CONTRAINDICATIONS:

Do not use in patients with known or suspected:

• hypersensitivity to the active or inactive ingredients
• gastrointestinal obstruction or perforation
• ileus
• disorders of gastric emptying (e.g. gastroparesis, gastric retention, etc.)
• phenylketonuria (due to the presence of aspartame)
• glucose-6-phosphate dehydrogenase deficiency (patients may be at risk of acut
• haemolysis due to the presence of ascorbate)
• unconsciousness
• severe dehydration
• severe inflammatory conditions of the intestinal tract, such as Crohn’s disease, ulcerative colitis and toxic megacolon.

PRECAUTIONS:

The fluid content of PLENVU when reconstituted with water does not replace regular fluid intake and adequate fluid intake must be maintained. Patients should be advised to hydrate adequately before, during, and after the use of any bowel preparation. If a patient develops significant vomiting or signs of dehydration after taking PLENVU, consider performing post-colonoscopy laboratory tests. As with other macrogol containing products, allergic reactions including rash, urticaria, pruritus, angioedema and anaphylaxis are a possibility.

Caution should be used with the administration of PLENVU to frail or debilitated patients.

PLENVU should also be used with caution in patients with:

• impaired gag reflex, with the possibility of regurgitation or aspiration, or with diminished levels of consciousness. Such patients should be closely observed during administration especially if given via a nasogastric route
• renal impairment whose creatinine clearance is less than 30 mL/minute/1.73 m2
• grade III or IV cardiac failure
• those at risk of arrhythmia, for example those with or on treatment for cardiovascular disease, thyroid disease or electrolyte imbalance.
• 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. Any suspected dehydration should be corrected for before use of PLENVU.

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 develop any symptoms indicating arrhythmia or shifts of fluid/electrolytes during or after treatment (e.g. oedema, shortness of breath, increasing fatigue, cardiac failure), plasma electrolytes should be measured, ECG monitored and any abnormality treated appropriately.

PLENVU contains 458.5 mmol (10.5 g) sodium per course of treatment. This should be taken into consideration for patients on a controlled sodium diet.

PLENVU contains 29.4 mmol (1.1 g) potassium per course of treatment. This should be taken into consideration by patients with reduced kidney function or patients on a controlled potassium diet.

If patients experience severe bloating, abdominal distension, or abdominal pain, administration should be slowed or temporarily discontinued until the symptoms subside.

In patients with mild to moderate hepatic impairment no special dosage adjustment of PLENVU is deemed necessary. Patients with elevated liver function tests were included in clinical studies.

Use in pregnancy: There are no data on the use of PLENVU during pregnancy. The preparation should only be used during pregnancy if considered essential by the physician.

Use in lactation: There are no data on the use of PLENVU during lactation. The preparation should only be used during lactation if considered essential by the physician.

Effects on fertility: There are no data on the effects of PLENVU on fertility.

Paediatric Use: The safety and efficacy of PLENVU in children below 18 years of age has not yet been established. PLENVU is therefore not recommended for use in this population.

Preclinical Safety Data: Preclinical studies provide evidence that macrogol 3350, ascorbic acid and sodium sulfate have no significant systemic toxicity potential.

No studies have been carried out on the genotoxicity, carcinogenicity, or toxic effect on reproduction with this product. However, available data on macrogols of relevant size, sodium sulfate and ascorbic acid did not reveal any special hazard for humans based studies of genotoxicity, carcinogenicity and reproductive toxicity.

INTERACTIONS WITH OTHER MEDICINES:

Medicinal products taken orally (e.g. oral contraceptive pill) within one hour of starting colonic lavage with PLENVU may be flushed from the gastrointestinal tract unabsorbed. Medications such as diuretics, calcium channel blockers or corticosteroids, may affect electrolyte levels or may exacerbate hypokalaemia. Medications such as diuretics may exacerbate volume depletion associated with bowel cleansing.