NiteHerb – SPC Summary of Product Characteristics 1 Name of the medicinal product Niteherb® Tablets Lloydspharmacy Sleep Well Tablets Higher Nature Valerian Sleep Aid Tablets Simply Supplements Valerian Sleep Aid Tablets 2 Qualitative and quantitative composition Each coated tablet contains: 150 mg of extract (as dry extract) from Valerian root (Valeriana officinalis L.)(equivalent to 450-900 mg of Valerian root). Also contains 35 mg of glucose and 136 mg of sucrose. (See Section 4.4 Special warnings and precautions for use.’) For full list of excipients, see section 6.1 3 Pharmaceutical form Coated tablet. White, glossy, round, biconvex. 4 Clinical particulars 4.1 Therapeutic indications A traditional herbal medicinal product used for the temporary relief of sleep disturbances due to symptoms of mild anxiety based on traditional use only. 4.2 Posology and method of administration For oral short term use only. For adults and the elderly take 1 to 2 tablets half an hour before bedtime. If necessary, an additional tablet can be taken earlier in the evening. The tablets should not be chewed. As treatment effects may not be apparent immediately, NiteHerb should be taken for 2-4 weeks continuously. If symptoms worsen or do not improve after 4 weeks a doctor or qualified healthcare practitioner should be consulted. The use in children or adolescents under 18 years of age is not recommended (see Section 4.4 ‘Special warnings and precautions for use.’) 4.3 Contraindications Hypersensitivity to the active ingredient or any of the excipients 4.4 Special warnings and precautions for use Do not exceed the stated dose This product contains glucose. 1 coated tablet contains max. 35mg of glucose. This product contains sucrose. 1 coated tablet contains max. 136mg of sucrose or 0,21 carbohydrate units. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine The use in children or adolescents under 18 years of age is not recommended and medical advice should be sought. If symptoms worsen, or do not improve after 4 weeks a doctor or qualified healthcare practitioner should be consulted. 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 metabolized by the CYP 2D6, CYP 3A4/5, CYP 1A2 or CYP 2E1 pathway has not been observed. Additive effects with hypnotics and other sedative drugs cannot be excluded and therefore co-medication is not recommended as a general precaution. The effect of Valerian may be potentiated by alcohol. Excessive concomitant consumption of alcohol should therefore be avoided. 4.6 Fertility, pregnancy and lactation The safety of the product during pregnancy and lactation has not been established. In the absence of sufficient data the use during pregnancy and lactation is not recommended. Studies on the effects on fertility have not been performed. 4.7 Effects on ability to drive and use machines May impair the ability to drive and use machines. If affected, patients should not drive or operate machinery. 4.8 Undesirable effects Gastrointestinal symptoms, such as nausea, vomiting, abdominal cramps and diarrhoea may occur. The frequency is not known. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation 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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard 4.9 Overdose Valerian root at a dose of approximately 20 g (equivalent to 10 tablets) 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. After intake of very high doses of Valerian root over several years (daily consumption corresponding to approximately 30 g of the drug) withdrawal symptoms (delirium) have been reported. 5 Pharmacological properties 5.1 Pharmacodynamic properties Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC as amended 5.2 Pharmacokinetic properties Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC as amended 5.3 Preclinical safety data Reverse mutation assays (Ames test) on bacteria indicated that the product was not mutagenic in Salmonella typhimurium (strains TA 98, TA 100, TA 102, TA 1535 and TA 1537) mutation assays with or without metabolic activation. Adequate tests on reproductive toxicity and carcinogenicity have not been performed. 6 Pharmaceutical particulars 6.1 List of excipients Liquid glucose, spray dried Silica, colloidal anhydrous Cellulose, powdered Croscarmellose sodium Stearic acid Talc Sucrose Calcium carbonate E170 Acacia Tragacanth Titanium dioxide E 171 Capol 600 T.S. containing: Beeswax, white Carnauba wax Shellac 6.2 Incompatibilities Not applicable. 6.3 Shelf life 3 years 6.4 Special precautions for storage Do not store above 25°C. Store in the original container. 6.5 Nature and contents of container Original packages containing 30 or 60 Niteherb coated tablets. Original packages containing 30 coated tablets (Boots Sleep Well Valerian tablets, Lloydspharmacy Sleep Well tablets, Higher Nature Valerian Sleep Aid tablets) or 60 (ZipVit Valerian Sleep Aid tablets, Simply Supplements Valerian Sleep Aid tablets). The tablets are packed in PVC/ PVDC aluminium blisters and inserted into a carton together with the package leaflet. Not all package sizes may be marketed. 6.6 Special precautions for disposal No special requirements 7 Registration holder Schwabe Pharma (UK) Ltd Alexander House Mere Park Dedmere Road Marlow Buckinghamshire SL7 1PD 8 Registration number THR 23056/0006 9 Date of first authorisation/renewal of the authorisation 02/06/2017 Date of revision of the text 08/02/2022
