Nutrition Warehouse Herbal Kalma
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Nutrition Warehouse Herbal Kalma Holland & Barrett Herbal Kalma
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
30 mg Hops strobiles (Humulus lupulus L.)
45 mg extract (as dry extract) from Passion Flower herb (Passiflora incarnata L.) (46:1)
Extraction solvent: Ethanol 70 %v/v
42.5 mg of extract (as dry extract) from Valerian root (Valeriana officinalis L.) (56:1)
Extraction solvent: Ethanol 70%v/v For full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Tablet
Brown oval biconvex tablet.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
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 mild anxiety - One to two tablets three times daily.
To aid sleep - one to two tablets earlier in the evening and one to two tablets at bedtime.
Maximum daily dose: 6 tablets
As treatment effects may not be apparent immediately, this medicine should be taken for at least 2 - 4 weeks continuously
If symptoms worsen or persist after 4 weeks, a doctor or a 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 substance or any of the excipients.
4.4 Special warnings and precautions for use
Do not exceed the stated dose.
The use in children and adolescents under 18 years of age is not recommended due to the lack of data on safety and efficacy.
If symptoms persist or worsen 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 interactions with drugs metabolised by the CYP 2D6, CYP 3A4/5, CYP1A2 or CYP 2E1 pathway has 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.
4.6 Fertility, pregnancy and lactation
Safety 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 ability to drive and use machines. If affected patients should not drive or operate machines.
4.8 Undesirable effects
Gastrointestinal symptoms (eg nausea, abdominal cramps) may occur after ingestion of Valerian root preparations. The frequency is not known.
One case of hypersensitivity (vasculitis) and one case of nausea and tachycardia have been reported with Passion flower. 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 20g (equivalent to 100 tablets) 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 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.
Symptomatic and supportive measures should be taken as appropriate.
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
Adequate tests on reproductive toxicity, genotoxicity and carcinogenicity have not been performed.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Extract excipients Maltodextrin
Colloidal anhydrous silica Tablet core
Orange Flower Powder Calcium Sulphate Dihydrate Dibasic Calcium Phosphate Potato Starch Stearic Acid Ethylcellulose N100
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
Polystyrene tampertainer.
Pack size: 60 tablets.
6.6 Special precautions for disposal
No special requirements.
7 MARKETING AUTHORISATION HOLDER
Nutrition Warehouse Limited
Samuel Ryder House
Barling Way
Eliot Park
Nuneaton
Warwickshire
CV10 7RH
United Kingdom
8 MARKETING AUTHORISATION NUMBER(S)
THR 14010/0033
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
28/03/2013
10 DATE OF REVISION OF THE TEXT
28/03/2013