Summary of medicine characteristics - VALDRIAN
1 NAME OF THE MEDICINAL PRODUCT
VALDRIAN Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 400mg of Valerian root. (Valeriana officinalis L.)
For list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Hard capsules.
Clear size 0 hard capsules.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
VALDRIAN is a traditional herbal medicinal product used for the temporary relief of symptoms of mild anxiety and to aid sleep, based on traditional use only.
4.2 Posology and method of administration
For oral short term use only.
Adults and the elderly.
For the temporary relief of symptoms of mild anxiety, take one capsule 3 times daily swallowed with water.
To aid sleep, take one capsule 30 minutes before bedtime with an earlier dose during the evening if necessary.
As treatment effects may not be apparent immediately, VALDRIAN should be taken 2–4 weeks continuously.
Maximum daily dose:- 4 single doses.
Duration of use:-
If symptoms worsen, or do not improve after 4 weeks, of taking VALDRIAN, a doctor or a qualified healthcare care practitioner should be consulted.
Not recommended for children or adolescents under 18 years (See ‘Section 4.4. Special warnings and precautions for use.’)
4.3 Contraindications
Hypersensitivity to Valerian root or to any of the excipients.
4.4 Special warnings and precautions for use
Do not exceed the stated dose.
If symptoms worsen, or do not improve after 4 weeks of taking VALDRIAN, a doctor or a qualified healthcare care practitioner should be consulted.
The use of this product is not recommended in children and adolescents below the age of 18 years because data are not sufficient and medical advice should be sought.
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 interactions with drugs metabolised by the CYP 2D6, CYP 3A4/5, CYP 1A2 or CYP 2E1 pathway have not been observed.
Additive effects with hypnotics and other sedatives 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 VALDRIAN during pregnancy and lactation has not been established.
Due to the lack of data, use during pregnancy and lactation is not recommended.
Studies on the effect on fertility have not been performed.
4.7 Effects on ability to drive and use machines
VALDRIAN may impair ability to drive and use machines.
Patients who are affected 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.
If other adverse reactions not mentioned above occur, a doctor or qualified healthcare practitioner should be consulted.
Reporting of suspected adverse reactions
Reporting of 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: Yellow card scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store
4.9 Overdose
4.9 OverdoseIf symptoms arise, treatment should be supportive.
Valerian root at a dose of approximately 20g (equivalent to 50 VALDRIAN capsules) caused benign symptoms (fatigue, abdominal cramp, chest tightness, light headedness, hand tremor and mydriasis), which disappeared within 24 hours
After intake of very high doses of Valerian root over several years (daily consumption corresponding to approximately 30g 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 dataExtracts 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.
No mutagenicity was observed in an Ames test conducted with this product.
Studies on carcinogenicity and reproductive toxicity have not been performed.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Hypromellose (capsule shell)
6.2 Incompatibilities
Not Applicable.
6.3 Shelf life
2 years.
6.4 Special precautions for storage
Store below 25°C. Store in the original package.
6.5 Nature and contents of container
Duma 110ml HDPE plastic container and tamper evident threaded Duma cap.
VALDRIAN pack contains 60 Capsules.
6.6 Special precautions for disposal
6.6 Special precautions for disposalThere are no special precautions for disposal of VALDRIAN capsules. When the container is empty the label should be removed and the container placed in a recycling bin.
Bio-Health Limited
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Medway City Estate
Rochester
Kent
ME2 4HU
8 MARKETING AUTHORISATION NUMBER(S)
THR 15817/0004