IBUSTICK 50 mg/g GEL

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

Do not use Ibustick:

• If you are allergic (hypersensitive) to ibuprofen or any of the other components of this medication.
• If you have a sunburn in the affected area.
• If you have experienced allergic reactions caused by acetylsalicylic acid or other non-steroidal anti-inflammatory drugs, such as:
• • Asthmatic allergic reactions (difficulty breathing, shortness of breath, chest tightness, and in some cases coughing or wheezing).
  • Swelling of the face, lips, mouth, tongue, or throat that can cause difficulty swallowing or breathing (angioedema).
  • Other allergic reactions such as rhinitis, itching, or hives.

• If you are in the last 3 months of pregnancy.

Warnings and Precautions

• It should not be used on mucous membranes or on skin with wounds or eczema.
• This medication should only be applied to intact skin.
• If you are asthmatic or allergic to any food coloring or medication (such as yellow-orange, tartrazine, etc.), you should consult your doctor before using this medication.
• Avoid contact with the eyes and mucous membranes.
• Treated areas should not be exposed to the sun (even on cloudy days) or to ultraviolet (UVA) lamps.
• Do not use with occlusive dressings.
• Do not apply the gel to large areas or for extended periods. Use exclusively on the affected area.
• Do not apply Ibustick simultaneously to the same area where other medications 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 syndrome), and acute generalized exanthematous pustulosis (AGEP), have been reported in association with ibuprofen treatment. Discontinue treatment with Ibustick and seek immediate medical attention if you notice any symptoms related to these severe skin reactions described in section 4.

Special caution is recommended with Ibustick 50 mg/g gel.

Skin Reactions

Severe skin reactions have been reported in association with Ibustick treatment. Stop using Ibustick and consult a doctor immediately if you experience any skin rash, mucous membrane lesions, blisters, or other signs of allergy, as these may be the first signs of a severe skin reaction. See section 4.

Use of Other Medications

Inform your doctor or pharmacist if you are using or have recently used any other medication, especially pain relievers, including those purchased without a prescription.

Pregnancy and Breastfeeding

Consult your doctor or pharmacist before using any medication.

Pregnant or breastfeeding women should not use this medication without consulting their doctor or pharmacist.

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 Ibustick if you are in the last 3 months of pregnancy. Do not use Ibustick during the first 6 months of pregnancy unless it is clearly necessary and advised by your doctor. If treatment is needed 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 ibuprofen when used on the skin.

Use in Children

Do not use this medication in children under 12 years of age due to the lack of data in this population.

Driving and Using Machines

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

Ibustick contains B.H.T. (butylhydroxytoluene) (E 321).It may cause local skin reactions (such as contact dermatitis) or eye and mucous membrane irritation.

Ibustick contains ethanol.This medication contains 200 mg of alcohol (ethanol) per gram of gel. It may cause a burning sensation on damaged skin.

3. How to Use Ibustick

Follow the administration instructions exactly, unless your doctor has given you different instructions. Consult your doctor or pharmacist if you have doubts.

This medication is for cutaneous use (to be applied only to the skin).

The recommended dose is:

Adults and children over 12 years: Apply a thin layer of the product to the painful area 3 to 4 times a day and perform a gentle massage with the roll-on applicator to facilitate penetration.

Wash your hands after each application. Do not use for more than 7 consecutive days.

If symptoms worsen or persist after 7 days of treatment, or if irritation or redness of the area occurs, consult a doctor.

If you use more Ibustick than you should:

Due to its external use, it is unlikely that cases of intoxication will occur. However, if you have used this medication more than you should, or in case of accidental ingestion, go immediately to a medical center or call the Toxicology Information Service (Tel: 915620420), indicating the medication and the amount ingested, as it may cause: nausea, vomiting, abdominal pain, drowsiness, dizziness, spasms (cramps), and low blood pressure.

4. Possible Side Effects

Like all medications, Ibustick can have side effects, although not everyone experiences them.

You may experience the following side effects:

• Uncommon (may affect up to 1 in 100 people): redness, itching, and burning sensation on the skin at the application site, 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" Generalized red scaly rash, with bumps under the skin and blisters, mainly on the skin folds, trunk, and upper limbs, accompanied by fever at the start of treatment (acute generalized exanthematous pustulosis).

Stop using Ibustick if you experience these symptoms and seek medical attention immediately. See also section 2.

The skin becomes sensitive to light.

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

• Red patches, not raised, 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 skin rashes can be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].
• Generalized rash, elevated body temperature, and swollen lymph nodes (DRESS syndrome).
• Generalized red scaly rash, with bumps under the skin and blisters, accompanied by fever. 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 package leaflet, inform your doctor or pharmacist.

Reporting Side Effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Ibustick

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

No special storage conditions are required.

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

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Ibustick Composition

Each gram of gel contains 50 mg of ibuprofen as the active ingredient.

The other components (excipients) are: ethanol 96%, isopropyl alcohol, hydroxyethylcellulose, diethylene glycol monoethyl ether, macrogolglycerides of capric/caprylic acid, glycerol (E-422), sodium hydroxide (E-524) (15% aqueous solution), levomenthol, reflex aroma (camphor, menthone-L, methyl salicylate, B.H.T. (E-321)), and purified water.

Product Appearance and Package Contents

This medication is a clear, colorless gel with a reflex aroma.

It is presented in a bottle with a roll-on applicator containing 30 or 60 grams of gel.

Only some package sizes may be marketed.

Marketing Authorization Holder:

Farmasierra Laboratorios, S.L.

Ctra. de Irún km 26,200

28709, San Sebastián de los Reyes (Madrid)

Spain

Manufacturer:

Farmasierra Manufacturing, S.L.

Ctra. de Irún km 26,200

28709, San Sebastián de los Reyes

(Madrid)

Spain

This package leaflet was revised in December 2023

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/