Presentation and Status in Health Basket
Adults and Older people: A course of treatment consists of two liters of this product. It is strongly recommended that one liter of clear liquid, which may include, water, clear soup, fruit juice without pulp, soft drinks, tea and/or coffee without milk, is also taken during the course of treatment. A liter of this product consists of one ‘sachet 1’ and one ‘sachet 2’ dissolved together in water to make one liter of solution. The reconstituted solution should be drunk over a period of one to two hours. This process should be repeated with a second liter of this product to complete this course. This course of treatment can be taken either as divided or single doses as specified below:
1. Divided doses as one liter of This product in the evening before and one liter of This product in the early morning of the day of the procedure.
2. Single dose: two liters in the evening preceding the clinical procedure or two liters in the morning of the clinical procedure. For the divided dose and single dose taken the evening before the procedure there should be at least one hour between the end of intake of fluid (This product or clear liquid) and the start of the colonoscopy. For the single dose in the morning of the procedure, there should be at least two hours between the end of intake of this product and at least one hour between the end of intake of any clear liquid and the start of the colonoscopy. Patients should be advised to allow for appropriate time to travel to the colonoscopy unit. No solid food should be taken from the start of the course of treatment until after the clinical procedure. Paediatric population: Not recommended for the use in children below 18 years of age, as this product has not been studied in the paediatric population.
Method of administration: The route of administration is for oral use. A liter of this product consists of one sachet 1 and one sachet 2 dissolved together in water to make a one liter solution.
This product is indicated for bowel cleansing prior to any clinical procedures requiring a clean bowel e.g. bowel endoscopy or radiology.
Hypersensitivity to the active substances or to any of the excipients. Gastrointestinal obstruction or perforation. Disorders of gastric emptying (e.g. gastroparesis). Ileus. Phenylketonuria (due to presence of aspartame). Glucose-6-Phosphate Dehydrogenase deficiency (due to presence of ascorbate). Toxic megacolon which complicates very severe inflammatory conditions of the intestinal tract including Crohn’s disease and ulcerative colitis. Do not use in unconscious patients.
Diarrhoea is an expected effect resulting from the use of this product. This product should be administered with caution to fragile patients in poor health or patients with serious clinical impairment such as: Impaired gag reflex, or with a tendency to aspiration or regurgitation, Impaired consciousness, Severe renal insufficiency (creatinine clearance <30mL/min), Cardiac impairment (NYHA grade III or IV), Those at risk of arrhythmia, for example those on treatment for cardiovascular disease or who have thyroid disease, Dehydration, Severe acute inflammatory disease. The presence of dehydration should be corrected before the use of this product. The fluid content of this product when re-constituted with water does not replace regular fluid intake and adequate fluid intake must be maintained. Semi-conscious patients or patients prone to aspiration or regurgitation should be closely observed during administration, especially if this is via a nasogastric route. If patients develop any symptoms indicating arrhythmia or shifts of fluid/electrolytes (e.g. edema, shortness of breath, increasing fatigue, cardiac failure), plasma electrolytes should be measured, ECG monitored and any abnormality treated appropriately. In debilitated fragile patients, patients with poor health, those with clinically significant renal impairment, arrhythmia and those at risk of electrolyte imbalance, the physician should consider performing a baseline and post-treatment electrolyte, renal function test and ECG as appropriate. There have been rare reports of serious arrhythmias including atrial fibrillation associated with the use of ionic osmotic laxatives for bowel preparation. These occur predominantly in patients with underlying cardiac risk factors and electrolyte disturbance. If patients experience symptoms such as severe bloating, abdominal distention, abdominal pain or any other reaction which makes it difficult to continue the preparation, they may slow down or temporarily stop consuming this product and should consult their doctor. This medicinal product contains 56.2 mmol of absorbable sodium per liter. To be taken into consideration by patients on a controlled sodium diet. This medicinal product contains 14.2 mmol of potassium per liter. To be taken into consideration by patients with reduced kidney function or patients on a controlled potassium diet. The medicinal product contains aspartame, which is a source of phenylalanine. This may be harmful for people with phenylketonuria.
Sleep disorder, dizziness, headache, abdominal pain, nausea, abdominal distension, anal discomfort, vomiting, dyspepsia, malaise, pyrexia, rigors, thirst, and hunger.
See prescribing information for full details.
Oral medication should not be taken within one hour of administration of this product as it may be flushed from the gastro-intestinal tract and not absorbed. The therapeutic effect of drugs with a narrow therapeutic index or short half-life may be particularly affected.
Pregnancy and Lactation
Pregnancy: There are no data on the use of this product during pregnancy. The preparation should only be used during pregnancy if considered essential by the physician.
Lactation: There are no data on the use of this product during lactation. The preparation should only be used during lactation if considered essential by the physician.
In case of gross accidental overdose, where diarrhea is severe, conservative measures are usually sufficient; generous amounts of fluid, especially fruit juices, should be given. In the rare event of overdose provoking severe metabolic derangement, intravenous rehydration may be used.
Special precautions for disposal: Reconstitution of this product in water may take up to 5 minutes and is best performed by adding the powder to the mixing vessel first followed by the water. The patient should wait until all the powder has dissolved before drinking the solution. After reconstitution in water this product consumption may begin immediately or if preferred it may be cooled before use.
Shelf life: Sachets: 3 years. Reconstituted solution: 24 hours. This product contains 0.233g of aspartame per sachet 1.