Laxador Bisacodyl Suppositories 10 mg Suppository

LAXADOR BISACODYL SUPPOSITORIES is indicated for the treatment of occasional constipation.

Posology
Unless otherwise prescribed by your doctor, the following dosages are recommended:
Adults and children 12 years and over: Insert one suppository as a single daily dose.
Method of administration
For rectal administration. The suppositories should be unwrapped and inserted into the rectum pointed end first. Bowel movement is generally produced within 15 minutes to one hour.

LAXADOR BISACODYL SUPPOSITORIES is contraindicated in:
u2022 Patients with hypersensitivity to bisacodyl or to any excipients in LAXADOR BISACODYL SUPPOSITORIES (see section 6.1).
u2022 Ileus, intestinal obstruction, undiagnosed abdominal symptoms or acute surgical abdominal conditions like acute appendicitis, acute inflammatory bowel disease, severe abdominal pain associated with nausea and vomiting which may be indicative of the aforementioned severe conditions and in severe dehydration.
u2022 Presence of anal fissures or ulcerative proctitis with mucosal damage.

LAXADOR BISACODYL SUPPOSITORIES should not be used in the presence of abdominal pain, nausea or vomiting. If you have noticed a sudden change in bowel habits that has persisted for a period of greater than 2 weeks, consult a doctor before using the laxative. Frequent or prolonged use of LAXADOR BISACODYL SUPPOSITORIES may result in dependence on laxatives and loss of normal bowel function. The use of LAXADOR BISACODYL SUPPOSITORIES beyond 1 week is not recommended except on the advice of a doctor. If a laxative is needed every day, the cause of constipation should be investigated. LAXADOR BISACODYL SUPPOSITORIES should only be used if a therapeutic effect cannot be achieved by a change of diet or the administration of bulk forming medicines. Prolonged use may lead to diarrhoea with excessive loss of water and electrolytes and possible 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) LAXADOR BISACODYL SUPPOSITORIES should be discontinued and only be restarted under medical supervision. Stimulant laxatives (including LAXADOR BISACODYL SUPPOSITORIES) do not help with weight loss (see section 5.1). They do not reduce the absorption of calories or nutrients. They can cause watery stools (diarrhoea), abdominal cramps and dehydration. Dehydration can seem like weight loss. Overuse of laxatives may damage a patientu2019s health by:
u2022 Causing disturbances of electrolyte and mineral balances. Sodium, potassium, magnesium, and phosphorus are electrolytes and minerals that are present in very specific amounts necessary for proper functioning of the nerves and muscles, including those of the colon and heart. Upsetting this delicate balance can cause incorrect functioning of these vital organs.
u2022 Severe dehydration may cause tremors, weakness, blurry vision, fainting, kidney damage, and, in extreme cases, death. Dehydration often requires medical treatment.
u2022 Overuse of laxatives must be avoided as it may harm the intestinal function.
Patients may experience haematochezia (blood in stool) that is generally mild and self-limiting. If the symptoms worsen during the use of LAXADOR BISACODYL SUPPOSITORIES, a doctor or pharmacist should be consulted. Rectal bleeding or failure to have a bowel movement after use of a laxative may indicate a serious condition. Discontinue use and consult a doctor. Dizziness and / or syncope have been reported in patients who have taken LAXADOR BISACODYL SUPPOSITORIES. 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 (see sections 4.7 and 4.8). There have been reports of abdominal pain and bloody diarrhoea occurring after taking bisacodyl, as contained in LAXADOR BISACODYL SUPPOSITORIES, orally. Some cases have been shown to be associated with colonic mucosal ischaemia. Administration of suppositories may cause painful sensations and local irritation, care should be taken in patients with rectal fissures or ulcerated haemorrhoids. May cause irritation and repeated use may cause proctitis or sloughing of the epithelium. Excessive purgation has been reported. Care should be taken in patients with inflammatory bowel disease.

The concomitant use of diuretics or adreno-corticosteroids may increase the risk of electrolyte imbalance if excessive doses of LAXADOR BISACODYL SUPPOSITORIES 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 LAXADOR BISACODYL SUPPOSITORIES.

The safety of LAXADOR BISACODYL SUPPOSITORIES in pregnancy and lactation has not been established.
Pregnancy
There are no adequate and well-controlled studies in pregnant women.
Breastfeeding
Not applicable.
Fertility
No studies on the effect on human fertility have been conducted.

No studies on the effects of LAXADOR BISACODYL SUPPOSITORIES 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 (see sections 4.4 and 4.8).

a) Tabulated list of adverse reactions
System organ class Frequent Less frequent
Immune system disorders Anaphylactic reactions, angioedema, hypersensitivity (allergic reactions)
Metabolism and nutrition disorders Dehydration
Nervous system disorders Dizziness, syncope,
Gastrointestinal disorders Abdominal cramps, abdominal pain, diarrhoea, nausea
Haematochezia (blood in stool), vomiting, abdominal discomfort, anorectal discomfort, colitis including ischaemic colitis
Description of selected adverse reactions
Dizziness and syncope occurring after taking bisacodyl, as contained in LAXADOR BISACODYL SUPPOSITORIES, appear to be consistent with a vasovagal response (e.g. to abdominal spasm, defaecation) (see sections 4.4 and 4.8).
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 providers are asked to report any suspected adverse reactions to SAHPRA via the the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who-umc.org) found on SAHPRA website. By reporting side effects, you can help provide more information on the safety of LAXADOR BISACODYL SUPPOSITORIES. https://www.sahpra.org.za/Publications/Index/8 Aspen Pharmacare: E-mail: [email protected]
Tel: 0800 118 088

Symptoms
If high doses are taken, watery stools (diarrhoea), abdominal cramps and a clinically significant loss of potassium and other electrolytes can occur. Chronic overdose with LAXADOR BISACODYL SUPPOSITORIES 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.
Treatment
Treatment is symptomatic and supportive. 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.