SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Ailax Forte Oral Suspension 75/1000.

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

Per 5ml

Dantron    BP    75mg

Poloxamer 188    USP/NF    1000mg

3    PHARMACEUTICAL FORM

Oral Suspension.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

Constipation in terminally ill patients.

4.2    Posology and method of administration

For oral administration.

Adults: One 5ml spoonful at bedtime.

Children: Not recommended for children under 12 years.

Elderly: The adult dose is appropriate.

No specific dosage adjustment is required in renal or hepatic impairment.

This product should not be used where there is suspicion of intestinal obstruction.

4.4 Special warnings and precautions for use

Dantron has been associated with an increased incidence of liver and intestinal tumours in rodents. Because of the potential risk in humans, Ailax Forte is therefore recommended for use in specific clinical situations only.

Prolonged use of anthraquinones may result in loss of myenteric neurones and atrophy of the smooth muscle. After many years this may result in a nonfunctioning colon. Prolonged contact with the skin should be avoided, e.g. incontinent patients, since skin irritation and excoriation may occur.

4.5 Interaction with other medicinal products and other forms of interaction

Ailax Forte has no known interactions.

4.6 Pregnancy and lactation

This product is not recommended for use during pregnancy and lactation.

4.7 Effects on ability to drive and use machines

Ailax Forte does not affect the ability to drive or operate machinery.

4.8 Undesirable effects

Reported side effects include abdominal cramps, diarrhoea, faecal incontinence, pink or red discolouration of urine and irritation and discolouration of perianal skin. With prolonged use the mucosa of the large intestine may become discoloured.

Excessive ingestion may result in electrolyte disturbance requiring corrective treatment.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Dantron is metabolised by colonic bacteria and reduced to the active aglycon. The laxative action is exerted by an effect on water and electrolyte absorption and secretion, possibly mediated through effects on sodium-potassium-ATPase, increased colonic mucosal permeability, an influence on Meissner’s plexus or on prostaglandin mediated systems. Active metabolites of dantron have less direct perstaltic effect then those of senna, but may still produce an increase in colonic motility due to an increase in luminal volume.

Poloxamer 188 is adjunctive by increasing the penetration of water into the faecal mass.

5.2 Pharmacokinetic properties

The pharmacokinetics of dantron are not well defined. Dantron is not absorbed from the small intestine but aglycons which are formed after metabolism by colonic bacteria are absorbed to a minor degree. These undergo conjugation, biliary excretion and enterohepatic circulation. There is some extrahepatic metabolism since colonic tissue has an anthraquinone conjugating effect. Dantron is also excreted in urine, milk and saliva.

5.3 Preclinical safety data

Potential carcinogenic risks have been shown in rodent studies where dantron has been associated with an increased incidence of liver and intestinal tumours.

6.1 List of excipients

Sodium hydroxybenzoates HSE Saccharin sodium BP Glycerol BP Carbomer BP Propylene glycol BP Ethanol 96% BP Sodium Hydroxide BP Peach Flavour HSE Purified Water BP

6.2 Incompatibilities

There are no known incompatabilities.

6.3 Shelf life

24 months from the date of manufacture.

6.4 Special precautions for storage

Store below 25°C.

Protect from light.

6.5 Nature and contents of container

Amber glass bottles with polypropylene caps containing 50ml, 140ml, 200ml, 300ml, 500ml and 1L.

Special precautions for disposal

There are no special usage or handling instructions for this product.

7    MARKETING AUTHORISATION HOLDER

PINEWOOD LABORATORIES LIMITED BALLYMACABRY CLONMEL, CO TIPPERARY IRELAND

8    MARKETING AUTHORISATION NUMBER(S)

PL 04917/0135

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE

AUTHORISATION

21 July 2004

10 DATE OF REVISION OF THE TEXT

07/09/2009