4.1. Therapeutic indications

1. For the relief of the symptoms of sore throats.

2. For use on rough or chapped skin.

4.2. Posology and method of administration

1. Oral: 5-10ml, four hourly as required.

2. Topical: mix with an equal quantity of water and apply directly to the affected area up to six times daily.

This product is suitable for use by adults, children and the elderly.

4.3. Contraindications

Contraindicated in patients with known hypersensitivity to glycerol. Contraindicated in diabetics.

4.4. Special warnings and precautions for use

Glycerol should be administered with caution to patients with hypervolaemia, cardiac failure, renal disease or dehydration.

Labels to state: Use with caution if you suffer from heart or kidney disease.

4.5. Interaction with other medicinal products and other forms of interaction

None known.

4.6. Pregnancy and lactation

No adverse effects are considered likely if this product is used in the above conditions. However, all medicines, should be avoided if possible during pregnancy and lactation, and should only be used under a doctor's instruction.

4.7. Effects on ability to drive and use machines

None.

4.8. Undesirable effects

Glycerol when taken orally may cause headache, nausea and vomiting, and less frequently, diarrhoea, thirst, dizziness and mental confusion. Cardiac arrhythmias have been reported. Glycerol may cause severe dehydration in previously dehydrated patients.

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

Glycerol acts as a mild laxative. Large oral doses taken inadvertently may cause headache, thirst, nausea, hyperglycaemia and dehydration. Medication should be stopped and if ingestion is recent gastric lavage should be administered, followed by supportive therapy.