Stressless Herbal Tablets
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Stressless Herbal Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each coated tablet contains:
45 mg Hops strobiles (Humulus lupulus L.)
20 mg of extract (as dry extract) from Valerian root (Valeriana officinalis L.) (5:1) Extraction solvent: Ethanol 45% v/v
30 mg of extract (as dry extract) from Verbena herb (Verbena officinalis L.) (3:1) Extraction solvent: Methanol 60% v/v
Each coated tablet contains 210 mg sucrose.
For full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Coated tablet, white biconvex
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 short term use only.
Adults and the elderly: Two tablets three times a day.
As treatment effects may not be apparent immediately, the tablets should be taken for 2-4 weeks continuously.
Not for children or adolescents under 18 years (see Section 4.4. Special warnings and precautions for 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 ingredients or any of the excipients.
4.4 Special warnings and precautions for use
Do not exceed the stated dose.
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.
Contains sucrose, patients with rare hereditary problems of galactose or fructose intolerance, glucose-galactose malabsorption, the Lapp lactase deficiency or sucrase-isomaltase insufficiency should not take this medicine.
If symptoms worsen or do not improve after 4 weeks of using the 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. 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 the product 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 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, abdominal cramps may occur. The frequency is not known.
If other adverse reactions not mentioned above occur, a doctor or a 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 at: www.mhra.gov.uk/yellowcard
4.9 Overdose
Valerian root at a dose of approximately 20 g (equivalent to 200 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
Tests on reproductive toxicity, genotoxicity and carcinogenicity have not been performed.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Extract excipient
Maltodextrin
Tablet core
Sucrose
Talc
Potato starch Magnesium stearate Microcrystalline cellulose Colloidal hydrated silica Sodium starch glycolate
Tablet coat Sucrose Talc Kaolin
Titanium Dioxide (E171)
6.2 Incompatibilities
None.
6.3 Shelf life
3 years
6.4 Special precautions for storage
No special requirements.
6.5 Nature and contents of container
White polypropylene containers with tamper-evident polyethylene moulded cap or integral polypropylene cap. Containing 50, 75 or 100 tablets.
6.6 Special precautions for disposal
No special requirements.
7 MARKETING AUTHORISATION HOLDER
Brome and Schimmer Limited
T/A Diomed Herbals
Tatmore Place
Gosmore
Hitchin
Herts SG4 7QR UK
8 MARKETING AUTHORISATION NUMBER(S)
THR 17418/0029
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
08/04/2013
10 DATE OF REVISION OF THE TEXT
16/08/2016