Kalms Tablets
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Kalms Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each coated tablet contains:
45 mg Hop Strobiles (Humulus lupulus L.)
33.75 mg of extract (as dry extract) from Valerian root (Valeriana officinalis L.) (equivalent to 135 to 167mg of Valerian root)
Extraction solvent: Ethanol 60%v/v
22.5 mg of extract (as dry extract) from Gentian root (Gentiana lutea L.) (equivalent to 90mg of Gentian root)
Extraction solvent: Ethanol 50% v/v
Each coated tablet contains 247 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.
White circular biconvex sugar coated tablet.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
A traditional herbal medicinal product used for the temporary relief of;
symptoms associated with stress such as mild anxiety and irritability including symptoms associated with menopause such as flushings and cold sweats and sleep disturbances, based on traditional use only.
4.2 Posology and method of administration
For oral short terms use only.
For the temporary relief of symptoms associated with stress such as mild anxiety and irritability including symptoms associated with menopause such as flushings and cold sweats;
Adults and the elderly: Take 2 tablets three times per day with water after meals.
For the temporary relief of sleep disturbances;
Adults and the elderly: Take 2 tablets 30 to 60 minutes before bedtime. One additional tablet can be taken earlier during the evening if necessary.
Not more than six tablets to be taken in 24 in hours.
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, this medicine 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 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
Kalms Tablets 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.
Gastrointestinal disorders have been observed with Gentian root. The frequency was uncommon. In rare cases, tachycardia and pruritis have been reported. Headache may occur. The frequency is unknown.
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 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 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.
For some xanthones which are among the constituents of Gentiana lutea, positive results were found in the AMES test (pre-incubation method). Assessment of preclinical safety requires further studies towards these effects.
6 PHARMACEUTICAL PARTICULARS
Extract:
Maltodextrin Silicon Dioxide
Core:
Acacia, Spray-dried Icing Sugar Magnesium Stearate Maize Starch Silicon Dioxide Sodium Starch Glycolate Stearic Acid
Coating:
Acacia, Spray-dried Calcium Carbonate (Light) Carnauba Wax Mastercote White SP0950G Talc
Shellac Varnish Sucrose
Titanium Dioxide E171 Yellow Beeswax
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
100 and 200 tablets in amber glass bottles (USP Type III glass) fitted with white HDPE tamper evident caps.
84 tablets in PVC/PVDC-aluminium/polyethylene laminate blister packs
6.6 Special precautions for disposal
No special requirements
7 MARKETING AUTHORISATION HOLDER
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 01074/0235
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
04/03/2013
10 DATE OF REVISION OF THE TEXT
04/03/2013