Kalms Sleep
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Kalms Sleep
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each coated tablet contains:
60 mg Verbena Herb (Verbena officinalis L.)
34.65 mg of extract (as dry extract from Valerian root (Valeriana officinalis L.) (equivalent to 139 to 173mg of Valerian root)
Extraction solvent: Ethanol 60% v/v
30 mg Hop strobiles (Humulus lupulus L.)
22.5 mg of extract (as dry extract from Wild Lettuce leaf (Lactuca virosa L.) (equivalent to 90 mg of Wild Lettuce leaf).
Extraction solvent: Methanol 50% v/v
16.82 mg of extract (as dry extract from Passion Flower herb (Passiflora incarnata L.) (equivalent to 90 mg of Passion Flower herb).
Extraction solvent: Ethanol 60% v/v
Each coated tablet contains 168 mg sucrose.
(see section 4.4 ‘Special warnings and precautions for use.’)
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Coated tablet.
Dark grey, round biconvex sugar coated tablet.
4
CLINICAL PARTICULARS
Therapeutic indications
4.1
A traditional herbal medicinal product used for the temporary relief of sleep disturbances, based on traditional use only.
4.2 Posology and method of administration
For oral short term use only.
Adults and the elderly: Take 3 or 4 tablets one hour before bedtime.
Not recommended for use in children or adolescents under 18 years old (see Section 4.4 Special warnings and precautions for use’).
As treatment effects may not be apparent immediately, Kalms Sleep should be taken for 2-4 weeks continuously.
Duration of use:
If symptoms worsen or do not improve after 4 weeks, a doctor or a qualified healthcare practitioner should be consulted.
4.3 Contraindications
Hypersensitivity to the active substances or to any of the excipients.
4.4 Special warnings and precautions for use
Do not exceed the stated dose.
Contains sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
The use of this product in children or adolescents under 18 years of age is not recommended because data are 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. 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 sedative cannot be excluded and therefore co-medication is not recommended as a general precaution.
The effect of Kalms Sleep 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 the ability to drive and use machines. If affected, do not drive or operate any tools or machines.
4.8 Undesirable effects
Gastrointestinal symptoms, such as 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 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 20 g (equivalent to 111 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 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
Tests on reproductive toxicity, genotoxicity and carcinogenicity have not been performed.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Extract
Maltodextrin
Colloidal anhydrous silica
Cellulose
Gum Arabic
Core:
Acacia, Spray-dried Calcium Hydrogen Phosphate Croscarmellose Sodium
Icing Sugar Magnesium Stearate Stearic Acid
Coating:
Acacia, Spray-dried Calcium Carbonate (Light) Mastercote Grey SP0933 Opaglos 6000 Talc
Shellac Varnish Sucrose
Titanium Dioxide
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
50 or 84 tablets in amber glass jars with foil tamper-evident seals and white polypropylene screw-caps.
50 or 84 tablets in amber glass bottles (USP type III glass) with white HDPE tamper evident caps.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal
No special requirements
MARKETING AUTHORISATION HOLDER
7
G. R. Lane Health Products Limited
Sisson Road
Gloucester
GL2 0GR
United Kingdom
Tel: +44 (0)1452 524012
Fax: +44 (0)1452 507930
Email: info@laneshealth.com
8 MARKETING AUTHORISATION NUMBER(S)
THR 01074/0236
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
05/03/2013
10 DATE OF REVISION OF THE TEXT
05/03/2013