1. NAME OF THE MEDICINAL PRODUCT
BAUME SAINT BERNARD, cream
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
- Amyl salicylate: 5.00 g, - Racemic camphor: 2.00 g, - Levomenthol: 0.50 g, - Oleoresin of capsicum: 0.25 g. Per 100.00 g. For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Cream.
4. CLINICAL DATA
4.1 Therapeutic indications Local treatment of pain of muscular and tendino-ligamentary origin in adults. 4.2. Posology and method of administration FOR ADULTS ONLY. Dermal route. Apply by local massage to the painful area once or twice a day, until complete penetration. The recommended duration of treatment should not exceed 5 days. Wash hands after use. 4.3. Contraindications - Allergy to salicylates, substances with similar activity or to another component. - History of asthma. - Do not use on mucous membranes, eyes, oozing dermatitis, eczema, infected lesions or wounds or under occlusive dressings. - Do not use from the 6th month of pregnancy - History of epileptic seizures. - Related to the presence of terpene derivatives: o infants under 30 months, o children with a history of convulsions (febrile or not). 4.4. Special warnings and precautions for use Special warnings This product contains terpene derivatives which may cause neurological accidents such as convulsions in infants and children at excessive doses. Follow the advice on dosage and use, in particular - do not apply to a large area of the body, - do not apply to the breasts if breastfeeding. Precautions for use In case of previous epilepsy, take into account the presence of terpene derivatives. 4.5. Interactions with other medicinal products and other forms of interaction Not stated. 4.6. Pregnancy and lactation Pregnancy Do not use after the 6th month of pregnancy. Breast-feeding In case of breast-feeding, it is preferable not to use this medicinal product because of: - the absence of kinetic data on the passage of terpene derivatives into the milk, - and their potential neurological toxicity in infants. 4.7. Effects on ability to drive and use machines Not applicable. 4.8. Adverse reactions - Eczema has been reported. - Possible local allergic reaction requiring discontinuation of treatment. - Normal erythematous reaction at the application site may occur. - Due to the presence of terpene derivatives and if the recommended doses are not observed: o risk of convulsions in infants and children, o possibility of agitation and confusion in elderly subjects. 4.9. Overdose Not stated.
5. PHARMACOLOGICAL PROPERTIES
5.1. Pharmacodynamic properties ANTALGIC (M. LOCOMOTOR SYSTEM) This medicinal product contains terpene derivatives which may lower the epileptogenic threshold. 5.2. Pharmacokinetic properties Not available. 5.3. Preclinical safety data Not stated.
6. PHARMACEUTICAL DATA
6.1. List of excipients Stearic acid, ethylene glycol monostearate, light liquid paraffin, lavender essential oil, trolamine, purified water, shea butter. 6.2. Incompatibilities Not applicable. 6.3. Shelf life 2 years 6.4. Special storage precautions Store at a temperature not exceeding 25°C. 6.5. Nature and contents of outer packaging 42, 75 or 100 g sealed aluminium tube with epoxyphenolic coating 6.6. Special precautions for disposal and handling No special requirements.
7. MARKETING AUTHORISATION HOLDER
MERCK MEDICATION FAMILIALE SAS 37, RUE SAINT-ROMAIN 69379 LYON CEDEX 08
8. MARKETING AUTHORISATION NUMBER(S)
- 341 551-7: 100 g in tube (Aluminium coated).
9. DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION
[To be completed by the holder] 10.
10. DATE OF UPDATE OF THE TEXT
[to be completed by the holder] 11.
11. DOSIMETRY
Not applicable.
12. INSTRUCTIONS FOR THE PREPARATION OF RADIOPHARMACEUTICALS
Not applicable.
CONDITIONS OF PRESCRIPTION AND SUPPLY
Not subject to medical prescription.
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