CLEEN READY-TO-USE

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Hepatic impairment:

No dose adjustment is required in patients with hepatic impairment 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.

Cleen Ready-to-Use Enema is well tolerated when used as indicated. However, adverse events possibly associated with the use of Cleen Ready-to-Use Enema have been infrequently reported. In some cases, adverse events may occur, especially if the enema is misused.

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. g. urticaria. Skin and subcutaneous tissue disorders Very rare: blister, pruritus, stinging. Metabolism and nutrition disorders Very rare: dehydration, hyperphosphataemia, hypocalcaemia, hypokalaemia, hypernatremia, metabolic acidosis.

Gastrointestinal disorders:

Very rare: nausea, vomiting, abdominal pain, abdominal distension, diarrhoea, gastrointestinal pain, anal discomfort and proctalgia.

General disorders and administration site conditions:

Very rare: rectal irritation, pain, stinging, 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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Do not use Cleen Ready-to-Use Enema when nausea, vomiting or abdominal pain is present unless directed by a physician. g. g. losartan, candesartan, eprosartan, irbesartan, olmesartan, telmisartan, valsartan) or non-steroidal anti-inflammatory drugs (NSAIDs).

Since Cleen Ready-to-Use Enema contains sodium phosphates, 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 Cleen Ready-to-Use 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 Cleen Ready-to-Use 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. Repeated and prolonged use of Cleen Ready-to-Use Enema is not recommended as it may cause habituation.

1 . . , o symptoms suggestive of appendicitis, intestinal perforation or active inflammatory bowel diseaseUndiagnosed rectal bleeding • Congestive heart failure. • Dehydration • Children under 3 years of age. • Clinically significant impairment of renal function.

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