SUMMARY OF PRODUCT CHARACTERISTICS 1    NAME OF THE MEDICINAL PRODUCT

HRI Calm Life Tablets.

HRI Stress Relief Tablets

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each film coated tablet contains:

30 mg German Chamomile flower (Matricaria recutita L. flower)

30 mg Valerian root (Valeriana officinalis L. root)

40 mg Scullcap herb (Scutellaria lateriflora L. herb).

For full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Film-coated tablet Dark yellow convex tablet.

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

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

One or two tablets three times a day.

As treatment effects may not be apparent immediately, the tablets should be taken 2 - 4 weeks continuously.

Children and adolescents under 18 years

Not recommended for children and adolescents under 18 years of age. (See Section 4.4 Special warnings and precautions for use).

If symptoms worsen, or persist for more than 4 weeks, a doctor or a qualified healthcare practitioner should be consulted.

4.3 Contraindications

Hypersensitivity to the active substances or to plants of the Asteraceae (Compositae) family or any of the excipients.

4.4 Special warnings and precautions for use

Do not exceed the stated dose.

If symptoms worsen or persist for more than 4 weeks, a doctor or a 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.

The 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

Only limited data on pharmacological interactions with other medicinal products are available. Clinically relevant interactions with drugs metabolised by the CYP2D6, CYP 3AA4/5, CYP1A2 or CYP2E1 pathway have not been observed. Additive effects with hypnotics and other sedatives cannot be excluded and therefore co-medication is not recommended as a general precaution.

The effect of valerian may potentiated by alcohol. Excessive concomitant consumption of alcohol should therefore be avoided.

4.6 Fertility, pregnancy and lactation

Safety during human pregnancy and lactation had not been established.

In the absence of sufficient data the use in pregnancy and lactation is not recommended.

Studies on fertility have not been performed.

4.7 Effects on ability to drive and use machines

May impair the ability to drive and use machines. Patients who are affected should not drive or use machines.

4.8 Undesirable effects

Gastrointestinal symptoms (e.g. nausea, abdominal cramps) may occur after ingestion of valerian root.

The frequency is not known.

If other adverse reactions not mentioned above occur, a doctor, pharmacist or qualified healthcare practitioner should be consulted

4.9 Overdose

None reported with this product.

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 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Tablet Core

Microcrystalline cellulose Dicalcium phosphate

Silicon dioxide Magnesium stearate Stearic acid

Tablet Coating

Hypromellose

Talc

Yellow iron oxide (E172) Titanium dioxide (E171)

6.2 Incompatibilities

None known.

6.3 Shelf life

3 years

6.4 Special precautions for storage

Do not store above 25 °C. Store in the original packaging.

6.5 Nature and contents of container

Amber glass bottle with foil tamper evident seal and white polypropylene screw cap. Pack sizes: 30, 40, 50, 60.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal

No special requirements.

7 MARKETING AUTHORISATION HOLDER

The Herbal Research Company Limited (trading as Jessup Marketing)

27 Old Gloucester Street

London

WC1N 3XX

8    MARKETING AUTHORISATION NUMBER(S)

THR 02231/0007

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

22/03/2013

10    DATE OF REVISION OF THE TEXT

22/03/2013