- Approval Id
- 1868ed7769fc86e4
- Drug Approval Emc Name
- Glycerin BP
- Drug Name
- Glycerin BP
- Company Address
- Linthwaite, Huddersfield, West Yorks, HD7 5QH
- Company Website
- http://www.thorntonandross.co.uk
- Company Medical Info Direct Line
- +44 (0) 1484 848164
- Company Medical Info Email
- thorntonross@medinformation.co.uk
- Company Customer Care Direct Line
- +44(0)1484 848200
- Legal Category
- General Sales List
- Authorisation Holder
- L.C.M. Ltd
Linthwaite Laboratories
Huddersfield
HD7 5QH
England
- Authorisation Number
- PL: 12965/0012
- Authorisation Date
- 17/04/2003
- Instruction Authorisation Holder
- L.C.M. Ltd
Linthwaite Laboratories
Huddersfield
HD7 5QH
England
- Instruction Authorisation Number
- PL: 12965/0012
- Instruction Authorisation Date
- 17/04/2003
- Instruction Composition
- Glycerol 100 % v/v
- Instruction Dosage Form
- Liquid.
- Instruction 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.
\*\*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.
- Instruction Pharmacology
- 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
- Instruction 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 Special precautions for disposal and other handling
None.
- Instruction Content
- ## Composition
Glycerol 100 % v/v
## Pharmaceutical Form
Liquid.
## 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.
\*\*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.
## 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
## 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 Special precautions for disposal and other handling
None.
- Company Detail Path
- /organization/thornton-and-ross-ltd
