BAUME AROMA Cr T/100g

JAMAICAN PEPPER (Pimenta officinalis (Lindl.) (essential oil from leaves of)................0,20 g

CLOVE (Syzygium aromaticum (L.) Merill et L. M. Perry)

(essential oil from leaves/ flower bud of)..........................................................................................3,00 g

METHYL SALICYLATE.....................................................................................................................10,00 g

For 100 g of cream.

Excipients with known effect: terpene derivatives.

Adjunctive local treatment of pain of muscular and tendino-ligamentous origin.

Dosage

RESERVED FOR ADULTS AND CHILDREN OVER 7 YEARS.

BAUME AROMA, cream must not be used in children under 7 years of age.

Apply BAUME AROMA, cream 1 to 2 times a day, without exceeding 2,5 g per application.

Method of administration

Cutaneous use.

Apply strictly to the painful area and massage until complete penetration.

Wash hands thoroughly after each use.

Duration of use

It is recommended not to exceed 5 days of treatment without medical advice.

• Hypersensitivity to the active substances or to any of the excipients listed in section Composition.

• Allergy to salicylates, to substances of similar activity or to any other component.

• Do not use on mucous membranes, the eyes, an oozing dermatosis, an infected lesion or a wound, nor under an occlusive dressing.

• Linked to salicylic derivatives and terpene derivatives, it is contraindicated from the start of the 6th month of pregnancy (beyond 24 weeks of amenorrhea) (see section Fertility, pregnancy and breastfeeding).

Linked to the presence of terpene derivatives:

• Infants under 30 months,

• Children with a history of convulsions (febrile or not).

Warnings

This specialty contains terpene derivatives, contained in an active ingredient (clove essential oil) and an excipient (levomenthol), which may lower the epileptogenic threshold and, at excessive doses, cause neurological adverse events such as convulsions in infants and children.

Respect the dosages and instructions for use, in particular:

• do not apply to a large surface area of the body,

• do not apply to the breasts in case of breastfeeding.

Precautions for use

In case of a history of epilepsy, take into account the presence of terpene derivatives.

No interaction studies have been performed.

BAUME AROMA, cream is a locally acting specialty; consequently, drug interactions are unlikely.

Associations to be taken into account

Vitamin K antagonists: possible increase in the risk of bleeding. Monitoring of the INR.

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

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 went from less than 1% in the general population to approximately 1,5% in people 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 embryofetal 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 phase of gestation.

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

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

• in utero, which may be observed from 12 weeks of amenorrhea (onset of fetal 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 amenorrhea until birth

Beyond the 24th week of amenorrhea, NSAIDs may expose the fetus to cardiopulmonary toxicity (premature closure of the ductus arteriosus and pulmonary arterial hypertension). Constriction of the ductus arteriosus may occur from the start of the 6th month (beyond the 24th week of amenorrhea) and may lead to fetal or neonatal right heart failure or even fetal death in utero. This risk is all the 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 antiplatelet action, which 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 should 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 a single one, is contraindicated. Inadvertent intake from this date warrants cardiac, renal, fetal and/or neonatal monitoring depending on the stage of exposure. The duration of this monitoring should 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.

BAUME AROMA cream has no or negligible effect on the ability to drive vehicles and use machines.

The following undesirable effects are classified by organ system class and may occur with an unknown frequency (cannot be estimated from the available data).

Immune system disorders

Unknown frequency: local allergic reaction requiring discontinuation of treatment.

Psychiatric disorders

Unknown frequency: agitation and confusion in elderly subjects (due to the presence of terpene derivatives and in case of failure to respect the recommended doses).

Nervous system disorders

Unknown frequency: convulsions in infants and children (due to the presence of terpene derivatives and in case of failure to respect the recommended doses).

General disorders and administration site conditions

Unknown frequency: normal erythematous reaction at the application site, burns at the application site.

Paediatric population

Risk of convulsions in infants and children due to the presence of terpene derivatives and in case of failure to respect the recommended doses.

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

Increased serum concentrations of methyl salicylate at high doses and after prolonged use may lead to an exacerbation of neurological and skin-type undesirable effects. In case of overdose, rinse abundantly with water and soap.

If necessary, the medicine must be stopped and symptomatic treatment must be initiated.

Regarding accidental oral ingestion:

• Accidental oral ingestion of the cream may cause gastrointestinal symptoms such as vomiting and diarrhoea. Treatment is symptomatic.

• Acute intoxication may be observed after a significant accidental ingestion, with the occurrence of nausea, vomiting, abdominal pain and headache, dizziness, feeling of heat/flushing, convulsions, respiratory depression and coma.

Patients presenting with severe gastrointestinal or neurological symptoms of intoxication must be monitored and symptomatic treatment must be initiated. Do not induce vomiting.

Pharmacotherapeutic class: analgesic purpose, ATC code: M02AC.

The 2 active substances, namely eugenol (main constituent of the essential oil of cloves and clove leaves and of the essential oil of Jamaican pepper leaves) and methyl salicylate, possess analgesic and anti-inflammatory properties.

The analgesic properties of eugenol and methyl salicylate are related to modulation of the TRPV1 channel (Transient Receptor Potential Vanilloid 1) and an antagonistic action of eugenol on N-methyl-D-aspartate ionotropic receptors.

Eugenol exerts anti-inflammatory effects by decreasing the expression and production of pro-inflammatory cytokines and by inhibiting the activity of cyclooxygenase-2 (COX-2) and of 5-lipoxygenase.

The anti-inflammatory properties of methyl salicylate are associated with COX inhibition and are also mediated by a COX-independent pathway involving inhibition of inflammatory cytokines and transcription factors such as NF-κB (Nuclear factor-kappa B) and AP-1 (Activator protein 1).

Eugenol

Eugenol is rapidly absorbed and metabolised after oral administration. Eugenol is mainly metabolised by the liver into sulfate and glucuronic acid conjugated metabolites. It is completely excreted (in metabolised form) in the urine within 24 h after administration.

Methyl Salicylate

Methyl salicylate is predominantly metabolised by the liver into salicylic acid, eliminated by renal excretion, with an elimination half-life of 2 to 3 h.

Non-clinical data from the literature on repeated-dose toxicology, genotoxicity and carcinogenicity studies conducted with methyl salicylate and eugenol, the main constituent of the two essential oils present in BAUME AROMA, crème, did not reveal any particular risk associated with the use of BAUME AROMA, crème at therapeutic doses in humans.

No reproductive and developmental toxicity study with eugenol has been published in the literature.

Several reproductive and developmental toxicity studies have been published with methyl salicylate by the dermal, subcutaneous or oral route in rats, hamsters and rabbits. In rats and hamsters, the effects of methyl salicylate ranged from severe toxicity and total resorption to neural tube abnormalities and visceral and skeletal malformations in offspring. Nevertheless, none of these effects was observed in rabbits by the subcutaneous route.

3 years.

No special precautions for storage.

No special requirements.