Glycerin Suppositories BP 4g Adult Size

Suppository.

4.1 Therapeutic indications For the relief of occasional constipation4.2 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. Fertility, 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 *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 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.

5.1 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.

6.1 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 monthsPVC/PVDC/PE laminate inside a cardboard carton: 36 months6.4 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 carton24's: 2 x 12 sealed, PVC/PVDC/PE laminates inside a cardboard cartonNot all pack sizes may be marketed6.6 Special precautions for disposal and other handling None.