OsmoLax powder contains macrogol 3350 powder 1g/g for reconstitution.

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1 PRODUCT INFORMATION OsmoLax (Macrogol 1g/g) Product description OsmoLax powder contains macrogol 3350 powder 1g/g for reconstitution. Active Ingredient: Macrogol (Polyethylene glycol) 3350 is a synthetic polyglycol having an average molecular weight of CAS Number: The chemical formula is H(C 2 H 4 O)nOH in which n represents the average number of oxyethylene groups. The average value of n for macrogol 3350 is Macrogol 3350 is a free flowing white powder freely soluble in water. Inactive ingredients: Nil Pharmacology After oral administration, macrogol 3350 is unchanged in the gut. It is virtually unabsorbed from the gastrointestinal tract. Any macrogol 3350 that is absorbed is excreted via the urine. The laxative action of macrogol has a time course which will vary according to the severity of the constipation being treated. Pharmacodynamics Macrogol 3350 has a laxative effect in the gut. It works by restoring the natural rhythm by using the body s own water to increase the frequency of bowel movements and to soften the stool so it is easier to pass. Clinical Trials Adults Five randomised, placebo controlled trials were conducted for the treatment of constipation in a total of 602 adults, using an identical formulation to OsmoLax (consisting of macrogol 3350 as the only ingredient). These studies support the safety and efficacy of OsmoLax in the treatment of constipation in adults. Four of these studies used a dose of 17g daily in water.

2 Duration of treatment ranged from overnight to 6 months. With respect to safety, no statistically or clinically significant differences between the placebo and laxative groups were detected for laboratory measurements. Patients treated with macrogol reported more abdominal distension, diarrhoea, loose stools, flatulence and nausea. Children Nine studies were conducted using an identical formulation for treatment of constipation in a total of 570 children, 231 of whom were aged from 4 to 16 years with duration of treatment from 2 weeks to 12 months. Of these 9 studies, one was a randomised, placebo controlled trial. This trial showed that there were no electrolyte abnormalities or differences in laboratory values among groups. There was also no difference in the type of nongastrointestinal related adverse events. The frequency of GI adverse events was greater in the macrogol treated patients and the incidence of flatulence, abdominal pain, nausea and diarrhoea increased with dose. Indications For effective relief of constipation and treatment of chronic constipation. Contraindications Where there is a known hypersensitivity to macrogol 3350 (polyethylene glycol 3350) or any other macrogol. Intestinal perforation or obstruction due to structural or functional disorder of the gut wall, ileus and severe inflammatory conditions of the intestinal tract, such as Crohn's disease, ulcerative colitis or toxic megacolon. Cardiac failure, ascitic conditions, clinically significant impairment of renal function and patients at risk of dehydration due to altered senses and/or poor fluid intake. Precautions Patients at risk of electrolyte imbalances OsmoLax does not contain electrolytes. OsmoLax should be used with caution in patients who are at risk of electrolyte imbalances, for example patients with congestive heart failure, ascitic conditions, clinically significant impairment of renal function and patients at risk of dehydration due to altered senses and/or poor fluid intake. If any patient develops symptoms indicating shifts of fluid or electrolytes (e.g. oedema, shortness of breath, increasing fatigue, dehydration, cardiac failure), OsmoLax should be stopped immediately, electrolytes measured and any abnormality treated appropriately.

3 Use in children Constipation is the less-frequent-than-usual passage of large, firm or hard stools. Most normal children will occasionally experience constipation. A substantial proportion of children will have a tendency to recurring or persisting mild constipation. This will usually require no more than a healthy diet, plenty of exercise, regular toilet use and, sometimes, occasional use of a laxative. A small proportion of children will pass stools less frequently than 3 times per week, with excessive straining and discomfort or pain at these times. If your child has this more severe type of constipation, he or she requires medical assessment and a medically-supervised plan of treatment over 6 to 12 months. Treatment may require daily use of a product such as OsmoLax, which can keep the stools of normal consistency and restore a normal pattern of passing stools. Not recommended for children under 4 years of age. Use in the elderly OsmoLax is safe and effective for use in the elderly. Use in pregnancy There is no experience of the use of OsmoLax during pregnancy. No preclinical tests of its effects on reproduction have been conducted. OsmoLax should only be used in pregnancy if considered essential by the doctor. Use in lactation There is no experience of the use of OsmoLax during lactation. No preclinical tests of its effects on reproduction have been conducted. OsmoLax should only be used in lactation if considered essential by the doctor. Genotoxicity and carcinogenicity Preclinical studies show that macrogol 3350 has no significant systemic toxicity potential, although no tests of its genotoxicity have been conducted. Interaction with other medicines No clinical interactions have been reported. Macrogol 3350 raises the solubility of drugs that are soluble in alcohol and relatively insoluble in water. There is, therefore, a theoretical possibility that the absorption of such drugs could be transiently reduced. A theoretical

4 potential also exists for decreased absorption (rate and extent) of drugs which are generally poorly absorbed or are contained in sustained or modified release dosage forms. This is more likely to occur if OsmoLax is overdosed to induce watery diarrhoea. Based on the potential for decreased absorption, OsmoLax should be taken at least 2 hours before or after other medication. Adverse reactions Abdominal distension and pain, borborygmi and nausea and mild vomiting, attributable to the expansion of the contents of the intestinal tract, can occur. Mild diarrhoea, which usually responds to dose reduction, can occur. Other adverse events include bloating, flatulence and abdominal cramping. Reported adverse effects in children include perianal inflammation and soreness. Allergic reactions are a possibility. Dosage and administration Adults and children over the age of 12 years: One level 17g measuring scoop mixed with 1 cup (approximately 240mL) of liquid once daily. This can be increased to a maximum of 2 doses of 17g daily, dependent on the severity of the constipation. For chronic constipation, the dose may be reduced to one 8.5g scoop mixed with ½ cup (approximately 120mL) of liquid daily, according to individual response. Children aged 6 to 12 years: The usual starting dose is two level 8.5g measuring scoops (or one 17g scoop), mixed with 1 cup (approximately 240mL) of liquid once daily. The dose should be adjusted up or down as required to produce regular soft stools. The maximum dose should not exceed three 8.5g scoops (equivalent to 25.5g) daily. Children aged 4 to 5 years: The usual starting dose is one level 8.5g measuring scoop mixed with ½ cup (approximately 120mL) of liquid once daily. This can be increased to a maximum of two 8.5g scoops (equivalent to 17g) daily if required. Children under 4 years of age: Not recommended. Use in children aged 4 years and older should not exceed a period of 3 months except under medical supervision. The powder should be dissolved in water or any other beverage according to the patient s preference. Patients should be advised to drink plenty of water and increase fibre in the diet, except in

5 cases of medication-induced constipation (eg codeine). OsmoLax should be taken 2 hours before or after other medication. Prolonged use of laxatives is undesirable and may lead to dependence.

6 Overdosage Symptoms of overdose may include diarrhoea or vomiting, which may result in excessive loss of fluid (water) and electrolytes (salts) from the body. Signs of excessive fluid and electrolyte loss may include weakness, breathlessness, extreme thirst with a headache, puffy ankles, confusion, or seizure. For information on the management of overdose, contact the Poisons Information Centre on (Australia). Presentation OsmoLax is a free flowing white powder and is available in jar containing 510g of powder. A double-ended 8.5g & 17g measuring scoop is included in each pack. Storage Store below 30 C. Poison Schedule Unscheduled. Sponsor Key Pharmaceuticals Pty Ltd 12 Lyonpark Road Macquarie Park NSW 2113 Date of TGA approved information: 21 November 2012