Summary of medicine characteristics - IMED NATRAHERB STRESS RELIEF TABLETS, KALMS RHODIOLA TABLETS, VITANO RHODIOLA TABLETS, HOLLAND & BARRETT RHODIOLA STRESS RELIEF TABLETS
1 NAME OF THE MEDICINAL PRODUCT
Vitano Rhodiola Tablets
Holland & Barrett Rhodiola Stress Relief Tablets
iMed Natraherb Stress Relief Tablets
Kalms Rhodiola Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One film-coated tablet contains:
200 mg of extract (as dry extract) from Rhodiola rosea L. roots and rhizomes (1.5 –
5: 1) (WS 1375)
(equivalent to 300 – 1000 mg of Rhodiola rosea roots and rhizomes)
Extraction agent: ethanol 60 % (m/m)
For a full list of excipients see section 6.1.
Film-coated tablet; round, red tablet.
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
Adults and the elderly
Two tablets daily, one before breakfast and one before lunch, to be taken with a glass of water, preferably 30 minutes before food intake.
Children and adolescents less than 18 years old
Use in children and adolescents under 18 years of age is not recommended (see Section 4.4).
Duration of use
If the symptoms worsen, or persist for more than 2 weeks a doctor or a qualified healthcare practitioner should be consulted.
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 associated with stress. Patients with signs and symptoms of depression should seek medical advice for appropriate treatment.
The use in children and adolescents under 18 years of age is not recommended because data are not sufficient and medical advice should be sought.
4.5 Interaction with other medicinal products and other forms of interaction
None 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.
No studies on the effects on fertility have been undertaken.
4.7 Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been undertaken.
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 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 or search for MHRA Yellow Card in the Google Play or Apple App Store
4.9 Overdose
4.9 OverdoseNo 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
5.3 Preclinical safety dataNon-clinical data on Rhodiola rosea extract revealed no special hazard for humans based on limited studies of single-dose toxicity and repeat-dose.
Reverse mutation assays (Ames test) on bacteria indicated that the product was not mutagenic in Salmonella typhimurium (strains TA 1535, TA 1537, TA98, TA 100 and TA102) 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
Microcrystalline cellulose,
Croscarmellose sodium
Precipitated silicon dioxide
Magnesium stearate
Hypromellose
Stearic acid
Iron oxide red (iron (III) oxide)
Titanium dioxide
Anti foam emulsion.
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
4 years.
6.4 Special precautions for storage
This medicinal product does not require any special storage conditions.
6.5 Nature and contents of container
Original packages containing 16 or 30 film-coated tablets (Vitano Rhodiola tablets), 20 film-coated tablets (Kalms Rhodiola tablets), 30 film-coated tablets (Holland & Barrett Rhodiola Stress Relief Tablets and iMed Natraherb Stress Relief Tablets) or 60 film-coated tablets (Holland & Barrett Rhodiola Stress Relief Tablets).
The tablets are packed in PVC/ PVDC aluminium blisters and inserted into a carton together with the package leaflet.
Not all pack sizes may be marketed
6.6 Special precautions for disposal
6.6 Special precautions for disposalNo special requirements.
Any unused product or waste material should be disposed of in accordance with local requirements.