COLOPEG Powder for oral solution 4Sachet/68,6g

Sodium chloride ..................................................................................................................... 1,461 g

Anhydrous sodium sulfate .......................................................................................................... 5,682 g

Potassium chloride ................................................................................................................. 0,746 g

Sodium bicarbonate ................................................................................................................ 1,680 g

Polyethylene glycol 3350 (Macrogol 3350)................................................................................. 59,000 g

For one sachet of 68,569 g

Each sachet contains 2874,6 mg of sodium and 390 mg of potassium.

Colonic lavage preparing patients prior to endoscopic or radiological examinations, or to colonic surgery.

Dosage

Reserved for adults.

Dissolve the contents of the sachet in one litre of water. The box may be used to prepare the solution. Stir until the powder is completely dissolved.

The average dosage is 3 to 4 litres of reconstituted solution depending on the patient's body weight.

The preparation may be ingested as a single dose or in divided doses according to two dosage schedules, provided that the entire prepared solution is always ingested:

In divided doses: half of the total dose the day before the procedure and the other half between 3 and 8

hours before the examination according to one of the following schedules:

 - either 2 litres ingested the evening before and 2 litres the morning of the examination, ingesting the last glass 3 to 4 hours before the examination,

 - either 3 litres ingested the evening before and 1 litre the morning of the examination, ingesting the last glass 3 to 4 hours before the examination.

In a single dose: 3 to 4 litres the evening before (approximately 1 litre per 20 kg of body mass) with

optionally a one-hour pause after administration of the first 2 litres.

The recommended rate of ingestion is 1 to 1,5 litre per hour (i.e. 250 ml every 10 to 15 minutes).

The physician may adapt the recommended rate according to the patient's clinical condition and any comorbidities.

Method of administration

Oral use.

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

• Severe heart failure.

• Severe alterations of general condition such as dehydration.

• Advanced carcinoma or any other colonic pathology causing excessive mucosal fragility.

• Acute phases of inflammation of the intestinal tract including Crohn's disease and ulcerative colitis.

• Digestive perforation or risk of perforation.

• Patients likely to present with or who already have ileus.

• Patients likely to present with or who already have gastrointestinal obstruction or stenosis.

• Gastric emptying disorders (e.g., gastroparesis, gastric stasis).

• Toxic colitis or toxic megacolon.

• Children under 15 years of age.

This medicine contains polyethylene glycol. Very rare allergic-type reactions (rash, urticaria, edema) have been described with products based on polyethylene glycol. Exceptional cases of anaphylactic shock have been reported.

Diarrhea resulting from the use of this medicine may considerably disrupt the absorption of medicines administered simultaneously (see section Interactions).

This medicine contains 2874,6 mg of sodium per sachet, which is equivalent to 143,73% of the maximum recommended daily dietary intake of 2 g of sodium per adult set by the WHO.

COLOPEG is considered to have a high sodium content. This must be taken into particular consideration for patients on a low-sodium diet (heart failure, hypertension, for example).

This medicine contains 390 mg of potassium per sachet; therefore, the product should be used with caution and under medical supervision in patients prone to fluid and electrolyte disorders (such as patients with impaired renal function, heart failure, a controlled potassium intake, or those concomitantly treated with diuretics).

The product must be administered with caution and under close supervision in patients prone to regurgitation, bedridden patients, or patients with impaired neurological function and/or motor disorders, due to the risk of inhalation. In these patients, the product should be given in a sitting position, possibly via a gastric tube.

Ischemic colitis

Pharmacovigilance has shown that cases of ischemic colitis, some of them serious, have been reported in patients treated with macrogol as part of bowel preparation. Macrogol should be used with caution in patients with known risk factors for ischemic colitis or when stimulant laxatives (such as bisacodyl or sodium picosulfate) are used concomitantly. Patients presenting with sudden abdominal pain, rectal bleeding or other symptoms of ischemic colitis should undergo prompt evaluation.

Convulsion

Cases of convulsions associated with the use of macrogol 3350 with electrolytes for colonic preparation have been observed in patients, with or without a history of convulsions. These cases were mainly associated with electrolyte abnormalities such as severe hyponatremia (see section Adverse effects). Use with caution in patients with a history of convulsions, an increased risk of convulsions, or a risk of electrolyte imbalance. In the event of neurological symptoms, fluid and electrolyte imbalances must be corrected.

