KETUM 2,5 % Gel for topical use T back/120g

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

For 100 g of gel.

Excipients with known effect: ethanol (alcohol), citral, citronellol, coumarin, farnesol, geraniol, d-limonene, linalool

• Symptomatic treatment of superficial tendinitis.
• Symptomatic treatment in minor trauma: sprains, bruises.
• Symptomatic treatment of osteoarthritis of the small joints.
• Symptomatic treatment of acute low back pain.
• Treatment of post-sclerotherapy venous inflammation (phlebitis), in cases of intense inflammatory reaction.

Dosage and mode of administration

Reserved for adults (over 15 years).

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.

Tube:

• Sprains, contusions, post-sclerotherapy venous inflammation (phlebitis) in cases of intense inflammatory reaction: 2 applications per day of 2 g of gel (i.e. approximately 5 cm of gel) per day.
• Superficial tendinitis: 2 applications of 4 g of gel (i.e. approximately 10 cm of gel) per day.
• Osteoarthritis of the small joints: 3 applications of 4 g (i.e. approximately 10 cm of gel) per day.
• Acute low back pain: 3 applications of 5 g (i.e. approximately 12 cm of gel) for the first 3 days, then 2 applications of 5 g of gel per day for the following 4 days.

Metering tube:

1 dose = 1,2 g of gel, i.e. 30 mg of ketoprofen.

The dosage is 3 to 12 doses in 2 to 3 applications per day depending on the indications:

• Sprains, contusions, post-sclerotherapy venous inflammation (phlebitis) in cases of intense inflammatory reaction: 3 doses per day.
• Superficial tendinitis: 6 doses per day.
• Osteoarthritis of the small joints: 9 doses per day.
• Acute low back pain: 12 doses per day for the first days then 8 doses 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 months (beyond 24 weeks of amenorrhoea) (see section Fertility, pregnancy and breastfeeding)
• history of photosensitivity reactions,
• known hypersensitivity reactions such as asthma symptoms and allergic rhinitis to ketoprofen, fenofibrate, tiaprofenic acid, acetylsalicylic acid or other N.S.A.I.D.s,
• history of skin allergy to ketoprofen, tiaprofenic acid, fenofibrate, UV screens or perfumes;
• damaged skin, whatever the lesion: weeping dermatoses, eczema or acne, infected lesion, burn or wound.

Exposure to the sun, even under hazy sun, as well as to UV radiation in a solarium, must be avoided throughout the duration of treatment and within two weeks following its discontinuation.

• Children: The efficacy and safety of ketoprofen gel in children have not been established. In the absence of specific safety studies conducted in children, this medicine 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 two weeks following its discontinuation in order to avoid any risk of photosensitization.
• Carry out thorough and prolonged washing of hands after each use of the gel.
• Treatment must be stopped immediately in the event of the appearance of a skin reaction, including skin reactions appearing after co-application of products containing octocrylene.
• Do not apply to mucous membranes, nor to the eyes.
• It is not advisable to apply ketoprofen gel under an occlusive dressing.
• 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.
• KETUM 2,5 PERCENT, gel contains ethanol (alcohol) and perfumes containing citral, citronellol, coumarin, farnesol, geraniol, d-limonene and linalool.
• This medicine contains 40 ml of alcohol (ethanol) per 100 g of gel. This may cause a burning sensation on damaged skin.
• This medicine also contains perfumes containing citral, citronellol, coumarin, farnesol, geraniol, d-limonene and linalool. They may cause allergic reactions.

Due to the low systemic passage during normal use of the gel, drug interactions reported for oral ketoprofen are unlikely.

Pregnancy

Inhibition of prostaglandin synthesis by NSAIDs may affect the course of pregnancy and/or the development of the embryo or fetus. There are few clinical data on the use of topical forms of KETUM 2,5 PERCENT, gel, during pregnancy; the recommendations relating to systemically administered NSAIDs apply given that systemic exposure remains possible.

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 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 increased embryo-foetal lethality. In addition, a higher incidence of certain malformations, including cardiovascular ones, 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 amenorrhoea 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 from 12 weeks of amenorrhea (onset of fetal diuresis): oligohydramnios (may occur shortly after the start of treatment and is generally reversible upon discontinuation of treatment), or even anhydramnios, particularly during prolonged exposure.
  • at birth, renal failure (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 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) 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:

-   prolonged bleeding time due to an antiaggregant 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 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.

Intake from the 20th week of amenorrhea warrants cardiac and renal monitoring. In case of oligohydramnios or constriction of the ductus arteriosus, treatment with KETUM 2,5 PERCENT must be discontinued.

From the beginning of the 6th months (beyond 24 weeks of amenorrhea): any intake of this medicinal product, even a single one, is contraindicated. Accidental intake from this date onward warrants cardiac, 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

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 extend beyond the application area. Exceptionally, bullous or phlyctenular eczema-type reactions may occur, which can be severe and may secondarily spread or become generalized. Other systemic effects of NSAIDs: these depend on the transdermal passage of the active ingredient and therefore on the quantity of gel applied, the surface area treated, 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 adverse effects have been reported. They have been listed according to the System Organ Class classification and ranked 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 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 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: topical non-steroidal anti-inflammatory drug, 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.

Aluminium tube: 5 years

Dispensing tube: 3 years

This medicine does not require any particular storage precautions.

No special requirements.