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1. Potters Extracalm Mixture
2. Potters Extracalm Mixture

SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Potter’s Extracalm Mixture

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each 5ml of oral liquid contains: -

1.25 ml Tincture of Valerian Root (Valeriana officinalis) (1:5)

Extraction solvent: Ethanol 25% v/v

0.65 ml Tincture of Scullcap (Scutellaria lateriflora L.) (1:5)

Extraction solvent: Ethanol 45% v/v

Excipients:

5 ml of oral liquid contains approximately 0.785 ml ethanol, 0.152 ml glucose, 0.833 g sucrose and also sorbitol. (See section 4.4 ‘Special warnings and precautions for use’.)

For full list of excipients see Section 6.1

3 PHARMACEUTICAL FORM

Oral Liquid.

A dark brown liquid.

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 one 5ml teaspoonful 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.

Not recommended for children and adolescents under 18 years of age because data are not sufficient and medical advice should be sought.

This medicinal product contains 15.7% v/v ethanol (alcohol), i.e. up to 628 mg per dose, equivalent to 15.7 ml beer, 6.5 ml wine per dose.

Harmful for those suffering from alcoholism. To be taken into account in pregnant or breast-feeding women, children and high-risk groups such as patients with liver disease or epilepsy.

This medicinal product contains glucose, sucrose and sorbitol.

Patients with rare hereditary problems of fructose intolerance, glucose-glactose 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.

Contains alcohol and should be avoided in patients taking other medicines known to interact with alcohol (e.g. metronidazole).

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.

This product contains alcohol and therefore may impair ability to drive or operate machines. If affected do not drive or operate machines (See Section 4.4 ‘Special warnings and precautions for use’.)

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. Overdose of this product may result in alcohol intoxication: the amount of alcohol in a full bottle (12.56 g in 100 ml; 25.12 g in 200 ml: equivalent to 0.4 and 0.8 large glasses of wine, respectively) may result in intoxication and should be treated accordingly.

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

Glucose Liquid Sucrose Syrup Glycerol

Cardamom Compound Tincture (cochineal (E120), cardamom oil, caraway oil, cinnamon bark oil, glycerol, water)

Nutmeg Oil Clove Oil

Cinnamon Bark Oil

Liquorice Liquid Extract (liquorice root, sorbitol, glucose liquid, caramel, ethanol, water)

Ethanol

Caramel (E150)

Water

6.2 Incompatibilities

None known.

10 DATE OF REVISION OF THE TEXT

28/09/2015