- Approval Id
- c1bdcb0ca54bb0b6
- Drug Approval Emc Name
- Glycerin Suppositories BP 1g Infants' Size
- Drug Name
- Glycerin Suppositories BP 1g Infants' 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
- Thornton & Ross Ltd.Linthwaite LaboratoriesHuddersfieldHD7 5QH.
- Authorisation Number
- PL 00240/6100R
- Authorisation Date
- 1st August 1986 \*/\* 22nd April 1993, 9th September 1998
- Instruction Authorisation Holder
- Thornton & Ross Ltd.Linthwaite LaboratoriesHuddersfieldHD7 5QH.
- Instruction Authorisation Number
- PL 00240/6100R
- Instruction Authorisation Date
- 1st August 1986 \*/\* 22nd April 1993, 9th September 1998
- Instruction Composition
- Glycerol BP 70% w/w
- Instruction Dosage Form
- Suppositories.
- Instruction Clinical Particulars
- 4.1 Therapeutic indications
For the relief of occasional constipation.4.2 Posology and method of administration
| | |
| --- | --- |
| Route of administration: | Rectal. |
| Dose: | One suppository. |
| Dosage schedule: | As required. |
The suppository should be dipped in water before insertion.The suppositories are defined as infants' size, therefore there is no adults' or children's use recommendation.4.3 Contraindications
Contraindicated in patients with known hypersensitivity to glycerol.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. Consult your doctor before use.4.5 Interaction with other medicinal products and other forms of interaction
None known.4.6. Fertility, pregnancy and lactation
Not applicable.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 required. 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 available.5.3 Preclinical safety data
None.
- Instruction Pharmaceutical Particulars
- 6.1 List of excipients
GelatinPurified Water6.2 Incompatibilities
None known.6.3 Shelf life
18 months unopened.6.4 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.6.6 Special precautions for disposal and other handling
None.
- Instruction Content
- ## Composition
Glycerol BP 70% w/w
## Pharmaceutical Form
Suppositories.
## Clinical Particulars
4.1 Therapeutic indications
For the relief of occasional constipation.4.2 Posology and method of administration
| | |
| --- | --- |
| Route of administration: | Rectal. |
| Dose: | One suppository. |
| Dosage schedule: | As required. |
The suppository should be dipped in water before insertion.The suppositories are defined as infants' size, therefore there is no adults' or children's use recommendation.4.3 Contraindications
Contraindicated in patients with known hypersensitivity to glycerol.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. Consult your doctor before use.4.5 Interaction with other medicinal products and other forms of interaction
None known.4.6. Fertility, pregnancy and lactation
Not applicable.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 required. 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 available.5.3 Preclinical safety data
None.
## Pharmaceutical Particulars
6.1 List of excipients
GelatinPurified Water6.2 Incompatibilities
None known.6.3 Shelf life
18 months unopened.6.4 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.6.6 Special precautions for disposal and other handling
None.
- Company Detail Path
- /organization/thornton-and-ross-ltd
