BOIRON Sedatif Pc 90 tablets

1. NAME OF THE MEDICINAL: Sedatif PC

2. QUALITATIVE AND QUANTITATIVE COMPOSITION: Aconitum napellus 6CH, Belladonna 6CH, Calendula officinalis 6CH, Chelidonium majus 6CH, Abrus precatorius 6CH, Viburnum opulus 6CH a.a. 0.5 mg. The other ingredients are: sucrose (225 mg), lactose monohydrate (72 mg) and magnesium stearate q.s. 1 tablet of 300 mg.

3. PHARMACEUTICAL FORM: Tablets.

4. CLINICAL DATA.

4.1 Therapeutic indications: Homeopathic medicinal product traditionally used to alleviate emotional and anxiety disorders which may be accompanied by possible sleep disorders.

4.2 Dosage and method of administration: Dissolve 2 tablets 3 times a day in the mouth. Oral use.

4.3 Contraindications: Do not administer this medicinal product to patients with hypersensitivity to the active ingredients or to any component of the preparation.

4.4 Special warnings and precautions for use: Warnings about excipients: 2 tablets of this medicinal product contain 144 mg lactose. Patients with hereditary galactose intolerance, Lapp lactase insufficiency (insufficiency observed in certain Lapland populations) or glucose or galactose malabsorption should not take this medicinal product. 2 tablets of this medicinal product contain 450 mg of sucrose. Patients with hereditary fructose intolerance, glucose or galactose malabsorption, or sucrase-isomaltase insufficiency should not take this medicinal product.

4.5 Interaction with other medicinal products and other forms of interaction: None described to date. 4.6 Pregnancy and lactation: There are no specific studies in pregnant women or during lactation. For general reasons pregnant and breast-feeding women are advised to consult a doctor before using a medicinal product.

4.7 Effects on ability to drive and use machines: At the recommended dose, Sedatif PC has no effect on the ability to drive vehicles or operate machinery. 4.8 Adverse reactions: No adverse reactions have been reported to date. Reporting of suspected adverse reactions: It is important to report suspected adverse reactions to the medicinal product after authorisation. This allows continued monitoring of the benefit/risk ratio of the medicinal product. Healthcare professionals are encouraged to report suspected adverse reactions through the Spanish Pharmacovigilance System for Medicinal Products for Human Use: https://www.notificaram.es.

4.9 Overdosage: No cases of overdosage have been reported to date.

5. PHARMACOLOGICAL PROPERTIES: The properties of this medicinal product, for the proposed indications, are described in the homeopathic materia medica.

6. PHARMACEUTICAL PARTICULARS:

6.1 List of excipients: sucrose, lactose monohydrate and magnesium stearate. 6.2 Incompatibilities: None described.

6.3 Shelf life: 5 years.

6.4 Special storage precautions: No special storage conditions are required. This medicinal product must not be used after the expiry date stated on the container.

6.5 Nature and contents of pack: Carton of 90 tablets in 5 blister packs (aluminium/PVC) of 18 tablets each.

6.6 Special precautions for disposal: The Integrated System for the Management and Collection of Pharmaceutical Packaging (SIGRE) should be used for disposal.

7. MARKETING AUTHORISATION HOLDER: Boiron S.I.H., Avenida Valdelaparra, 27 - 28108 Alcobendas - Madrid. MANUFACTURER : BOIRON - 2, avenue de l'Ouest Lyonnais - 69510 Messimy - France.

8. MARKETING AUTHORISATION: This medicinal product is marketed in accordance with the 6th Transitional Provision of Royal Decree 1345/2007.

9. CONDITIONS OF DISPENSATION: Without medical prescription, not reimbursable by the National Health System. Information reserved for healthcare professionals.