Package Insert: Information for the Patient

Ibustick 50 mg/g Gel

Ibuprofen

Read this entire package insert carefully before starting to use this medication, as it contains important information for you.

Follow exactly the administration instructions for the medication contained in this package insert or those indicated by your doctor, pharmacist, or nurse.

• Keep this package insert, as you may need to refer to it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package insert. See section 4
• You should consult a doctor if your condition worsens or does not improve after 7 days.

1. What is Ibustick and what is it used for.

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

3. How to use Ibustick.

4. Possible adverse effects.

5. Storage of Ibustick.

6. Contents of the package and additional information

The ibuprofen, active ingredient of this medication, acts as an analgesic and local anti-inflammatory.

This medication is indicated in adults and adolescents from 12 years of age for the relief of pain and mild and occasional inflammation caused by: small contusions, blows, strains (muscle pulls), torticollis (neck pain and stiffness) or other contractures, lower back pain and mild sprains resulting from a twist.

No use Ibustick:

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

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

Advertencias y precauciones

• Do not use it on mucous membranes, or on skin with wounds or eczema.
• Apply this medication only on intact skin.
• If you are asthmatic or allergic to any food coloring or medication (such as yellow-orange, tartrazine, etc.) 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 lamps (UVA).
• Do not use with occlusive dressings.
• Do not apply the gel to large areas, or for prolonged periods. Use exclusively on the affected area.
• Do not apply Ibuprofen Ibustick simultaneously in 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), generalized acute pustular exanthema (PEGA), have been reported in association with ibuprofen treatment. Discontinue Ibustick treatment and seek medical attention immediately if you notice any of the symptoms related to these severe skin reactions described in section 4.

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

Reacciones cutáneas

Severe skin reactions have been reported associated with Ibustick treatment. Stop using Ibustick and seek medical attention immediately if you present any skin rash, membrane lesions, blisters, or other signs of allergy, as these may be the first signs of a severe skin reaction. See section 4.

Uso de otros medicamentos

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

Embarazo y lactancia

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 become pregnant, 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 your doctor advises it. If you need treatment during this period, use the lowest dose for the shortest possible time.

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

Uso en niños

Do not use this medication in children under 12 years old, due to the scarcity of data in this population.

Conducción y uso de máquinas

No effects on the ability to drive vehicles and use machinery have been described when using Ibustick externally on the skin.

Ibustick contains B.H.T. (butyl hydroxytoluene) (E 321).It may cause local skin reactions (such as contact dermatitis) or irritation of the eyes and mucous membranes.

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

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

This medication is for topical use (only to be applied on the skin)

The recommended dose is:

Adults and children over 12 years old: apply a thin layer of the product to the affected area 3 to 4 times a day and perform a gentle massage with the roll-on applicator to facilitate its 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 occurs in the area, you must consult your doctor

If you use more Ibustick than you should:

Due to its external use, cases of intoxication are unlikely. 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 Toxicological Information Service (Tel: 915620420), indicating the medication and the amount ingested, as the following symptoms may occur: nausea, vomiting, abdominal pain, drowsiness, dizziness, muscle spasms, and decreased blood pressure.

Like all medications, Ibustick may have side effects, although not everyone may experience them.

You may experience the following side effects:

• Rare (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.

• Uncommon (may affect up to 1 in 1,000 people): sun-induced dermatitis (inflammation of the skin).

-Frequency «unknown» Generalized red scaly rash, with bumps under the skin and blisters located mainly in skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (acute generalized pustular psoriasis).

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

The skin becomes sensitive to light.

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

• Flat, red, circular, or target-shaped patches on the trunk, often with blisters in the center, skin peeling, mouth, throat, nose, genital, and eye ulcers. These severe skin eruptions may 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 swollen lymph nodes (DRESS syndrome).
• Generalized, red, scaly rash, with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized pustular psoriasis).

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

Reporting side effects

If you experienceany type of side effect, consult your doctor or pharmacist, even if it is apossibleside effect not listed in this leaflet.You can also report them directly to theSpanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medication.

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 that appears on the packaging, after CAD:. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medications at the SIGRE collection point at the pharmacy. 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 Ibustick

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

The other components (excipients) are: ethanol at 96%, isopropyl alcohol, hydroxyethylcellulose, diethylene glycol monoethyl ether, caprocaproil macrogolglycerides, 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.

Appearance of the product and contents of the packaging

This medication is a transparent and colorless gel with a reflex aroma.

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

Only some sizes of packaging may be commercially available.

Marketing Authorization Holder:

Farmasierra Laboratorios, S.L.

Ctra. de Irún km 26,200

28709, San Sebastián de los Reyes (Madrid)

Spain

Responsible for Manufacturing:

Farmasierra Manufacturing, S.L.

Ctra. de Irún km 26,200

28709, San Sebastián de los Reyes

(Madrid)

Spain

This prospectus has been reviewed in December 2023

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es