IBUDOL 50 MG/G GEL

Introduction

Package Leaflet: Information for the User

Ibudol 50 mg/g gel

Ibuprofen

Read the entire package leaflet carefully before starting to use this medication because it contains important information for you.

Follow the administration instructions of the medication contained in this package leaflet or as indicated by your doctor, pharmacist, or nurse exactly.

• Keep this package leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.
• You should consult a doctor if it worsens or does not improve after 7 days (5 days in the case of adolescents) of treatment.

Contents of the Package Leaflet:

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

1. What is Ibudol and what is it used for

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

This medication is indicated in adults and adolescents from 12 years of age for the symptomatic relief of mild occasional muscle and joint pain such as that produced by: minor bruises, blows, sprains, torticollis, or other contractures, lumbago, and mild sprains caused by twisting.

2. What you need to know before starting to use Ibudol

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 non-steroidal analgesic or anti-inflammatory drug.
• On open wounds, mucous membranes, or eczematous skin.
• If you have a 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 medication is for cutaneous use only, do not ingest.
• Apply only to intact skin, without wounds.
• You should avoid contact with mucous membranes (nose, mouth) and eyes.
• Do not apply the gel to very large areas of skin or for prolonged periods.
• Do not use with tight bandages or apply heat to the area where it is used. If you cover the area where you have used this medication, do so in a way that the garment covering the treated area remains slightly loose.
• The treated areas should not be exposed to the sun (even if cloudy) or to ultraviolet lamps (UVA rays).

Cutaneous reactions

Be especially careful with Ibudol:

Severe cutaneous 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 and seek immediate medical attention if you notice any of the symptoms related to these severe cutaneous reactions described in section 4.

Children and adolescents

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

Using Ibudol with other medications

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

Do not apply other cutaneous preparations to the same area of 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 have a baby, consult your doctor or pharmacist before taking this medication.

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 it is clearly necessary and advised by your doctor. If you need treatment during this period, you should use the lowest dose for the shortest possible time.

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

Driving and using machines

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

Ibudol contains propylene glycol laurate

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

3. How to use Ibudol

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

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

How to use:

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

Apply a thin layer of gel to the painful area by means of a gentle massage to facilitate penetration.

Wash your hands after each application.

If you use more Ibudol than you should

Due to its external use, it is unlikely that cases of intoxication will occur. In case of accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone: 91 562 04 20, indicating the medication and the amount ingested.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

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

• Red patches, not elevated, 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 cutaneous eruptions can be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].
• Widespread cutaneous eruption, elevated body temperature, and swollen lymph nodes (DRESS syndrome).
• Widespread, red, and scaly eruption, with bumps under the skin and blisters, accompanied by fever. The symptoms usually appear at the start 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 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 eruption, 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 taking Ibudol if you experience these symptoms and seek immediate medical attention. See also section 2. The skin becomes sensitive to light.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package 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

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

Do not store above 25°C.

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

Medications should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medication in the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Contents of the pack and further information

Composition of Ibudol

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

Appearance of the product and pack contents

Transparent and colorless gel. It is presented 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 last revision of this package leaflet: 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/