Stresseeze Rhodiola Tablets
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
StressEeze Rhodiola Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One film-coated tablet contains:
166mg of extract (as dry extract) from Rhodiola rosea L roots and rhizomes (equivalent to 832 - 996 mg Rhodiola rosea roots and rhizomes).
Extraction solvent: ethanol 80% v/v.
Also contains glucose monohydrate.
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Film-coated tablet.
Light brown speckled biconvex film-coated tablets.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
A traditional herbal medicinal product used for the temporary relief of symptoms associated with stress, such as fatigue, exhaustion and mild anxiety based on traditional use only.
4.2 Posology and method of administration
For oral use only
Adults and the elderly.
Take two tablets daily, one before breakfast and one before lunch. The tablets should be taken with a glass of water preferably 30 minutes before food intake.
The use in children and adolescents under 18 years of age is not recommended (see section 4.4 Special warnings and Precautions for use).
Duration of use
If symptoms worsen or persist for more than 2 weeks a doctor or qualified healthcare practitioner should be consulted.
Not to be taken for more than 2 months.
4.3 Contraindications
Hypersensitivity to the active ingredient or to any of the excipients.
4.4 Special warnings and precautions for use
Do not exceed the stated dose
This product is intended for relief of symptoms of stress. Patients with signs and symptoms of depression should seek medical advice for appropriate treatment.
If symptoms worsen or persist for more than 2 weeks a doctor or qualified healthcare practitioner should be consulted.
The use of this product in children and adolescents under 18 years of age is not recommended because data are not sufficient and medical advice should be sought.
Patients with rare glucose-galactose malabsorption should not take this medicine
Use in patients with impaired hepatic or renal function is not recommended .
4.5 Interaction with other medicinal products and other forms of interaction
In vitro, Rhodiola rosea extract at a concentration of 10pg ml-1 resulted in inhibition of CYP2C9 and CYP2C19 isoenzymes. The clinical relevance of these findings is not known.
4.6 Fertility, Pregnancy and lactation
Safety during pregnancy and lactation has not been established. In the absence of sufficient data, the 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
No studies on the effects on the ability to drive and operate machines have been performed.
4.8 Undesirable effects
There have been sporadic case reports of hypersensitivity and hypoglycaemia. There is no clear relationship between the development of hypoglycaemia and the use of Rhodiola rosea extract.
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 registration 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
No case of overdose has 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
Tests on reproductive toxicity, genotoxicity and carcinogenicity have not been performed
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Herbal extract:
maltodextrin
colloidal anhydrous silica.
Tablet core:
anhydrous calcium hydrogen phosphate microcrystalline cellulose
colloidal hydrated silica croscarmellose sodium stearic acid magnesium stearate Tablet coating:
sodium carboxymethyl cellulose dextrin
glucose monohydrate lecithin
sodium citrate dihydrate
6.2 Incompatibilities
Not applicable
6.3 Shelf life
2 years
6.4 Special precautions for storage
Store below 250C
Store in the original package.
6.5 Nature and contents of container
Ph Eur type III glass bottles with polypropylene closure incorporating an induction heat seal liner. Printed outer carton containing Patient Information Leaflet.
Pack sizes: 30, 60, 90, 120 tablets. Not all pack sizes may be marketed.
6.6 Special precautions for disposal
No special requirements.
7 MARKETING AUTHORISATION HOLDER
Natures Aid Ltd St Georges Park
Kirkham
Preston PR4 2DQ.
Tel: 01772 686231
Fax: 01772 671688
email: sales@naturesaid.co.uk
8 MARKETING AUTHORISATION NUMBER(S)
THR 33336/0008
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
02/05/2012
10 DATE OF REVISION OF THE TEXT
27/02/2014