Ibukey 50 mg/g gel

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Ibukey 50 mg/g gel

ibuprofen

Read the entire leaflet carefully because it contains important information for you.

This medicine can be purchased without a prescription. However, to achieve the best results, it must be used correctly.

• Keep this leaflet, as you may need to read it again.

• If you need additional information or advice, consult your pharmacist.

• If symptoms worsen, or if they persist after 7 days of treatment, you should consult a doctor.

• If you consider any of the adverse effects you experience to be serious, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

Leaflet contents

1. What Ibukey is and what it is used for
2. Before you use Ibukey
3. How to use Ibukey
4. Possible adverse effects
5. How to store Ibukey
6. Further information

1. What Ibukey is and what it is used for

Ibukey is a gel for cutaneous use (on the skin).

This medicine acts as a local analgesic and anti-inflammatory.

Ibukey is indicated to relieve mild and occasional local pain and inflammation caused by minor bruises, blows, sprains, torticollis or other muscle spasms, lumbago, and mild sprains resulting from twisting injuries.

2. Before using Ibukey

Do not use Ibukey if:

• You are allergic to ibuprofen or to any of the components of the medicine.

• You have a sunburn in the affected area.

• You have experienced allergic reactions (rhinitis, breathing difficulties or asthma, urticaria, pruritus or others) caused by acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs.

• You are in the last 3 months of pregnancy.

Take special care with Ibukey because:

• It must not be used on mucous membranes or on skin with wounds or eczema.

• If you are asthmatic or allergic to any food or medicine dyes (for example: tartrazine yellow-orange, etc...).

• You must avoid contact with the eyes.

• You must not expose the treated area to sunlight, or use bandages, or apply it over extensive skin areas.

• You must not apply Ibukey simultaneously on the same area where other medicines have been applied.

• Serious 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), acute generalized exanthematous pustulosis (AGEP), associated with ibuprofen treatment. Discontinue treatment with Ibukey and seek immediate medical attention if you notice any of the symptoms related to these serious skin reactions described in section 4.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

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

Oral forms (e.g., tablets) of ibuprofen may cause adverse effects in the fetus. It is unknown whether the same risk applies to Ibukey when used on the skin.

Use in children

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

Use of other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, especially analgesics, including homeopathic remedies, herbal medicines, and other health-related products purchased without a prescription.

Driving and using machines

No effects have been reported.

3. How to use Ibukey

Follow these instructions unless your doctor has given you different advice.

This is a medicine for topical use only (on the skin).

Adults and children over 12 years: apply a thin layer of the product to the affected area 3 to 4 times daily and gently massage to aid penetration.

Wash your hands after each application.

Do not use for more than 7 consecutive days.

If you feel that the effect of Ibukey is too strong or too weak, inform your doctor or pharmacist.

If you use more Ibukey than you should:

Due to its external use, cases of poisoning are unlikely. In case of accidental ingestion, go immediately to a medical center or call the Toxicology Information Service (Tel: 915.620.420), indicating the medicine and the amount ingested, as symptoms such as nausea, vomiting, abdominal pain, drowsiness, dizziness, spasms, and low blood pressure may occur.

If you forget to use Ibukey

If you miss a dose, wait until the next scheduled application. Do not apply a double dose to make up for the missed dose.

If you have any further questions about the use of this product, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Ibukey may have adverse effects, although not everyone experiences them.

• Uncommon (may affect up to 1 in 100 patients): redness, itching, and burning sensation of the skin at the application site, which disappear when treatment is discontinued.

• Rare (may affect up to 1 in 1,000 patients): dermatitis (skin inflammation) caused by sunlight exposure.

• Skin becomes sensitive to light: frequency not known.

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

• Flat, red, target-shaped or circular spots on the trunk, often with blisters in the center, peeling of the skin, 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 skin rash, high body temperature, and swollen 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).

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effect not listed in this leaflet, inform your doctor or pharmacist.

5. Storage of Ibukey

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

No special storage conditions are required.

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

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

6. Additional Information

Composition of Ibukey

• The active substance is Ibuprofen. Each gram of gel contains 50 mg of ibuprofen.
• The other components (excipients) are sodium hydroxide, isopropyl alcohol, hydroxyethylcellulose, benzyl alcohol, herbal perfume 72353, and purified water.

Appearance of the product and contents of the package:

It is a homogeneous, colorless and transparent gel, packaged in white, multilayer low-density polyethylene tubes with a white high-density polyethylene cap.

Available in tubes containing 30 g and 60 g of gel. It is possible that not all pack sizes are marketed.

This leaflet was approved: August 2025.

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)

http://www.aemps.gob.es/