- Approval Id
- de518031f7969266
- Drug Approval Emc Name
- Glycerin Suppositories BP 4g Adult Size
- Drug Name
- Glycerin Suppositories BP 4g Adult Size
- 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.
- Authorisation Number
- PL 12965/0015
- Authorisation Date
- 20/06/2008
- Instruction Authorisation Holder
- L.C.M. LTD.,Linthwaite laboratories,HUDDERSFIELD,HD7 5QH.
- Instruction Authorisation Number
- PL 12965/0015
- Instruction Authorisation Date
- 20/06/2008
- Instruction Composition
- Glycerol 70.0% w/w
- Instruction Dosage Form
- Suppository.
- Instruction Clinical Particulars
- 4.1 Therapeutic indications
For the relief of occasional constipation4.2 Posology and method of administration
Rectal.
\*\*RECOMMENDED DOSES AND DOSAGE SCHEDULES\*\*
One suppository as required.The suppository should be dipped in water before insertion.The suppositories are defined as adult size, therefore there is no children's use recommendation.They are suitable for use by the elderly, dose and dosage schedule as above.4.3 Contraindications
Contra-indicated in patients with known hypersensitivity to glycerol. Adults suppositories are not suitable for use by children and infants.4.4 Special warnings and precautions for use
Keep all medicines away from children.Not to be swallowed.Suppositories must not be taken by mouth.4.5 Interaction with other medicinal products and other forms of interaction
None known.4.6. Fertility, pregnancy and lactation
All medicines should be avoided if possible during pregnancy and lactation. Use only under a doctor's instruction in these conditions.4.7 Effects on ability to drive and use machines
None.4.8 Undesirable effects
\*Gastrointestinal Disorders\*: May cause irritation and occasionally abdominal cramps.
\*\*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 has a mildly laxative action, however, if the product is accidentally swallowed it is unlikely to cause such effects and it is unlikely that active measures will be needed. Accidental ingestion of a large number of suppositories may cause headache, nausea and vomiting less frequently diarrhoea, thirst, dizziness, mental confusion and cardiac arrhythmias can occur.
- Instruction Pharmacology
- 5.1 Pharmacodynamic properties
Glycerol by the rectal route promotes peristalsis and evacuation of the lower bowel by virtue of its irritant action.5.2 Pharmacokinetic properties
No information has been found on the pharmacokinetics of glycerol administered rectally.5.3 Preclinical safety data
No data of relevance, which is additional to that included on other sections of the SPC.
- Instruction Pharmaceutical Particulars
- 6.1 List of excipients
Gelatin BP, Purified Water BP, Purified Water BP QS.6.2 Incompatibilities
None known.6.3 Shelf life
PVC/PE laminate inside a cardboard carton: 18 monthsPVC/PVDC/PE laminate inside a cardboard carton: 36 months6.4 Special precautions for storage
Store below 25°C in a dry place.6.5 Nature and contents of container
12's: Sealed, PVC/PE laminate inside a cardboard carton.12's: Sealed, PVC/PVDC/PE laminate inside a cardboard carton24's: 2 x 12 sealed, PVC/PVDC/PE laminates inside a cardboard cartonNot all pack sizes may be marketed6.6 Special precautions for disposal and other handling
None.
- Instruction Content
- ## Composition
Glycerol 70.0% w/w
## Pharmaceutical Form
Suppository.
## Clinical Particulars
4.1 Therapeutic indications
For the relief of occasional constipation4.2 Posology and method of administration
Rectal.
\*\*RECOMMENDED DOSES AND DOSAGE SCHEDULES\*\*
One suppository as required.The suppository should be dipped in water before insertion.The suppositories are defined as adult size, therefore there is no children's use recommendation.They are suitable for use by the elderly, dose and dosage schedule as above.4.3 Contraindications
Contra-indicated in patients with known hypersensitivity to glycerol. Adults suppositories are not suitable for use by children and infants.4.4 Special warnings and precautions for use
Keep all medicines away from children.Not to be swallowed.Suppositories must not be taken by mouth.4.5 Interaction with other medicinal products and other forms of interaction
None known.4.6. Fertility, pregnancy and lactation
All medicines should be avoided if possible during pregnancy and lactation. Use only under a doctor's instruction in these conditions.4.7 Effects on ability to drive and use machines
None.4.8 Undesirable effects
\*Gastrointestinal Disorders\*: May cause irritation and occasionally abdominal cramps.
\*\*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 has a mildly laxative action, however, if the product is accidentally swallowed it is unlikely to cause such effects and it is unlikely that active measures will be needed. Accidental ingestion of a large number of suppositories may cause headache, nausea and vomiting less frequently diarrhoea, thirst, dizziness, mental confusion and cardiac arrhythmias can occur.
## Pharmacological Properties
5.1 Pharmacodynamic properties
Glycerol by the rectal route promotes peristalsis and evacuation of the lower bowel by virtue of its irritant action.5.2 Pharmacokinetic properties
No information has been found on the pharmacokinetics of glycerol administered rectally.5.3 Preclinical safety data
No data of relevance, which is additional to that included on other sections of the SPC.
## Pharmaceutical Particulars
6.1 List of excipients
Gelatin BP, Purified Water BP, Purified Water BP QS.6.2 Incompatibilities
None known.6.3 Shelf life
PVC/PE laminate inside a cardboard carton: 18 monthsPVC/PVDC/PE laminate inside a cardboard carton: 36 months6.4 Special precautions for storage
Store below 25°C in a dry place.6.5 Nature and contents of container
12's: Sealed, PVC/PE laminate inside a cardboard carton.12's: Sealed, PVC/PVDC/PE laminate inside a cardboard carton24's: 2 x 12 sealed, PVC/PVDC/PE laminates inside a cardboard cartonNot all pack sizes may be marketed6.6 Special precautions for disposal and other handling
None.
- Company Detail Path
- /organization/thornton-and-ross-ltd
