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 purchased without a prescription. Nevertheless, for the best results, it must 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 symptoms worsen, or if they persist after 7 days of treatment, you must consult a doctor.

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

1. What Ibukey is and for what it is used

2. Before using Ibukey

3. How to use Ibukey

4. Possible adverse effects

5. Storage of Ibukey

6. Additional information

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

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

Ibukey is indicated to relieve locally mild and occasional pain and inflammation caused by: small bruises, blows, strains, torticollis or other contractures, lower back pain, and mild sprains resulting from a twist.

Do not use Ibukey if:

- You are allergic to ibuprofen or any of the components of the medication.

- You have a sunburn on the affected area.

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

Be extra cautious with Ibukey because:

- It should not be used on mucous membranes, or on skin with wounds or eczema.

- If you are asthmatic or allergic to any food coloring or medication (such as yellow-orange tartrazine, etc...)

- You should avoid contact with the eyes.

- Do not expose the treated area to the sun, or use with bandages or on large areas.

- Do not apply Ibukey simultaneously on the same area where other medications have been applied.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using a medication.

Use in children

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

Use of other medications

Inform your doctor or pharmacist if you are using or have recently used any other medication, especially pain relievers, even those purchased without a prescription, homeopathic, herbal, or other health-related products.

Driving and operating machines

No effects have been described.

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

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

Over 12 years old: apply a thin layer of the product to the painful area3 to4 times a day and gently massage it in to help it penetrate.

Wash your hands after each application.

Do not use for more than 7 consecutive days.

If you think Ibukey's action 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 you will experience cases of overdose. In case of accidental ingestion, go to a medical center immediately or call the Toxicological Information Service (Tel: 915.620.420), indicating the medication and the amount ingested, as it may cause: nausea, vomiting, abdominal pain, drowsiness, dizziness, muscle spasms, and low blood pressure.

If you forgot to useIbukey

If you forget a dose, wait for the next one. However, do not use a double dose to make up for the missed dose.

If you have any other questions about using this product, ask your doctor or pharmacist.

Like all medications, Ibukey may have adverse effects, although not all people will experience them

- Infrequent (may affect up to 1 in 100 patients): redness, itching, and burning sensation on the skin at the application site, which disappear upon discontinuing treatment.

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

If you consider any of the adverse effects you are experiencing to be severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Keepthis medicationout of the reach and sight of children

No special storage conditions are required.

Do not use this medication after the expiration date that appears on the packaging after the abbreviation: CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging of unused medications at your usual pharmacy's designated collection point. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

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, herbal fragrance 72353, and purified water.

Appearance of the product and contents of the package:

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

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

This prospectus has been approved: May 2011.

The detailed and updated information of this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)

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