VALUE HEALTH GLYCERIN BP, GLYCERIN BP - summary of medicine characteristics

Summary of medicine characteristics - VALUE HEALTH GLYCERIN BP, GLYCERIN BP

SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Glycerin BP

Value Health Glycerin BP

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Active Ingredient

Glycerol Ph Eur 100 % v/v

3. PHARMACEUTICAL FORM

Liquid

4. CLINICAL PARTICULARS

4.1. Therapeutic indications

For the symptomatic relief of coughs and soreness of the throat.

For the symptomatic relief of dry skin conditions.

4.2. Posology and method of administration

For oral and topical administration.

Adults and Children over 12 years: l0ml

Children 5 to 12 years: 5ml

Children 1 – 5 Years: 2.5ml

The dose should be mixed with a little water and sipped three or four times a day.

Elderly: There is no need for dosage reduction in the elderly.

For external application apply undiluted or mixed with a little water

4.3. Contraindications

Hypersensitivity to glycerin.

4.4. Special warnings and precautions for use

Glycerin should be administered with caution to diabetic patients and those at risk of dehydration.

Keep all medicines out of the reach of children.

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

No clinically significant drug interactions known.

4.6. Pregnancy and lactation

The safety of glycerin taken during pregnancy and lactation has not been established but use during these periods is not considered to constitute a hazard.

4.7. Effects on ability to drive and use machines

No adverse effects known.

4.8 Undesirable effects

Headache, nausea and vomiting; less frequently diarrhoea, thirst and dizziness may occur.

Immune system disorder: hypersensitivity reactions, including anaphylaxis.

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 overdosage include headache, thirst, nausea, dehydration and non-ketotic hyperosmolar hyperglycaemia. Treatment should be symptomatic and supportive.

5. PHARMACOLOGICAL PROPERTIES

5.1. Pharmacodynamic properties

When taken by mouth, glycerin has demulcent properties.

Externally, glycerin has humectant emollient properties.

5.2. Pharmacokinetic properties

Glycerin is readily absorbed from the gastrointestinal tract and peak serum concentrations occur within 60–90 minutes. Following absorption, glycerin is distributed throughout the blood. It is metabolised to carbon dioxide and glycogen and is used in the synthesis of body fats principally in the liver. The elimination half life of glycerin is about 30–45 minutes.

5.3. Preclinical safety data

There are no preclinical data of relevance to the prescriber which are additional to that already included.

6. PHARMACEUTICAL PARTICULARS

6.1. List of excipients

None.

6.2. Incompatibilities

None known.

6.3. Shelf life

36 months.

6.4. Special precautions for storage