Source: Health Products Regulatory Authority (IE) Revision Year: 2021 Publisher: Laboratoires Mayoly Spindler, 6 avenue de leurope BP 51, 78401 CHATOU Cedex, France
This medicine is indicated for cleansing of the bowel when required as a preparation for certain diagnostic procedures such as colonoscopy.
Coloprep is indicated in adults over 18 years of age.
The usual adult dosage of this medicine is 32 tablets. The total dose of phosphate is 32.79 g.
The intake of this medicine should begin the day before the colonoscopy. The day before the colonoscopy, patients may have a light, low-fibre breakfast (coffee or tea with or without sugar, toast, butter or equivalent, fruit jelly or honey). After noon, taking only “clear liquids” is permitted. “Clear liquid” may be water, light soup, diluted fruit juice without pulp, weak tea or black coffee, light soda with or without bicarbonate.
The evening before the colonoscopy procedure:
The day of the colonoscopy procedure, (starting 3-5 hours before the procedure):
For early morning colonoscopy, it is possible to adapt the dosing schedule by taking all the tablets in the evening before the procedure, and with an interval of at least 4 hours between the beginning of the intake of the first 20 tablets (to be absorbed at the rate of 4 tablets with 250ml of water or another clear liquid every 15 minutes) and the intake of the last 12 tablets (to be absorbed at the rate of 4 tablets with 250ml of water or another clear liquid every 15 minutes).
Patients should be advised of the importance of following the recommended fluid regimen and of drinking as much liquid as possible to replace lost fluids by increased intestinal peristalsis. Drinking large amounts of clear liquid also helps ensure the cleanliness of the colon during colonoscopy. See Section 4.4 Special warnings and precautions for use.
Patients should not repeat this dosage for at least seven days. No additional laxatives are necessary when taking this medicine, particularly those agents containing sodium phosphate
In the elderly, the dosage is identical to that of adults. It may be useful to assess renal function before use in the elderly. This product is contraindicated in patients over 75 years of age (See section 4.3).
Do not administer to children and adolescents under 18 years of age.
This medicine should be administered orally according to the recommended administration regimen or to the alternative administration regimen in case of morning colonoscopy as described above.
Each intake of 4 tablets must be done with 250 ml of water or another clear liquid.
No solid food should be taken from the start of the course of treatment until after the clinical procedure.
In case of overdose, patients may experience the following symptoms: dehydration, hypovolaemia, hypotension, cardiac arrhythmias, tachypnea, cardiac arrest, shock, respiratory failure, dyspnea, convulsions, paralytic ileus, anxiety, pain. Overdoses can lead to high sodium and phosphate serum concentrations and to a decrease in calcium and potassium concentrations. In such cases, hypernatraemia, hyperphosphataemia, hypocalcaemia, hypokalaemia and acidosis may occur.
When taking excessive doses of this medicine, fatal cases of hyperphosphataemia with concomitant hypocalcaemia, hypernatraemia and acidosis have been reported in children or patients with bowel obstruction.
Cases of complete recovery after overdose have also been documented both in children after accidental ingestion of this medicine and in patients with bowel obstruction, one having taken six times the recommended dose.
Treatment of overdose usually consists in rehydration; the administration of intravenous 10% calcium gluconate may be needed.
36 months.
Keep the bottle tightly closed in order to protect from moisture.
High-density polyethylene (HDPE) bottles with sealing pad and child-resistant cap, containing 2 silica gel desiccants.
There are 32 tablets in each bottle.
Not applicable.
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