KETOPROFENE BIOGARAN 2,5 % Gel T/60g

Ketoprofen......................................................................................................................................................2,50 g

For 100 g of gel.

Excipients with known effect: ethanol (alcohol).

Symptomatic treatment in minor trauma: sprains, contusions.

Reserved for adults (over 15 years).

Dosage

2 applications per day.

Method of administration

Topical use.

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

Wash hands thoroughly and for a prolonged period after use.

This medicine is contraindicated in the following situations:

• cutaneous hypersensitivity to the active substance, to tiaprofenic acid, to fenofibrate, to sunscreens, to fragrances or to any of the excipients mentioned in section Composition ;

• history of photosensitivity reactions;

• known hypersensitivity reactions such as asthma and allergic rhinitis symptoms to ketoprofen, fenofibrate, tiaprofenic acid, acetylsalicylic acid or other NSAIDs;

• pregnancy, from the beginning of the 6th month (beyond 24 weeks of amenorrhoea) (see section Fertility, pregnancy and breastfeeding) ;

• damaged skin, whatever the lesion: weeping dermatoses, eczema or acne, infected lesion, burn or wound;

• from the beginning of the 6th month of pregnancy (beyond 24 weeks of amenorrhoea) (see section Fertility, pregnancy and breastfeeding) ;

• exposure to the sun, even under hazy sun, as well as to UV radiation in solariums, must be avoided throughout the duration of treatment and for two weeks following its discontinuation.

• In the absence of specific safety studies conducted in children, this medicinal product is reserved for adults (over 15 years);

•  The gel should be used with caution in patients with cardiac, hepatic or renal insufficiency: isolated cases of systemic adverse effects affecting the kidneys have been reported;

• It is recommended to protect treated areas by wearing clothing throughout the duration of treatment and for the two weeks following its discontinuation in order to avoid any risk of photosensitisation;

• Wash hands thoroughly and for a prolonged period after each use of the gel;

• Treatment must be stopped immediately if a skin reaction occurs, including skin reactions occurring after co-application of products containing octocrylene;

• Do not apply to mucous membranes or to the eyes;

• Application of ketoprofen gel under an occlusive dressing is not recommended;

• The recommended duration of treatment must not be exceeded due to the risk of contact dermatitis and an increase in photosensitivity reactions over time.

• Patients with asthma associated with chronic rhinitis, chronic sinusitis, and/or nasal polyposis have a higher risk of allergy to aspirin and/or NSAIDs than the rest of the population.

Due to low systemic exposure during normal use of the gel, the drug interactions reported for ketoprofen 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.

Risks associated with use during the 1st trimester

Epidemiological study data 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 increased from less than 1% in the general population to approximately 1,5% in individuals 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 ones, has been reported in animals given a prostaglandin synthesis inhibitor during the organogenesis period of gestation.

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

From the 12th week of amenorrhoea and until birth, all NSAIDs, through inhibition of prostaglandin synthesis, may expose the foetus to functional renal impairment:

• in utero which may be observed as early as 12 weeks of amenorrhoea (onset of foetal diuresis): oligohydramnios (most often reversible on stopping 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).

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

Beyond the 24th week of amenorrhoea, NSAIDs may expose the foetus to cardiopulmonary toxicity (premature closure of the ductus arteriosus and pulmonary arterial hypertension). Constriction of the ductus arteriosus may occur from the beginning of the 6th month (beyond the 24th week of amenorrhea) and may lead to fetal or neonatal right heart failure or even intrauterine fetal death. This risk is all the greater the closer the intake is to term (lower reversibility). This effect exists even for a single intake.

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

• prolonged bleeding time due to an anti-aggregant action that may occur even after administration of very low doses of the medicine;

• inhibition of uterine contractions resulting in delayed term or prolonged labour.

Consequently:

Unless absolutely necessary, this medicine must not be prescribed to a woman who is planning a pregnancy or during the first 5 months of pregnancy (first 24 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 should be as low as possible and the duration of treatment as short as possible. Prolonged use is strongly discouraged.

From the start of the 6th month (beyond 24 weeks of amenorrhea): any intake of this medicine, even occasional, is contraindicated. Accidental intake from this date onward warrants cardiac and renal, fetal and/or neonatal monitoring depending on the timing 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

As with all NSAIDs, the use of this medicine may temporarily impair female fertility by affecting ovulation; it is therefore not recommended for women wishing to conceive a child. In women having difficulty conceiving or undergoing fertility testing, discontinuation of treatment should be considered.

Local skin reactions have been reported which may subsequently spread beyond the application area. Cases of more severe reactions such as bullous or vesicular eczema, which may spread or become generalised, have rarely occurred.

Other systemic effects of NSAIDs.

They depend on the transdermal passage of the active ingredient and therefore on the quantity of gel applied, the treated surface area, the degree of skin integrity, the duration of treatment and the use of an occlusive dressing (hypersensitivity, digestive or renal effects).

Since marketing, the following undesirable effects have been reported. They have been listed according to the "System Organ Class" classification and classified by frequency: very common (≥10 %); common (from 1 % to 10 %); uncommon (from 0,1 % to 1 %); rare (from 0,01 % and 0,1 %); very rare (< 0,01 %), including isolated cases.

Elderly patients are particularly susceptible to the undesirable effects of NSAIDs.

Related to excipients

Due to the presence of ethanol (alcohol), frequent applications to the skin may cause irritation and skin dryness.

Reporting ofs suspected adverse effects

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 reaction via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Centres of Pharmacovigilance - Website: https://signalement.social-sante.gouv.fr/.

An overdose is unlikely to be caused by topical administration. In case of overdose, rinse thoroughly with water. Take into account the presence of terpene derivatives as excipients, which may lower the epileptogenic threshold and cause agitation and confusion in elderly subjects.

Application of excessively high doses may also lead to exacerbation of adverse effects: irritation, erythema, pruritus.

In case of accidental ingestion, the gel may cause systemic adverse effects depending on the quantity ingested. Symptomatic and supportive treatments will be identical to those used in the case of an overdose with oral anti-inflammatory drugs.

Pharmacotherapeutic class: NON-STEROIDAL ANTI-INFLAMMATORY DRUG FOR TOPICAL USE - ATC code: M02AA10.

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

In gel form, it has anti-inflammatory and analgesic activity.

Applied locally in gel form, ketoprofen is absorbed slowly through the skin. It accumulates little in the body. The systemic passage of the gel compared with that of oral forms of ketoprofen is of the order of 5 percent, which allows a local effect to be obtained.

3 years

This medicine does not require any particular storage precautions.

No special requirements.