NOTICE
ANSM - Updated on : 07/11/2024
Product name
BAUME SAINT BERNARD, cream
Isoamyl salicylate, racemic camphor, levomenthol, capsicum oleoresin
Enclosed
Please read this leaflet carefully before using this medicine, as it contains important information for you.
You must always use this medicine in strict accordance with the information given in this leaflet or by your doctor or pharmacist.
Keep this leaflet. You may need to read it again.
Ask your pharmacist for advice and information.
If you experience any undesirable effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. See section 4.
You should contact your doctor if you do not feel any improvement or if you feel less well after 5 days.
What does this leaflet contain?
1. What is BAUME SAINT BERNARD, cream and what is it used for?
2. What do I need to know before using BAUME SAINT BERNARD, cream?
3. How do I use BAUME SAINT BERNARD, cream?
4. What are the possible side effects?
5. How should BAUME SAINT BERNARD cream be stored?
6. Package contents and other information.
1. WHAT IS BAUME SAINT BERNARD, cream AND WHAT IS IT USED FOR?
Pharmacotherapeutic class: A VISEE ANTALGIQUE / M: SYSTEME LOCOMOTEUR - Code ATC: M02AC
Local adjunctive treatment of pain of muscular and tendino-ligamentary origin in adults.
Consult your doctor if you feel no improvement or if you feel less well.
2. WHAT DO I HAVE TO KNOW BEFORE USING BAUME SAINT BERNARD, cream?
Never use BAUME SAINT BERNARD, cream:
If you are allergic to any of the active ingredients or to any of the other components of this product, as listed in section 6.
If you have a history of allergy to salicylates or related drugs (NSAIDs, aspirin).
A history of asthma.
history of epileptic seizures.
If you are pregnant, from the beginning of the 6th month of pregnancy (beyond 24 weeks of amenorrhea).
Due to the presence of terpene derivatives, this drug MUST NOT BE USED in the following cases:
o infants under 30 months of age,
o children who have had convulsions, with or without fever.
Do not apply to mucous membranes, eyes, wounds, oozing lesions, infected lesions or under occlusive dressings.
Warnings and precautions
Talk to your doctor or pharmacist before using BAUME SAINT BERNARD, cream.
Severe skin reactions such as exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported in association with the use of NSAIDs. Stop using BAUME SAINT BERNARD and consult a doctor immediately if you notice any of the symptoms of these severe skin reactions described in section 4.
Follow the instructions for use:
- never apply more than the recommended dose (see section 3. HOW TO USE BAUME SAINT BERNARD, cream),
- do not apply over a large area of the body,
- respect the recommended frequency and duration of treatment.
Do not exceed 5 days' treatment without medical advice.
After use, wash hands to avoid inadvertent contact with eyes and mucous membranes.
In case of old or recent epilepsy, SEEK ADVICE FROM YOUR DOCTOR.
Limonene may cause allergic reactions.
Children
This product contains terpene derivatives which, in excessive doses, may cause neurological accidents such as convulsions in infants and children.
Other medicinal products and BAUME SAINT BERNARD, cream
Tell your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
BAUME SAINT BERNARD, cream with food, drink and alcohol
Not applicable.
Pregnancy, breast-feeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
- Before the beginning of the 6th month of pregnancy (up to the 24th week of amenorrhea), you should not take this medicine unless absolutely necessary, as determined by your doctor, due to the potential risk of miscarriage or malformations. In such cases, the dose should be kept as low as possible and the duration of treatment as short as possible.
- Starting at 12 weeks' gestation , BAUME SAINT-BERNARD may cause kidney problems in your baby if taken for several days, leading to a low level of amniotic fluid (oligohydramnios). A narrowing of the blood vessels (constriction of the ductus arteriosus) in your baby's heart may be observed as early as 20 weeks of amenorrhea. If treatment over several days is required, your doctor may recommend additional monitoring.
- From the beginning of the 6th month to the end of pregnancy (beyond the 24th week of amenorrhea), this medicine is contraindicated, and you should under NO CIRCUMSTANCES take this medicine, as its effects on your child may have serious or even fatal consequences, particularly on the heart, lungs and/or kidneys, even with a single dose. It can also affect you and your baby by increasing bleeding, leading to a later or longer-than-expected delivery.
