DANLAX SUSPENSION - summary of medicine characteristics

1 NAME OF THE MEDICINAL PRODUCT

Danlax Suspension

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Dantron BP             25.0mg

Poloxamer 188 USNF     200.0mg

3 PHARMACEUTICAL FORM

Oral Suspension

4 CLINICAL PARTICULARS

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

Constipation in terminally ill patients of all ages.

4.2 Posology and method of administration

Dose:

Adults:         5 to 10 ml at night

Children:       2.5 to 5 ml at night

Elderly:         2.5 to 5 ml at night

Method of Administration:

To be taken by mouth.

4.3 Contraindications

In common with other gastrointestinal evacuants co-danthramer suspension should not be given when acute or painful conditions of the abdomen are present, or the cause of the constipation is suspected to be intestinal inflammation or obstruction.

4.4 Special warnings and precautions for use

Oral administration of Dantron has been reported to cause intestinal tumours in rats and mice. It has also been reported to be hepatocarcinogenic in rats as well as in mice. There is no sound evidence to conclude a no effect dose and therefore there may be a risk of such effects in humans. Co-danthramer suspension may cause staining of the buttocks in incontinent and/or bedridden patients. This may lead to superficial sloughing of the skin. Therefore co-danthramer preparations should not be given to infants in nappies and be used with caution in all incontinent patients.

4.5 Interaction with other medicinal products and other forms of interaction

None known.

4.6 Fertility, Pregnancy and lactation

There is inadequate evidence of the safety of co-danthramer preparations in pregnancy and lactation and therefore its use is not recommended.

4.7 Effects on ability to drive and use machines

None.

4.8 Undesirable effects

Pink colouration of urine and staining of anal skin.

4.9 Overdose

4.9 Overdose

Patients should be given plenty of fluids. An anticholinergic preparation such as atropine methonitrate may be given to offset the excessive intestinal motility.

5.1 Pharmacodynamic properties

Dantron is an anthraquinone stimulant laxative with activity similar to senna.

Poloxamer 118 is a wetting agent increasing the water content of the faeces and improving gut lubrication.

5.2 Pharmacokinetic properties

Dantron:

The activity of Dantron is largely a localised effect on the gut wall which occurs within 6–12 hours of administration. Treatment often results in the production of pink coloured urine indicative of some absorption. Excretion of Dantron occurs in the faeces and its presence in breast milk has been demonstrated. Pharmacokinetic data is not available.

Poloxamer 188

This active ingredient is not absorbed.

5.3 Preclinical safety data

5.3 Preclinical safety data

There is no pre-clinical data of relevance to a prescriber which is additional to that already included in other sections of the SmPC.

6.1 List of excipients

Sucrose, Colloidal anhydrous silica, Xanthan gum, Lemon spirit, Citric acid monohydrate, Benzoic acid, Vanillin, Purified water.

6.2 Incompatibilities

None Known.

6.3 Shelf life

24 Months.

6.4 Special precautions for storage

Store at a temperature not exceeding 25°C.

Protect from light.

6.5 Nature and contents of container

1. Amber glass bottle.

2. Polyethylene terephthalate (PET) bottle.

Closure: Polypropylene cap (with option for use of EPE faced sarenex liner).

6.6 Special precautions for disposal

6.6 Special precautions for disposal

Keep bottle tightly closed.