SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Hills Balsam Chesty Cough Pastilles

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each Pastille contains the following ingredients:

Active Ingredients		mg/pastille
Benzoin Tincture Compound	BP	12.719
Ipecacuanha Liquid Extract	BP	9.044
Menthol	Ph Eur	2.002
Peppermint Oil	Ph Eur	0.724

3 PHARMACEUTICAL FORM

Pastilles for oral administration.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

Hill’s Balsam Chesty Cough Pastilles are indicated for the symptomatic relief of coughs, colds and catarrh.

4.2 Posology and method of administration

Adults and the elderly: One pastille to be dissolved in the mouth as required.

Children over 12 years of age: One pastille to be dissolved in the mouth as required.

Children under 12 years of age: Not recommended.

Contraindications

Patients who are known to be allergic to any of the constituents.

4.4 Special warnings and precautions for use

Medical advice should be sought if the condition worsens.

4.5 Interaction with other medicinal products and other forms of interaction

There are no known interactions.

4.6 Fertility, Pregnancy and lactation

There are no human or animal data which indicate an adverse effect with any of the ingredients of the product during pregnancy or lactation; however the product should be used with caution in both conditions.

4.7 Effects on ability to drive and use machines

None.

4.8 Undesirable effects

None known for the active ingredients at the recommended dosage.

4.9 Overdose

In the event of ingestion of large quantities of Hill’s Balsam Chesty Cough Pastilles, and emetic response would be provoked due to the ipecacuanha content of the formulation.

5    PHARMACOLOGICAL PROPERTIES

5.1    Pharmacodynamic properties

The product contains a number of well established galenicals, all contributing to the overall effect of expectorant activity, relief of bronchial and bronchitic conditions, reduction of bronchial catarrh, and local rubefacient action.

5.2 Pharmacokinetic properties

There is a local action by contact with oro-pharynx, and by ‘inhalation’ through the nasal and oro-pharyngeal cavities.

5.3 Preclinical safety data

There are no- preclinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Hill’s Balsam Chesty Cough Pastilles contain the following excipients: Granulated sugar, liquid glucose, modified starch, aniseed oil, capsicum oleoresin, annatto extract OF 323, natural red di liquid OF 339, NI special flavour 225892, caster sugar and water.

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

Three years.

6.4 Special precautions for storage

None.

6.5 Nature and contents of container

Heat sealed sachet of polyethylene/aluminium foil/polypropylene or metallised polyester, integral with the carton, in pack sizes of 45g and 50g.

6.6 Special precautions for disposal

Not applicable.

7 MARKETING AUTHORISATION HOLDER

Boston Healthcare Limited Unit 6, Navigation Court Calder Park Wakefield

West Yorkshire WF2 7BJ United Kingdom

8    MARKETING AUTHORISATION NUMBER(S)

PL 39974/0014

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

2^nd February 2005

10 DATE OF REVISION OF THE TEXT

06/01/2012