Agiolax Granules

For relief of constipation.

Posology

Adults and children 12 years and older: (5 g granules = 7 ml = approximately 1 heaped medicine measure.) 5 g to 10 g (half to one sachet) after the evening meal. If necessary, the same dose should be taken before breakfast. Note for diabetics: 5 g of Agiolax u00ae contains approximately 0,96 g sucrose.

Method of administration

Oral use. The granules should be swallowed with a full glass of liquid (preferably water). The granules should not be chewed or dissolved but swallowed whole.

• Hypersensitivity to the ingredients.
• Intestinal obstruction, or conditions likely to lead to intestinal obstruction.
• Undiagnosed abdominal symptoms.

Agiolax u00ae should not be used if there is abdominal pain, nausea or vomiting. Laxatives should not be taken by patients with intestinal obstruction or with undiagnosed abdominal symptoms. If a change in bowel habit occurs and persists for more than two weeks, a medical practitioner should be consulted to determine the cause.

Rectal bleeding or inability to have a bowel movement after the use of a laxative may indicate a serious condition. Discontinue use and consult a medical practitioner.

Inadequate fluid intake may cause obstruction of the bowel. Agiolax u00ae should be taken with adequate liquid to prevent faecal impaction and oesophageal obstruction. Agiolax u00ae lowers the transit time through the gut and could interfere with the absorption of other substances. Bulk laxatives increase flatulence and distension.

Agiolax u00ae should not be used for a period longer than one week, unless directed by a medical practitioner. Frequent of prolonged use of laxatives, including Agiolax u00ae , may result in loss of normal bowel function and dependence. Prolonged use of overdosage can result in diarrhoea with excessive loss of water and electrolytes, particularly potassium. Potassium loss can produce disorders of cardiac function and myasthenia, in particular of cardiac glycosides, diuretics and adrenocortical steroids are taken concurrently. In the case of chronic use, albuminuria and haematuria can occur. There is also the possibility of developing an atonic non-functioning colon.

Anthraquinone derivatives may colour the urine yellowish-brown at acid pH, and red at alkaline pH, and may interfere with diagnostic tests. Patients with inflammatory bowel disease must be monitored. Each 5 g Agiolax u00ae contains 1,04 g sucrose. Patients with rare hereditary conditions such as fructose intolerance, glucose-galactose mal-absorption or sucrase-isomaltase insufficiency should not take Agiolax u00ae .

Contains sucrose which may have an effect on the glycaemic control of patients with diabetes mellitus.

In cases of chronic use/abuse potassium deficiency may potentiate the action of cardiac glycosides and may affect the action of antidysrhythmic agents. Potassium loss may be aggravated in combination with certain medicines e.g. which increase the urine output (diuretics), cortisone and cortisone-like substances (adrenocortical steroids) and liquorice root. Intestinal absorption of medicines taken at the same time may be delayed or reduced. In insulin-dependent diabetics it may be necessary to reduce the insulin dose.

Pregnancy: During the first three months of pregnancy, Agiolax u00ae should be used only if constipation cannot be remedied by a change in diet or with the aid of bulking agents. It should only be used after consultation with a medical practitioner.

Lactation: Breakdown products of senna pods, such as rhein have a laxative action and pass in small amounts into the maternal milk.

Agiolax u00ae does not affect the ability to drive or operate machinery.

a. Summary of the safety profile

Very rare (< 0,01 %): Hypersensitivity reactions to Plantago ovata, oesophagus obstructions, spasmodic gastro-intestinal complaints which as colic or cramps can be caused by senna, reversible pseudomelanosis coli following chronic use, which, as a rule, recedes after discontinuation of the preparation.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Healthcare professionals are asked to report any suspected adverse reactions to SAHPRA via the u201cReport Drug Reaction Processu201d, found online under SAHPRAu2019s safety publications: https://www.sahpra.org.za/

Treatment is symptomatic and supportive.