IBUFETUM 5 % Gel Tube/60g

Gel at 5 %.
Tube (lacquered aluminium) containing 60 g.

For 100 g:

Ibuprofen: 5,00 g

Excipient with known effect: Ethanol (alcohol)

Symptomatic treatment in minor traumatology: sprains, contusions.

Symptomatic treatment of superficial tendinitis.

Reserved for adults (over 15 years).

Topical use.

Method of administration :

Apply the gel by gentle and prolonged massage, on the painful or inflammatory area.

Wash hands thoroughly after each use.

Dosage :

1 application, 3 times per day.

This medicine is contraindicated in the following situations:

• Hypersensitivity to the active substance or to any of the excipients listed in section Composition.
• pregnancy, from the beginning of the 6th month (beyond 24 weeks of amenorrhea) (see section Fertility, pregnancy and breastfeeding),
• damaged skin, whatever the lesion: weeping dermatoses, eczema, infected lesion, burn or wound.

• In the absence of specific safety studies conducted in children, this medicine is reserved for adults (over 15 years).
• Do not apply to mucous membranes, nor to the eyes.
• Severe cutaneous adverse reactions: Severe cutaneous adverse reactions, including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), and acute generalised exanthematous pustulosis (AGEP), which may be life-threatening or fatal, have been reported in association with the use of ibuprofen (see section Adverse effects). The majority of these reactions occurred during the first month.
• Patients should be informed of the signs and symptoms of serious cutaneous adverse reactions and advised to consult their doctor immediately at the first appearance of any suggestive sign or symptom.
• If signs and symptoms suggestive of these reactions appear, ibuprofen must be stopped immediately and an alternative treatment should be considered (as appropriate).
• If the patient has developed a serious skin reaction with the use of ibuprofen, treatment must under no circumstances be restarted.
• Wearing gloves by the physiotherapist, in case of intensive use, is recommended.
• This medicine contains 32,30 g of alcohol (ethanol) per 100 g of gel. This may cause a burning sensation on damaged skin.

Due to the low systemic exposure during normal use of the gel, the drug interactions reported for ibuprofen per os are unlikely.

Pregnancy

Inhibition of prostaglandin synthesis by NSAIDs may affect the course of pregnancy and/or the development of the embryo or foetus. There are no clinical data on the use of topical forms of IBUFETUM 5 %, gel, during pregnancy. Even though the systemic exposure achieved with IBUFETUM 5 %, gel after topical administration is lower compared with that observed after oral administration, its potential harmful effect on the embryo/foetus is not known. The recommendations for systemically administered NSAIDs apply, given that systemic exposure remains possible.

Risks associated with use during the 1st trimester

Data from epidemiological studies suggest an increased risk of miscarriage, cardiac malformations and gastroschisis after treatment with a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk of cardiovascular malformation rose from less than 1 % in the general population to approximately 1,5 % in women exposed to NSAIDs. The risk appears to increase with dose and duration of treatment. In animals, administration of a prostaglandin synthesis inhibitor has been shown to cause increased pre- and post-implantation loss and an increase in embryo-foetal lethality. In addition, a higher incidence of certain malformations, including cardiovascular, has been reported in animals that received a prostaglandin synthesis inhibitor during the organogenesis phase of gestation.

Risks associated with use from the 12th week of amenorrhea until birth:

• From the 12^th week of amenorrhoea and until birth, all NSAIDs, through inhibition of prostaglandin synthesis, may expose the foetus to a functional renal impairment:
  • in utero, which may be observed from 12 weeks of amenorrhoea (onset of foetal diuresis): oligohydramnios (may occur shortly after the start of treatment and is generally reversible upon discontinuation of treatment), or even anhydramnios, particularly with prolonged exposure.
  • at birth, renal insufficiency (reversible or not) may persist, particularly in cases of late and prolonged exposure (with a risk of delayed severe hyperkalaemia).

Constriction of the ductus arteriosus may occur during the second trimester (most often reversible upon discontinuation of treatment).

Risks associated with use beyond the 24th week of amenorrhoea and up to birth:

Beyond the 24^th week of amenorrhoea, NSAIDs may expose the foetus to cardiopulmonary toxicity (premature closure of the ductus arteriosus and pulmonary arterial hypertension) and lead to fetal or neonatal right heart failure or even intrauterine fetal death. This risk is greater the closer the intake is to term (less reversibility). This effect exists even for a single intake.

At the end of pregnancy, the mother and the newborn may present:

• prolongation of bleeding time due to an anti-aggregant action, which may occur even after administration of very low doses of the medicinal product;
• inhibition of uterine contractions resulting in delayed labour or prolonged delivery.

Consequently:

Unless absolutely necessary, this medicine must not be prescribed to a woman planning a pregnancy or during the first 5 months of pregnancy (24 first weeks of amenorrhea). If this medicine is administered to a woman wishing to become pregnant or who is pregnant for less than 6 months, the dose must be as low as possible and the duration of treatment as short as possible. Prolonged use is strongly discouraged.

Intake from the 20^th week of amenorrhoea warrants cardiac and renal monitoring. In case of oligohydramnios or constriction of the ductus arteriosus, treatment with IBUFETUM 5 %, gel must be discontinued.

From the beginning of the 6^th months (beyond 24 weeks of amenorrhea): any intake of this medicine, even a single dose, is contraindicated. Accidental intake from this date warrants cardiac and renal, fetal and/or neonatal monitoring depending on the term of exposure. The duration of this monitoring will be adapted to the elimination half-life of the molecule.

Breast-feeding

As NSAIDs pass into breast milk, this medicine is not recommended for women who are breastfeeding.

In case of breastfeeding, this medicine must under no circumstances be applied to the breast.

Fertility

Like all NSAIDs, use of this medicinal product may temporarily impair female fertility by affecting ovulation; it is therefore not recommended in women wishing to conceive. In women having difficulty conceiving or undergoing fertility investigations, discontinuation of treatment should be considered.

• Adverse effects related to the route of administration: local skin hypersensitivity reactions such as pruritus or localized erythema.
• Hypersensitivity reactions:
  • dermatological,
  • respiratory: the occurrence of asthma attacks may be linked, in some subjects, to an allergy to aspirin or to an NSAID (see section Contraindications),
  • general: anaphylactic-type reactions.
• Other systemic effects of NSAIDs: they depend on transdermal passage of the active substance and therefore on the quantity of gel applied, the treated surface area, the degree of skin integrity, the duration of treatment and whether or not an occlusive dressing is used (digestive and renal effects).
• Photosensitivity reactions - frequency unknown
• Severe cutaneous adverse reactions (including erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis) - very rare frequency
• Drug reaction with eosinophilia and systemic symptoms (DRESS syndrome). Acute generalized exanthematous pustulosis (AGEP) - frequency not determined

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centres - Website: https://signalement.social-sante.gouv.fr.

In case of overdose, rinse thoroughly with water.

Application of excessively high doses may lead to exacerbation of undesirable effects.

Pharmacotherapeutic class: NON-STEROIDAL ANTI-INFLAMMATORY DRUG FOR TOPICAL USE ATC code: M02AA13 (M: Musculoskeletal System)

Ibuprofen is a non-steroidal anti-inflammatory drug of the propionic acid group, derived from aryl-carboxylic acid.

In the form of a gel for cutaneous application, it has anti-inflammatory and analgesic activity.

The relative bioavailability of the gel containing 5 % ibuprofen compared with oral administration is 5 to 7,4 %.

No known incompatibilities.

3 years.

No special precautions for storage.