Lebalax 5 Mg/10 Mg Suppository

For the relief of occasional constipation.

Unless otherwise prescribed by your doctor, the following dosages are recommended:

• Adults and children 12 years and over: One 10 mg suppository as a single daily dose.
• Children 1 - 12 years: One 5 mg suppository as a single daily dose.

Method of administration: The suppositories should be unwrapped and inserted into the rectum pointed end first. Bowel movements is generally produced within 15 minutes to one hour.

• Hypersensitivity to bisacodyl or to any of the ingredients of LEBALAX listed in section 6.1.
• In cases of ileus, intestinal obstruction, undiagnosed symptoms, or acute surgical abdominal conditions like acute appendicitis, acute inflammatory bowel disease or in severe dehydration.
• When anal fissures or ulcerative proctitis with mucosal damage are present.

Safety in pregnancy and breastfeeding has not been established (see section 4.6).

LEBALAX should not be used in the event of abdominal pain, nausea and vomiting. LEBALAX 5 mg should not be used by children without medical advice. LEBALAX should not be used on a continuous daily basis for more than five days without investigating the cause of constipation. Using LEBALAX often or for a long period may result in dependence on laxatives and loss of normal bowel function. Long-term everyday use of stimulant laxatives may harm the intestinal function and should be avoided. If laxatives are needed every day the cause of the constipation should be investigated.

LEBALAX should only be used if a therapeutic effect cannot be achieved by a change of diet or the administration of bulk forming medicines.

Prolonged excessive use may lead to fluid and electrolyte imbalance, hypokalaemia, and possible an atonic non-functioning colon. Intestinal loss of fluids can promote dehydration. Symptoms may include thirst and oliguria. In patients suffering from fluid loss where dehydration may be harmful (e.g. renal insufficiency, elderly patients), LEBALAX should be discontinued and only be restarted under medical supervision.

Stimulant laxatives including LEBALAX do not help with weight loss (see section 5.1). Patients may experience haematochezia (blood in stool) that is generally mild and self-limiting. If symptoms worsen during the use of LEBALAX, a health care provider should be consulted. Dizziness and/or syncope have been reported in patients who have taken LEBALAX. The details available for these cases suggest that the events would be consistent with defaecation syncope (or syncope attributable to straining at stool), or with a vasovagal response to abdominal pain related to the constipation, and not necessarily to the administration of bisacodyl itself. The use of suppositories may lead to painful sensations and local irritation, especially in patients with anal fissures and ulcerative proctitis. Repeated use may cause inflammation of the rectum or sloughing of the epithelium. Caution is advised in cases of inflammatory bowel disease, rectal fissures or ulcerated haemorrhoids.

The concomitant use of diuretics or adreno-corticosteroids may increase the risk of electrolyte imbalance if excessive doses of LEBALAX are taken. Electrolyte imbalance may lead to increased sensitivity to cardiac glycosides. The concomitant use of other laxatives may enhance the gastrointestinal side effects of LEBALAX.

Pregnancy: Safety in pregnancy and breastfeeding has not been established. There are no adequate and well-controlled studies in pregnant women. Long experience has shown no evidence of undesirable or damaging effects during pregnancy.

Breastfeeding: Clinical data show that neither the active moiety of LEBALAX (BHPM or bis-(p-hydroxyphenyl)-pyridyl-2-methane) nor its glucuronides are excreted into the milk of healthy lactating females. LEBALAX suppositories should not be taken in pregnancy, especially the first trimester, and during breast feeding.

Fertility: No studies on the effect on human fertility have been conducted.

No studies on the effects of LEBALAX on the ability to drive and use machines have been performed. However, patients should be advised that due to a vasovagal response (e.g. to abdominal spasm) they may experience dizziness and / or syncope. If patients experience abdominal spasm, they should avoid potentially hazardous tasks such as driving or operating machinery.

Summary of the safety profile: The most frequently reported adverse reactions during treatment are abdominal pain and diarrhoea.

Structured list of adverse reactions:

• Immune system disorders: Less frequent: hypersensitivity reactions (including isolated cases of anaphylactoid reactions, angioedema)
• Metabolism and nutrition disorders: Less frequent: dehydration
• Nervous system disorders: Less frequent: dizziness, syncope
• Gastrointestinal disorders: Frequent: abdominal cramps, abdominal pain, diarrhoea, nausea; Less frequent: haematochezia (blood in stool), vomiting, abdominal discomfort, anorectal discomfort, colitis (including ischaemic colitis).

Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of LEBALAX is important. It allows continued monitoring of the benefit/risk balance of LEBALAX. Health care providers are asked to report any suspected adverse reactions via the u201c6.04 Adverse Drug Reaction Reporting Formu201d, found online under SAHPRAu2019s publications: https://www.sahpra.org.za/Publications/Index/8.

Symptoms: If high doses are taken watery stools (diarrhoea), abdominal cramps and a clinically significant loss of fluid, potassium and other electrolytes can occur. Laxatives when taken in chronic overdose may cause chronic diarrhoea, abdominal pain, hypokalaemia, secondary hyperaldosteronism and renal calculi. Renal tubular damage, metabolic alkalosis and muscle weakness secondary to hypokalaemia have also been described in association with chronic laxative abuse.

Therapy: Replacement of fluids and correction of electrolyte imbalance may be required. This is especially important in the elderly and the young. Administration of antispasmodics may be of value. Treatment must be symptomatic and supportive.