IBUPROFEN MABO 50 mg/g GEL

2. What you need to know before using Ibuprofen MABO

Do not use Ibuprofen MABO:

• If you are allergic to ibuprofen or any of the other components of Ibuprofen 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 breastfeeding period.
• If you have open wounds, mucous membranes, or eczematous skin.
• If you are in the last 3 months of pregnancy.

Warnings and precautions:

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

• If you suffer from asthma.
• If you have a stomach ulcer (also called 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 associated with Ibuprofen MABO treatment have been reported. Stop using Ibuprofen MABO and consult a doctor immediately if you present 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.

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. Discontinue ibuprofen treatment and seek immediate medical attention if you notice any symptoms related to these severe skin reactions described in section 4.

Children and adolescents

This medication is indicated in adolescents from 12 years of age.

You should consult a doctor if it worsens or does not improve after 5 days.

Pregnancy and breastfeeding:

Pregnancy:

If you are pregnant or breastfeeding, 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. You should not use ibuprofen during the first 6 months of pregnancy unless it is clearly necessary and advised by your doctor. If you need treatment during this period, you should use the lowest dose for the shortest possible time.

Oral forms (e.g., tablets) of ibuprofen may produce adverse reactions in the fetus. It is unknown if 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.

Breastfeeding:

Women who are breastfeeding should consult their doctor or pharmacist before using this medication.

Using Ibuprofen MABO with other medications:

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

Ibuprofen MABO contains ethanol and propylene glycol laurate

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

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

3. How to use Ibuprofen MABO

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

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

To pierce the tube, invert the cap and press.

Apply by gentle massage to facilitate penetration and wash your hands after each application.

Use in children:

Do not administer to children (under 12 years).

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

If you think the action of this medication is too strong or too weak, tell your doctor or pharmacist.

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

If you use more Ibuprofen MABO than you should:

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

If you forget to use Ibuprofen MABO:

Do not use a double dose to make up for forgotten doses; simply continue with the usual treatment as soon as possible.

Do not exceed the recommended application frequency or treatment duration.

If you stop using Ibuprofen MABO

If you have any other doubts about using this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, Ibuprofen MABO can produce side effects, although not everyone will experience them.

The reported side effects are detailed 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 blisters, mainly in skin folds, trunk, and upper limbs, accompanied by fever at the start of treatment (acute generalized exanthematous pustulosis). Stop taking Ibuprofen MABO if you present these symptoms and seek immediate medical attention. See also section 2.

If you think any of the side effects you are experiencing is serious or if you notice any side effect not mentioned in this package leaflet, consult your doctor or pharmacist.

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

• Red, non-raised spots, target-like or circular on the trunk, often with blisters in the center, skin peeling, mouth, throat, nose, genital, and eye ulcers. These severe skin reactions 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, and scaly rash, with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the start of treatment (acute generalized exanthematous pustulosis).

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 notification system included in the Spanish Pharmacovigilance System for Human Use Medicines. Website: www.notificaRAM.es.

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

5. Storage of Ibuprofen MABO

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 stated on the packaging after EXP. The expiration date is the last day of the month indicated.

Medications should not be disposed of via 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

Composition of Ibuprofen MABO 50 mg/g Gel

• The active ingredient is Ibuprofen. Each gram of gel contains 50 mg of ibuprofen.
• The other ingredients are: diethylene glycol monoethyl ether, macrogolglycerides of capric and caprylic acid, propylene glycol laurate, hydroxypropylcellulose, ethanol 44.8% v/v, menthol, purified water.

Appearance of the Product and Package Contents

Ibuprofen MABO is a bright, translucent gel with a menthol odor, spreadable, evanescent, and washable.

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

Available in 30 and 60 g tubes for external use.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Holder

MABO-FARMA, S.A.

Calle Vía de los Poblados, 3, Edificio 6

28033 Madrid,

Spain.

Manufacturers

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

Date of the last revision of this package leaflet:January 2024

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/