SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Vitano Rhodiola Tablets Boots Stress Relief film-coated tablets Higher Nature Stress Relief film-coated tablets Healthspan Rhodiola Stress Relief tablets Holland & Barrett Rhodiola Stress Relief Tablets Simply Supplements Rhodiola Stress Relief 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.

3 PHARMACEUTICAL FORM

Film-coated tablet; round, red tablet.

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

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).

Hepatic and renal impairment

Use in patients with impaired hepatic or renal function is not recommended (see Section 4.3).

Duration of use

If the 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. Children and adolescents under the age of 18 years.

Patients with impaired hepatic or renal function.

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 and in patients with impaired hepatic and renal function 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

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. 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.

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

Non-clinical data on Rhodiola rosea extract revealed no special hazard for humans based on limited studies of single-dose toxicity, repeated-dose toxicity and mutagenicity.

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), 30 film-coated tablets (Higher Nature Rhodiola Stress Relief film-coated tablets, Boots Stress Relief Rhodiola tablets and Holland & Barrett Rhodiola Stress Relief Tablets) or 60 film-coated tablets (Healthspan Rhodiola Stress Relief tablets, Holland & Barrett Rhodiola Stress Relief Tablets and Simply Supplements 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

No special requirements.

Any unused product or waste material should be disposed of in accordance with local requirements.

7    MARKETING AUTHORISATION HOLDER

Dr. Willmar Schwabe GmbH & Co. KG

Willmar-Schwabe-Str. 4

D-76227 Karlsruhe

GERMANY

UK distributor:

Schwabe Pharma (UK) Ltd Alexander House, Mere Park,

Dedmere Road,

Marlow, Bucks, SL7 1PD

8    MARKETING AUTHORISATION NUMBER(S)

THR 05332/0004

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

24/07/2008

10 DATE OF REVISION OF THE TEXT

16/08/2014