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1. Potters Calm & Relax
2. Potters Calm & Relax

SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Potter’s Calm & Relax

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

Each coated tablet contains: -

75 mg Hop strobile (Humulus lupulus L.)

45 mg Scullcap (Scutellaria lateriflora L.)

30 mg of extract (as dry extract) from Vervain Herb (Verbena officinalis L.) (3:1) (equivalent to 90 mg Vervain herb) Extraction solvent: Water

25 mg of extract (as dry extract) from Valerian Root (Valeriana officinalis L.) (4:1) (Equivalent to100 mg Valarian root) Extraction solvent: Water.

Excipient of known effect:

Each tablet contains 46.5 mg of sucrose. (See Section 4.4 “Special warnings and precautions for use”.)

For full list of excipients see Section 6.1.

3    PHARMACEUTICAL FORM

Tablet.

A peach coloured, round, biconvex sugar-coated tablet

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

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

4.2 Posology and method of administration

For oral use only.

Adults and the elderly: Take two tablets three times a day.

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 health care practitioner should be consulted.

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

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 under 18 years of age because data are not sufficient and medical advice should be sought.

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

This medicinal product contains sucrose.

Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

4.5 Interaction with other medicinal products and other forms of interaction

Valerian extract: Only limited data on pharmacological interactions with other medicinal products are available. Clinically relevant interactions with drugs, metabolized by the CYP2D6, CYP3A4/5, CYP1A2 or CYP2E1 pathway has not been observed.

Combination with synthetic sedatives is not recommended.

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

4.6 Fertility, Pregnancy and lactation

The safety of this product during pregnancy and lactation has not been established, therefore the use of this product during pregnancy and lactation is not recommended.

Studies on fertility have not been carried out.

4.7 Effects on ability to drive and use machines

May impair ability to drive and use machines. If affected, patients should not drive or operate machinery.

4.8 Undesirable effects

Gastrointestinal symptoms such as nausea, abdominal cramps may occur after ingestion of valerian root preparations. The frequency is not known.

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

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

4.9 Overdose

Valerian root at a dose of approximately 20 g 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 30g of the drug) withdrawal symptoms (delirium) have been reported.

Symptomatic and supportive measures should be taken as appropriate.

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 excipients Maltodextrin

Colloidal anhydrous silica

Tablet

Sucrose

Acacia

Talc

Magnesium Stearate Sodium Starch Glycolate Kaolin Light

Yellow Iron Oxide (E172)

Red Iron Oxide (E 172)

Titanium Dioxide (E171)

Shellac

6.2 Incompatibilities

None known.

6.3 Shelf life

Three years.