Mundipharma Pharmaceuticals Limited - Formerly Napp Laboratories

CODALAX^® 200mg /25 mg capsules

CODALAX^® forte 500 mg /37.5 mg capsules

CODALAX capsules contain 200 mg Poloxamer 188 and 25 mg Dantron.

CODALAX forte capsules contain 500 mg Poloxamer 188 and 37.5 mg Dantron.

For a full list of excipients, see section 6.1.

Capsule, hard (capsule).

CODALAX capsules are opaque orange/light brown, size 3, hard gelatin capsules marked 'CX' and 'NAPP' in white

CODALAX Forte capsules are opaque green/light brown, size 0, hard gelatin capsules marked 'CXF' and 'NAPP' in white

Use only in the treatment of analgesic induced constipation in the terminally ill patient.

Route of administration

Oral

Adults

One or two capsules at bedtime.

Children under 12 years

CODALAX capsules - one at bedtime or as recommended by the physician.

CODALAX forte capsules are not recommended for children under 12 years of age.

Elderly

As recommended by the physician.

1. In common with other gastro-intestinal evacuants, CODALAX/CODALAX forte 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 intestinal obstruction.

2. Pregnancy and lactation.

3. Hypersensitivity to any of the constituents of the product.

1. 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. CODALAX/CODALAX forte use should therefore be restricted to the licensed indications.

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

None stated.

CODALAX/CODALAX forte 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 cases 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: A06 AB53

Dantron is an anthraquinone derivative which 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

Contains:

Erythrosine (E127)

Iron oxide (E172)

Indigo carmine (E132)

Titanium dioxide (E171)

Sodium laurilsulphate

Printing ink

Opacode S-1-7085

Contains:

Shellac

Simeticone

Propylene glycol (E1520)

Titanium dioxide (E171)

Not applicable

Three years.

Do not store above 30°C.

a) Polypropylene containers with polyethylene lids.

b) PVdC coated PVC blister packs with aluminium backing foil.

Pack sizes of 60 capsules and a medical sample pack of 10 capsules.

No special requirements.

Mundipharma Pharmaceuticals Limited

Millbank House

Arkle Road

Sandyford

Dublin 18

Date of first authorisation: 26 June 1995

Date of last renewal: 26 March 2008

May 2011

® CODALAX and the Napp device are Registered Trade Marks.

© Napp Pharmaceuticals Ltd, 2011.