VALERIANA OFFICINALIS 445 MG COATED TABLET Summary of Product Characteristics

Transcription

1 Sandoz Business use only Page 1 of 5 Summary of Product Characteristics 1. NAME OF THE MEDICINAL PRODUCT Valeriaan Sandoz omhulde tablet 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each coated tablet contains 445 mg of extract (as dry extract) from Valeriana officinalis L. s.l., radix (valerian root) (3-6:1), Extraction solvent Ethanol 70% (V/V) Excipient with known effect: 95.6 mg Sucrose For the full list of excipients, see section PHARMACEUTICAL FORM coated tablet round, white convex coated tablets with a diameter of 12 mm. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Herbal medicinal product for the relief of sleep disorders and mild nervous tension. Valeriaan Sandoz is indicated in adolescents over 12 years of age, adults and elderly. 4.2 Posology and method of administration Posology Adolescents over 12 years of age, adults and elderly For relief of mild nervous tension one coated tablet up to 3 times daily. For relief of sleep disorders, a single coated tablet half to one hour before bedtime with an earlier dose during the evening if necessary. Maximum daily dose: 4 coated tablets Duration of use: Because of its gradual onset of efficacy valerian root is not suitable for acute interventional treatment of mild nervous tension or sleep disorders. To achieve an optimal treatment effect, continued use over 2 4 weeks is recommended. If symptoms persist or worsen after 2 weeks of continued use, a doctor should be consulted. Paediatric population The safety and efficacy of Valerian coated tablet in children under 12 years of age have not yet been established. No data are available. Method of administration

2 Sandoz Business use only Page 2 of 5 For oral use. The coated tablets should be taken with a sufficient amount of cold liquid (preferably a glass of cold water). The coated tablets should be swallowed whole, i.e. not broken or chewed due to the unpleasant smell and taste of valerian extract. 4.3 Contraindications Hypersensitivity to the active substance or to any of the excipients listed in section Special warnings and precautions for use Valeriaan Sandoz contains sucrose (95.6 mg per tablet). Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine. Paediatric population The use of this product is not recommended in children below the age of 12 years due to lack of adequate data. 4.5 Interaction with other medicinal products and other forms of interaction Only limited data on pharmacological interactions with other medicinal products are available. Clinically relevant interaction with drugs metabolised by the CYP 2D6, CYP 3A4/5, CYP 1A2 or CYP 2E1 pathway has not been observed. Combination with synthetic sedatives requires medical diagnosis and supervision. 4.6 Fertility, pregnancy and lactation Pregnancy There are no or limited amount of data from the use of valerian in pregnant women. Animal studies are insufficient with respect to reproductive toxicity (see section 5.3). Valeriaan Sandoz is not recommended during pregnancy. Breast-feeding It is unknown whether constituents of valerian or their metabolites are excreted in human milk. A risk to the newborns/infants cannot be excluded. Valeriaan Sandoz should not be used during breast-feeding. Fertility There are no data on the effects of Valeriaan Sandoz on male and female fertility. 4.7 Effects on ability to drive and use machines Valeriaan Sandoz may impair ability to drive and use machines. Affected patients should not drive or operate machinery. 4.8 Undesirable effects a) Summary of the safety profile Gastrointestinal symptoms (e.g. nausea, abdominal cramps) may occur after ingestion of valerian root preparations. The frequency is not known.

3 Sandoz Business use only Page 3 of 5 If other adverse reactions not mentioned above occur, a doctor or a pharmacist should be consulted. b) Tabulated summary of adverse reactions Frequencies are defined as follows: 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 Not known cannot be estimated from the available data Gastrointestinal disorders The frequency is not known. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorization 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 listed in Appendix V]. 4.9 Overdose Valerian root at a dose of approximately 20 g caused benign symptoms (fatigue, abdominal cramp, chest tightness, lightheadedness, hand tremor and mydriasis), which disappeared within 24 hours. If symptoms arise, treatment should be supportive. 5. PHARMACOLOGICAL PROPERTIES 5.1 Pharmacodynamic properties Pharmacotherapeutic group: Hypnotics and sedatives ATC-Code: N05C M09 Mechanism of action The sedative effects of preparations of valerian root, which have long been recognised empirically, have been confirmed in preclinical tests and controlled clinical studies. Orally administered dry extracts of valerian root prepared with ethanol/water (ethanol max. 70 % (V/V)) in the recommended dosage have been shown to improve sleep latency and sleep quality. These effects cannot be attributed with certainty to any known constituents. Several mechanisms of action possibly contributing to the clinical effect have been identified for diverse constituents of valerian root (sesquiterpenoids, lignans, flavonoids) and include interactions with the GABA-system, agonism at the A1 adenosine receptor and binding to the 5-HT1A receptor. 5.2 Pharmacokinetic properties No data are available. 5.3 Preclinical safety data Extracts with ethanol and the essential oil of valerian root have shown low toxicity in rodents during acute tests and from repeated dose toxicity over periods of 4 8 weeks.

4 Sandoz Business use only Page 4 of 5 An AMES-test on mutagenicity for the dry extract (DER 3-6:1), extraction solvent: ethanol 70% (V/V) did not give any reason for concern. Tests on reproductive toxicity and carcinogenicity have not been performed. 6. PHARMACEUTICAL PARTICULARS 6.1 List of excipients Tablet core: Maltodextrin, Colloidal anhydrous silica, Microcrystalline cellulose, Magnesium stearate, Precipitated silica, Tablet coat: Talc, Sucrose, Calcium carbonate (E170), Spray dried acacia, Titanium dioxide (E171), Shellac, Heavy kaolin, Castor oil, refined, Macrogol Incompatibilities Not applicable 6.3 Shelf Life 2 years. 6.4 Special precautions for storage Do not store above 30 C 6.5 Nature and contents of container The coated tablets are packaged in PVC/PVDC blister packs. Pack sizes: 15, 30, 45 and 60 coated tablets. Not all pack sizes may be marketed. 6.6 Special precautions for disposal No special requirements Any unused medicinal product or waste material should be disposed of in accordance with local requirements. 7. MARKETING AUTHORISATION HOLDER

5 Sandoz Business use only Page 5 of 5 Sandoz B.V Veluwezoom AH Almere The Netherlands 8. MARKETING AUTHORISATION NUMBER DATE OF FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION Datum van eerste verlening van de vergunning: 14 juni DATE OF REVISION OF THE TEXT