Summary of Product Characteristics (SmPC) - Kalms Day Plus
1 NAME OF THE MEDICINAL PRODUCT
Kalms Day Plus
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 52 mg of extract (as dry extract) from Valeriana officinalis L. radix (equivalent to 208 mg – 260 mg of Valerian root). Extraction solvent: Ethanol 60% V/V.
Each tablet contains 9 mg of extract (as dry extract) from Humulus lupulus L., strobiles (equivalent to 81 mg – 99 mg of Hop strobile). Extraction solvent: Ethanol 45% V/V
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film coated tablet
White, circular, biconvex film 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, based on traditional use only.
4.2 Posology and method of administration
For oral use.
Adults and the elderly: One tablet to be taken 3 times a day. As treatment effects may not be apparent immediately, Kalms Day 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.
The use in children or adolescents under 18 years of age is not recommended (see Section 4.4. Special warnings and precautions of use).
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.
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 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 sedatives cannot be excluded and therefore co-medication is not recommended as a general precaution. The effect of Kalms Day 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. As a precautionary measure, because of lack of data, 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 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 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 the 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
Valerian root at a dose of approximately 20 g (equivalent to 8 to 13 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 10 g 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
Reverse mutation assays (Ames test) on bacteria indicated that the product was not mutagenic in Salmonella typhimurium (strains TA 98, TA 100, TA 102, TA 1535 and TA 1537) mutation assays with or without metabolic activation..
Tests on reproductive toxicity and carcinogenicity have not been performed.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Extracts Excipients
Maltodextrin
Colloidal Anhydrous Silica
Tablet Core
Croscarmellose
Sodium
Microcrystalline
Cellulose
Magnesium
Stearate
Pregelatinised
Starch Silicon
Dioxide
Stearic Acid
Tablet Coating
Opadry (TM) 07F28588 White (Hypromellose, Talc, Titanium Dioxide, PEG, Saccharin Sodium)
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
30 months
6.4 Special precautions for storage
Do not store above 25°C.
Store in the original package.
6.5 Nature and contents of container
21 or 42 tablets stored in PVC/Aclar®-aluminium/polyethylene laminate blister packs
- pocketpack format with sliding blisters attached to the carton. 21, 42 or 84 tablets stored in PVC/Aclar®-aluminium/polyethylene laminate blister packs.
100 tablets stored in 60ml amber glass bottles (Ph. Eur. type III glass) fitted with white HDPE tamper evident caps.
100 tablets stored in 60ml white HDPE bottles fitted with white HDPE tamper evident caps.
Not all pack sizes may be marketed
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 01074/0027
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
10/07/2018
10 DATE OF REVISION OF THE TEXT
08/04/2022