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1. Stressless Herbal Tablets
2. Stressless Herbal Tablets

SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Stressless Herbal Tablets

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

Each coated tablet contains:

45 mg Hops strobiles (Humulus lupulus L.)

45 mg Scullcap herb (Scutellaria lateriflora L.).

20 mg of extract (as dry extract) from Valerian root (Valeriana officinalis L.) (5:1). Extraction solvent: Ethanol 45% v/v

30 mg of extract (as dry extract) from Verbena herb (Verbena officinalis L.) (3:1).Extraction solvent: Methanol 60% v/v Each coated tablet contains 210 mg sucrose.

For full list of excipients, see section 6.

3    PHARMACEUTICAL FORM

Coated tablet, white biconvex

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

A traditional herbal medicinal product used for the temporary relief of symptoms associated with stress such as mild anxiety, based on traditional use only.

4.2 Posology and method of administration

For oral short term use only.

Adults and the elderly: Two tablets three times a day.

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

Not for children or adolescents under 18 years (see Section 4.4. Special warnings and precautions for use).

If symptoms worsen or do not improve after 4 weeks, a doctor or a qualified healthcare practitioner should be consulted.

4.3 Contraindications

Hypersensitivity to the active ingredients or any of the excipients.

4.4 Special warnings and precautions for use

Do not exceed the stated dose.

The use of this product is not recommended in children and adolescents below the age of 18 years because data are not sufficient and medical advice should be sought.

Contains sucrose, patients with rare hereditary problems of galactose or fructose intolerance, glucose-galactose malabsorption, the Lapp lactase deficiency or sucrase-isomaltase insufficiency should not take this medicine.

If symptoms worsen or do not improve after 4 weeks of using the product, a doctor or qualified healthcare practitioner should be consulted.

4.5 Interaction with other medicinal products and other forms of interaction

Only limited data on pharmacological interactions with other medicinal products are available. Additive effects with hypnotics and other sedative drugs cannot be excluded and therefore co-medication is not recommended as a general precaution.

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

4.6 Fertility, pregnancy and lactation

Safety during pregnancy and lactation has not been established. In the absence of sufficient data the use in 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

May impair the ability to drive and use machines. If affected, do not drive or operate machines.

4.8 Undesirable effects

Gastrointestinal symptoms such as nausea, abdominal cramps may occur. The frequency is not known.

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

4.9 Overdose

Valerian root at a dose of approximately 20 g (equivalent to 200 tablets) caused benign symptoms (fatigue, abdominal cramp, chest tightness, lightheadedness, hand tremor and mydriasis), which disappeared within 24 hours. If symptoms arise, treatment should be supportive.

After intake of very high doses of Valerian root over several years (daily consumption corresponding to approximately 30 g of the drug) withdrawal symptoms (delirium) have 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 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Extract excipient

Maltodextrin

Tablet core

Sucrose

Talc

Potato starch Magnesium stearate

Tablet coat Sucrose Talc Kaolin

Titanium Dioxide (E171)

6.2 Incompatibilities

None.

6.3 Shelf life

3 years

6.4 Special precautions for storage

No special requirements.

6.5 Nature and contents of container

White polypropylene containers with tamper-evident polyethylene moulded cap or integral polypropylene cap. Containing 50, 75 or 100 tablets.

6.6 Special precautions for disposal

No special requirements.

MARKETING AUTHORISATION HOLDER

Brome and Schimmer Limited

T/A Diomed Herbals

Tatmore Place

Gosmore

Hitchin

Herts SG4 7QR UK

08/04/2013