1. Name Of The Medicinal Product
Glycerin Suppositories BP 2g Children's 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
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The suppository should be dipped in water before insertion.
The suppositories are defined as children's size, therefore there is no infants' or adults' recommendation
4.3 Contraindications
Contraindicated in patients with known hypersensitivity to glycerol. Children's Suppositories are not suitable for use by infants (under 1 year).
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 Pregnancy And Lactation
Not applicable.
4.7 Effects On Ability To Drive And Use Machines
None.
4.8 Undesirable Effects
May cause irritation.
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 Preclinical Safety Data
None.
6. 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
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.
7. Marketing Authorisation Holder
Thornton & Ross Ltd.
Linthwaite Laboratories
Huddersfield
HD7 5QH.
8. Marketing Authorisation Number(S)
PL 00240/6101R
9. Date Of First Authorisation/Renewal Of The Authorisation
01.08.86 / 22.04.93, 25.11.98
10. Date Of Revision Of The Text
18.04.02
11 DOSIMETRY
Not Applicable
12 INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS
Not Applicable
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