NOTICE
ANSM - Updated on : 23/01/2024
Product name
IBUFETUM 5%, gel
Ibuprofen
Sidebar
Please read this leaflet carefully before taking this medicine, as it contains important information for you.
Always take this medicine exactly as instructed in this leaflet or by your doctor or pharmacist.
- Keep this leaflet as you may need to read it again.
- Ask your pharmacist for any advice or information you may need.
- If you experience any of the side effects listed above, please tell your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. See section 4.
- You should contact your doctor if you do not feel any improvement or if you feel less well.
What does this leaflet contain?
1. What is IBUFETUM 5% gel and what is it used for?
2. What do I need to know before using IBUFETUM 5% gel?
3. How do I use IBUFETUM 5% gel?
4. What are the possible side effects?
5. How do I keep IBUFETUM 5% gel?
6. Package contents and other information.
1. WHAT IS IBUFETUM 5%, gel AND WHAT IS IT USED FOR?
Pharmacotherapeutic class: non-steroidal anti-inflammatory agents for topical use - ATC code: M02AA13.This medicine contains a non-steroidal anti-inflammatory agent.
Therapeutic indications
For short-term local treatment in adults (over 15 years of age):
- benign traumas such as sprains and contusions,
- tendinitis (inflammation of tendons).
2. WHAT DO I HAVE TO KNOW BEFORE USING IBUFETUM 5% gel?
Never use IBUFETUM 5% gel in the following cases:
- if you are allergic to the active substance or to any of the other ingredients of this medicine, as mentioned in section 6.
- if you are pregnant, from the beginning of the 6th month of pregnancy (beyond 24 weeks of amenorrhea),
- if your skin is damaged in any way: oozing lesions, eczema, infected lesions, burns or wounds.
Warnings and precautions
Be careful with IBUFETUM 5%, gel:
- Do not apply to mucous membranes or eyes,
- If you develop a rash after applying the gel, discontinue use immediately.
- If used frequently by healthcare professionals, gloves should be worn.
Take particular care with IBUFETUM 5% gel:
Severe skin reactions, including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), acute generalized exanthematous pustulosis (AGEP), have been reported in association with treatment with IBUFETUM 5%, gel. Stop using IBUFETUM 5%, gel and consult a doctor immediately if you notice any of the symptoms of these severe skin reactions, described in section 4.
Follow the instructions for use:
- never apply more than the recommended dose(see Dosage section),
- do not apply to large areas of the body,
- respect treatment frequency and duration.
Other drugs and IBUFETUM 5% gel
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Interactions with food and drink
Not applicable.
Interactions with herbal products or alternative therapies
Not applicable.
Pregnancy, breast-feeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking any medicine.
Pregnancy
Before the beginning of the 6th month of pregnancy (up to the 24th week of amenorrhea), you should not take this medicine unless absolutely necessary, as determined by your doctor, due to the potential risk of miscarriage or malformations. In such cases, the dose should be kept as low as possible and the duration of treatment as short as possible.
From 12 weeks of amenorrhea onwards, IBUFETUM 5% gel can cause kidney problems in your baby, if taken for several days, leading to a low level of amniotic fluid (oligohydramnios). A narrowing of the blood vessels (constriction of the ductus arteriosus) in your baby's heart may be observed as early as 20 weeks of amenorrhea. If treatment over several days is required, your doctor may recommend additional monitoring.
From the beginning of the 6th month to the end of pregnancy (beyond the 24th week of amenorrhea), this medicine is contraindicated. You should NEVER take this medicine, as its effects on your child may have serious or even fatal consequences, particularly on the heart, lungs and/or kidneys, even with a single dose. It can also affect you and your baby by increasing bleeding, leading to a later or longer-than-expected delivery.
If you have taken this medicine while pregnant, talk to your obstetrician-gynecologist immediately, so that suitable monitoring can be offered if necessary.
Breast-feeding
As this drug passes into breast milk, it is not recommended to use it while breast-feeding.
If you are breast-feeding, do not apply this product to your breasts.
