2. Qualitative and Quantitative Composition
Names of the active ingredients have been updated to reflect European Pharmacopoeial nomenclature:
Sodium Dihydrogen Phophate Dihydrate and Disodium Phosphate Dodecahydrate
3. Pharmaceutical Form
The short term “enema” has been added to read: Rectal Solution (Enema)
The product description has been added to read:
Clear, colourless, odourless, solution, free from precipitation and turbidity.
4.1 Therapeutic indications
This section has been re-formatted and slightly reworded for ease of reading:
· For use in the relief of occasional constipation
· For use where bowel cleansing is required, such as before and after lower bowel surgery, delivery and post partum, before proctoscopy, sigmoidoscopy or colonoscopy and before radiological examinations of the lower bowel
4.2 Posology and method of administration
Method of administration moved from section 6.6
4.3 Contraindications
This section has been reformatted for clarity.
The following contraindications have been added:
· suspected intestinal obstruction
· paralytic ileus
· anorectal stenosis
· acquired megacolon
· symptoms of appendicitis, intestinal perforation or active inflammatory bowel disease
· undiagnosed rectal bleeding
· dehydration and generally in all cases where absorption capacity is increased or elimination capacity is decreased
· Children under 3 years of age
The use in children under 3 years of age has been contraindicated to reinforce the message in section 4.2.
4.4 Special warnings and precautions for use
This section has been revised extensively to accommodate upgrading of warnings to contraindications and to reflect current practise.
New warnings and precautions:
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
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.
4.5 Interaction with other medicinal products and other forms of interaction
The well established potential interaction with lithium treatment has been added, and the possibility of dehydration due to disturbed electrolyte levels.
4.6 Pregnancy and lactation
This section has been revised to add pragmatic advice for use in pregnancy and while breast feeding:
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.
4.8 Undesirable effects
This section has been extensively revised to reflect post-marketing experience and reformatted to display undesirable effects by System Organ Class and Preferred term.
The undesirable effects below have been added:
Hypersensitivity e.g. urticria, pruritus
Dehydration
Hyperphosphataemia
Hypocalcaemia
Hypokalaemia
Hypernatraemia
Metabolic acidosis
Nausea
Vomiting
Abdominal pain
Abdominal distension
Diarrhoea
Gastrointestinal pain
Pruritis ani
Chills
Rectal irritation
Blistering
Stinging
Pruritus
Pain
4.9 Overdose
This section has been revised to reflect post-marketing experience and provide additional advice on using dialysis in an overdose situation:
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
5.1 Pharmacodynamic properties
This section has been rephrased for clarity to read:
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
This section has been expanded to include pharmacokinetic data which informs the contraindications, and special warnings and special precautions sections:
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 sample Under normal conditions the greatest phosphorus absorption occurs in the small bowel which is never reached from rectal administration.
7. Marketing Authorisation Holder
The MAH address has been updated:
E. C. De Witt and Company Limited
Aegon House
Daresbury Park
Daresbury
Warrington
Cheshire
WA4 4HS
United Kingdom
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