Fleet Phospho-soda 24.4g / 10.8g oral solution

Each 45ml bottle contains 5.0 g sodium.

Fleet Phospho-soda contains a very small amount of ethanol, less than 100 mg per dose.

For a full list of excipients, see Section 6.1

Oral solution. Clear colourless solution with a ginger-lemon odour, free from precipitation and turbidity.

As a bowel cleanser in preparing the patient for colon surgery, or for preparing the colon for x-ray or for endoscopic examination.

Bowel cleansing agents are not to be considered as treatments for constipation.

Adults Only: Not to be given to children under the age of 18 years.

Elderly patients: As for Adults.

The taking of Fleet Phospho-soda should be started the day before the hospital appointment.

For hospital appointments before 12 noon the dosage instructions for morning appointments should be followed and for appointments after 12 noon the dosage instructions for an afternoon appointment should be followed.

MORNING APPOINTMENT:

Day before appointment

7am – In place of breakfast drink at least one full glass of “clear liquid” or water, more if desired.

“Clear liquids” include water, clear soup, strained fruit juices without pulp, black tea or black coffee, clear carbonated and non-carbonated soft drinks.

1^st Dose – Straight afterwards, dilute 45ml in half a glass (120ml) cold water. Drink this solution followed by one full glass (240ml) cold water, more if desired.

Drink as much extra liquids as possible to replace the fluids lost during bowel movements.

1pm lunch – In place of lunch drink at least three full glasses (720ml) of “clear liquid” or water, more if desired.

7pm supper – In place of supper drink at least one full glass of “clear liquid” or water, more if desired.

2^nd Dose – Straight afterwards, dilute 45ml in half a glass (120ml) cold water. Drink this solution followed by one full glass (240ml) cold water, more if desired.

Additional water or “clear liquids” may be taken up until midnight if necessary.

Drinking large amounts of clear liquids also helps ensure that the bowel will be clean for the procedure.

AFTERNOON APPOINTMENT:

Day before appointment

1pm lunch – A light snack may be taken. After lunch, no more solid food must be taken until after the hospital appointment.

7pm supper – In place of supper drink at least one full glass of “clear liquid” or water, more if desired.

1^st Dose – Straight afterwards, dilute 45ml in half a glass (120ml) cold water. Drink this solution followed by one full glass (240ml) cold water, more if desired.

Drink as much extra liquids as possible to replace the fluids lost during bowel movements.

During the evening, drink at least three full glasses of water or “clear liquid” before going to bed.

Day of appointment

7am breakfast – In place of breakfast drink at least one full glass of “clear liquid” or water, more if desired.

2^nd Dose – Straight afterwards, dilute 45ml in half a glass (120ml) cold water. Drink this solution followed by one full glass (240ml) cold water

Drink as much extra liquids as possible to replace the fluids lost during bowel movements. Drinking large amounts of clear liquids also helps ensure that the bowel will be clean for the procedure.

More water or “clear liquid” may be taken up until 8am.

This product normally produces a bowel movement in ½ to 6 hours.

After the procedure:

In order to replace fluid lost during the preparation for the procedure patients should be encouraged to drink plenty of fluid afterwards.

Do not use:

• In children under the age of 18 years.

• When nausea, vomiting or abdominal pain are present.

• There is a hypersensitivity to the active ingredients or any of excipients.

Do not use in patients with:

• Clinically significant impairment of renal function;

• Primary hyperparathyroidism associated with hypercalcaemia

• Congestive heart failure;

• Ascites;

• Known or suspected gastrointestinal obstruction;

• Megacolon (congenital or acquired);

• Perforation;

• Ileus;

• Active inflammatory bowel disease.

Fleet Phospho-soda should not be used in combination with other laxative products containing sodium phosphate.

Dehydration

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.

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.

Patients with conditions that may predispose to dehydration or those taking medications which may decrease glomerular filtration rate, should be assessed for hydration status prior to use of purgative preparations and managed appropriately.

