Danlax Suspension
SUMMARY OF PRODUCT 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
4.1. 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. Contra-Indications
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 Special 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. Interactions with Other Medicinal Products and Other Forms of Interaction
None known.
4.6. 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
Patients should be given plenty of fluids. An anticholinergic preparation such as atropine methonitrate may be given to offset the excessive intestinal motility.
5.
PHARMACOLOGICAL PROPERTIES
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
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 PHARMACEUTICAL PARTICULARS
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. Instruction for Use, Handling and Disposal
Keep bottle tightly closed.
7. MARKETING AUTHORISATION HOLDER
Waymade PLC Sovereign House Miles Gray Road Basildon Essex SS14 3FR
8 MARKETING AUTHORISATION NUMBER(S)
PL 06464/0461
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
11/08/1999
10. DATE OF (PARTIAL) REVISION OF THE TEXT
Dec 2004