IBUKEY 50 mg/g GEL

Introduction

Leaflet: information for the user

Ibukey 50 mg/g gel

ibuprofen

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

This medicine can be obtained without a prescription. Nevertheless, to obtain the best results, it should be used properly.

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

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

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

• If you consider that any of the adverse effects you are experiencing is serious or if you notice any adverse effect not mentioned in this leaflet, inform your doctor or pharmacist.

Contents of the leaflet

1. What is Ibukey and what is it used for
2. Before using Ibukey
3. How to use Ibukey
4. Possible side effects
5. Storage of Ibukey
6. Additional information

1. What is Ibukey and what is it 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 locally relieve mild and occasional pain and inflammation caused by: minor bruises, blows, sprains, torticollis or other contractures, mild low back pain and sprains caused as a consequence of a twist.

2. Before using Ibukey

Do not use Ibukey if:

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

• You have a sunburn in the affected area.

• You have suffered allergic reactions (rhinitis, difficulty breathing or asthma, urticaria, itching or other) caused by acetylsalicylic acid or other non-steroidal anti-inflammatory drugs.

• If you are in the last 3 months of pregnancy

Be careful with Ibukey because:

• It should not be used on mucous membranes, nor on skin with wounds or eczema.

• If you are asthmatic or allergic to any colorant used in food or medicine (such as yellow-orange tartrazine, etc...)

• You should avoid contact with the eyes.

• Do not expose the treated area to the sun, nor use with bandages or on extensive areas.

• Do not apply Ibukey simultaneously in the same area where other medicines have been applied.

• Severe skin reactions, such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP), have been reported in association with ibuprofen treatment. Interrupt treatment with Ibukey and seek immediate medical attention if you notice any of the symptoms related to these severe skin reactions described in section 4.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using a medicine.

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 medicine.

Do not use Ibukey if you are in the last 3 months of pregnancy. Do not use Ibukey during the first 6 months of pregnancy unless it is clearly necessary and advised by your doctor. If you need treatment during this period, use the lowest dose for the shortest possible time.

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

Use in children

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

Use of other medicines

Inform your doctor or pharmacist if you are using or have recently used any other medicine, especially analgesics, including those purchased without a medical prescription, homeopathic products, herbal remedies, and other health-related products.

Driving and using machines

No effects have been described.

3. How to use Ibukey

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

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

Over 12 years old: apply a thin layer of the product to the painful area 3 to 4 times a day and perform a gentle massage to facilitate penetration.

Wash your hands after each application.

Do not use for more than 7 consecutive days.

If you think the effect of Ibukey is too strong or too weak, tell your doctor or pharmacist.

If you use more Ibukey than you should:

Due to its external use, it is unlikely that cases of intoxication will occur. 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 it can cause: nausea, vomiting, abdominal pain, drowsiness, dizziness, spasms, and low blood pressure.

If you forget to use Ibukey

In case of forgetting a dose, wait for the next one. But do not use a double dose to make up for the forgotten dose.

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

4. Possible side effects

Like all medicines, Ibukey can have side effects, although not everyone will experience them

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

• Rare (may affect up to 1 in 1000 patients): dermatitis (skin inflammation) caused by the sun.

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

• red spots, not elevated, in a target or circular shape on the trunk, often with blisters in the center, skin peeling, mouth ulcers, throat, nose, genitals, and eyes. These severe skin rashes can be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].

• Generalized skin rash, elevated body temperature, and hypertrophic lymph nodes (DRESS syndrome).

• Generalized, red, and scaly rash, with bumps under the skin and blisters, accompanied by fever. The symptoms usually appear at the start of treatment (acute generalized exanthematous pustulosis).

If you consider that any of the side effects you are experiencing is serious or if you notice any side effect not mentioned 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 expiration date shown on the packaging after the abbreviation: EXP. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging of medicines you no longer need at the SIGRE point in your usual pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Additional information

Composition of Ibukey

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

Appearance of the product and packaging content:

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

It is available in 30 g and 60 g gel tubes. It is possible that not all presentations are marketed.

This leaflet was approved: May 2011.

Detailed and updated information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS)

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