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GLYCERIN BP (GLYCEROL)
NAME OF THE MEDICINAL PRODUCT
Glycerin BP (Glycerol).
QUALITATIVE AND QUANTITATIVE COMPOSITION
Glycerol B.P. 100% v/v.
Taken orally for coughs and minor infections of the throat for its demulcent
and mild antiseptic effects.
Used externally as an emollient and for its water retaining properties.
Posology and method of administration
Oral use –
Not recommended for children under 1 year old.
For children aged 1 to 5 years:
Half 5ml spoonful mixed with a little water to be sipped three or four times a
For children aged 1 to 6 years:
Not more than 4 doses should be given in any 24 hours. Do not exceed the
Do not take with any other cough and cold medicine
Consult a pharmacist or other healthcare professional before use in children
under 6 years
For children aged 6 to 12 years:
One 5ml spoonful mixed with a little water to be sipped three or four times a
Is contraindicated in patients with known hypersensitivity to the active or the
Special warnings and precautions for use
To be administered with caution to diabetic patients and those at risk of
If kept at low temperatures may solidify to a mass of crystals, which will not
melt until the temperature is raised to about 20°C.
Interaction with other medicinal products and other forms of interaction
Incompatible with oxidising agents.
Fertility, pregnancy and lactation
There are no known adverse affects during pregnancy and lactation, though it
is best to avoid in early pregnancy.
Effects on ability to drive and use machines
Very large doses by mouth can exert systematic effects such as headache,
thirst, nausea and hyperglycaemia. The ingestion of large doses may induce
convulsions, paralysis, haemolysis and renal failure.
Treatment for the ingestion of very large doses should be symptomatic and
supportive. Emergency procedures and antidotes for hyperglycaemia,
convulsions, haemolysis and renal failure are as normal for these conditions.
Oral use When used as directed, the demulcent action of glycerin helps to soothe any
External use - Glycerin is used as a humectant and emollient when diluted and
for its hygroscopic action when used undiluted.
The glycerol is absorbed and metabolised to carbon dioxide and glycogen, or it
is used in the synthesis of body fats.
Preclinical safety data
List of excipients
Special precautions for storage
Glycerin should be stored in airtight containers.
Nature and contents of container
Glass bottle with cap: 50ml
Glass bottle with cap: 100ml
Glass bottle with cap: 200ml
Plastic bottle with cap: 2000ml
Special precautions for disposal
MARKETING AUTHORISATION HOLDER
Activase Pharmaceuticals Limited,
11 Boumpoulinas, 3rd Floor,
MARKETING AUTHORISATION NUMBER(S)
DATE OF FIRST AUTHORISATION/RENEWAL OF THE
DATE OF REVISION OF THE TEXT