Boots Catarrh Pastilles

1. Name Of The Medicinal Product

Potter's catarrh pastilles

Boots catarrh pastilles

2. Qualitative And Quantitative Composition

Menthol BP 0.8% W/W

Pumilio pine oil BP 1980 0.6% V/W

Eucalyptus oil BP 0.02 % V/W

For full list of excipients, see section 6.1

3. Pharmaceutical Form

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 Contraindications

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 Pregnancy And Lactation

There is no evidence of safety of the active ingredients in human pregnancy nor is there evidence from animal studies that they are free from hazard. However, they have been widely used for many years without apparent ill effects. Avoid in pregnancy if a better known or safer alternative is available. No information is available on excretion in breast milk.

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.

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 absorption, 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 Preclinical Safety Data

There is no preclinical data available specific to the product.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Sucrose EP/BP

Liquid Glucose BPC

Modified Starch

Thymol

Marshmallow Liquid Extract

Carmoisine E122

Vegetable Oil

Beeswax

Water

6.2 Incompatibilities

None known

6.3 Shelf Life

36 months for the unopened pack when stored at room temperature (15 to 25° C).

6.4 Special Precautions For Storage

None

6.5 Nature And Contents Of Container

51 g or 45 g of pastilles sealed in a foil laminate sachet integral with a carton. The carton is printed with all product details.

6.6 Special Precautions For Disposal And Other Handling

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 0094/0009

9. Date Of First Authorisation/Renewal Of The Authorisation

First granted 12 December 1991 / Renewed 3 April 2002

10. Date Of Revision Of The Text

24 February 2009