POTTERS RELAX & SLEEP TABLETS - summary of medicine characteristics

1 NAME OF THE MEDICINAL PRODUCT

Potter’s Relax & Sleep tablets

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each coated tablet contains:

120 mg of extract (as dry extract) from Valerian root (Valeriana officinalis L.) (3–4:1) (equivalent to 360 – 480 mg of Valerian root).

Extraction solvent: ethanol 70 % v/v

80 mg of extract (as dry extract) from Lemon balm leaf (Melissa officinalis L.) (4–6:1) (equivalent to 320 – 480 mg of Lemon balm leaf).

Extraction solvent: methanol 30 % v/v

Excipients with known effect:

Each coated tablet also contains 111.4 mg of sucrose and 31.7 mg of glucose.

For full list of excipients, see section 6.1

3 PHARMACEUTICAL FORM

Coated tablet.

Grey-blue sugar-coated, round biconvex. 11 mm in diameter

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

A traditional herbal medicinal product used for the temporary relief of sleep disturbances due to symptoms of mild anxiety, based on traditional use only.

4.2 Posology and method of administrationMethod of administration

For oral short term use only.

Two to three tablets to be taken half to one hour before bedtime.

Swallow the tablets whole with liquid.

Maximum daily dose: 3 tablets

The use in children and adolescents under 18 years of age is not recommended (see section 4.4 ‘Special warnings and precautions for use’).

As treatment effects may not be apparent immediately, tablets should be taken for at least 2–4 weeks continuously.

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

4.3 Contraindications

Hypersensitivity to the active substances or any of the excipients.

4.4 Special warnings and precautions for use

Do not exceed the stated dose.

The use in children under 18 years of age is not recommended because data are not sufficient and medical advice should be sought.

If the symptoms worsen, or persist after 4 weeks, a doctor or a qualified healthcare practitioner should be consulted.

This product contains glucose. One tablet contains 31.7 mg of glucose. Patients with rare glucose-galactose malabsorption should not take this medicine.

This product contains sucrose. One tablet contains 111.4 mg of sucrose. Patients with rare hereditary problems of fructose intolerance, glucosegalactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

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 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 during pregnancy and lactation is not recommended.

Tests on the effects on fertility have not been performed

4.7 Effects on ability to drive and use machines

May impair ability to drive and use machines. Affected patients should not drive or operate machinery.

4.8 Undesirable effects

Gastrointestinal symptoms such as nausea, vomiting, abdominal cramps and diarrhoea 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 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: Yellow card scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

4.9 Overdose

Valerian root at a dose of approximately 20 g caused symptoms, such as fatigue, abdominal cramp, chest tightness, light-headedness, hand tremor and mydriasis, which disappeared within 24 hours. If symptoms arise, treatment should be supportive.

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

Data from in vitro and animal studies indicate that the water extract of Melissa officinalis L., folium may inhibit the activity of thyroid stimulating hormone (TSH). The clinical relevance of these findings is not known.

AMES-tests on mutagenicity with extracts of Valeriana officinalis L., representing the two extremes of the polarity range did not give any reason for concern.

Reverse mutation assays (Ames test) on bacteria indicated that the product was not mutagenic in Salmonella typhimurium (strains TA 98, TA 100, TA 1535, TA 1537 and Escherichia coli strain WP2 uvrA) mutation assays with or without metabolic activation.

Tests on reproductive toxicity and carcinogenicity have not been performed

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Extract excipients

Glucose, liquid, spray-dried

Silica, colloidal anhydrous

Tablet core

Microcrystalline cellulose

Colloidal anhydrous silica

Sodium starch glycollate (Type A)

Magnesium stearate

Tablet coat

Sucrose

Purified talc

Acacia, spray dried

Titanium dioxide (E171)

Indigo carmine (E132)

Macrogol

Carnauba wax

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

3 years

6.4 Special precautions for storage

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

6.5 Nature and contents of container

PVC/PVDC/Al blister strip

Pack size: 30 tablets

6.6 Special precautions for disposal

No special requirements.

7 MARKETING AUTHORISATION HOLDER

Soho Flordis UK Limited

1 Botanic Court

Martland Park

Wigan

WN5 0JZ