IBUDOL 50 MG/G GEL

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Ibudol 50 mg/g gel

Ibuprofen

Read the entire leaflet carefully before you start using this medicine, as it contains important information for you.

Follow exactly the instructions for use provided in this leaflet or those given 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 adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
• You should consult a doctor if your condition worsens or if you do not improve after 7 days (5 days in adolescents) of treatment.

Contents of the leaflet:

1. What Ibudol is and what it is used for
2. What you need to know before using Ibudol
3. How to use Ibudol
4. Possible side effects
5. How to store Ibudol
6. Contents of the pack and other information

1. What Ibudol is and what it is used for

Ibudol is presented as a gel for topical use. This medicine belongs to the group of topical anti-inflammatory agents.

This medicine is indicated in adults and adolescents aged 12 years and older for the symptomatic relief of mild occasional muscular and joint pain, such as that caused by minor bruises, blows, sprains, torticollis or other contractures, lumbago, and mild sprains resulting from twists or strains.

2. What you need to know before using Ibudol

Do not use Ibudol

• If you are allergic to ibuprofen or to any of the other ingredients of this medicine (listed in section 6).
• If you are allergic to acetylsalicylic acid or to any other analgesic or non-steroidal anti-inflammatory drug.
• On open wounds, mucous membranes, or eczematous skin.
• If you have sunburn in the affected area.
• In children (under 12 years of age).
• If you are in the last 3 months of pregnancy.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Ibudol.

• This medicine is for topical use only; do not ingest.
• Apply only to intact, unbroken skin.
• Avoid contact with mucous membranes (nose, mouth) and eyes.
• Do not apply the gel over large areas of skin or for prolonged periods.
• Do not use with tight bandages or apply heat to the area of application. If covering the treated area, do so loosely with clothing or dressing.
• Treated areas must not be exposed to sunlight (even on cloudy days) or to ultraviolet lamps (UVA rays).

Skin reactions

Take special care with Ibudol:

Severe skin reactions have been reported, 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), associated with ibuprofen treatment. Discontinue treatment with Ibudol and seek immediate medical attention if you notice any symptoms related to these serious skin reactions described in section 4.

Children and adolescents

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

Use of Ibudol with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

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

Pregnancy, breastfeeding and fertility

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

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

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 using machines

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

Ibudol contains propylene glycol laurate

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

3. How to use Ibudol

Follow exactly the administration instructions for this medicine provided in this leaflet or those given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

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

How to use:

This medicine is for external cutaneous use only, applied exclusively on intact skin.

Apply a thin layer of gel to the painful area with a gentle massage to enhance penetration.

Wash your hands after each application.

If you use more Ibudol than you should

Due to its external use, cases of poisoning are unlikely. In case of accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

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

• Non-elevated reddish spots, target-shaped or circular, on the trunk, often with blisters in the center, skin peeling, mouth ulcers, and sores in the throat, nose, genitals, and eyes. These serious skin rashes may be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].
• Generalized rash, high body temperature, and enlarged lymph nodes (DRESS syndrome).
• Widespread, red, scaly rash with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis).

Uncommon (may affect up to 1 in 100 people): at the application site, redness, skin inflammation (dermatitis), local irritation, and itching may occur, which disappear upon discontinuation of treatment.

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

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is an adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Ibudol

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

Do not store above 25°C.

Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ibudol

• The active substance is ibuprofen. Each gram of gel contains 50 mg of ibuprofen.
• The other components are diethylene glycol monoethyl ether, macrogol glycerides of caprylic and caproic acids, propylene glycol laurate, hydroxypropylcellulose (E-463), and 96% ethanol.

Appearance of the product and contents of the pack

Clear, colourless gel. It is supplied in tubes containing 30 or 60 grams of gel.

Marketing Authorization Holder and Manufacturer

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Date of the most recent review of this leaflet: January 2024

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/