BAUME SAINT BERNARD Cr T/100g

Isoamyl salicylate.....................................................................................................................................5,00 g

Racemic camphor......................................................................................................................................2,00 g

Levomenthol...................................................................................................................................................0,50 g

Capsicum oleoresin...............................................................................................................................0,25 g

For 100 g of cream

Excipients with known effect: perfume allergens.

Allergens contained in lavender essential oil: linalool, geraniol, limonene.

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

Dosage

Apply by local massage to the painful area 1 to 2 times a day, until complete penetration

Wash hands after use.

The recommended duration of treatment should not exceed 5 days.

This medicine is reserved for adults.

Method of administration

Cutaneous use.

• 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.

• History of asthma.

• Do not use on mucous membranes, eyes, weeping dermatosis, eczema, infected lesion or wound, nor under occlusive dressing.

• History of epileptic seizures.

• Related to the presence of terpene derivatives:

• infants under 30 months,
• children with a history of convulsions (febrile or not).

Due to the presence of salicylic and terpene derivatives in its composition, it is contraindicated from the beginning of the 6th month of pregnancy (beyond 24 weeks of amenorrhea) (see section Fertility, pregnancy and breastfeeding).

This product contains terpene derivatives which may cause neurological accidents of the convulsion type in infants and children at excessive doses.

Observe the dosage and administration advice, in particular:

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

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

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

Serious skin reactions, some fatal, notably exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs (see section Adverse effects).

Most of these reactions occur during the first month of treatment.. BAUME SAINT BERNARD, cream must be discontinued at the first appearance of a skin rash, mucosal lesions or any other sign of hypersensitivity.

This medicine contains lavender essential oil containing the following allergens: linalool, geraniol, limonene. These allergens may cause allergic reactions.

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 rose from less than 1% in the general population to approximately 1,5% in individuals exposed to NSAIDs. The risk appears to increase with the 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 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 12th week of amenorrhea until birth, all NSAIDs, through inhibition of prostaglandin synthesis, may expose the fetus to renal functional 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, in particular 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 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) 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-aggregating 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.

Accordingly: 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.

Intake from the 20th week of amenorrhea warrants cardiac and renal monitoring. In case of oligohydramnios or constriction of the ductus arteriosus, treatment with BAUME SAINT BERNARD, cream must be discontinued.

From the start of the 6th month (beyond 24 weeks of amenorrhoea): any intake of this medicine, even a single dose, is contraindicated. Accidental intake from this date onward warrants cardiac and renal, foetal 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 are classified according to the MedDRA system organ class classification and by decreasing order of frequency with the following conventions: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1 000 to < 1/100); rare (≥ 1/10 000 to < 1/1 000); very rare (< 1/10 000), frequency not known (cannot be estimated from the available data).

Due to the presence of terpene derivatives and in case of non-compliance with the recommended doses:

• Risk of convulsions in infants and children,

• Possibility of agitation and confusion in elderly subjects.

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/.

Overdose may cause skin irritation.

Take into account the presence of terpene derivatives, which may lower the epileptogenic threshold and cause agitation and confusion in elderly subjects.

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 / (M: LOCOMOTOR SYSTEM), ATC code: M02AC

This medicine contains terpene derivatives which may lower the epileptogenic threshold.

2 years.

Store at a temperature not exceeding 25°C.

No special requirements.