Summary of Product Characteristics (SmPC) - Healthspan Valerian Sleepaid tablets
1 NAME OF THE MEDICINAL PRODUCT
Healthspan Valerian SleepAid Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film coated tablet contains 300 mg of extract (as dry extract) from Valerian root (Valeriana officinalis L.) (equivalent to 900mg - 1500mg of Valerian root)
Extraction solvent Ethanol 60% v/v
For full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film coated tablet
Brown speckled oval film coated tablet.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
A traditional herbal medicinal product used for the temporary relief of sleep disturbances due to symptoms of mild anxiety based on traditional use only.
4.2 Posology and method of administration
For oral short term use only.
Adults and the elderly. Take two tablets half an hour before bedtime.
This product is not recommended 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: 2 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 the symptoms worsens, 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 18years 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. Affected patients should 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 (equivalent to 11 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 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
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
Excipients in the extract
Maltodextrin
Colloidal Anhydrous Silica
Tablet Core
Maltodextrin
Microcrystalline cellulose
Sodium croscarmellose
Stearic Acid
Colloidal Hydrated Silica
Magnesium Stearate
Film Coating
Hypromellose
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
Thompson and Capper limited
Hardwick Road
Astmoor
Runcorn
Cheshire
WA7 1PH
8 MARKETING AUTHORISATION NUMBER(S)
THR 01359/0004
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10/01/2018
10 DATE OF REVISION OF THE TEXT
05/01/2024