Value Health Glycerin Bp
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Glycerin BP Or
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
None.
6.5. Nature and content of container
An amber glass bottle fitted with a polypropylene cap with an aluminium rollon pilfer-proof cap with a triseal (LDPE/EPE/LDPE) liner.
Pack size: 100, 200ml.
Or
A white flint glass bottle fitted with an unlined polypropylene cap.
Alternative cap:aluminium roll-on pilfer proof cap with a triseal (LDPE/EPE/LDPE) liner.
Pack size: 100, 200ml.
6.6. Instructions for use, handling and disposal
None stated.
7. MARKETING AUTHORISATION HOLDER
The Boots Company PLC 1 Thane Road West Nottingham NG2 3AA
Trading as: Value Health
8. MARKETING AUTHORISATION NUMBER
PL 00014/5444R
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10/10/2005
10
DATE OF REVISION OF THE TEXT
14/07/2015