Fertility
This drug, like all non-steroidal anti-inflammatory drugs (NSAIDs), may impair fertility in women, leading to difficulties in becoming pregnant, which may be reversible on discontinuation of treatment. Inform your doctor if you are planning a pregnancy or have difficulty conceiving.
Driving and use of machinery
Not applicable.
List of notable excipients
IBUFETUM 5% gel contains ethanol (alcohol).
This medicine contains 32.30 g of alcohol (ethanol) per 100 g of gel. This may cause a burning sensation on damaged skin.
3. HOW TO USE IBUFETUM 5%, gel
Dosage
The usual dose is 1 application, 3 times a day.
If you feel that the effect of IBUFETUM 5%, gel is too strong or too weak, consult your doctor or pharmacist.
Method of administration
Local use.
Gently massage the gel into the painful or inflammatory area.
Wash hands thoroughly after each use.
Duration of treatment
Treatment is limited to 5 days in the absence of a medical prescription.
If you have used more IBUFETUM 5% gel than you should: rinse off with plenty of water.
If you forget to use IBUFETUM 5%, gel: do not take a double dose to make up for the single dose you forgot to take.
If you stop using IBUFETUM 5%, gel: not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, IBUFETUM 5% gel may cause undesirable effects, although not everyone is subject to them.
- Exceptionally, the following may occur
o allergic reactions:
§ cutaneous,
§ asthma-like respiratory reactions,
§ general.
o reddish, target-shaped or circular patches on the trunk, often accompanied by central blisters, desquamation of the skin, ulcers of the mouth, throat, nose, genitals and eyes. These severe rashes may be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].
o extensive rash, elevated body temperature and enlarged lymph nodes (DRESS syndrome).
o a 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).
Stop using IBUFETUM 5% gel and consult a doctor immediately if you notice any of the above symptoms.
- May also occur:
o local skin effects such as redness and itching.
o other general effects of non-steroidal anti-inflammatory drugs, depending on the amount of gel applied, the surface treated and its condition, the duration of treatment and whether or not a closed dressing is used.
o skin sensitivity to light - frequency unknown.
In all these cases, tell your doctor.
Reporting side effects
If you experience any side effects, please tell your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. You can also report adverse reactions directly via the national reporting system: Agence nationale de sécurité du médicament et des produits de santé (ANSM) and the network of Centres Régionaux de Pharmacovigilance - Website: https://signalement.social-sante.gouv.fr.
By reporting adverse reactions, you are helping to provide more information on drug safety.
5. HOW TO USE IBUFETUM 5% gel?
Keep out of the reach and sight of children.
Do not use IBUFETUM 5%, gel after the expiration date stated on the box.
No special storage precautions.
Do not dispose of in the household waste. Ask your pharmacist to dispose of any medicines you no longer use. These measures will help protect the environment.
6. CONTENTS AND OTHER INFORMATION
What IBUFETUM 5% gel contains
The active substance is: ibuprofen.
Other ingredients arehydroxyethylcellulose, sodium hydroxide, 96% ethanol, lavandin essential oil, purified water.
What IBUFETUM 5% gel is and what it contains
IBUFETUM is available as a gel for cutaneous application in 50 g or 60 g tubes, or in 60 g or 120 g bottles with pump.
Marketing authorization holder
MENARINI FRANCE
1-7 RUE DU JURA
94633 RUNGIS CEDEX
Marketing authorization holder
MENARINI FRANCE
1-7 RUE DU JURA
94633 RUNGIS CEDEX
Manufacturer
A. MENARINI MANUFACTURING LOGISTICS AND SERVICES S.R.L.
VIA SETTE SANTI 3
FIRENZE 50131
Italy
or
LABORATORIOS MENARINI S.A.
ALFONSO XII 587
08918 BADALONA (BARCELONA)
SPAIN
Product names in member states of the European Economic Area
Not applicable.
The last date on which this leaflet was revised was :
[to be completed subsequently by the holder].
Other
Detailed information on this drug is available on the ANSM (France) website.