Fletcher’s Phosphate Enema (Long Tube)

Routine treatment of constipation. Pre- and post-operative cleansing of the bowel, in obstetrics and prior to proctoscopy, sigmoidoscopy or X-ray examination.

Posology

Adults, elderly and children over 12 years old:

One enema no more than once daily or as directed by a physician (see section 4.4).

Children aged 3 years to less than 12 years:

As directed by a physician (see sections 4.4 and 4.9).

Reduce adult dosage in proportion to body weight.

Children under 3 years of age:

Fletchers' Phosphate Enema is contraindicated in children under 3 years of age (see section 4.3).

Renal impairment

Do not administer to patients with clinically significant impairment of renal function (see section 4.3).

The product should be used with caution in patients with impaired renal function, when the clinical benefit is expected to outweigh the risk of hyperphosphataemia (see section 4.4).

Method of administration

For rectal administration only. The enema may be administered at room temperature or warmed in water before use.

Fletchers' Phosphate Enema is contraindicated in patients with:

• Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.

• Conditions causing increased absorptive capacity or decreased elimination capacity, such as when bowel obstruction or decreased bowel motility is present; e.g.,

  - congenital or acquired megacolon

  - imperforate anus

  - anorectal stenosis

  - Hirschsprung's disease

  - suspected intestinal obstruction

  - paralytic ileus.

• Undiagnosed gastrointestinal pathology, e.g.,

  - symptoms suggestive of appendicitis, intestinal perforation or active inflammatory bowel disease.

• Undiagnosed rectal bleeding.

• Congestive heart failure.

• Dehydration.

• Children under 3 years of age.

• Clinically significant impairment of renal function.

No other sodium phosphate preparations including sodium phosphate oral solution or tablets should be given concomitantly (see section 4.5).

Do not use Fletchers' Phosphate 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, especially patients with conditions that may predispose to dehydration or those taking medications which may decrease glomerular filtration rate, such as diuretics, angiotensin converting enzyme inhibitors (ACE-Is, e.g. enlaparil, ramipril, lisinopril), angiotensin receptor blockers (ARBs, e.g. losartan, candesartan, eprosartan, irbesartan, olmesartan, telmisartan, valsartan) or non-steroidal anti-inflammatory drugs (NSAIDs).

Since Fletchers' Phosphate Enema contains sodium phosphate, there is a risk of elevated serum levels of sodium and phosphate and decreased levels of calcium and potassium and consequently hypernatremia, hyperphosphatemia, hypocalcemia and hypokalemia may occur with clinical signs like tetany and renal failure. Electrolyte shifts are of particular concern in children with megacolon or any other condition where there is retention of enema solution, and in patients with co-morbidities. That is why Fletchers' Phosphate Enema should be used with caution in: elderly or debilitated patients and in patients with uncontrolled arterial hypertension, ascites, heart disease, rectal mucosal changes (ulcers, fissures), colostomy patients who are taking diuretics or other medications which may affect electrolyte levels, who are taking medications known to prolong the QT interval (such as amiodarone, arsenic trioxide, astemizole, azithromycin, erythromycin, clarithromycin, chlorpromazine, cisapride, citalopram, domperidone, terfenadine, procainamide), or pre-existing electrolyte imbalance such as hypocalcaemia, hypokalaemia, hyperphosphataemia, hypernatraemia. Use also with caution in patients who are taking medications known to affect renal perfusion or function, or hydration status. Where electrolyte disorders are suspected and in patients who may experience hyperphosphataemia, electrolyte levels should be monitored before and after administration of Fletchers' Phosphate Enema.

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

Use with caution in patients with intestinal obstruction. Care should be taken not to use undue force in administration of the enema especially in the elderly or debilitated patients or those with neurological disorders. Patients should be warned to stop administration if resistance is encountered as forced administration of the enema may cause injury. Rectal bleeding after using Fletchers' Phosphate Enema may indicate a serious condition. If this occurs, administration must be discontinued immediately and the condition of the patient assessed by a physician.

Repeated and prolonged use of Fletchers' Phosphate Enema is not recommended as it may cause habituation. Administration of more than one enema in a 24-hour period can be harmful. Unless directed by a physician Fletchers' Phosphate Enema should not be used for more than one week.

In general, evacuation occurs approximately 5 minutes after sodium phosphate enema administration. Retention time over 10 minutes is not recommended. If evacuation does not occur after using sodium phosphate enema or if the retention time lasts for more than 10 minutes, phosphatemia could occur. No further administrations should be given and the condition of the patient should be assessed by a physician who will decide if laboratory tests should be completed in order to detect possible electrolyte abnormalities and to minimise the risk of severe hyperphosphatemia (see sections 4.8 and 4.9).

Fletchers' Phosphate Enema and Phosphates Enema BP Formula B contain benzalkonium chloride which may cause local irritation.

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

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 (see section 4.4).

No other sodium phosphate preparations including sodium phosphate oral solution or tablets should be given concomitantly (see section 4.3).

As there is no relevant data available to evaluate the potential for foetal malformation or other foetotoxic effects when administered during pregnancy, Fletchers' Phosphate Enema should only be used as directed by a physician at the time of delivery or postpartum.

Fletchers' Phosphate Enema has no or negligible influence on the ability to drive and use machines.

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

Organized by MedDRA System Organ Class the undesirable effects are listed below using the following frequency classification: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data):

Immune system disorders

Not known: hypersensitivity e.g. urticaria.

Metabolism and nutrition disorders

Very common: hyperphosphataemia.

Common: hypocalcaemia.

Not known: hypernatremia, hypokalaemia, dehydration, metabolic acidosis, tetany.

Nervous system disorders

Common: dizziness.

Not known: syncope (primarily observed in elderly patients).

Gastrointestinal disorders

Very common: anal discomfort and proctalgia, abdominal pain and cramp, vomiting.

Common: nausea, diarrhoea.

Skin and subcutaneous tissue disorders

Very rare: blister, pruritus, stinging.

General disorders and administration site conditions

Very common: rectal irritation, pain, stinging.

Common: general malaise, chills.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

There have been fatalities when phosphate enema has been administered in excessive doses or retained, used in children or used in obstructed patients.

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

Recovery from the toxic effects can normally be achieved by rehydration. Treatment of electrolyte imbalance may require immediate medical intervention with appropriate electrolyte and fluid replacement therapy.

Pharmacotherapeutic group: Drugs for constipation, enemas, ATC code: A06AG11

Fletchers' Phosphate Enema is a solution of sodium dihydrogen phosphate dehydrate and disodium phosphate dodecahydrate. The formulation is equivalent to Phosphates Enema BP Formula B. Following rectal administration the active ingredients exert their laxative effect via their osmotic properties. The resulting fluid retention in the bowel encourages evacuation.

Saline laxatives are poorly and slowly absorbed following rectal administration. Transient serum phosphorus concentrations increase above the upper limit of normal were observed in 58% healthy volunteers between 10 minutes and 2 hours after administration of sodium phosphate enema (250 ml). The mean value of serum phosphorus concentration was 1,5 times higher in the treatment group than in the control group. Four subjects (17%) in this study had serum phosphorus concentration value ≥7 mg/dL, that is considered serious hyperphosphatemia.

Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction and development.

Benzalkonium chloride

Disodium Edetate

Purified Water

Not applicable.

3 years

Do not store above 25°C.

Translucent LDPE bottle with rubber non-return valve, plastic nozzle and nozzle plug containing 128 ml solution packed singly in a cardboard carton, or alternatively long-tube version with separate applicator with extension tube for attachment before use.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.