SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Co-danthrusate Capsules BP

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

Each capsule contains 50 mg Dantron BP and 60 mg Docusate Sodium USP

3    PHARMACEUTICAL FORM

Capsules.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

Constipation in terminally ill patients of all ages.

4.2    Posology and method of administration

Co-danthrusate Capsules are given in doses of 1-3 capsules in adults including elderly patients. Children between the ages of 6 to 12 years are given 1 capsule. Doses are usually given at bedtime.

Children under 6 years - not recommended.

4.3    Contraindications

Like all laxatives, Co-danthrusate is contraindicated in cases of intestinal obstruction or undiagnosed abdominal pain.

4.4 Special warnings and precautions for use

Some studies have suggested that administration of high doses of dantron in rats and mice for prolonged periods may be associated with the development of tumours in the liver and intestine. Prolonged use should be avoided.

Dantron should be used with caution in patients who are incontinent to avoid the possibility of causing erythema associated with dantron excreted in the urine or metabolised dantron excreted in the faeces.

Dantron-containing laxatives like co-danthrusate should not be used for the general management of constipation in the elderly.

4.5 Interaction with other medicinal products and other forms of interaction

Docusates may facilitate gastro-intestinal absorption of other drugs. They should not be used with liquid paraffin.

4.6 Pregnancy and lactation

Co-danthrusate should not be used during pregnancy or lactation.

4.7 Effects on ability to drive and use machines

None Known.

4.8 Undesirable effects

A mild discolouration of the urine may be observed due to the dantron. A mild griping feeling in the abdomen may occur.

Chronic use of stimulant laxatives like co-danthrusate may lead to fluid and electrolyte imbalance, colonic atony and tolerance to their effects.

Overdose

After overdosage, the patient should be encouraged to drink plenty of fluids. An anticholinergic preparation may be necessary to ease excessive intestinal motility.

5    PHARMACOLOGICAL PROPERTIES

5.1    Pharmacodynamic properties

Dantron is an anthraquinone stimulant laxative which is given by mouth to treat constipation.

Docusates are faecal softeners. They are anionic surfactants which act by increasing the penetration of fluid into the faeces.

Co-danthrusate Capsules are poorly absorbed from the small intestine. Their effects are limited mainly to the large intestine and occur 6 hours or more after oral administration.

5.2    Pharmacokinetic properties

Dantron is absorbed from the small intestine to some extent. It is excreted in the bile, saliva, faeces and urine, also in secretions including breast milk.

Docusate salts are absorbed from the gastro-intestinal tract and excreted in bile.

5.3    Preclinical safety data

None stated.

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Lactose	BP
Pre-gelatinised Starch	BP
Colloidal Silicon Dioxide	BP
Magnesium Stearate	BP

6.2 Incompatibilities

None.

6.3 Shelf life

Shelf life of the product as packaged for sale is 24 months.

6.4 Special precautions for storage

Store in a dry place, below 25 °C.

6.5 Nature and contents of container

2

White PVdC film (250pm/60gm^- ) aluminium (20pm) foil blister packs, and yellow PVC film (350pm) aluminium (30pm) blister packs. 21, 28, 42, 56 and 63 capsules.

6.6 Special precautions for disposal

Not applicable.

7 MARKETING AUTHORISATION HOLDER

Tillomed Laboratories Limited

3 Howard Road

Eaton Socon

St Neots

Cambridgeshire

PE19 8ET

UK

MARKETING AUTHORISATION NUMBER(S)

PL 11311/0371

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

19/03/2009

10    DATE OF REVISION OF THE TEXT

19/03/2009