KLEAN-PREP 69G SACHET POWDER FOR ORAL SOLUTION - summary of medicine characteristics

1 NAME OF THE MEDICINAL PRODUCT

KLEAN PREP 69g, sachet powder for oral solution

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each sachet of Klean-Prep contains the following active ingredients:

The content of electrolyte ions per sachet when made up to one litre of water is as follows:

Excipient with known affect:

Aspartame 49mg per sachet.

For the full list of excipients, see 6.1.

3 PHARMACEUTICAL FORM

Powder for oral solution.

A whitish powder which, when dissolved in water, gives a clear, colourless solution for oral administration.

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

For colonic lavage prior to diagnostic examination or surgical procedures requiring a clean colon, eg colonoscopy, barium enema or colonic resection.

4.2 Posology and method of administration

Adults: Each sachet should be dissolved in 1 litre of water. The usual dose is up to 4 sachets taken at a rate of 250ml every 10 to 15 minutes until the total volume is consumed or rectal effluent is clear, or as directed by the physician. The solutions from all 4 sachets should be drunk within 4 to 6 hours. Alternatively, administration may be divided, for example, taking 2 sachets during the evening before the examination, and the remaining 2 sachets on the morning of the examination.

If administration is by nasogastric tube, the usual rate should be 20 to 30ml/minute.

Children: There is no recommended dosage.

Renal patients: No dosage adjustment need be made.

4.3. Contrain­dications

Do not use in patients with known or suspected:

– hypersensitivity to the active substances or to any of the excipients listed in section 6.1

– gastrointestinal obstruction or perforation

– ileus

– gastric retention

– toxic colitis and toxic megacolon

– congestive cardiac failure (NYHA class III or IV)

4.4. Special warnings and precautions for use

The fluid content of Klean-Prep when reconstituted with water does not replace regular fluid intake and adequate fluid intake must be maintained.

No solid food should be eaten for at least 2 hours before taking Klean-Prep. The product should only be administered with caution to patients with impaired gag reflex, reflux oesophagitis, or those with diminished levels of consciousness and patients with ulcerative colitis.

There have been rare reports of serious arrhythmias including atrial fibrillation associated with the use of ionic osmotic laxatives for bowel preparation. These occur predominantly in patients with underlying cardiac risk factors and electrolyte disturbance.

Unconscious, semi-conscious patients or patients prone to aspiration or regurgitation should be observed during administration especially if this is via the nasogastric route. There have been reports of pulmonary oedema resulting from aspiration of macrogol lavage solutions requiring immediate treatment.

Although not expected due to the isotonic composition of the product, cases of electrolyte disturbances have been rarely reported in at-risk patients. Therefore, Klean-Prep should be used with care in patients at risk of electrolyte disturbance, such as patients with renal failure, mild (NYHA class I and II) congestive cardiac impairment (see also section 4.3), or those simultaneously treated with diuretics.

Convulsions associated with severe hypnoatraemia in patients taking Klean-Prep have been

reported (see section 4.8).

Patients may also develop confusional state/disorien­tation associated with hyponatraemia (see section 4.8).

Should nausea, vomiting, abdominal distension or pain arise, the rate of administration should be slowed down or temporarily stopped until symptoms subside.

In debilitated patients, patients with poor health, those with clinically significant renal impairment, arrhythmia and those at risk of electrolyte imbalance, the physician should consider performing a baseline and post-treatment electrolyte, renal function test and ECG as appropriate.

Caution should be used in patients with an impaired gag reflex, reflux oesophagitis, or diminished levels of consciousness.

Klean-Prep contains aspartame, which is metabolised to phenylalanine. This may be harmful for patients with phenylketonuria.

Ischaemic colitis

Post-marketing cases of ischaemic colitis, including serious, have been reported in patients treated with macrogol for bowel preparation. Macrogol should be used with caution in patients with known risk factors for ischaemic colitis or in case of concomitant use of stimulant laxatives (such as bisacodyl or sodium picosulfate). Patients presenting with sudden abdominal pain, rectal bleeding or other symptoms of ischaemic colitis should be evaluated promptly.

Neither non-clinical nor clinical data are available to assess aspartame use in infants below 12 weeks of age.

This medicinal product contains 125 mmol (2.9 g) sodium per sachet of treatment. To be taken into consideration by patients on a controlled sodium diet.

4.5 Interactions with other medicinal products and other forms of interaction

Oral medication taken within one hour of administration of Klean-Prep may be flushed from the gastro-intestinal tract and not absorbed.

4.6. Fertility, Pregnancy and lactation

The preparation should only be used during pregnancy and lactation if considered essential by the physician. There is no experience of use during pregnancy. The purpose and mechanisms of use should be borne in mind if the physician is considering administration.

4.7 Effects on ability to drive and use machines

There is no known effect on the ability to drive and use machines.

4.8. Undesirable effects

The most commonly experienced undesirable effects are gastrointestinal in nature.

The following Adverse Events have been observed in post-marketing experience and therefore the frequencies are not known:

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 Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple store.

4.9 Overdose

5   PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

ATC Code: A06A D

Macrogol 3350 exerts its effects by virtue of its osmotic effect in the gut, which induces a laxative effect. Electrolytes are present in the formulation and are exchanged across the intestinal barrier (mucosa) with serum electrolytes and water to prevent the occurrence of potential clinically significant variations of net electrolyte or net water balance.

Macrogol 3350 increases the stool volume, which triggers colon motility via neuromuscular pathways. The physiological consequence is an improved propulsive colonic transportation of the softened stools and a facilitation of the defecation.

5.2. Pharmaco­kinetic properties

Macrogol 3350 is unchanged along the gut. It is virtually unabsorbed from the gastro-intestinal tract. Any macrogol 3350 that is absorbed is excreted via the urine.

Osmotically-acting bowel preparations lead to a copious diarrhoea, resulting in extensive elimination of most of the product via the faeces. They can also lead to changes in electrolyte balance in the body, often with depletion of sodium and potassium. The additional sodium and potassium included in the Klean-Prep formulation help to balance the electrolytes. While some absorption of sodium takes place, the bulk of sodium is expected to be excreted in the faeces as the sodium salts of sulfate, the osmotic active ingredients included in the Klean-Prep composition.

5.3 Preclinical safety data

Preclinical studies provide evidence that macrogol 3350 has no significant systemic toxicity potential.

6.1 List of excipient(s)

Vanilla flavour

Aspartame 0.049 g per sachet

6.2 Incompatibilities

None are known

6.3 Shelf life

Sachets: 3 years

Solution after reconstitution: 24 hours

6.4 Special precautions for storage

Sachets: Store in a dry place. Do not store above 25°C.

Reconstituted solution: Store in a refrigerator (2 – 8°C)

6.5 Nature and contents of container

Sachets containing 69gm white powder, in a box of 4 sachets

6.6 Special precautions for disposal

The solution should be used within 24 hours.