Summary of medicine characteristics - LIFECYCLE RHODIOLA ROSEA CAPSULES,NATURES GARDEN RHODIOLA ROSEA CAPSULES,HOLLAND & BARRETT RHODIOLA ROSEA CAPSULES,NATURES BOUNTY RHODIOLA ROSEA CAPSULES,GNC LIVE WELL RHODIOLA ROSEA CAPSULES
Holland & Barrett Rhodiola rosea Capsules
GNC Live Well Rhodiola rosea Capsules
Lifecycle Rhodiola rosea Capsules
Nature’s Garden Rhodiola rosea Capsules
Nature’s Bounty Rhodiola rosea Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 153mg of extract (as dry extract) from Rhodiola rosea roots and rhizomes (Rhodiola rosea L.) (equivalent to 764mg – 916 mg of Rhodiola rosea roots and rhizomes).
Extraction solvent: Ethanol 80% v/v
For full list of excipients, see section 6.1
Capsule, hard
Two piece clear hard capsules with light brown fill.
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. This is based on traditional use only.
4.2 Posology and method of administration For oral use only.
Adults and the elderly
Take 1 capsule 2 times daily. Take one capsule before breakfast and one before lunch, preferably 30 minutes before food intake. Swallow the whole capsule with water.
Not recommended for use in children or adolescents under 18 years (see section 4.4 Special warning and precautions for use)
Duration of use
If symptoms worsen or persist for more than 2 weeks, a doctor or a 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
Not recommended for children or adolescents under 18 years of age because data are not sufficient and medical advice should be sought
Use in patients with impaired hepatic or renal function is not recommended
This product is intended for the relief of symptoms associated with stress.
Patients with signs and symptoms of depression should seek medical advice for appropriate treatment.
4.5 Interaction with other medicinal products and other forms of interaction
In vitro, Rhodiola rosea extract at a concentration of 10 microgram/ml 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. Due to the lack of data, 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 effect on the ability to drive and use 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.
4.9 Overdose
4.9 OverdoseNo case of overdose has 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
5.3 Preclinical safety dataTests on reproductive toxicity, genotoxicity and carcinogenicity have not been performed.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Microcrystalline cellulose Magnesium stearate
Silica colloidal hydrated
Excipients in the extract:
Maltodextrin
Silica colloidal anhydrous
Capsule Shell:
Hypromellose
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
36 months
6.4 Special precautions for storage
6.4 Special precautions for storageDo not store above 25°C.
Keep in the original container.
Keep the bottle tightly closed
6.5 Nature and contents of container
Container:
Green Polyethylene terephthalate (PET) bottles with a green hinge cap (Polypropylene), with an inner seal liner designed to lift ‘n’ peel. The inner seal acts as a tamper evident seal under the cap. The Inner seal liner is made up of polyester film, polymer adhesive layer, polyester tab, polyolefin foam, aluminium foil and sealable polyester film
Pack size: 50 capsules
6.6 Special precautions for disposal No special requirements.
7 MARKETING AUTHORISATION HOLDER
NBTY Europe Limited
Samuel Ryder House
Barling Way
Nuneaton
Warwickshire
CV10 7RH
United Kingdom
8 MARKETING AUTHORISATION NUMBER(S)
THR 21710/0020
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
09/05/2012