NAME OF THE MEDICINAL PRODUCT

Co-danthrusate 50mg/60mg Capsules. Normax 50mg/60mg Capsules.

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

Docusate Sodium 60mg Dantron    50mg

For excipients, see 6.1.

3    PHARMACEUTICAL FORM

Capsule for oral administration.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

Constipation in terminally ill patients.

4.2    Posology and method of administration

Adults (including elderly): One to three capsules at bedtime.

Children (6-12 years): One capsule at bedtime.

4.3 Contraindications

In common with all laxatives, Co-danthrusate is contraindicated in cases of non-specific abdominal pain and when intestinal obstruction is suspected.

4.4 Special warnings and precautions for use

In experimental animals, dantron has been associated with adenocarcinomas in the bowel and tumours in the liver. A theoretical risk of similar effects in humans cannot be excluded.

Dantron is excreted in the urine and metabolised dantron in the faeces. There is evidence that these may cause perineal erythema in patients with urinary and/or faecal incontinence. It is recommended therefore that Co-danthrusate should be used with caution in all incontinent patients.

As with all laxatives, prolonged use is not recommended.

4.5    Interaction with other medicinal products and other forms of interaction

Docusate may enhance the gastrointestinal or hepatic cell uptake of mineral oil and quinidine potentiating their activity and possibly increasing their toxicity.

4.6    Pregnancy and lactation

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

4.7 Effects on ability to drive and use machines

None known.

4.8 Undesirable effects

Occasionally an orange tint in the urine may be observed due to the dantron component. Skin rash may occur and reports of skin irritation, skin discolouration and superficial sloughing of the perianal skin have been reported after prolonged use of Co-danthrusate.

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

The patient should be encouraged to drink fluids. An anticholinergic preparation may be used to ease excessive intestinal motility if necessary.

5    PHARMACOLOGICAL PROPERTIES

5.1    Pharmacodynamic properties

Dantron is a mild peristaltic stimulant acting on the lower bowel to encourage normal bowel movement without causing irritation. Docusate sodium is a softening agent which prevents excessive colonic dehydration and hardening of stools.

5.2 Pharmacokinetic properties

None available.

5.3 Preclinical safety data

In experimental animals, dantron has been associated with adenocarcinomas in the bowel and tumours in the liver.

6.1    List of excipients

Lactose

Sodium benzoate (intra and extragranular)

Povidone

Colloidal silicon dioxide Magnesium stearate

Capsule Shell:

Gelatin

Black iron oxide (E172)

Red iron oxide (E172)

Titanium dioxide (E171)

Yellow iron oxide (E172)

Printing Ink:

Titanium dioxide (E171)

Shellac

Ammonium hydroxide Propylene glycol (E1520)

Simeticone

6.2    Incompatibilities

None known.

6.3    Shelf life

5 years for blister packs and aluminium canisters.

3 years for securitainers.

6.4    Special precautions for storage

Do not store above 25^oC.

Store in a dry place.

6.5    Nature and contents of container

Blister pack containing 3 (professional sample pack), 21 or 63 capsules. Aluminium canisters containing 12, 30 or 250 capsules.

Securitainers containing 30 or 250 capsules.

Not all pack sizes may be marketed

6.6    Special precautions for disposal

None.

7    MARKETING AUTHORISATION HOLDER

Galen Limited Seagoe Industrial Estate Craigavon BT63 5UA UK

8    MARKETING AUTHORISATION NUMBER(S)

PL 27827/0008.

17/06/2010

10 DATE OF REVISION OF THE TEXT

21/11/2014