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.