Label: information for the patient

Ibuprofen MABO 50 mg/g gel

Ibuprofen

Read this label 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 label or those indicated by your doctor or pharmacist.

-Keep this label as you may need to refer to it again.

-For advice or more information, consult your pharmacist.

-If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

-You should consult a doctor if your condition worsens or does not improve after 7 days (5 days in adolescents).

Ibuprofeno is a nonsteroidal anti-inflammatory drug (NSAID) that acts by relieving pain.

This medication is indicated for the local symptomatic relief of mild and occasional muscle and joint pain in adults and adolescents 12 years of age and older.

You should consult a doctor if it worsens or does not improve after 7 days (5 days in adolescents).

Do not use Ibuprofeno MABO:

• If you are allergic to ibuprofen or any of the other components of Ibuprofeno MABO.
• If you have had problems associated with acetylsalicylic acid or other related analgesics (including after oral administration), especially asthma, allergic rhinitis (nasal allergy) or urticaria (skin allergy).
• If you are pregnant or think you may be pregnant, or during the lactation period.
• If you have open wounds, mucous membranes or eczematous skin.
• If you are in the last 3 months of pregnancy.

Warnings and precautions:

Ibuprofeno MABO is applied directly to the painful area on the skin, so it is unlikely to cause the adverse effects associated with oral administration of ibuprofen or other similar analgesics. However, consult your doctor or pharmacist before using this medication:

• If you suffer from asthma.
• If you have a stomach ulcer (also known as gastric or peptic ulcer).
• If you have ever had kidney problems.
• If you have already taken aspirin or other analgesics.

Skin reactions

Severe skin reactions have been reported associated with treatment with Ibuprofeno MABO. Stop using Ibuprofeno MABO and seek medical attention immediately if you experience 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.

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

Children and adolescents

This medication is indicated for adolescents aged 12 years and older.

Consult a doctor if it worsens or does not improve after 5 days.

Pregnancy and lactation:

Pregnancy:

If you are pregnant or in the lactation period, or think you may be pregnant or are planning to have a baby, consult your doctor or pharmacist before using this medication.

Do not use this medication if you are in the last 3 months of pregnancy. Do not use ibuprofen 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 (e.g., tablets) of ibuprofen may cause adverse reactions in the fetus. It is unknown whether the same risk applies to ibuprofen when used on the skin.

The preparation should not be used during the first two-thirds of pregnancy due to its effect on prostaglandin synthesis.

Lactation:

Women in the lactation period should consult their doctor or pharmacist before using this medication.

Use of Ibuprofeno MABO with other medications:

Inform your doctor or pharmacist if you are using, have used recently or may need to use any other medication.

Ibuprofeno MABO contains ethanol and propylene glycol laurate

This medication contains 375 mg of alcohol (ethanol) in each gram of gel. It may cause a burning sensation on damaged skin.

This medication contains 50 mg of propylene glycol laurate in each gram of gel. Propylene glycol may cause skin irritation.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Ibuprofeno MABO is a topical gel for external use (on the skin) only.

To pierce the tube, invert the cap and press.

Apply by gently massaging to facilitate penetration and wash your hands after each application.

Use in children:

Do not administer to children (under 12 years old).

Adults and adolescents(over 12 years old):Apply a thin layer of the preparation to the painful area by gently massaging to facilitate penetration 3 to 4 times a day.

If you estimate that the action of this medication is too strong or too weak, inform your doctor or pharmacist.

If symptoms worsen or persist after 7 days (5 days in adolescents), you must consult a doctor.

If you use more Ibuprofeno MABO than you should:

If you have used more Ibuprofeno MABO than you should or have accidentally ingested the contents of the tube, consult your doctor or pharmacist immediately or the Toxicological Information Service, phone: 91 5620420, indicating the medication and the amount taken.

If you forgot to use Ibuprofeno MABO:

Do not use a double dose to compensate for the missed doses, simply continue with the usual treatment as soon as possible.

Do not exceed the recommended frequency of applications or the duration of treatment.

If you interrupt treatment with Ibuprofeno MABO

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

Like all medicines, Ibuprofeno MABO can cause side effects, although not everyone will experience them.

The recorded side effects are listed below according to the following frequencies: Frequent (observed in up to 1 in 10 people), Infrequent (may affect up to 1 in 100 people), Rare (may affect up to 1 in 1,000 people), Very rare (may affect up to 1 in 10,000 people), including isolated cases and unknown frequency (cannot be estimated from available data).

Infrequent: Redness, skin inflammation (dermatitis), local irritation, itching at the application site that disappears when treatment is discontinued.

Unknown frequency: The skin becomes sensitive to light. Generalized red scaly rash, with bumps under the skin and localized blisters, mainly on the skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (generalized acute pustular exanthema). Stop taking Ibuprofeno MABO if you experience these symptoms and seek medical attention immediately. See section 2.

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, consult your doctor or pharmacist.

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

• Flat, red, circular, or target-like 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 [dermatitis exfoliativa, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].
• Generalized skin rash, elevated body temperature, and swollen lymph nodes (DRESS syndrome).
• Generalized, red, and scaly rash, with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (generalized acute pustular exanthema).

Reporting of 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 leaflet. You can also report them directly through the notification system included in the Spanish System for Pharmacovigilance of Medicinal Products for Human Use. Website: www.notificaRAM.es.

By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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.

Medications should not be disposed of through drains or in the trash. Dispose of 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 Ibuprofeno MABO 50 mg/g gel

• The active ingredient is Ibuprofeno. Each gram of gel contains 50 mg of ibuprofeno.
• The other components are: diethylglycol monoethyl ether, caprilocaprylocyclol macrogolglycerides, propylene glycol laurate, hydroxypropylcellulose, ethanol 44.8 % v/v, menthol, purified water.

Appearance of the product and content of the packaging

Ibuprofeno MABO is a shiny, translucent, menthol-scented, extensible, evanescent, and washable gel.

It is presented in an aluminum tube coated with an internal protective varnish and a high-density polyethylene cap.

30 g and 60 g containers for cutaneous use.

Only some sizes of containers may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing.

Holder

MABO-FARMA, S.A.

Calle Vía de los Poblados, 3, Edificio 6

28033 Madrid,

Spain.

Responsible for manufacturing

ARAFARMA GROUP, S.A

C/ Fray Gabriel de San Antonio, 6-10.

Pol. Ind. Del Henares

19180 Marchamalo (Guadalajara)

Spain

INDUSTRIA QUÍMICA Y FARMACÉUTICA VIR, S.A

Laguna, 66-68-70.

Polígono industrial Urtinsa II

28923 Alcorcón (Madrid)

Spain

Spain

Last review date of this leaflet:January 2024

The detailed and updated information of this medicine is available on the webpage of the Spanish Agency of Medicaments and Sanitary Products (AEMPS) http://www.aemps.gob.es/