Summary of medicine characteristics - LLOYDS PHARMACY VALERIAN SLEEP RELIEF, GERARD HOUSE VALERIAN PEACEFUL SLEEP, HERBALSTORE VALERIAN SLEEP RELIEF
1 NAME OF THE MEDICINAL PRODUCT
Herbalstore Valerian Sleep Relief
Gerard House Valerian Peaceful
Sleep
Lloyds Pharmacy Valerian Sleep Relief
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film coated tablet contains 100mg of extract (as dry extract) from Valerian root (Valeriana officinalis L.) (4.5–6:1) (equivalent to 450mg – 600mg of Valerian root.)
Extraction solvent: Ethanol 60% (v/v)
For full list of excipients see 6.1.
3 PHARMACEUTICAL FORM
Clear film coated tablet
Grey, mottled, circular biconvex, clear film coated tablet
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.
Adults and the elderly:
Two tablets to be taken approximately one hour before bedtime.
If required, an additional tablet may be taken earlier in the evening.
Not recommended for use in children or adolescents under 18 years of age (See Section 4.4. ‘special warnings and precautions for use’)
Tablets should be swallowed whole with some water or other liquid. The tablets should not be chewed.
Duration of use:
As the effects of this product may not occur immediately, it should be taken continuously for 2 – 4 weeks.
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 is not recommended for use by children or adolescents under 18 years of age because data is not sufficient and medical advice should be sought.
If symptoms worsen, or do not improve after 4 weeks, a doctor or a 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. 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
Safety during pregnancy and lactation has not been established.
Due to the lack of data, use during pregnancy and lactation is not recommended.
Test 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 or operate machines. If affected, do not drive or operate machines.
4.8 Undesirable effects
Gastrointestinal symptoms, such as nausea, vomiting, abdominal cramps and diarrhoea may occur after ingestion of Valerian root. The frequency is not known.
If other adverse effects not mentioned above occur, a doctor or a qualified healthcare practitioner should be consulted.
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 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
Or search for MHRA Yellow Card in the Google Play or Apple App Store
4.9 Overdose
4.9 OverdoseValerian root at a dose of 20g caused benign symptoms (fatigue, abdominal cramp, chest tightness, light headedness, hand tremor and mydriasis) which disappeared within 24 hours. If symptoms arise, treatment should be supportive.
After intake of high doses of Valerian root over several years (daily consumption corresponding to approximately 10g 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
5.3 Preclinical safety dataAMES-tests on mutagenicity with extracts, representing the two extreme of the poarity range 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
Extract excipients
Maltodextrin
Colloidal Anhydrous Silica
Core excipients
Calcium Hydrogen Phosphate
Microcrystalline Cellulose
Stearic Acid
Magnesium Stearate
Film-coat
Hypromellose
Talc
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 package.
6.5 Nature and contents of container
Blister packs of PVC/PVdC laminate / aluminium foil containing 24, 30, 48, 60, 90 or 120 tablets.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal
6.6 Special precautions for disposalNo special requirements