1. NAME OF THE MEDICINAL PRODUCT
STODALINE SUGAR-FREE, syrup sweetened with sorbitol and liquid maltitol
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Antimonium tartaricum 6CH .................................... 2 g Bryonia 3CH.......................................................... 2 g Coccus cacti 4CH..................................................2 g Drosera 3CH...........................................................2 g Ipeca 3 CH............................................................2 g Rumex crispus 6 CH .............................................. g Spongia tosta 4 CH.................................................2 g Sticta pulmonaria 3 CH............................................2 g Per 100 g of syrup Notable excipients: liquid maltitol, sorbitol (E420). For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Syrup sweetened with sorbitol and liquid maltitol.
4. CLINICAL DATA
4.1 Therapeutic indications Homeopathic medicinal product traditionally used in the treatment of cough. 4.2. Posology and method of administration Oral use. This medicine should not be used in children under the age of 2 without medical advice. In adults: 1 dose of 15 ml using the measuring cup 3 to 5 times a day In children: 1 dose of 5 ml using the measuring cup 3 to 5 times a day. The duration of treatment should not exceed one week. However, if there is no improvement after 3 days, medical advice should be sought. 4.3. Hypersensitivity to the active substances or to any of the excipients mentioned in section 6.1. 4.4. Special warnings and precautions for use This medicinal product contains sorbitol and liquid maltitol (or hydrogenated glucose syrup). Its use is not recommended in patients with fructose intolerance. Due to the presence of liquid maltitol and sorbitol, this medicine may cause a moderate laxative effect. Caloric value: 2.3 kcal/g of liquid maltitol and 2.6 kcal/g of sorbitol, which corresponds to approximately 28.4 kcal per 15 ml dose and 9.5 kcal per 5 ml dose. 4.5. Interactions with other medicinal products and other forms of interaction Not applicable. 4.6. Pregnancy and lactation In the absence of experimental and clinical data, and as a precautionary measure, the use of this medicinal product should be avoided during pregnancy and lactation. 4.7. Effects on ability to drive and use machines Not applicable. 4.8. Adverse reactions Reporting of suspected adverse reactions after authorisation of the medicinal product is important. It allows continuous monitoring of the benefit/risk profile of the medicinal product. Health professionals should report any suspected adverse reaction via the national reporting system: Agence nationale de sécurité du médicament et des produits de santé (ANSM) and the network of Regional Pharmacovigilance Centres - Website: www.ansm.sante.fr. 4.9. Overdose Not applicable. 5. PHARMACOLOGICAL PROPERTIES 5.1. Pharmacodynamic properties Pharmacotherapeutic class: Homeopathic medicinal product. In the absence of scientific data, the indication of this medicinal product is based on the traditional homeopathic use of its ingredients. 5.2. Pharmacokinetic properties Not applicable. 5.3. Pre-clinical safety data Not applicable.
5. PHARMACOLOGICAL PROPERTIES
5.1. Pharmacodynamic properties Pharmacotherapeutic class: Homeopathic medicinal product. In the absence of scientific data, the indication of this medicinal product is based on the traditional homeopathic use of its ingredients. 5.2. Pharmacokinetic properties Not applicable. 5.3. Pre-clinical safety data Not applicable.
6. PHARMACEUTICAL DATA
6.1. List of excipients Liquid maltitol, sorbitol (E420), sodium benzoate (E211), citric acid monohydrate (E330), blackberry flavour, vanilla flavour, purified water. 6.2. Incompatibilities Not applicable. 6.3. Shelf life 4 years before opening, 1 year after first opening. 6.4. Special precautions for storage No special precautions for storage. 6.5. Nature and contents of outer packaging Box containing 1 x 200 ml bottle (type III glass) and 1 x 15 ml measuring cup, graduated to 5 ml and 15 ml (PP). 6.6. Special precautions for disposal and handling Not applicable.
7. MARKETING AUTHORISATION HOLDER
BOIRON 2 AVENUE DE L'OUEST LYONNAIS 69510 MESSIMY FRANCE 8. MARKETING AUTHORISATION NUMBER(S) - 34009 279 994 1 3: 200 ml bottle (glass) with 15 ml measuring cup. 9. 9. DATE OF FIRST AUTHORISATION/REPEAL OF AUTHORISATION Not applicable. 10. DATE OF UPDATE OF TEXT To be completed at a later stage by the holder. 11. DOSIMETRY Not applicable. INSTRUCTIONS FOR THE PREPARATION OF RADIOPHARMACEUTICALS Not applicable. CONDITIONS OF PRESCRIPTION AND DELIVERY Not subject to medical prescription.
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