Short-term local treatment in adults (from 15 years) of trauma, benign: sprains, bruises

Reserved for adults (over 15 years).

Local channel.

Mode of administration

Make the gel penetrate through a gentle and prolonged massage on the painful or inflammatory area.

Wash hands thoroughly after each use.

Dosage

1 application, 3 times a day.

The duration of treatment is limited to 5 days.

No information in the marketing authorization.

Pharmacotherapeutic group: ANTI-INFLAMMATORY NON-STEROIDAL FOR TOPICAL USE, Code: AT0: M02AA13.
Ibuprofen is a non-steroidal anti-inflammatory drug of the group of propionics, derived from the acid, aryl-carboxylic acid.
In the form of a gel, it possesses an anti-inflammatory and analgesic activity.
Not applicable.

This drug is contraindicated in the following situations

· Over 24 weeks of amenorrhea (5 months of pregnancy) (see section Pregnancy and lactation)

· A history of allergy or asthma triggered by the use of ibuprofen or other active substances such as non-steroidal anti-inflammatory drugs (NSAIDs) aspirin
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· Antecedent of allergy to any of the excipients

· Injured skin, regardless of lesion, oozing dermatoses, eczema, lesion, infected, burn or wound

Do not apply on the mucous membranes or on the eyes.

The appearance of a skin reaction after application of the gel requires immediate cessation of treatment.

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

Not applicable.

In case of overdose, rinse thoroughly with water.
The application of too high doses may lead to exacerbation of undesirable effects.

(By extrapolation with other routes of administration)

Pregnancy

Malformative aspect: 1st quarter

Animal studies have not demonstrated teratogenicity

In the absence of teratogenic effect in animals, a malformative effect in the human species is not expected. Indeed, to date, the substances responsible for malformations in the human species have been shown to be teratogenic in animals during studies, well conducted on 2 species.

In the human species, no particular malformative effect related to administration during the first trimester of pregnancy has been reported. However, supplementary epidemiological studies are needed to confirm the absence of risk.

Fetotoxic and neonatal aspect, 2 nd and 3 rd quarter

This is class toxicity, involving all prostaglandin synthesis inhibitors.

Administration during the 2nd and 3rd quarter exposes to

· Renal Functional Impairment

O utero can be observed as early as 12 weeks, amenorrhea (initiation of diuresis, fetal): oligoamnios (most often reversible at cessation of treatment), or even anamnios Extended exposure.

O at birth, renal insufficiency (reversible or not) may persist especially in cases of late and prolonged exposure (with a risk of delayed severe hyperkalaemia)
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A risk of cardiopulmonary involvement Partial or complete constriction in utero of the duct arterial. Constriction of the ductus arteriosus can occur after 5 months and may lead to fetal or neonatal right heart failure or even fetal death in utero. This risk is all the more important since the catch is close to the term (lesser, reversible). This effect exists even for a one-time catch.

· A risk of longer bleeding time for the mother and the child

As a result

· Up to 12 weeks of amenorrhoea, the use of this medication should only be considered if necessary

· Between 12 and 24 weeks of amenorrhea (between the beginning of the fetal diuresis and 5 months): a brief intake should only be prescribed if necessary. A prolonged take is strongly discouraged.

• Over 24 weeks of amenorrhoea (5 months, complete): any single dose is contraindicated (see section Contraindications). An intake, inadvertently over 24 weeks, amenorrhea (5 months) warrants cardiac and renal, fetal and / or neonatal monitoring according to the term of exposure. The duration of this monitoring will be adapted to the half-life, elimination of the molecule.

Breastfeeding

A.I.N.S. Passing through the maternal milk, as a precaution, it is advisable to avoid administering them to the nursing woman.

Administration-related adverse reactions

· Local skin reactions of hypersensitivity, localized pruritus or erythema

Hypersensitivity reactions

· Dermatological

· Respiratory: The onset of an asthma attack may be linked in some individuals to an allergy to aspirin or NSAIDs. In this case, this medication is contraindicated

· General: type reactions, anaphylactic.

Other systemic effects of NSAIDs

They are a function of the transdermal passage of the active ingredient and therefore of the amount of applied gel, the surface treated, the degree of skin integrity, the duration of treatment and the use or not of a dressing Occlusive (digestive effects, renal).
Short-term local treatment in adults (from 15 years) of trauma, benign: sprains, bruises