BOOTS SORE THROAT RELIEF LOZENGES CHERRY FLAVOUR - summary of medicine characteristics

1 NAME OF THE MEDICINAL PRODUCT

2.   QUALITATIVE AND QUANTITATIVE COMPOSITION

3.   PHARMACEUTICAL FORM

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 12 years: One throat drop to be sucked when required up to a maximum of 8 throat drops in 24 hours.

Children 5 – 12 years: One throat drop to be sucked when required up to a maximum of 4 throat drops in 24 hours.

Children under 5 years: Not suitable.

For oral administration.

4.3. Contra-indications

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. Interactions with other Medicaments and other forms of Interaction

No clinically significant interactions are known.

4.6. Pregnancy and Lactation

The safety of Antiseptic Throat Drops has not been established during 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 activated charcoal by mouth.

5.1 Pharmacodynamic properties

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

Cherry Flavour

Levomenthol Natural or Synthetic

Solids from Liquid Sugar for Confectionary

Solids from Liquid Glucose

Anthocyanin

Malic Acid

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 card carton containing push-through PVC/PVdC blisters heat-sealed to hard-tempered 20 micron aluminium foil.

Pack sizes: 16, 24, 36 lozenges

or a card carton, having a cellophane inner bag containing lozenges individually wrapped in laminate.

Pack size: 20 lozenges.

6.6. Instruction for Use/Handling

None stated.

7. MARKETING AUTHORISATION HOLDER

8.   MARKETING AUTHORISATION NUMBER(S)

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THEAUTHORISATION

30 November 1978 / 11 April 1995