Summary of Product Characteristics (SmPC) - Glycerin BP
1 NAME OF THE MEDICINAL PRODUCT
Glycerin BP.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Glycerol 100 % v/v
3. PHARMACEUTICAL FORM
Liquid.
4. CLINICAL PARTICULARS
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 Contra-indications
Contraindicated in patients with known hypersensitivity to glycerol. Contraindicated in diabetics.
4.4. Special Warnings and Special 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. Interactions 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.
5. PHARMACOLOGICAL PROPERTIES
5.1. Pharmacodynamic Properties
Glycerol acts as a demulcent and is mildly laxative when taken by mouth.
5.2. Pharmacokinetic Properties
Glycerol is readily absorbed from the intestine and is metabolised to carbon dioxide and glycogen or is used in the synthesis of body fats.
5.3. Pre-clinical Safety Data
None
6. PHARMACEUTICAL PARTICULARS
6.1. List of excipients
None.
6.2. Incompatibilities
None known.
6.3 Shelf life
36 months unopened.
6.4. Special precautions for storage
None.
6.5 Nature and contents of container
100ml: Glass bottle with white tamper evident 28mm polypropylene cap with EPE/Saranex liner and ROPP neck finish. 200ml: Glass bottle with white tamper evident 28mm polypropylene cap with EPE/Saranex liner and ROPP neck finish.
6.6. Instruction for use and handling
None.
7 MARKETING AUTHORISATION HOLDER
L.C.M. Ltd
Linthwaite Laboratories
Huddersfield
HD7 5QH
England
8. MARKETING AUTHORISATION NUMBER
PL: 12965/0012
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
17/04/2003
10 DATE OF REVISION OF THE TEXT
13/04/2015