1. Name Of The Medicinal Product
Glycerin Suppositories BP 4g Adult Size
Superdrug Glycerine Constipation Relief Suppositories
Boots Constipation Relief Suppositories
Sainsburys Constipation Relief Suppositories
Tesco Constipation Relief Suppositories
2. Qualitative And Quantitative Composition
Glycerol BP 70.0% w/w
3. Pharmaceutical Form
Suppository.
4. Clinical Particulars
4.1 Therapeutic Indications
For the relief of occasional constipation
4.2 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 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
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 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.
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 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
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
PVC/PE laminate inside a cardboard carton: 18 months unopened
PVC/PVDC/PE laminate inside a cardboard carton: 36 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.
12's: Sealed, PVC/PVDC/PE laminate inside a cardboard carton
24's: 2 x 12 sealed PVC/PVDC/PE laminates inside a cardboard carton
6.6 Special Precautions For Disposal And Other Handling
None.
7. Marketing Authorisation Holder
L.C.M. LTD.,
LINTHWAITE,
HUDDERSFIELD,
HD7 5QH.
8. Marketing Authorisation Number(S)
PL 12965/0015
9. Date Of First Authorisation/Renewal Of The Authorisation
23.07.93 / 21.08.98 / 30/10/02
10. Date Of Revision Of The Text
19.11.2010
11 DOSIMETRY
Not applicable
12 INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS
Not applicable
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