If you have taken this medicine while pregnant, talk to your obstetrician-gynecologist immediately, so that appropriate monitoring can be arranged.
Breast-feeding
If you are breast-feeding, it is preferable not to use this medicine, and under no circumstances should it be applied to the breasts.
Fertility
This drug, like all non-steroidal anti-inflammatory drugs (NSAIDs), may impair fertility in women, leading to difficulties in becoming pregnant which may be reversible on discontinuation of treatment. Inform your doctor if you are planning a pregnancy or have difficulty conceiving.
Driving and use of machinery
Not applicable.
BAUME SAINT BERNARD, cream contains
Not applicable.
3. HOW DO I USE BAUME SAINT BERNARD, cream?
Always use this medicine exactly as instructed in this leaflet or as directed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
FOR ADULTS ONLY.
The recommended dose is 1 application, massaged locally into the painful area 1 to 2 times a day, until completely absorbed.
Wash hands after use.
For cutaneous use.
Do not use for prolonged periods without medical advice.
Use in children and adolescents
Baume Saint Bernard, crème should not be used on children and adolescents.
If you have used more BAUME SAINT BERNARD, cream than you should have
Overdosage may cause skin irritation.
In the event of accidental oral ingestion of Baume Saint Bernard cream by a child, it is important to consult a doctor immediately in order to provide the necessary treatment. Do not induce vomiting.
If you forget to use BAUME SAINT BERNARD, cream
Not applicable.
If you stop using BAUME SAINT BERNARD, cream
Not applicable.
If you have any further questions about the use of this medicine, please ask your doctor or pharmacist.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this product may cause undesirable effects, but they do not occur systematically in everyone.
Cases of eczema have been reported.
Possible local allergic reaction requiring discontinuation of treatment, possibility of normal skin redness at the application site.
Reddish, target- or circle-shaped patches on the trunk, often accompanied by central blisters, desquamation of the skin, and ulcers of the mouth, throat, nose, genitals and eyes. These severe skin rashes may be preceded by fever and flu-like symptoms (exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis).
Due to the presence of terpene derivatives and if recommended doses are not followed:
- risk of convulsions in infants and children,
- possibility of agitation and confusion in the elderly.
Reporting side effects
If you experience any side effects, please tell your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. You can also report adverse reactions directly via the national reporting system: Agence nationale de sécurité du médicament et des produits de santé (ANSM) and the network of Centres Régionaux de Pharmacovigilance - Website: https://signalement.social-sante.gouv.fr/.
By reporting adverse reactions, you are helping to provide more information on drug safety.
5. HOW TO USE BAUME SAINT BERNARD, cream?
Keep out of sight and reach of children.
Store at a temperature not exceeding 25°C.
Do not use this medicine after the expiration date indicated on the box. The expiry date refers to the last day of that month.
Do not dispose of any medicine down the drain or in the household waste. Ask your pharmacist to identify any medicines you no longer use. These measures will help protect the environment.
6. CONTENTS AND OTHER INFORMATION
What BAUME SAINT BERNARD cream contains
The active ingredients are :
Isoamyl salicylate........................................................................................................ 5.00 g
Racemic camphor.......................................................................................................... 2.00 g
Levomenthol.................................................................................................................... 0.50 g
Capsicum oleoresin................................................................................................... 0.25 g
Per 100 g
Other components are :
Stearic acid, ethylene glycol monostearate, light liquid kerosene, lavender essential oil, trolamine, purified water, shea butter.
What is BAUME SAINT BERNARD, cream and what does it contain?
This medicine comes in the form of a cream.
Tubes of 42, 75 and 100 g.
Marketing authorization holder
P&G HEALTH France
163/165, quai aulagnier
92600 asnieres-sur-seine
Marketing authorization holder
P&G HEALTH France
18C, boulevard Winston Churchill
21000 Dijon
Manufacturer
P&G Health Austria GmbH & Co. OG
Hösslgasse 20
9800 Spittal an der Drau
AutriCHE
Product names in member states of the European Economic Area
Not applicable.
The last date on which this leaflet was revised was :
[to be completed subsequently by the holder]
< {MM/YYYY}>< {month/YYYY}.>
Other
Detailed information on this drug is available on the ANSM (France) website.