Skip to Content

GLYCERIN SUPPOSITORIES BP 1G INFANTS SIZE

Active substance(s): GLYCEROL

PDF options:  View Fullscreen   Download PDF

PDF Transcript

SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Glycerin Suppositories BP 1g Infants’ Size

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION
Glycerol BP 70% w/w.

3.

PHARMACEUTICAL FORM
Suppositories.

4

CLINICAL PARTICULARS

4.1.

Therapeutic Indications
For the relief of occasional constipation.

4.2.

Posology and Method of Administration
Route of administration:
Dose:
Dosage schedule:

Rectal.
One suppository.
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.

Contra-Indications
Contraindicated in patients with known hypersensitivity to glycerol.

4.4.

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
Interaction
None known.

4.6.

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.

5

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.

Pre-clinical Safety Data
None.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Gelatin
Purified Water

6.2.

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 Content of Container

12’s: Sealed, PVC/PE laminate inside a cardboard carton.

6.6.

Instructions for Use, Handling and Disposal
None.

7

MARKETING AUTHORISATION HOLDER
Thornton & Ross Ltd.
Linthwaite Laboratories
Huddersfield
HD7 5QH.

8.

MARKETING AUTHORISATION NUMBER
PL 00240/6100R

9.
DATE
OF
AUTHORISATION

FIRST

AUTHORISATION/RENEWAL

1st August 1986 / 22nd April 1993, 9th September 1998

10

DATE OF REVISION OF THE TEXT
26/11/2014

OF

+ Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide