Summary of medicine characteristics - KALMS NIGHT
Kalms Night
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 96mg of extract (as dry extract) from Valerian root (Valeriana officinalis L.)(equivalent to 384 – 480mg of Valerian root)
Extraction solvent: Ethanol 60%V/V
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film coated tablet
White, circular
4.1 Therapeutic indications
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 use.
Adults and the elderly: Swallow 4 tablets 30–60 minutes before bedtime. If necessary, on subsequent evenings, swallow 4 additional tablets earlier during the evening.
As treatment effects may not be apparent immediately, Kalms Night 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 substance or to any of the excipients.
4.4 Special warnings and precautions for use
Do not exceed 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 persist or worsen after 4 weeks of using the medicinal product, 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 Night 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
4.9 OverdoseValerian root at a dose of approximately 20 g (equivalent to 42 to 51 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 16 c (1) (a) (iii) of Directive 2001/83/EC as amended.
5.2 Pharmacokinetic properties
Not required as per Article 16 c (1) (a) (iii) of Directive 2001/83/EC as amended.
5.3 Preclinical safety data
5.3 Preclinical safety dataTests 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
Croscarmellose Sodium
Magnesium Stearate
Prosolv SMCC50 (Silicified Microcrystalline Cellulose)
Talc
Silicon Dioxide
Tablet Coating
Opadry TM White 07F28588 (Hypromellose, Titanium Dioxide, Polyethylene Glycol
(PEG) 3350, Saccharin Sodium)
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
2 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, 100 or 200 tablets stored in amber glass or white HDPE bottles with white HDPE tamper-evident caps.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal
6.6 Special precautions for disposalNo special requirements.