SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Bronchosan Pine Cough syrup

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

5 ml [6.95 g] of oral liquid contains 1,445 mg of extract (as soft extract) from fresh Picea abies (L.) Karsten (spruce) shoots (0.9 - 1.2:1).

Extraction solvent: Water

5 ml of syrup contains 5.25 g of carbohydrate mainly present as sucrose, glucose and fructose.

For a full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Syrup

It is brown syrup.

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, irritating coughs, and catarrh based on traditional use only.

4.2 Posology and method of administration

For oral use only.

Adults and children over 12 years:

5-10 ml 2-4 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.

4.3 Contraindications

Hypersensitivity to the active ingredient, Pine species, colophony or to any of the excipients.

4.4    Special warnings and precautions for use

Do not exceed stated dose.

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

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

Contains sucrose as well as sources of glucose and fructose (honey and concentrated pear juice). Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

Contains 5.25 g of carbohydrate per 5 ml dose. This should be taken into account in patients with diabetes mellitus.

4.5    Interaction with other medicinal products and other forms of interaction

No interaction studies have been performed.

4.6 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.

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.

4.8 Undesirable effects

Very rare (<1/10,000)

Skin and subcutaneous tissue disorders:

•    Pruritis

•    Rash

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

4.9 Overdose

There are no data on human overdose with spruce. 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 Preclinical safety data

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

6 PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Purified water Raw cane sugar Honey

Concentrated pear juice Pine oil

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

5 years

6.4 Special precautions for storage

This medicinal product does not require any special storage conditions.

6.5 Nature and contents of container

Amber glass bottle (type III glass (Ph.Eur.)) with white pilver-proof PE-HD screw cap.

A measuring cup with a 5, 10 and 15 ml measure is supplied with this pack.

Pack sizes:    100 mls

200 mls

Not all pack sizes may be marketed.

6.6 Special precautions for disposal

No special requirements.

7 MARKETING AUTHORISATION HOLDER

Bioforce (UK) Ltd,

2 Brewster Place,

Irvine

KA11 5DD, UK Telephone: 01294 277344 enquiries@avogel.co.uk

8    MARKETING AUTHORISATION NUMBER(S)

THR 13668/0019

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

06/08/2010

10    DATE OF REVISION OF THE TEXT

06/10/2010