SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Potter’s Strong Bronchial Catarrh Pastilles Superdrug Strong Bronchial Catarrh Pastilles Sainsbury's Strong Bronchial Catarrh Pastilles

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

Levomenthol    0.6 % w/w

Benzoin Tincture    0.5 % v/w

Star Anise Oil    0.02 % v/w

Peppermint Oil    0.02 % v/w

Also contains a total of 0.8 g sucrose and glucose (see section 4.4. Special warnings and precautions for use).

For full list of excipients see section 6.1

3    PHARMACEUTICAL FORM

Pastille (Lozenge)

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

For the relief of symptoms of bronchial catarrh, coughs and colds.

4.2    Posology and method of administration

Posology:

Adults, the Elderly and Children over 12 years: Do not take more than 12 pastilles in 24 hours.

Children over 6 and up to 12 years: Do not take more than 8 pastilles in 24 hours.

Children under 6 years: Not recommended.

Method of Administration:

One pastille to be dissolved slowly in the mouth when required.

4.3    Contraindications

Hypersensitivity to menthol, peppermint, benzoin, star anise oil or any of the other ingredients.

4.4.    Special Warnings and Precautions for Use

Keep out of reach and sight of children. If symptoms persist consult your doctor.

Contains sucrose and liquid glucose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

4.5.    Interaction with other Medicinal Products and other Forms of Interaction

None have been reported.

4.6. Fertility, Pregnancy and Lactation

Pregnancy

There is no or inadequate evidence of the safety of the active ingredients in this medicine in human pregnancy. The potential risk for humans is unknown.

In the absence of sufficient data, the use during pregnancy is not recommended.

Lactation

It is not known whether the active ingredients of this product are excreted in human breast milk.

In the absence of sufficient data, the use during lactation is not recommended.

Fertility

Studies on the effects on fertility have not been investigated.

4.7. Effects on Ability to Drive and Use Machines

None.

4.8    Undesirable effects

Isolated cases of hypersensitivity reactions including anaphylaxis, angioedema, bronchospasm, rash, urticaria and flushing have been reported with menthol-containing preparations.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov .uk/yellowcard.

4.9.    Overdose

No example of overdose has been reported.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Benzoin and menthol relieve the symptoms of bronchitis, sinusitis and similar conditions. Peppermint is a source of menthol. Star anise oil has expectorant properties.

5.2. Pharmacokinetic Properties

Not applicable.

5.3. Pre-clinical Safety Data

There is no preclinical data available specific to the product.

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Sucrose

Modified Starch (maize, tapioca)

Glucose Liquid Capsicum Tincture Quinoline Yellow (E104)

Green S (E142)

Vegetable Oil

Beeswax

Water

6.2. Incompatibilities

None known.

6.3. Shelf Life

Blister pack: 36 months

Bag in box: 60 months

Bag in box: use 6 months after first opening

Special Precautions for Storage

Do not store above 25^oC. Store in the original package.

6.5.    Nature and Contents of Container

Bag in box pack

Heat-sealed bag of polypropylene and polyethylene in carton., 45g. Heat-sealed triple laminate bag integral with carton, 45g Tied polythene bag and Securitainer, 500g.

Blister pack

Blister strips of 250pm PVC coated 60g/m² PVDC with 20pm hard temper aluminium foil in a carton.

Pack sizes: 4, 6, 8, 10, 12, 20, 24, 30 pastilles.

Not all pack sizes may be marketed

6.6.    Instructions for Use, Handling and Disposal

None specific to the packs.

7.    MARKETING AUTHORISATION HOLDER

Ernest Jackson & Co Ltd

High Street

Crediton

Devon

EX17 3AP, UK.

8.    MARKETING AUTHORISATION NUMBER(S)

PL 0094/5013R

9.    DATE OF FIRST AUTHORISATION / RENEWAL OF AUTHORISATION

First granted 01 October 1987.

Last renewed 01 October 1997.

10 DATE OF REVISION OF THE TEXT

05/03/2014