Skip to Content

CO-DANTHRAMER 75/1000 ORAL SUSPENSION

PDF options:  View Fullscreen   Download PDF

PDF Transcript

SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Co-Danthramer 75/1000 Oral Suspension

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml of suspension contains:

3

Dantron
Poloxamer 188

75 mg
1000 mg

PHARMACEUTICAL FORM
Oral Suspension.
Peach flavoured, yellow suspension.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
A lubricant, faecal softener and laxative for the prophylaxis and treatment of
constipation in terminally ill patients of all ages.

4.2

Posology and Method of administration
Adults:
Children:

4.3

Contraindications
1.
2.
3.
4.

4.4

One 5 ml spoonful at bedtime.
Not recommended in children under the age of 12.

Pinorax Strong Co-Danthramer Suspension 75/1000 Oral Suspension is
contraindicated in pregnant and nursing mothers.
Pinorax Strong Co-Danthramer Suspension 75/1000 Oral Suspension
should not be used in intestinal obstruction.
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).
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 alcohol-like symptoms.
Ethlyhydroxybenzoate (E214), propylhydroxybenzoate (E216) and
methylpropylbenzoate (E218) may cause allergic reactions (possibly delayed).
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 highrisk groups such as patients with liver disease, or epilepsy.

4.5

Interactions with other Medicaments and other forms of Interaction
Concurrent use with a stool softener laxative may enhance the systemic
absorption of Dantron.

4.6

Pregnancy and Lactation
Pinorax 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.

4.7

Effects on ability to drive or operate machinery
Pinorax Strong Co-Danthramer 75mg/1000mg Oral Suspension may cause
unusual tiredness or weakness, therefore, if affected, the patient should not
drive or operate machinery while taking this medicine.

4.8

Undesirable Effects

1.

As a stimulant laxative it increased motility and may cause abdominal
cramp.

2.

3.

Superficial sloughing of discoloured skin may occur in incontinent
patients or children wearing napkins; Dantron should not be
used with such patients.

4.

The mucosa of the large intestine may be discoloured with prolonged use
or high dosage.

5.

Unusual tiredness or weakness.

6.

4.9

Dantron may colour the perianal skin pink or red as well as colour the
urine.

Rash

Overdose
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
metabolic acidosis.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
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
softener.

5.2

Pharmacokinetic Properties
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
the faeces.

5.3

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.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Aluminium Magnesium Silicate
Xanthan Gum
Glycerol
Sorbitol 70%
Saccharin Sodium
Propylene Glycol
Ethanol 96%
Methylhydroxybenzoate (E218)
Ethylhydroxybenzoate (E214)
Propylhydroxybenzoate (E216)
Citric Acid Monohydrate
Sodium Citrate
Purified Water
Peach Flavour Liquid

6.2

Incompatibilities
None known

6.3

Shelf Life
3 years

6.4

Special Precautions for Storage
Do not store above 25ºC. Store in the original container.

6.5

Nature and Contents of Container
Pharmaceutical Grade Type III amber glass bottles with pilfer proof screw
caps and high density polyethylene bottles with tamper evident seal.
Pack sizes: 100 ml, 150 ml, 200 ml, 300 ml, 500 ml and 1 litre.

6.6

Instructions for Use/Handling
Shake the bottle before use. Avoid contact with the skin to avoid staining.

7.

MARKETING AUTHORISATION HOLDER
Pinewood Laboratories Limited
Ballymacarbry
Clonmel
Co. Tipperary
Ireland

8.

MARKETING AUTHORISATION NUMBER
PL 04917/0026

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
16/03/2007

10

DATE OF REVISION OF THE TEXT
16/03/2007

+ Expand Transcript

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Hide