Fleet Ready-to-use enema

SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE MEDICINAL PRODUCT
Fleet Ready-to-Use 21.4g / 9.4g Enema

2. QUALITATIVE AND QUANTITATIVE COMPOSITION
The delivered dose contains 4.4 g of sodium
For a full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM
Rectal Solution (Enema)
Clear, colourless, odourless, solution, free from precipitation and turbidity.

4. CLINICAL PARTICULARS

4.1 Therapeutic indications
4.2 Posology and method of administration

Posology
Adults, Elderly and Children over 12 years old: 1 bottle (118ml delivered dose) no more than once daily or as directed by a physician
Children aged 3 years to less than 12 years: As directed by a physician.
Do not administer to children under 3 years of age

Method of administration
For rectal use only:

Lie on left side with both knees bent, arms at rest.
Remove orange protective shield.
With steady pressure, gently insert enema Comfortip into anus with nozzle pointing towards navel.
Squeeze bottle until nearly all liquid is expelled.
Discontinue use if resistance is encountered. Forcing the enema can result in injury.
Return enema to carton for disposal.
Generally, 2 to 5 minutes are sufficient to obtain the desired effect. If delayed discontinue further use and consult a physician

For occasional constipation rectal enemas are to be used to provide short-term relief only.

4.3 Contraindications
Fleet Ready-to-Use Enema is contraindicated in patients with:

disease
elimination capacity is decreased

4.4 Special warnings and precautions for use
Do not use Fleet Ready-to-use enema when nausea, vomiting or abdominal pain is present unless directed by a physician.

Patients should be advised to expect liquid stools and should be encouraged to drink clear liquids to help prevent dehydration
Use with caution in: elderly or debilitated patients and in patients with uncontrolled arterial hypertension, ascites, heart disease, rectal mucosal changes (ulcers, fissures), colostomy or pre-existing electrolyte imbalance as hypocalcaemia, hypokalaemia, hyperphosphataemia, hypernatraemia and acidosis may occur. Where electrolyte disorders are suspected and in patients who may experience hyperphosphataemia, electrolyte levels should be monitored before and after administration of Fleet Ready-to-Use Enema.

The product should be used with caution in patients with abnormal renal function. Where the clinical benefit is expected to outweigh the risk of hyperphosphataemia

Repeated and prolonged use of Fleet Ready-to-Use Enema is not recommended as it may cause habituation. Unless directed by a physician, Fleet Ready-to-use enema should not be used for more than two weeks.
Rectal bleeding or failure in bowel evacuation after using Fleet Ready-to-Use Enema (evacuation occurs within 5 minutes of administration) may indicate a serious condition. No further administrations should be given and the condition of the patient should be assessed by a physician.

Fleet Ready-to-Use Enema should be administered following the instructions for use and handling (see section 4.2). Patients should be warned to stop administration if resistance is felt because forced administration may cause local damage.

Keep all medicines out of the reach and sight of children.

4.5 Interaction with other medicinal products and other forms of interaction
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.

As hypernatraemia is associated with lower lithium levels, concomitant use of Fleet RTU Enema and lithium therapy could lead to a fall in serum lithium levels with a lessening of effectiveness.

4.6 Pregnancy and lactation
As there is no relevant data available to evaluate the potential for foetal malformation or other foetotoxic effects when administered during pregnancy Fleet Ready-to-Use Enema should only be used as directed by a physician at the time of delivery or postpartum.

As sodium phosphate may pass into the breast milk, it is advised that breast milk is expressed and discarded for up to 24 hours after receiving the Fleet Ready-to-Use Enema.

4.7 Effects on ability to drive and use machines
Not relevant.

4.8 Undesirable effects
The frequencies of adverse reactions to Fleet Ready-to-Use Enema are not known (cannot be estimated from the available data). Adverse reactions that have been reported are presented below by System Organ Class and Preferred term.

IMMUNE SYSTEM DISORDERS	Hypersensitivity e.g. urticria, pruritus
METABOLISM AND NUTRITION DISORDERS	Dehydration Hyperphosphataemia Hypocalcaemia Hypokalaemia Hypernatraemia Metabolic acidosis
GASTROINTESTINAL DISORDERS	Nausea Vomiting Abdominal pain Abdominal distension Diarrhoea Gastrointestinal pain Pruritis ani
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	Chills Rectal irritation Blistering Stinging Pruritus Pain

4.9 Overdose
There have been fatalities when Fleet Ready-to-use Enema has been administered in excessive doses or retained, used in children or used in obstructed patients.

Hyperphosphataemia, hypocalcaemia, hypernatraemia, hypernatraemic dehydration, acidosis and tetany may occur in overdose or retention.

Recovery from the toxic effects can normally be achieved by rehydration. In severe cases correction of electrolyte changes by providing calcium and magnesium salts (10% calcium gluconate) while promoting elimination of exogenous phosphorus and the use of dialysis should be considered

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties
ATC classification: A06AG01 Sodium phosphate enema
Fleet Ready-to-Use Enema will act as a saline laxative when administered by the rectal route. Fluid accumulation in the lower bowel produces distension and promotes peristalsis and bowel movement with only the rectum, sigmoid and part or all of the descending colon being evacuated.

5.2 Pharmacokinetic properties
Colonic absorption is probably minimal, but it has been reported that asymptomatic hyperphosphataemia up to 2–3 times above normal phosphorus levels occurs in nearly 25% of individuals with normal renal function after administration of ORAL sodium phosphate containing colonic preparations. Data for rectal solutions has been generated by a small, open-label, healthy volunteer company sponsored study which looked at both 250mL (high volume) and 133mL sodium phosphate enemas. This study confirmed a transient increase in serum phosphate above the upper limit of normal in 30% of subjects, with mean phosphorus levels falling after the 10-minute sampleUnder normal conditions the greatest phosphorus absorption occurs in the small bowel which is never reached from rectal administration.

5.3 Preclinical safety data
No preclinical safety studies have been performed.

6. PHARMACEUTICAL PARTICULARS

6.1 List of Excipients
Disodium Edetate

Benzalkonium Chloride

Purified water

Nozzle lubricant : white soft paraffin

6.2 Incompatibilities
None reported or expected

6.3 Shelf life
3 years

6.4 Special precautions for storage
Do not store above 25°C.
Do not refrigerate

6.5 Nature and contents of container
Fleet Ready-to-Use Enema is supplied in a 133ml disposable LDPE squeeze bottle, fitted with a LDPE cap, neoprene/isoprene free-latex valve and a soft pre-lubricated Comfortip (ethylene vinyl acetate), which is covered by a protective LDPE shield until use.

The bottle contains 133ml of Fleet Ready-to-Use Enema, which gives a delivered dose of 118ml.

6.6 Special precautions for disposal
No special requirements.

7. MARKETING AUTHORISATION HOLDER
Laboratorios Casen-Fleet S.L.U.
Autovía de Logroño, Km 13,300
50180 UTEBO
Zaragoza
Spain

8. MARKETING AUTHORISATION NUMBER(S)
PL 12695/0003

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
07th October 1993 / 09th February 1999 / 09th February 2004