Esophageal rupture

Cases of esophageal rupture (Boerhaave syndrome) associated with excessive vomiting after taking (see section Adverse effects) of macrogol 3350 with electrolytes for colonic preparation have been reported post-marketing, mainly in elderly patients. Advise patients to stop administration and consult a doctor immediately in the event of uncontrollable vomiting followed by thoracic, cervical or abdominal pain, dysphagia, hematemesis or dyspnea.

Precautions in the elderly :

Although the formula of Colopeg, oral solution powder, was designed to avoid possible variations in biological parameters, precaution is nevertheless recommended when using it in elderly patients.

The onset of secondary diarrhea due to increased intestinal motility caused by COLOPEG, oral solution powder, may lead to a significant decrease in the absorption of concomitantly administered medicines. For medicines with a narrow therapeutic margin or a short half-life (for example digoxin, antiepileptics), efficacy may be particularly affected.

Associations requiring precautions for use:

• Related to the presence of sodium chloride and sodium bicarbonate

+ Lithium

Risk of reduced efficacy of lithium due to increased renal elimination by sodium salts.

Avoid sodium overload and take into account the presence of sodium in certain medicines such as antacids.

+ Hydroquinidine

Increased plasma concentrations of hydroquinidine and risk of overdose (decreased renal excretion of hydroquinidine due to urinary alkalinisation).

Clinical monitoring, ECG and possibly monitoring of hydroquinidine concentrations; if necessary, adjust the dosage during alkalinising treatment and after its discontinuation.

+ Quinidine

Increased plasma concentrations of quinidine and risk of overdose (decreased renal excretion of quinidine due to urinary alkalinisation).

Clinical monitoring, ECG and possibly monitoring of quinidinaemia; if necessary, adjust the dosage during alkalinising treatment and after its discontinuation.

Associations to take into account:

• Related to the presence of macrogol

+ Medicinal products administered orally

With laxatives, particularly in view of endoscopic examinations: risk of reduced efficacy of the medicinal product administered with the laxative.

Avoid taking other medicinal products during and after ingestion for at least 2 h after taking the laxative, or even until the examination is performed.

Pregnancy

Animal studies have not shown any teratogenic effect.

There are no controlled studies on the use of Colopeg, powder for oral solution in pregnant women.

However, Colopeg, powder for oral solution is very poorly absorbed and has very low systemic passage. Consequently, its use should be considered during pregnancy only if necessary and after medical advice.

Breast-feeding

There are no controlled studies on the excretion of macrogol 3350 into milk. As macrogol 3350 is poorly absorbed, this medicinal product may be taken during breastfeeding only on medical advice.

Fertility

No study in humans has been performed.

Studies in animals (male and female) did not show any significant alterations of reproductive parameters.

COLOPEG, powder for oral solution has no or negligible effect on the ability to drive vehicles and use machines.

Diarrhoea is an expected effect of bowel preparation. Due to the nature of the examination, the most frequently observed adverse effects are gastrointestinal effects such as nausea, vomiting, flatulence, diarrhoea, abdominal pain and abdominal distension.

The table below lists adverse effects reported by system organ class and by frequency according to the following convention: very common (≥ 1/10); common (≥1/100, <1/10); uncommon (≥ 1/1000, <1/100); rare (≥ 1/10 000, <1/1000); very rare (<1/10 000); and frequency not known (cannot be estimated from the available data).

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 reaction via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Centres of Pharmacovigilance - Website: https://signalement.social-sante.gouv.fr/.

An overdose results in diarrhoea and/or metabolic acidosis, which resolve upon temporary discontinuation of treatment or dose reduction. Significant fluid losses during diarrhoea may require correction of electrolyte disturbances.

Pharmacotherapeutic class: OSMOTIC LAXATIVE ATC code: A06AD65  

High molecular weight macrogols (3350) are long linear polymers to which water molecules are retained by hydrogen bonds. When administered orally, they cause an increase in the volume of intestinal fluids.

The volume of unabsorbed intestinal fluid is responsible for the laxative properties of the solution.

The electrolyte content of the reconstituted solution is such that electrolyte exchanges between intestine and plasma can be considered nil.

Pharmacokinetic data confirm the absence of digestive absorption and biotransformation of macrogol 3350 after oral ingestion.

Before reconstitution: 5 years.

After reconstitution: 72 hours between 2°C and 8°C (in a refrigerator).

Before reconstitution : No special requirements.

After reconstitution : Store between 2°C and 8°C (in a refrigerator).

No special requirements.