3. Pharmaceutical Form
Description of the product added “Clear colourless solution with a ginger-lemon odour, free from precipitation and turbidity”
4.2 Posology and method of administration
Instructions added to drink as much extra liquids as possible to avoid dehydration, replace the fluids lost during bowel movements and help ensure that the bowel will be clean for the procedure.
4.3 Contraindications
Renal failure replaced with clinically significant impairment of renal function.
Ascites added.
4.4 Special warning and special precautions for use
Additional safety warnings and precautions have been added. New and revised sections are presented below:
Fleet® Phospho-soda® has been rarely associated with severe and potentially fatal cases of electrolyte disorders in elderly patients. The benefit/risk ratio of Fleet® Phospho-soda® needs to be carefully considered before initiating treatment in this at-risk population.
Special attention should be taken when prescribing Fleet® Phospho-soda® to any patient with regard to known contraindications and the importance of adequate hydration and, in at-risk populations (see below and sections 4.2 and 4.3.), the importance of also obtaining baseline and post-treatment electrolyte levels.
Use with caution in patients with heart disease an increased risk for underlying renal impairment, acute myocardial infarction, unstable angina, pre-existing electrolyte disturbances, increased risk for electrolyte disturbances (e.g. dehydration, gastric retention, colitis, inability to take adequate oral fluid, hypertension or other conditions in which the patients are taking drug products that may result in dehydration, see below), or with debilitated or elderly patients. In these at-risk patients, consider obtaining baseline and post-treatment sodium, potassium, calcium, chloride, bicarbonate, phosphate, blood urea nitrogen and creatinine values.
There is a risk of elevated serum levels of sodium and phosphate and decreased levels of calcium and potassium; consequently hypernatraemia, hyperphosphataemia, hypocalcaemia, hypokalaemia, and acidosis may occur.
If the patient has had a colostomy or ileostomy, or must keep to a salt-free diet, the preparation must be used with caution, since a disturbance of electrolyte balance, dehydration or a disturbance of acid balance may arise.
Patients should be warned to expect frequent, liquid stools. Patients should be encouraged to drink as much liquid as possible to help prevent dehydration. Inadequate fluid intake when using any effective purgative may lead to excessive fluid loss possibly producing dehydration and hypovolemia. Dehydration and hypovolemia from purgation may be exacerbated by inadequate oral fluid intake, nausea, vomiting, loss of appetite, or use of diuretics, angiotensin converting enzyme inhibitors (ACE-Is), angiotensin receptor blockers (ARBS), and non-steroidal anti-inflammatory drugs (NSAIDs) and may be associated with acute renal failure. There have been rare reports of acute renal failure with purgatives, including sodium phosphates and PEG-3350.
Nephrocalcinosis associated with transient renal insufficiency and renal failure has been very rarely reported in patients using sodium phosphates for bowel cleansing; the majority of these reports occurred in elderly female patients taking drugs to treat hypertension or other drug products, such as diuretics or NSAIDs, that may result in dehydration. Patients with conditions that may predispose to dehydration or those taking medications which may decrease glomerular filtration rate, such as angiotensin converting enzyme inhibitors (ACE-I) or angiotensin receptor blockers (ARBs), should be assessed for hydration status prior to use of purgative preparations and managed appropriately. Care should be taken to prescribe Fleet Phospho-soda per recommendations with a particular attention to known contraindications and adequate hydration.
This product usually works within ½ to 6 hours. If there has been no bowel movement within 6 hours of taking Fleet Phospho-soda, instruct the patient to stop use and contact a doctor immediately as dehydration could occur.
4.5 Interaction with other medicinal products and other forms of interaction
No other sodium phosphate preparations should be given concomitantly.
4.6 Pregnancy and lactation
New information on pregnancy and lactation has been added:
For Fleet Phospho-soda, no clinical data on exposed pregnancies and no data from animal studies with respect to effects on pregnancy, embryonal/fetal development, parturition and postnatal development are available. The potential risk for humans is unknown. Fleet Phospho-soda should not be used during pregnancy unless clearly necessary.
It is not known whether Fleet Phospho-soda is excreted in human milk. As sodium phosphate may pass into the breast milk, it is advised that breast milk is expressed and discarded from the first dose to 24 hours after the second dose of the bowel cleansing solution. Women should not breast-feed their infants until 24 hours after receiving the second dose of Fleet Phospho-soda.
4.8 Undesirable effects
This section has been reorganised in System, Organ, Class.
The following undesirable effects have been added:
Myocardial infarction
Arrhythmia
Chest pain
Hypersensitivity
Tetany
Paraesthesia
Loss of consciousness
Renal failure acute
Renal failure chronic
Nephrocalcinosis
4.9 Overdose
New information added:
Patients experiencing overdose have presented the following symptoms: dehydration, hypotension, tachycardia, bradycardia, tachypnoea, cardiac arrest, shock, respiratory failure, dyspnoea, convulsions, ileus paralytic, anxiety, pain. Overdoses can lead to elevated serum levels of sodium and phosphate and decreased levels of calcium and potassium. In those cases, hypernatremia, hyperphosphatemia, hypocalcemia, hypokalemia, and acidosis may occur.
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