Glycerin Suppositories BP 1g Infants' Size

Suppositories.

4.1 Therapeutic indications For the relief of occasional constipation.4.2 Posology and method of administration | | | | --- | --- | | Route of administration: | Rectal. | | Dose: | One suppository. | | Dosage schedule: | 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 Contraindications Contraindicated in patients with known hypersensitivity to glycerol.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. Consult your doctor before use.4.5 Interaction with other medicinal products and other forms of interaction None known.4.6. Fertility, 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.

5.1 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.

6.1 List of excipients GelatinPurified Water6.2 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.