• 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 performed

4.6. Fertility, 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 stated.

4.8. 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 A06AX01

Glycerol 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

Gelatin Purified Water

6.2. Incompatibilities

Not applicable

6.3. Shelf life

3 years

6.4. Special precautions for storage

Store below 25°C in a dry place

6.5. 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.

7. Marketing authorisation holder

Martindale Pharmaceuticals Ltd.Bampton Road, Romford, RM3 8UGUnited Kingdom

8. Marketing authorisation number(s)

PL 00156/0120

9. Date of first authorisation/renewal of the authorisation

13/07/2009

10. Date of revision of the text

02/10/2013

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

Children

One 2g 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

4.5 Interaction with other medicinal products and other forms of interaction

No interaction studies have been performed

4.6 Fertility, 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 stated.

4.8 Undesirable effects

Use of the product may occasionally cause abdominal cramps. Glycerol can cause irritation when given rectally.

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Reporting of suspected adverse reactions

Drug Licencing

Drugs appearing in this section are approved by UK Medicines & Healthcare Products Regulatory Agency (MHRA), & the European Medicines Agency (EMA).

Glycerol

Summary of product characteristics

4.1 Therapeutic indications

4.2 Posology and method of administration

4.3 Contraindications

4.4 Special warnings and precautions for use

4.5 Interaction with other medicinal products and other forms of interaction

4.6 Fertility, pregnancy and lactation

4.7 Effects on ability to drive and use machines

4.8 Undesirable effects

Drug section

Learning Zones

Disclaimer

Drug Licencing