Ibuprofen Mabo 50 mg/g gel
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Ibuprofeno MABO 50 mg/g gel
Ibuprofen
Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.
Follow exactly the instructions for use of this medicine as contained in this leaflet or as advised by your doctor or pharmacist.
- Keep this leaflet as you may need to read it again.
- If you need advice or more information, consult your pharmacist.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
- You should consult a doctor if your condition worsens or if you do not improve after 7 days (5 days in adolescents).
Leaflet contents:
- What Ibuprofeno MABO is and what it is used for
- What you need to know before using Ibuprofeno MABO
- How to use Ibuprofeno MABO
- Possible side effects
- How to store Ibuprofeno MABO
- Contents of the pack and other information
1. What is Ibuprofen MABO and what is it used for
Ibuprofen is a non-steroidal anti-inflammatory drug (NSAID) that works by relieving pain.
This medicine is indicated for the local symptomatic relief of mild and occasional muscular and joint pain in adults and adolescents aged 12 years and older.
You should consult a doctor if your condition worsens or does not improve after 7 days (5 days in adolescents).
2. What you need to know before using Ibuprofeno MABO
Do not use Ibuprofeno MABO:
- If you are allergic to ibuprofen or to any of the other ingredients 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 might be pregnant, or during breastfeeding.
- 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 that adverse effects associated with oral administration of ibuprofen or similar analgesics will occur. However, consult your doctor or pharmacist before using this medicine:
- 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 previously taken aspirin or other analgesics.
Skin reactions
Serious skin reactions have been reported with treatment using Ibuprofeno MABO. Stop using Ibuprofeno MABO and seek medical attention immediately if you develop any skin rash, lesions on mucous membranes, blisters, or other signs of allergy, as these may be the first signs of a very serious skin reaction. See section 4.
Serious 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 ibuprofen and seek immediate medical attention if you notice any symptoms related to these serious skin reactions described in section 4.
Children and adolescents
This medicine is indicated for adolescents aged 12 years and older.
You should consult a doctor if your symptoms worsen or do not improve within 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 medicine.
Do not use this medicine if you are in the last 3 months of pregnancy. You should not use ibuprofen during the first 6 months of pregnancy unless clearly necessary and advised by your doctor. If treatment is needed during this period, the lowest dose for the shortest possible duration should be used.
Oral forms (e.g., tablets) of ibuprofen may cause adverse effects in the fetus. It is unknown whether the same risk applies to ibuprofen when used on the skin.
This 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 medicine.
Use of Ibuprofeno MABO with other medicines:
Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Ibuprofeno MABO contains ethanol and propylene glycol laurate
This medicine contains 375 mg of alcohol (ethanol) in each gram of gel. It may cause a burning sensation on damaged skin.
This medicine contains 50 mg of propylene glycol laurate in each gram of gel. Propylene glycol may cause skin irritation.
3. How to use Ibuprofen MABO
Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
Ibuprofen MABO is a topical gel for external use only (on the skin).
To pierce the tube, invert the cap and press.
Apply with a gentle massage to promote penetration, and wash your hands after each application.
Use in children:
Do not administer to children (under 12 years of age).
Adults and adolescents (over 12 years of age): Apply a thin layer of the preparation to the painful area with gentle massage to enhance penetration, 3 to 4 times daily.
If you feel that the effect of this medicine is too strong or too weak, inform your doctor or pharmacist.
If symptoms worsen or persist for more than 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 recommended or have accidentally ingested the contents of the tube, consult your doctor or pharmacist immediately or contact the Toxicology Information Service at telephone number: 91 5620420, indicating the medicine and the amount taken.
If you forget to use Ibuprofen MABO:
Do not use a double dose to make up for missed doses. Simply continue with your usual treatment as soon as possible.
The recommended frequency of applications and treatment duration must not be exceeded.
If you stop treatment with Ibuprofen MABO
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, Ibuprofeno MABO can produce adverse effects, although not everyone experiences them.
The reported adverse effects are listed below according to the following frequencies: Common (observed in up to 1 in every 10 people), Uncommon (may affect up to 1 in every 100 people), Rare (may affect up to 1 in every 1,000 people), Very rare (may affect up to 1 in every 10,000 people), and Frequency not known (cannot be estimated from available data).
Uncommon: Redness, skin inflammation (dermatitis), local irritation, itching at the application site, which disappears upon discontinuation of treatment.
Frequency not known: Skin becomes sensitive to light. Generalized red, scaly rash, with bumps under the skin and blisters mainly located in skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis). Stop taking Ibuprofeno MABO if you experience these symptoms and seek immediate medical attention. See also section 2.
If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effect not mentioned in this leaflet, consult your doctor or pharmacist.
Stop treatment with ibuprofen and seek immediate medical attention if you notice any of the following symptoms:
- Flat, non-elevated reddish spots, target-like or circular rashes on the trunk, often with blisters in the center, skin peeling, mouth, throat, nose, genital, or eye ulcers. These serious skin rashes may be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].
- Generalized skin rash, high 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 exanthematous pustulosis).
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the reporting system included in the Spanish Pharmacovigilance System for Human Medicines. Website: www.notificaRAM.es.
By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Ibuprofen MABO
Keep this medicine out of the sight and reach of children.
No special storage conditions are required.
Do not use this medicine after the expiry date which is stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.
Medicines should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused containers and medicines. This will help protect the environment.
6. Contents of the pack and other information
Composition of Ibuprofeno MABO 50 mg/g gel
- The active substance is Ibuprofen. Each gram of gel contains 50 mg of ibuprofen.
- The other components are: diethylene glycol monoethyl ether, caprylocaproyl macrogol glycerides, propylene glycol laurate, hydroxypropylcellulose, ethanol 44.8 %v/v, menthol, purified water.
Appearance of the product and contents of the pack
Ibuprofeno MABO is a shiny, translucent gel with a menthol odour, easily spreadable, evaporating and washable.
It is presented in an aluminium tube coated with an internal protective varnish and closed with a high-density polyethylene cap.
Pack sizes of 30 g and 60 g for cutaneous use.
Only some pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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 latest revision of this leaflet: January 2024
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/