SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

English Herbal Medicines Herbal Quitacoff Herbs Hands Healing Lobelia and Squill Cough Mixture Brooke Green Lobelia & Squill Cough Mixture Swiss Herbal Remedies Lobelia and Squill Cough Liquid Napiers Lobelia and Squill Herbal Syrup

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each 5ml of oral liquid contains:

0.065 ml of liquid extract from dried Lobelia (Lobelia inflata L.) herb (1:1). Extraction solvent: ethanol 50% v/v.

and 1 ml of liquid extract from dried Squill (Urginea maritima L.) bulb (1:10). Extraction solvent: acetic acid (5.8 % w/v)

Each 5ml of oral liquid also contains approximately 26 mg Ethanol (alcohol) equivalent to 0.7 ml of beer or 0.3 ml of wine.

For list of excipients see Section 6.1.

3 PHARMACEUTICAL FORM

Oral liquid.

Straw to light brown liquid.

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

A traditional herbal medicinal product used for the relief of coughs, such as chesty coughs and dry, tickly coughs, based on traditional use only.

4.2 Posology and method of administration

For oral use only.

Adults, the elderly and children over 12 years

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

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

4.4 Special warnings and precautions for use

Do not exceed the stated dose.

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

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

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

Contains alcohol up to 26 mg ethanol (alcohol) per dose equivalent to 0.7 ml of beer or 0.3 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.

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).

4.6 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

Lobelia can cause similar effects to nicotine and include nausea, vomiting, diarrhoea, coughing, tremors and dizziness.The frequency is not known.

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

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

4.9 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.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC as amended.

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

Glycerol

Concentrated Apple Juice

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: 100ml, 150ml and 200ml.

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 28255/0019

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

29/10/2010

10    DATE OF REVISION OF THE TEXT

12/03/2014