SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Potter's Catarrh Pastilles Potter's Chesty Cough Pastilles Boots Catarrh Pastilles Potter's Mucus Cough Pastilles Sainsbury’s Catarrh Pastilles Superdrug Catarrh Pastilles

2.    Qualitative and Quantitative Composition

Levomenthol    0.813    %    w/w

Pumilio pine oil    0.604    %    v/w

Eucalyptus oil    0.022    %    v/w

Also contains a total of 0.5 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 symptomatic relief of catarrh, coughs and colds.

4.2. Posology and Method of Administration

Adults, the elderly and children of 12 years and over: One pastille to be sucked slowly as often as required. Do not take more than 20 pastilles in 24 hours.

Not recommended for children under 12 years old

4.3. Contra-Indications

Patients with known hypersensitivity to menthol, eucalyptus oil or any other of the ingredients.

4.4 Special warnings and precautions for use

If symptoms persist consult your doctor.

Keep out of reach of children

Dose restricted by age in any 24 hour period

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 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 known.

4.8. Undesirable Effects

Rare reports of hypersensitivity reactions including anaphylaxis, angioedema, urticaria, bronchospasm and rash, 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

Symptoms of overdose are unlikely unless the product is abused and taken grossly in excess of the recommended dose; gastrointestinal irritation, nausea and vomiting might be first seen. Supportive measures would be indicated.

5. PHARMACOLOGICAL PROPERTIES

5.1. Pharmacodynamic Properties

The decongestant activity of menthol, eucalyptus oil and pumilio pine oil is due to their volatility. Volatile oils are also said to have a mild irritant effect on the mucous membranes inducing a feeling of warmth and increasing salivation, which combined with the demulcent effect of the pastille base, helps to soothe a cough.

Eucalyptus oil and pumilio pine oil have been reported to possess antimicrobial activity which may also be of benefit.

It is claimed that eucalyptus oil also has some expectorant activity.

5.2. Pharmacokinetic Properties

After adsorption, menthol is excreted in the urine and bile as glucuronide.

Volatile oils such as eucalyptus oil and pumilio pine oil are excreted via the lungs, skin and kidneys.

5.3. Pre-clinical Safety Data

There is no pre clinical data available specific to the product.

Pharmaceutical Particulars

6.1. List of Excipients

Sucrose

Liquid Glucose

Modified Starch (maize, tapioca) Thymol

Marshmallow Root Liquid Extract

Carmoisine E122

Vegetable Oil

Carnauba wax

Water

6.2. Incompatibilities

None known.

6.3.    Shelf Life

36 months

6.4.    Special Precautions for Storage

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

6.5.    Nature and Contents of Container 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 product or pack.

7. MARKETING AUTHORISATION HOLDER

Ernest Jackson & Co Ltd

High Street

Crediton

Devon EX17 3AP UK

8. MARKETING AUTHORISATION NUMBER(S)

PL 00094/0009

9. DATE OF FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION

12 December 1991 / Renewed 29 November 1996

10 DATE OF REVISION OF THE TEXT

18/12/2014