BOOTS SORE THROAT RELIEF LOZENGES ORANGE AND MENTHOL FLAVOUR - summary of medicine characteristics

1 NAME OF THE MEDICINAL PRODUCT

Boots Sore Throat Relief Lozenges Orange and Menthol Flavour

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Active ingredient                       ­mg/lozenge

Amylmetacresol BP                  0­.6 mg

3 PHARMACEUTICAL FORM

Lozenge.

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

For the short-term symptomatic relief of sore throats.

4.2 Posology and method of administration

Adults and children

over                    O­ne throat drop to be sucked when required,

12 years:                up to a maximum of 8 throat drops in 24 hours.

For oral administration.

4.3 Contraindications

Hypersensitivity to any of the ingredients.

4.4 Special warnings and precautions for use Keep all medicines out of the reach of children.

Do not exceed the stated dose.

If symptoms persist or worsen see your doctor.

4.5 Interaction with other medicinal products and other forms of interaction No clinically significant interactions are known.

4.6 Pregnancy and lactation

The safety of this product has not been established in pregnancy and lactation, but is not expected to constitute a hazard. As with all drugs try to avoid taking them during pregnancy or lactation.

4.7 Effects on ability to drive and use machines No adverse effects are known.

4.8 Undesirable effects

Occasional hypersensitivity reactions and soreness of the tongue are a possibility.

4.9 Overdose

Slight overdosage should not present a problem other than gastrointestinal discomfort. Treatment should be symptomatic. In cases of severe overdosage, empty the stomach by gastric lavage. Administer a saline laxative and a activated charcoal by mouth.

5.1

Amylmetacresol has antiseptic properties.

5.2

Pharmacokinetic properties No data available.

5.3

Preclinical safety data None stated.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Levomenthol (natural or synthetic)

Solids from Liquid Sugar for confectionery

Solids from Liquid Glucose

Malic Acid

Sweet Orange Oil Special IFF

Annatto WSA acid stab colour

Ascorbic Acid RD-26216

Sodium Ascorbate

6.2 Incompatibilities

None stated.

6.3 Shelf life

PVC/PVdC blister: 24 months

Laminate wrapper/cellophane bag/carton: 36 months.

6.4 Special precautions for storage

PVC/PVdC blister: Do not store above 25°C. Store in the original package.

Laminate wrapper/Cellophane bag/Carton: None

6.5 Nature and contents of container

a) PVC/PVdC blisters heat sealed to hard tempered 20 micron aluminium foil.

Pack sizes: 16, 24 lozenges

or

b) Individually wrapped in laminate; 20 lozenges sealed into a cellophane bag and packed into a carton.