CO-DANTHRAMER 75MG/1000MG PER 5ML ORAL SUSPENSION
Active substance(s): DANTRON / POLOXAMER 188 / DANTRON / POLOXAMER 188 / DANTRON / POLOXAMER 188
NAME OF THE MEDICINAL PRODUCT
Co-Danthramer 75mg/1000mg per 5ml Oral Suspension
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml of suspension contains:
Peach flavoured, yellow suspension.
A lubricant, faecal softener and laxative for the prophylaxis and treatment of
constipation in terminally ill patients of all ages.
Posology and Method of administration
One 5 ml spoonful at bedtime.
Not recommended in children under the age of 12.
Co-Danthramer 75mg/1000mg per 5ml Oral Suspension is contraindicated in
pregnant and nursing mothers.
Co-Danthramer 75mg/1000mg per 5ml Oral Suspension should not be used
It should not be used if signs of appendicitis or inflamed bowel are apparent.
Hypersensitivity to dantron, poloxamer 188 and/or any of the excipients.
Special Warnings and Precautions for Use
Urine may be coloured red; avoid prolonged contact with skin (as in
incontinent patients) since irritation and excoriation may occur.
The oral administration of Dantron has been reported to cause
intestinal tumours in rats and mice.
The substance is hepatocarcinogenic in both species.
No evidence exists for a ‘no-effect’ dose. As such there may be a risk
of such effects in humans. In the presence of renal failure/insufficiency
hypermagnesemia may occur.
Not to be used in patients who are incontinent or in children wearing
napkins as superficial sloughing of discoloured skin may occur, (see
Section 4.8, Undesirable effects).
Glycerol may cause headache, stomach upset and diarrhea.
This product contains 1.3 g of sorbitol per 5 ml. When taken according
to the dosage recommendations each dose supplies up to 2.6 g of
sorbitol. Patients with rare hereditary problems of fructose intolerance
should not take this medicine. Propylene glycol may cause alcohollike symptoms.
Ethlyhydroxybenzoate (E214), propylhydroxybenzoate (E216) and
methylpropylbenzoate (E218) may cause allergic reactions (possibly
This medicinal product contains 3.71% v/v of ethanol. Each dose
contains up to 0.15 g of alcohol. Harmful for those suffering from
alcoholism. To be taken into account in pregnant or breast-feeding
women, children and high-risk groups such as patients with liver
disease, or epilepsy.
Interactions with other Medicaments and other forms of Interaction
Concurrent use with a stool softener laxative may enhance the systemic
absorption of Dantron.
Fertility, pregnancy and lactation
Co-danthramer 75mg/1000mg per 5ml Oral Suspension is contraindicated in
pregnant and nursing mothers. Dantron is excreted in breast milk. Some rodent studies
suggest that Dantron may be associated with a potential carcinogenic risk.
Effects on ability to drive and use machines
Co-Danthramer 75mg/1000mg per 5ml Oral Suspension may cause unusual
or weakness, therefore, if affected, the patient should not drive or
while taking this medicine.
As a stimulant laxative it increased motility and may cause
Dantron may colour the perianal skin pink or red as well as
colour the urine.
Superficial sloughing of discoloured skin may occur in
incontinent patients or children wearing napkins; Dantron
should not be used with such patients.
The mucosa of the large intestine may be discoloured with
prolonged use or high dosage.
Unusual tiredness or weakness.
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.
Laxatives can cause diarrhoea if taken in overdose and constipation if over
used. Chronic overuse of laxatives may lead to the development of a ‘cathartic
colon’, with accompanying metabolic disturbances such as hypokalaemia and
Dantron is an anthraquinone stimulant laxative, which acts on nerve endings in
the colonic mucosa. Poloxamer 188 is a wetting agent, which acts as a stool
Like other anthraquinone compounds, Dantron is partially absorbed from the
small intestine, where it has no action, and is carried via the circulation to the
large intestine where it acts on the nerve endings of the myenteric plexus to
stimulate the muscles of the large intestine. Dantron begins to act between 6
and 12 hours after administration.
Poloxamer 188, a non-ionic surfactant is not absorbed and is fully recovered in
Preclinical Safety Data
The oral administration of Dantron has been reported to cause intestinal
tumours in rats and mice.
The substance is hepatocarcinogenic in both species.
No evidence exists for a ‘no-effect’ dose. As such there may be a risk of such
effects in humans.
In the presence of renal failure/insufficiency hypermagnesemia may occur.
Rodents treated for 16 months with doses approximately 300 times those used
in humans associate Dantron with the development of intestinal and liver
tumours. However, two major studies did not show any association between
ingestion of anthraquinones and cancer in humans. Because of the concern
over rodent carcinogenicity use of Dantron tends to be restricted to the elderly
and terminally ill patients.
List of excipients
Aluminium Magnesium Silicate
Citric Acid Monohydrate
Peach Flavour Liquid
Special Precautions for Storage
Do not store above 25ºC. Store in the original container.
Nature and Contents of Container
Pharmaceutical Grade Type III amber glass bottles with pilfer proof
screw cap and high density polyethylene bottles with tamper evident
Pack sizes: 100 ml, 150 ml, 200 ml, 300 ml, 500 ml, and 1 litre
Special precautions for disposal and other handling
Shake the bottle before use. Avoid contact with the skin to avoid
MARKETING AUTHORISATION HOLDER
Pinewood Laboratories Limited
MARKETING AUTHORISATION NUMBER
DATE OF FIRST AUTHORISATION/RENEWAL OF THE
DATE OF REVISION OF THE TEXT
Source: Medicines and Healthcare Products Regulatory Agency
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