Glycerin BP

1. Name Of The Medicinal Product

Glycerin BP.

2. Qualitative And Quantitative Composition

Glycerol BP 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 Contraindications

Contraindicated in patients with known hypersensitivity to glycerol. Contraindicated in diabetics.

4.4 Special Warnings And 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 Interaction 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.

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 Preclinical Safety Data

None

6. Pharmaceutical Particulars

6.1 List Of Excipients

None.

6.2 Incompatibilities

None known.

6.3 Shelf Life

50ml:	36 months unopened.
100ml:	36 months unopened.
200ml:	36 months unopened.
500ml:	36 months unopened.
2000ml:	36 months unopened.
6000g:	36 months unopened.
25000g:	36 months unopened.

6.4 Special Precautions For Storage

None.

6.5 Nature And Contents Of Container

50ml:	Glass bottle with polypropylene cap or white 28mm polypropylene cap with EPE/Saranex liner and ROPP neck finish.
100ml:	Glass bottle with polypropylene cap or white 28mm polypropylene cap with EPE/Saranex liner and ROPP neck finish.
200ml:	Glass bottle with polypropylene cap or white 28mm polypropylene cap with EPE/Saranex liner and ROPP neck finish.
500ml:	Glass bottle and plastic cap with liner.
2000ml:	Glass bottle and plastic cap with liner.
6000g:	Polythene bottle with plastic cap.
25000g:	Polythene bottle with plastic cap.

6.6 Special Precautions For Disposal And Other Handling

None.

7. Marketing Authorisation Holder

LCM Ltd.

Linthwaite Laboratories

Huddersfield

HD7 5QH.

8. Marketing Authorisation Number(S)

PL 12965/0012

9. Date Of First Authorisation/Renewal Of The Authorisation

21.09.93/24.11.98

10. Date Of Revision Of The Text

September 2004

11 DOSIMETRY

Not Applicable

12 INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS

Not Applicable