SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

English Herbal Medicines Horehound Plus Cough Syrup Brooke Green Horehound Plus Cough Mixture Napiers Cough Soother Herbal Syrup Quest Herbal Horehound Plus Cough Mixture

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each 5ml of oral liquid contains:-

75 microlitres of liquid extract from dried Pleurisy root* (Asclepias tuberosa L.) (1:1).

Extraction solvent: ethanol 35% v/v.

75 microlitres of liquid extract from dried Elecampane root * (Inula helenium L.) (1:1).

Extraction solvent: ethanol 21% v/v.

75 microlitres of liquid extract from dried White Horehound leaves and flowering tops*    (Marrubium vulgare L.) (1:1). Extraction

solvent: ethanol 20% v/v.

75 microlitres of liquid extract from dried Skunk cabbage root (Symplocarpus foetidus (L.) Salisb.) (1:1). Extraction solvent: ethanol 21% v/v.

112.5 microlitres of Tincture Lobelia Acid from dried Lobelia herb* (Lobelia inflata L.) (1:12).

Extraction solvent: ethanol 50 % v/v. Also contains 5.8 % acetic acid.

* Organically produced herbal ingredient.

Each 5ml of oral liquid also contains approximately:

158 mg Ethanol (alcohol) equivalent to 4 ml of beer or 1.7 ml of wine - 4 % (v/v).

2.77g Sucrose

For a full list of excipients see section 6.1.

3 PHARMACEUTICAL FORM

Oral liquid.

Dark reddish-brown slightly viscous liquid.

4.1 Therapeutic indications

A traditional herbal medicinal product used for the symptomatic relief of coughs, based on traditional use only

4.2 Posology and method of administration

For oral use only.

Adults and the Elderly

Take two 5ml spoonfuls three times a day.

Children over 12:

Take one 5ml spoonful three times a day.

The use is not recommended in children under 12 years of age (see 4.4. Special warnings and precautions for use).

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

4.3 Contraindications

Patients with known hypersensitivity to any of the active ingredients, any of the excipients or to plants of the Asteraceae (Compositae) family.

4.4 Special warnings and precautions for use

Do not exceed the stated dose.

Contains alcohol - up to 316 mg ethanol per 10ml dose (equivalent to 8 ml of beer or 3.5 ml of wine).

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.

Contains sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. May be harmful to the teeth.

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

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

The use is not recommended in children under 12 years of age because no data on safety are available

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.

Contains alcohol, and should therefore be avoided in patients taking other medication known to interact with alcohol (e.g. Metronidazole).

4.6 Fertility, pregnancy and lactation

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

4.7 Effects on ability to drive and use machines

No studies on the effect of this product on the ability to drive or use machinery have been performed.

This product contains alcohol (see Section 2).

4.8 Undesirable effects

Allergic reactions, including contact dermatitis may occur after ingesting Elecampane, White Horehound and Skunk Cabbage and Pleurisy root. The frequency is not known.

Lobelia can cause nausea, vomiting, diarrhoea, tremors and dizziness. The frequency is not known.

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

Overdose

No case of overdose has been reported.

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.

Large doses of Elecampane may cause vomiting, diarrhoea, spasms and symptoms of paralysis.

Overdose of Pleurisy root may cause diarrhoea and vomiting.

Overdose of this product may result in alcohol intoxication: the amount in a full bottle (3.2g in 100ml or 6.3 g in 200 ml: equivalent to 0.2 or 0.4 large glasses of wine respectively) may result in intoxication and should be treated accordingly.

Symptomatic and supportive measures should be taken as appropriate.

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

6.1 List of excipients

Wild Cherry Liquid Extract

Alcohol (90%)

Star anise Oil

Capsicum Tincture

Caramel

Glycerol

Sucrose

Water

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

Three years.

6.4 Special precautions for storage

This medicinal product does not require any special storage conditions.

6.5 Nature and contents of container

Glass bottle with bakelite screw-cap: 100 ml, 150 ml and 200 ml.

6.6 Special precautions for disposal

No special requirements.

7    MARKETING AUTHORISATION HOLDER

Rutland Biodynamics Ltd, Town Park Farm, Brooke, Rutland, LE15 8DG.

8    MARKETING AUTHORISATION NUMBER(S)

THR 28255/0022

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

17/10/2011

10    DATE OF REVISION OF THE TEXT

06/06/2014