Summary of Product Characteristics (SmPC) - Vitabiotics Sleepnite Valerian tablets
1 NAME OF THE MEDICINAL PRODUCT
Vitabiotics Sleepnite Valerian Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film coated tablet contains 350 mg of extract (as dry extract) from Valerian root
(Valeriana officinalis L.) (equivalent to 1050 – 1750 mg of Valerian root)
Extraction solvent Ethanol 60% v/v
For full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film coated tablet.
Oval, biconvex, green film coated tablet.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
A traditional herbal medicinal product used for the temporary relief of sleep disturbances and mild anxiety based on traditional use only
4.2 Posology and method of administration
For oral short term use only.
Adults and the elderly
For mild anxiety: Take one tablet twice a day.
For sleep disturbances: Take 1 to 2 tablets half an hour before bedtime.
Not for children or adolescents under 18 years (see Section 4.4. Special warnings and precautions for use).
Tablets should be swallowed whole with some water or other liquid. The tablets should not be chewed.
As treatment effects may not be apparent immediately, tablets should be taken for at least 2-4 weeks continuously.
Maximum dose: 4 tablets per day.
Duration of use
If symptoms worsen, or do not improve after 4 weeks a doctor or qualified healthcare practitioner should be consulted.
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.
If symptoms worsen, or do not improve after 4 weeks a doctor or qualified healthcare practitioner should be consulted.
The use of this product is not recommended in children and adolescents below the age of 18 years because data are not sufficient and medical advice should be sought.
4.5 Interaction with other medicinal products and other forms of interaction
Only limited data on pharmacological interactions with other medicinal products are available. Additive effects with hypnotics and other sedative drugs cannot be excluded and therefore co-medication is not recommended as a general precaution.
The effect of valerian 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 in 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 cause dizziness and impair the ability to drive and use machines. If affected, do not drive or operate machines.
4.8 Undesirable effects
Gastrointestinal symptoms, such as nausea, vomiting, abdominal cramps and diarrhoea may occur. Dizziness, headaches and nightmares or vivid dreams may also occur. The frequency is not known.
If other adverse reactions not mentioned above occur, a doctor or a pharmacist 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 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 30 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
AMES-tests on mutagenicity with extracts, representing the two extremes of the polarity range did not give any reason for concern.
Tests on reproductive toxicity and carcinogenicity have not been performed.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Excipients in the extract
Maltodextrin
Silica Colloidal Anhydrous
Tablet Core
Maltodextrin
Microcrystalline cellulose
Sodium croscarmellose
Stearic Acid
Magnesium Stearate
Colloidal Hydrated Silica
Film Coating
Hypromellose
Titanium Dioxide (E171)
Copper Chlorophyllin
Glycerol
6.2 Incompatibilities
None known.
6.3 Shelf life
2 Years
6.4 Special precautions for storage
Do not store above 25 °C. Store in the original packaging.
6.5 Nature and contents of container
Tablets are packed into PVC/PVDC blister strips in the following pack sizes; 30, 60, 90 tablets and packed into a carton.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal
No special requirements.
7 MARKETING AUTHORISATION HOLDER
Vitabiotics
1 Aspley Way
London
NW2 7HF
8 MARKETING AUTHORISATION NUMBER(S)
THR 00387/0057
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
31/01/2020
10 DATE OF REVISION OF THE TEXT
29/02/2024