is used. If you need to cover the area where you have used this medication, do it in a way that the garment covering the treated area is slightly loose.
• The treated areas should not be exposed to the sun (even on cloudy days), or to ultraviolet lamps (UVA rays).

Skin reactions

Be especially careful with Ibudol:

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 exanthema (PEGA), have been reported in association with ibuprofen treatment. Discontinue Ibudol treatment and seek medical attention immediately if you notice any of the symptoms related to these severe skin reactions described in section 4.

Children and adolescents

Do not use this medication in children under 12 years old.

Use of Ibudol with other medications

Inform your doctor or pharmacist that you are using, have used recently, or may need to use any other medication.

Do not apply other topical preparations to the same area of the skin where you are using this medication.

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 if you are in the last 3 months of pregnancy. Do not use Ibudol 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 (e.g., tablets) of Ibudol may cause adverse reactions in the fetus. It is unknown whether the same risk applies to Ibudol when used on the skin.

Driving and operating machinery

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

Ibudol contains propylene glycol laurate

This medication may cause skin irritation because it contains propylene glycol laurate.

Follow exactly the administration instructions for this medication contained in this leaflet or those indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

The recommended dose in adults and adolescents 12 years and older is 3 to 4 applications per day.

How to use:

This medication is for external use on the skin only, on intact skin.

Apply a thin layer of gel to the painful area by gently massaging it in to facilitate penetration.

Wash your hands after each application.

If you use more Ibudol than you should

Due to its external use, cases of overdose are unlikely. In case of accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Discontinue treatment with Ibudol and seek immediate medical attention 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, 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).

Rare (may affect up to 1 in 100 people): redness, inflammation of the skin (dermatitis), local irritation, and itching at the application site, which disappear when treatment is discontinued.

Uncommon (may affect up to 1 in 1,000 people): sun-induced dermatitis (inflammation of the skin).

Frequency not known: 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 taking Ibudol if you experience these symptoms and seek immediate medical attention. See also section 2. The skin becomes sensitive to light.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is an adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

Do not store at a temperature above 25°C.

Do not use this medication after the expiration date that appears 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. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Composition of Ibudol

• The active ingredient is ibuprofen. Each gram of gel contains 50 mg of ibuprofen.
• The other components are diethylglycol monoethyl ether, caproilocaproyl macrogolglycerides, propylene glycol laurate, hydroxypropylcellulose (E-463) and 96% ethanol.

Appearance of the product and content of the packaging

Transparent and colorless gel. It is presented in tubes containing 30 or 60 grams of gel.

Holder of the marketing authorization and responsible for manufacturing

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Last review date of this leaflet: 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/