GLYCERIN SUPPOSITORIES BP 1G INFANTS SIZE
Active substance(s): GLYCEROL
NAME OF THE MEDICINAL PRODUCT
Glycerin Suppositories BP 1g Infants’ Size
QUALITATIVE AND QUANTITATIVE COMPOSITION
Glycerol BP 70% w/w.
For the relief of occasional constipation.
Posology and Method of Administration
Route of administration:
The suppository should be dipped in water before insertion.
The suppositories are defined as infants’ size, therefore there is no adults’ or
Contraindicated in patients with known hypersensitivity to glycerol.
Special Warnings and Special 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. Interactions with other Medicinal Products and other Forms of
Pregnancy and Lactation
Effects on Ability to Drive and Use Machines
Gastrointestinal Disorders: May cause irritation and occasionally abdominal
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:
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
Glycerol by the rectal route promotes peristalsis and evacuation of the lower
bowel by virtue of its irritant action.
No information available.
Pre-clinical Safety Data
List of excipients
18 months unopened.
Special Precautions for Storage
Store below 25°C in a dry place.
Nature and Content of Container
12’s: Sealed, PVC/PE laminate inside a cardboard carton.
Instructions for Use, Handling and Disposal
MARKETING AUTHORISATION HOLDER
Thornton & Ross Ltd.
MARKETING AUTHORISATION NUMBER
1st August 1986 / 22nd April 1993, 9th September 1998
DATE OF REVISION OF THE TEXT