SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

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

3 PHARMACEUTICAL FORM

Capsule, hard

Two piece clear hard capsules with light brown fill.

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. 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

No 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

Tests on reproductive toxicity, genotoxicity and carcinogenicity have not been performed.

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

Do 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

10    DATE OF REVISION OF THE TEXT

04/04/2014