SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

‘Normax’ Suspension or Co-danthrusate Suspension

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each 5 ml containing 60 mg Sodium Docusate BP and 50 mg Dantron BP For excipients, see 6.1

3 PHARMACEUTICAL FORM

Suspension

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

Constipation in terminally ill patients of all ages.

4.2 Posology and method of administration

Adults: One to three 5ml doses at bedtime Children One 5ml dose at bedtime Method of Administration: Oral

4.3 Contraindications

In common with all laxatives, ‘Normax’ or 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.

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 other drugs 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.

Melanosis coli (discolouration of the colonic mucosa) after prolonged use or high doses of Co-Danthrusate.

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

ATC Code: A06A G10

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

Not available.

5.3 Preclinical safety data

No further information.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Methylcellulose Xanthan Gum

Glycerol

Propyl Parahydroxybenzoate Methyl Parahydroxybenzoate Sorbitol Powder (E200)

Saccharin Sodium

Disodium Hydrogen Orthophosphate (Anhydrous) Sodium Dihydrogen Orthophosphate Peppermint Oil Purified Water

6.2 Incompatibilities

Not known

6.3 Shelf life

36 month (200 ml) 24 month (30 ml)

6.4 Special precautions for storage

0

Do not store above 25 C. Store in the original package.

6.5 Nature and contents of container

Amber glass bottle with either roll-on pilfer proof aluminium cap with ‘steran’ faced wad or plastic cap with ‘saranex’ faced wad. The 30ml volume is for promotional purposes only. The 200ml volume is for prescription.

6.6 Special precautions for disposal

None.

7 MARKETING AUTHORISATION HOLDER

RPH Pharmaceuticals AB,

Lagervagen 7,

136 50 Haninge,

Sweden

8    MARKETING AUTHORISATION NUMBER(S)

PL 36301/0023

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

18/01/2005

10 DATE OF REVISION OF THE TEXT

17/08/2010