SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Bronchoforce Chesty Cough Ivy Complex oral drops

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

1 ml of oral liquid contains:

376 mg of tincture from fresh ivy herb (Hedera helix L.) (1:5.7-6.0). Extraction solvent: Ethanol 51% V/V

329 mg of tincture from fresh aerial parts of thyme (Thymus vulgaris L.) (1:8.0-8.2). Extraction solvent: Ethanol 51% V/V

234 mg of tincture from liquorice root (Glycyrrhiza glabra L.) (1:10-11).

Extraction solvent: Ethanol 51% V/V.

1 ml is equivalent to 38 drops

1 ml of oral liquid contains approximately 403 mg ethanol (alcohol) equivalent to 10.2 ml beer or 4.3 ml wine.

For a full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Oral drops, solution It is a brown clear liquid.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

A traditional herbal medicinal product used for the relief of chesty coughs, mucus coughs and catarrh, based on traditional use only.

4.2 Posology and method of administration

Adults, the elderly and children over 12 years: Take 20 drops 3-5 times daily

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

Duration of use:

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

For oral use only

4.3 Contraindications

Hypersensitivity to the active ingredients ivy, thyme or liquorice or to any of the excipients.

4.4 Special warnings and precautions for use

Do not exceed stated dose.

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

If symptoms worsen or persist for more than one week a doctor or qualified healthcare practitioner should be consulted.

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

Patients taking liquorice medication should not take other liquorice containing products as serious adverse events may occur such as hypokalemia, hypertension, cardiac rhythm disorders.

Liquorice medication should be used with caution in patients affected by hypertension, kidney diseases, liver or cardiovascular disorders or hypokalemia, as they are more sensitive to the adverse effects of liquorice.

Concomitant use with diuretics, cardiac glycosides, corticosteroids, stimulant laxatives or other medications which may aggravate electrolyte imbalance is not recommended (see section 4.5).

This product contains 51 vol% ethanol (alcohol).

This corresponds to:

212 mg alcohol equivalent to 5.4 ml beer or 2.25 ml wine (20 drops)

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 interaction studies have been performed.

Liquorice root may counteract antihypertensive action of prescribed medicines.

Not to be used concomitantly with diuretics, cardiac glycosides, corticosteroids, stimulant laxatives or other medications which may aggravate electrolyte imbalance (see section with 4.4).

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

Studies in animals have shown reproductive toxicity (see section 5.3 ‘Preclinical safety data’).

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 performed.

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 (See Section 4.4 for details of alcohol content).

4.8    Undesirable effects

Gastrointestinal symptoms (e.g. nausea and vomiting), skin hypersensitivity reactions, hypokalaemia, hypertension, cardiac rhythm disorders, hypertension encephalopathy may occur. The frequency is not known.

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

4.9 Overdose

No case of overdose has been reported with the product.

Cases of overdose have been reported with prolonged use (more than 4 weeks) and/or intake of high amount of liquorice, with symptoms such as water retention, hypokalaemia, hypertension, cardiac rhythm disorders, hypertensive encephalopathy.

Overdose of this product may result in alcohol intoxication: the amount of alcohol in a full bottle (20.4 g in 50 ml: 40.8 g in 100ml: equivalent to 2 or 4 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

A study has shown that 18p-glycyrrhetinic acid¹ crosses through the placental barrier and can be detected in the rat foetuses. Following feeding of dams with 100 mg 18p-glycyrrhetinic acid/kg/day commencing on the 13th day of gestation, on the 17th,

19th and 21st days of gestation the maternal plasma 18p-glycyrrhetinic acid concentrations were approximately 100 pg/ml, whereas the foetal concentrations were 5, 18 and 32 p/ml, respectively.

In developmental toxicity studies, glycyrrhizin (ammonium salt) exhibited some embryotoxicity to the developing rat foetus, but the foetal effects were considered as minor. These effects were shown at the dose of 100 and 250 mg/kg of ammonium glycyrrhizin from 7^th to 20^th day of pregnancy (soft-tissue abnormalities, mostly renal, and external haemorrhages) and at the dose of 1000 mg/kg of 18p-glycyrrhetinic acid from the 13 ^th day of gestation (significant reduction in lamellar body content of lungs and reduced number alveolar lamellar body and surfactant clusters, but no apparent increase in malformation or foetal death rate).

Another study suggested that 100 mg/kg of liquorice extract repeated for 7 days may also aggravate body weight loss and malformations of foetuses, induced by intrauterine exposure to cyclophosphamide.

No mutagenic effects of Bronchoforce were detected in an Ames’ test (with or without metabolic activation).

Tests on reproductive toxicity and carcinogenicity of the product have not been performed.

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

List of Excipients

Star Anise oil Eucalyptus oil

From tinctures:

Ethanol Purified water

6.2    Incompatibilities

Not applicable.

6.3    Shelf life

4 years

6.4    Special precautions for storage

This medicinal product does not require any special storage conditions.

6.5 Nature and contents of container

Brown glass dropper bottles (Type III glass) with a two part dropper (PE-LD)/dispenser cap (PP) and ring (PE-HD).

Pack sizes:    15 ml

50 ml 100 ml

Not all pack sizes may be marketed.

Special precautions for disposal

No special requirements.

MARKETING AUTHORISATION HOLDER

Bioforce (UK) Ltd

2 Brewster Place

Irvine, Ayrshire

KA11 5DD, United Kingdom

Tel: 01294 277344

enquiries@avogel.co.uk

07/02/2014