Glycerol 1g Suppositories

Amber coloured suppository, of nominal weight 1g intended for rectal administration.

4.1 Therapeutic indications For occasional use as a stimulant laxative for the treatment of constipation.4.2 Posology and method of administration For rectal use **Infants** One 1g suppository, to aid insertion the suppository tip should be moistened with water before use.4.3 Contraindications • Hypersensitivity to the active substance(s) or to any of the excipients.• The product is contraindicated if there is intestinal obstruction or blockage.4.4 Special warnings and precautions for use The product is intended for occasional use only. Prolonged or excessive use of the product is not recommended as this may cause diarrhoea. Use of this product may interfere with glucose control in diabetic patients. If symptoms persist consult a doctor.4.5 Interaction with other medicinal products and other forms of interaction No interaction studies have been performed4.6 Pregnancy and lactation No evidence of harmful affects available. However, best avoided during the first trimester of pregnancy. May be used during breast feeding.4.7 Effects on ability to drive and use machines None stated4.8 Undesirable effects Use of the product may occasionally cause abdominal cramps. Glycerol can cause irritation when given rectally.4.9 Overdose Overdosage via rectal route is unlikely. However, if ingested treat symptomatically.

5.1 Pharmacodynamic properties ATC code A06AX01Glycerol is commonly classified as an osmotic laxative but may act additionally or alternatively by promoting peristalsis and evacuation of the lower bowel by virtue of a mild irritant effect. Glycerol suppositories possess also lubricating and faecal softening actions.5.2 Pharmacokinetic properties Glycerol following rectal administration is poorly absorbed.5.3 Preclinical safety data There are no preclinical data of relevance to the prescriber, which are additional to those already included in other sections of the SmPC

6.1 List of excipients GelatinPurified Water6.2 Incompatibilities Not applicable6.3 Shelf life 3 years6.4 Special precautions for storage Store below 25°C in a dry place6.5 Nature and contents of container Heat sealed cavities composed of Polyvinyl Chloride (PVC) coated with Polyvinylidene Chloride (PVDC) and laminated with polyethylene (PE), each containing 1x 4g suppository in strips of 6. The strips and a patient leaflet are packed into cardboard cartons. Pack size available: 12 x 4g**.**6.6 Special precautions for disposal and other handling Wash hands before opening individual packaging. The suppository is shaped for rectal insertion, ensure the tip of the suppository is inserted first. The tip should be moistened with a little cold water to aid insertion.