Nephrocalcinosis

Nephrocalcinosis associated with acute renal failure and deposits of calcium-phosphate crystals in the renal tubules has been rarely reported in patients using sodium phosphates for bowel cleansing; Nephrocalcinosis is a serious adverse event that may result in permanent renal function impairment and the requirement of long-term dialysis. 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.

Care should be taken to prescribe Fleet Phospho-soda per recommendations with a particular attention to known contraindications and adequate hydration.

At risk patients

Use with caution in patients with an increased risk for underlying renal impairment, 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 products that may result in dehydration, see below), hypotension with clinical impact or associated with hypovolaemia, , heart disease, acute myocardial infarction, unstable angina, , 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.

Electrolyte disorders

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.

Slight QT interval prolongation may rarely occur as a result of electrolyte imbalances such as hypocalcaemia or hypokalaemia. These changes are clinically insignificant.

Hypomotility

Use with caution in patients with hypomotility disorders or who have had gastro-intestinal surgery or have other medical conditions predisposing them to hypomotility disorders. 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.

Lesions

Single or multiple aphthoid-like punctiform lesions located in the rectosigmoid region have been observed by endoscopy. These were either lymphoid follicles or discrete inflammatory infiltrates or epithelial congestions/changes revealed by the colonic preparation. These abnormalities are not clinically significant and disappear spontaneously without any treatment.

Sodium content

Fleet Phospho-soda contains 5.0g sodium in each 45 ml dose. Consideration should therefore be given to the potential harm to patients requiring a low-sodium diet.

Use with caution in patients taking calcium channel blockers, diuretics, lithium treatment or other medications that might affect electrolyte levels as hyperphosphataemia, hypocalcaemia, hypokalaemia, hypernatraemic dehydration and acidosis may occur.

During the intake of Fleet Phospho-soda the absorption of drugs from the gastrointestinal tract may be delayed or even completely prevented. The efficacy of regularly taken oral drugs (e.g. oral contraceptives, antiepileptic drugs, antidiabetics, antibiotics) may be reduced or completely absent. Caution is also advised when taking medicines known to prolong the QT interval.

Use with caution in patients who are taking parathyroid hormone medications.

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.

Fleet^® Phospho-Soda^® may cause dizziness, probably as a result of dehydration, and this may have a mild to moderate effect on the ability to drive or use machinery.

The following adverse reactions were reported with frequencies corresponding to: Very common (>1/10), Common ( 1/100, < 1/10), Uncommon ( 1/1,000, < 1/100), Rare (1/10,000, < 1/1,000), Very rare ( 1/10,000). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

There have been fatal cases of hyperphosphataemia with concomitant hypocalcaemia, hypernatraemia and acidosis when Fleet Phospho-soda has been used in excessive doses, given to children or to obstructed patients.

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.

There are also documented cases of complete recovery from overdoses in both children accidentally given Fleet Phospho-soda, and also in patients with obstruction, one of whom received a six-fold overdose.

Recovery from the toxic effect of excess ingestion can normally be achieved by rehydration, though the intravenous administration of 10% calcium gluconate may be necessary.

A06AD – Osmotically acting laxative.

Fleet Phospho-soda is a saline laxative that acts by osmotic processes to increase fluid retention in the lumen of the small intestine. Fluid accumulation in the ileum produces distension and, in turn, promotes peristalsis and bowel evacuation.

Not applicable.

No animal studies on reproduction toxicity have been conducted with Fleet Phospho-soda.

Glycerol

Saccharin Sodium

Sodium Benzoate (E211)

Ginger Lemon Flavour*

Purified Water

*Ginger Lemon Flavour:

Not applicable.

3 years

Once opened, use immediately. Discard any unused portion.

Do not store above 25°C.

Fleet Phospho-soda is supplied in cartons containing 2 x 45ml or 100 x 45ml (hospital pack) polyethylene bottles with polypropylene, aluminium foil-lined screw caps.

Not all pack sizes may be marketed.

This product must be diluted with water before use.

Laboratorios Casen-Fleet S.L.U.

Autovía de Logroño, Km. 13,300

50180 UTEBO. Zaragoza (Spain)

PL 12695/0001

06 July 1995 / 30 April 2010

30 April 2010