Novartis Consumer Health
Psyllium – Senna
Bulk Forming Laxative – Mild Stimulant
Action And Clinical Pharmacology: Prodiem Plus is a unique combination of a bulk forming fibre and a mild stimulant. It is a gentle method for the relief of acute and obstinate constipation without harsh chemical laxatives and is often effective in 12 to 24 hours
Psyllium is a high fibre bulk forming laxative. It absorbs water and expands to provide increased bulk and moisture content to the stool. The increased bulk encourages normal peristalsis and bowel motility.
Senna is a mild stimulant laxative in the family of the anthraquinones. The primary active principles of senna are sennosides. Precise mechanism of action is unknown. Recent studies suggest that stimulant laxatives alter fluid and electrolyte absorption, producing net intestinal fluid accumulation and laxation.
Indications And Clinical Uses: The relief of acute and obstinate constipation, the early stages of more severe simple constipation and constipation of the elderly caused by loss of muscle tone and neuromuscular reflex. For use in patients being weaned off harsh laxatives or where a straight bulk forming preparation has failed to provide regular bowel evacuation.
Contra-Indications: In the presence of nausea, fever or vomiting, abdominal pain or symptoms of an acute abdomen or fecal impaction, Prodiem Plus should not be used without consulting a physician.
Manufacturers’ Warnings In Clinical States: Should not be used in the presence of undiagnosed abdominal pain. Frequent or prolonged use without the direction of a physician is not recommended as it may lead to laxative dependence.
Do not use in patients with a history of psyllium allergy. Psyllium allergy is rare but can be severe. If an allergic reaction occurs, discontinue use.
Bulk forming agents have the potential to obstruct the esophagus, particularly in the presence of esophageal narrowing or when consumed with insufficient fluid. Taking this product without adequate fluid may cause it to swell and block the throat or esophagus and may cause choking . Patients should be made aware of the symptoms of esophageal obstruction, including chest pain/pressure, vomiting and difficulty swallowing. Patients experiencing these symptoms should seek immediate medical attention. Patients with esophageal narrowing or dysphagia should not use this product.
Precautions: For patients with a history of esophageal disorders. Taking this product without enough liquid may cause choking (see Warnings) .
As with all laxatives, this product should not be taken for more than 1 week, unless a special schedule has been ordered by the physician.
Drug Interactions: As with all laxatives, this product should not be taken within 2 hours of another medication because the desired effect of the other medication may be reduced.
Adverse Reactions: In therapeutic oral doses, all stimulant laxatives may produce some degree of abdominal discomfort, nausea, mild cramps, griping, and/or faintness. If mild cramping occurs, dosage should be reduced.
Dosage And Administration: Adults: 5 to 10 g (1 or 2 teaspoonfuls) once or twice/day. This dose may be taken before breakfast and/or in the evening, depending on the condition being treated, its severity and individual responsiveness. Moisten the mouth with a sip of beverage. Place the measured dose on the tongue and swallow unchewed with at least 240 mL of any cool or warm beverage including juice, milk or water. The dosage may be taken a little at a time or all at once. Do not chew.
Children 6 to 12 years: half the adult dose.
Availability And Storage: Each 5 g (1 level teaspoonful) of dark brown, minty tasting granules contains: psyllium 2.71 g and senna pod 0.62 g (equivalent to 15 mg of sennosides). Nonmedicinal ingredients: acacia, flavors, iron oxide, paraffin, sucrose and talc. Energy: 16 kJ (3.85 kcal). Potassium: 30 mg. Sodium:
PRODIEM® PLUS Novartis Consumer Health Psyllium – Senna Bulk Forming Laxative – Mild Stimulant