Co-danthramer capsules

Strong Co-danthramer capsules

Co-danthramer capsules contain Dantron 25 mg and Poloxamer 188 200 mg.

Strong Co-danthramer capsules contain Dantron 37.5 mg and Poloxamer 188 500 mg.

For excipients, see section 6.1.

Capsule, hard

Co-danthramer capsules have light brown bodies, opaque orange caps and are marked CX and Napp.

Strong Co-danthramer capsules have light brown bodies, opaque green caps and are marked CXF and Napp.

Constipation in terminally ill patients

Adults

One or two capsules at bedtime.

Children under 12 years of age

Co-danthramer capsules: One capsule at bedtime or as recommended by the physician.

Strong Co-danthramer capsules: Not recommended.

Elderly

As recommended by the physician.

In common with other gastro-intestinal evacuants, Co-danthramer capsules should not be given when acute or painful conditions of the abdomen are present or when the cause of the constipation is thought to be an intestinal obstruction. Hypersensitivity to any of the constituents of the product. Pregnancy and lactation.

Oral administration of dantron has been reported to cause liver or intestinal tumours in rats and 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 use should therefore be restricted to the licensed indications.

In babies, children and patients wearing nappies there may be staining of the buttocks. This may lead to superficial sloughing of the skin. Therefore, Co-danthramer should not be given to infants in nappies and should be used with caution in all incontinent patients.

None stated.

Co-danthramer capsules are contraindicated in pregnant women and nursing mothers.

None stated.

Dantron may cause temporary harmless pink or red colouring of the urine and peri-anal skin. With prolonged high dosage the mucosa of the large intestine may become coloured.

In case of overdosage, patients should be given plenty of fluids. An anti-cholinergic preparation such as atropine sulphate may be given to offset the excessive intestinal motility.

Pharmacotherapeutic group: Dantron combinations

ATC code: A06A B53

Co-danthramer owes its laxative action to the mild purgative dantron which is the subject of a monograph in the British Pharmacopeia. This is an anthraquinone derivative chemically related to emodin, the active principle of cascara and other naturally occurring products such as senna, aloes and rhubarb. It acts on the nerve endings of the myenteric plexus and stimulates the muscles of the large intestine.

Poloxamer 188 is a wetting agent which increases the penetration of water into faecal material. The surface activity of the poloxamer has a lubricant effect on the gut contents.

Like other anthraquinone compounds, dantron is partially absorbed from the small intestine. Because it does not affect the small intestine, griping and cramping do not occur. Dantron begins to act between 6-12 hours after administration.

Poloxamer 188 is not absorbed and is fully recovered in the faeces.

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

Butylhydroxytoluene (E321)

Capsule shell

Gelatin

Erythrosine (E127)

Iron oxide (E172)

Indigo carmine (E132)

Titanium dioxide (E171)

Sodium laurilsulphate

Printing ink

Opacode S-1-7085

(containing shellac, simeticone, propylene glycol (E1520), titanium dioxide E171))

Not applicable.

Three years

Do not store above 30^oC.

Clear or pale yellow blister packs (aluminium foil sealed to 250µm PVC with a PVdC coating of at least 40 gsm thickness), containing 60 capsules.

No special requirements.

Napp Pharmaceuticals Ltd

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

PL 16950/0017-0018

19 October 1994/9 December 2005

July 2011

POM

® The Napp device is a Registered Trade Mark

© 2006-2011 Napp Pharmaceuticals Ltd