Kiwiherb Valerian Oral Liquid
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Kiwiherb Valerian Oral Liquid
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of oral liquid contains one ml of tincture from dried Valerian root* (Valeriana officinalis L.) 1:2 equivalent to 500 mg dried root.
Extraction solvent: Ethanol 45% v/v
5 ml oral liquid contains approximately 2.25 ml ethanol (see section 4.4 "Special warnings and precautions for use").
For a full list of excipients, see section 6.1.
* Certified organically produced herbal ingredient.
3 PHARMACEUTICAL FORM
Oral liquid; brown.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
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:
To aid sleep:
Take two or three 5ml spoonfuls half an hour before bedtime in a small amount of juice or water.
To relieve symptoms of mild anxiety:
Take one 5ml spoonfuls up to three times a day in a small amount of juice or water.
Maximum daily dose: Five doses per day (total of 25 ml).
Not recommended for children or adolescents under 18 years (see Section 4.4 Special warnings and precautions for use).
As treatment effects may not be apparent immediately, this product should be taken for 2 - 4 weeks continuously
Duration of use:
If symptoms worsen or do not improve after 4 weeks a doctor or qualified healthcare practitioner should be consulted.
4.3 Contraindications
Hypersensitivity to Valerian or any of the excipients.
4.4 Special warnings and precautions for use
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.
If symptoms worsen, or do not improve after 4 weeks, a doctor or qualified healthcare practitioner should be consulted.
This product contains 45 % v/v ethanol (alcohol), i.e. up to 2.25 ml per 5 ml dose, (equivalent to 45 ml beer or 18.8 ml wine), and may be harmful to those suffering from alcoholism, liver disease or epilepsy.
Do not exceed the stated dose.
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 this product may be potentiated by alcohol. Excessive concomitant consumption of alcohol should therefore be avoided.
Contains alcohol and should therefore be avoided in patients taking other medication known to interact with alcohol (e.g. metronidazole)
4.6 Fertility, pregnancy and lactation
The safety of the product during pregnancy has not been established. In the absence of sufficient data, the 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
May impair the ability to drive and use machines. Affected patients should not drive or operate machinery.
In addition, this product contains alcohol (see Section 4.4 Special warnings and precautions for use). This may impair your ability to drive and use machines.
4.8 Undesirable effects
Gastrointestinal symptoms (e.g. nausea, abdominal cramps) may occur. The frequency is not known.
If other adverse reactions not mentioned above occur, a doctor or qualified healthcare practitioner should be consulted.
4.9 Overdose
Valerian root at a dose of approximately 20 g (equivalent to 8 doses at the highest end of Kiwiherb Valerian) caused benign symptoms (fatigue, abdominal cramp, chest tightness, lightheadedness, 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.
Overdose of this product may result in alcohol intoxication and should be treated accordingly. The amount of alcohol in a full bottle of the product is:
18 g equivalent to 0.75 large glasses of wine in a 50 ml bottle
36 g equivalent to 1.5 large glasses of wine in a 100 ml bottle
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
Tests on reproductive toxicity, genotoxicity and carcinogenicity have not been performed.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Purified Water
Ethanol
6.2 Incompatibilities
Not applicable
6.3 Shelf life
3 years
6.4 Special precautions for storage
Do not store above 30oC. Store in the original container
6.5 Nature and contents of container
Amber glass bottle with a black polyolefin tamper-evident sealed screw-cap in a
6.6 Special precautions for disposal
No special requirements.
7 MARKETING AUTHORISATION HOLDER
Phytomed (UK) Ltd
2 Elmsfield Court Bridgend Wales CF31 4NJ
8 MARKETING AUTHORISATION NUMBER(S)
THR 39543/0001