SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Potter’s Chest Mixture

Napiers Herbal Cough and Chest Syrup

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each 5 ml of oral liquid contains:-

0.0144 ml extract (as liquid extract) from Lobelia herb (Lobelia inflata L.)(1.1) (equivalent to 1.44 mg Lobelia herb)

Extraction solvent: Ethanol 50% v/v

0.085 ml of extract (as liquid extract) from White Horehound herb (Marrubium vulgare L.) (1:1) (equivalent to 85 mg White Horehound herb ) Extraction Solvent: Water

0.06 ml of extract (as liquid extract) from Senega Root (Polygala senega L.) (1:1) (equivalent to 60 mg Senega root)

Extraction Solvent: Ethanol 60% v/v

0.06 ml of extract (as liquid extract) from Indian Squill bulb (Drimia indica (Roxb.) JP Jessop) (1:10) (equivalent to 6 mg Indian Squill)

Extraction solvent acetic acid 6% v/v

Excipients:

5 ml of oral liquid contains 0.5 ml ethanol, 3.4 g sucrose and also glucose (dextrose). (See section 4.4 ‘Special warnings and precautions for use’.)

3 PHARMACEUTICAL FORM

Oral liquid.

A dark reddish brown liquid.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

A traditional herbal medicinal product used for the symptomatic relief of chesty coughs and catarrh of the throat and chest, based on traditional only.

4.2 Posology and method of administration

For oral use only.

Adults, the elderly, children and adolescents over 12 years: Take one 5ml teaspoonful every three hours up to a maximum of four times per day.

Not recommended for use in children under 12 years of age. (See section 4.4 ‘Special warnings and precautions for use’).

Duration of use:

Do not use this product for more than 7 days.

If symptoms worsen or persist for more than 7 days, a doctor or a qualified health care practitioner should be consulted.

4.3 Contraindications

Hypersensitivity to the active ingredients or any of the excipients. Patients with any type of heart condition.

Obstruction of the bile duct, cholangitis, liver disease, ileus.

4.4 Special warnings and precautions for use

Do not exceed the stated dose.

If symptoms worsen or persist for more than 7 days, a doctor or a qualified healthcare practitioner should be consulted.

If dysponea, fever or purulent sputum occurs, a doctor or qualified healthcare practitioner should be consulted.

Not recommended for use in children under 12 years of age because data are not sufficient and medical advice should be sought.

Patients with active peptic ulcer, gallstones and any other biliary disorders should consult a doctor before using Marrubium (White horehound) preparations.

This medicinal product contains 10% v/v ethanol (alcohol), i.e. up to 400 mg per dose, equivalent to 10 ml beer, 4.2 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 sucrose and glucose (dextrose).

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

No studies have been carried out to determine if drug interactions occur with this product.

In view of the potential for Squill to interact with other medicines administered concurrently, the product should not be taken with digoxin or any medicine for heart conditions (see section 4.3).

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

No studies on the effect on the ability to drive and use machines have been performed.

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

Lobelia can cause similar effects to nicotine and include nausea, vomiting, diarrhoea, coughing, tremors and dizziness.

Allergic reaction including contact dermatitis may occur after ingesting White horehound. The frequency is not known.

Squill may cause gastric irritation. The frequency is not known.

If other adverse reactions 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

There is a possibility of arrhythmia occurring as a result of an overdose.

Overdose of Lobelia could produce nausea, vomiting or diarrhoea, profuse diaphoresis paresis, hypotension and coma. High doses could be cardioactive. If symptoms arise treatment should be supportive.

Overdose of this product may result in alcohol intoxication: the amount of alcohol in a full bottle (8 g in 100 ml; 16 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 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

Adequate tests on reproductive toxicity, genotoxicity and carcinogenicity have not been performed.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Ethanol

Syrup (sucrose)

Glycerol

Quillaia Tincture Special (Quillaia bark, water ethanol)

Fluid Extract Wild Cherry (Wild Cherry bark, water, ethanol) Capsicum Tincture (capsicum oleoresin, water, ethanol) Beetroot Powder (E162)

Viscarin (carrageenan, glucose (dextrose))

Star Anise Oil Water Acetic acid

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 container.

6.5 Nature and contents of container

Glass bottle with child-resistant safety cap contained in cardboard carton: 150 ml, 200 ml or 250 ml.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal

There are no special precautions for disposal.

7 MARKETING AUTHORISATION HOLDER

Soho Flordis UK Limited 1 Botanic Court,

Martland Park,

Wigan,

WN5 0JZ,

UK.

Trading as: Potters, Wigan WN5 0JZ

8    MARKETING AUTHORISATION NUMBER(S)

THR 44893/ 0022

DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

11/04/2013

DATE OF REVISION OF THE TEXT

28/09/2015