Mundipharma Pharmaceuticals Limited - Formerly Napp Laboratories

CODALAX^® 200 mg/25 mg per 5 ml suspension

CODALAX^® forte 1000 mg/75 mg per 5 ml suspension

5 ml of CODALAX suspension contains 200 mg Poloxamer 188 and 25 mg Dantron.

5 ml of CODALAX forte suspension contains 1000 mg Poloxamer 188 and 75 mg Dantron.

Excipients: Each 5 ml also contains 1000 mg sorbitol liquid (non-crystallising), 0.2 ml 96% ethanol and 10 mg Nipasept sodium containing sodium ethyl, methyl and propyl parahydroxybenzoates (E215, E219 and E217)

For a full list of excipients, see section 6.1.

Oral suspension

Orange-yellow coloured oral suspension, with an odour of peach and a sweet taste.

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

Codalax Suspension

Oral

Adults

One or two 5 ml spoonfuls daily

Children

Half to one 5 ml spoonfuls daily

Codalax Forte Suspension

Oral

Adults and Elderly

One 5 ml spoonful at bedtime

Children

Not recommended for children under twelve years of age.

1. In common with other gastro-intestinal evacuants, CODALAX and CODALAX forte suspensions should not be given when acute or painful conditions of the abdomen are present or when the cause of constipation is suspected to be intestinal obstruction.

2. Pregnancy.

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

1. 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.

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 and CODALAX forte suspensions should not be given to infants in nappies, and used with caution in all incontinent patients.

3. Patients with rare hereditary problems of fructose intolerance should not take this medicine.

None known.

CODALAX and CODALAX forte suspensions should not be administered during pregnancy and lactation.

None known.

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

In case of overdosage patients should be given plenty of fluids. An anticholinergic agent such as atropine sulphate may be given to offset excessive intestinal motility.

Pharmacotherapeutic group: Dantron, combinations

ATC code: A06 AB53

CODALAX suspensions owe their laxative action to the mild purgative dantron. 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, 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. Because it does not affect the small intestine, griping and cramping do not occur. 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.

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

Butyl hydroxytoluene (E321)

Sorbitol liquid (non-crystallising)

Ethanol 96%

Propylene glycol

Magnesium aluminium silicate

Peach flavour

Capsicum oleoresin (CODALAX forte suspension only)

Glyceryl mono/di-oleate

Disodium phosphate dodecahydrate

Nipasept sodium containing:

- Sodium methylparahydroxybenzoate (E219)

- Sodium ethylparahydroxybenzoate (E215)

- Sodium propylparahydroxybenzoate (E217)

Hydroxyethylcellulose (CODALAX suspension only)

Citric acid monohydrate

Potassium sorbate

Saccharin sodium

Potable water

Not applicable.

Three years.

Do not store above 25°C. Store in the original container.

Amber PET bottles with child-resistant, tamper-evident closures containing 100 ml or 300 ml suspension.

No special requirements.

Mundipharma Pharmaceuticals Limited

Millbank House

Arkle Road

Sandyford

Dublin

Ireland.

PA 1688/3/3,4

26 March 1993/26 March 2008

January 2011

® The Napp device and CODALAX are Registered Trade Marks.

© Napp Pharmaceuticals Ltd, 2009