GLYCERIN BP (GLYCEROL)

Active substance: GLYCEROL

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Glycerin BP (Glycerol).

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Glycerol B.P. 100% v/v.

3

PHARMACEUTICAL FORM
Glycerin

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
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.

4.2

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
day
For children aged 1 to 6 years:
Not more than 4 doses should be given in any 24 hours. Do not exceed the
stated dose

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
day

4.3

Contraindications
Is contraindicated in patients with known hypersensitivity to the active or the
excipients.

4.4

Special warnings and precautions for use
To be administered with caution to diabetic patients and those at risk of
dehydration.
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.

4.5

Interaction with other medicinal products and other forms of interaction
Incompatible with oxidising agents.

4.6

Fertility, pregnancy and lactation
There are no known adverse affects during pregnancy and lactation, though it
is best to avoid in early pregnancy.

4.7

Effects on ability to drive and use machines
None.

4.8

Undesirable effects
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.

4.9

Overdose
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.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Oral use When used as directed, the demulcent action of glycerin helps to soothe any
inflammation present.
External use - Glycerin is used as a humectant and emollient when diluted and
for its hygroscopic action when used undiluted.

5.2

Pharmacokinetic properties
The glycerol is absorbed and metabolised to carbon dioxide and glycogen, or it
is used in the synthesis of body fats.

5.3

Preclinical safety data
None stated.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients

None.

6.2

Incompatibilities
None.

6.3

Shelf life
3 years.

6.4

Special precautions for storage
Glycerin should be stored in airtight containers.

6.5

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

6.6

Special precautions for disposal
None stated.

7

MARKETING AUTHORISATION HOLDER
Activase Pharmaceuticals Limited,
11 Boumpoulinas, 3rd Floor,
P.C. 1060
Nicosia.

Cyprus

8

MARKETING AUTHORISATION NUMBER(S)
PL 28444/0057

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
27/10/2008

10

DATE OF REVISION OF THE TEXT
16/01/2012

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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