Summary of Product Characteristics (SmPC) - Bronchosan Pine Cough syrup
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 pilfer-proof PE-HD screw cap. A measuring cup with a 2.5, 5, 10, 15 and 20 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
A.Vogel Ltd,
2 Brewster Place,
Irvine
KA11 5DD, UK
Tel: 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
23/03/2020