ClearLax

Symptomatic treatment of constipation in adults and children from 8 years of age.

Colon cleansing while preparing the patient for the following procedures:

endoscopic or X-ray examination of the colon,

surgical interventions that require the absence of contents in the colon.

Preparation for endoscopic or X-ray examination of the colon, as well as for surgical interventions that require the absence of contents in the intestine.

Inside, 1-2 packages (preferably in the form of a single dose in the morning) or 1 package in the morning and evening in the case of taking 2 packages a day.

The daily dose should be adjusted according to the clinical effect and may vary from 1 packet each day (especially in children) to 2 packets per day.

The contents of each bag should be dissolved in a glass of water immediately before use.

The effect of taking the drug ClearLax^® expressed within 24-48 hours after administration.

The recommended course of treatment for children and adults is 3 months.

In children, treatment should not exceed 3 months due to insufficient clinical data.

Maintaining the effect after the restoration of normal bowel function should be carried out with the help of an active lifestyle and a diet rich in plant fiber.

If the symptoms of constipation persist for more than 3 months, it is necessary to conduct a second extended diagnostic examination.

Inside.

The drug can only be used in adult patients (older than 15 years).

The contents of one bag should be dissolved in 1 liter of water and stirred until completely dissolved.

The solution should be taken in a dosage equal to 1 liter per 15-20 kg of body weight, which is approximately 3-4 liters.

The solution can be taken once (4 liters in the evening, on the eve of the study or operation) or divided into 2 doses (2 liters the night before and 2 liters in the morning), the drug should be finished 3-4 hours before the procedure.

Inside, on an empty stomach. The contents of the package (14 g) are dissolved in 200 ml of water. Take 18-20 hours before the study or surgery 3 liters of solution (approximately 200 ml at intervals of 20 minutes).

During the reception and after it, only liquid food is consumed. The recommended hours of taking the drug are 14-19 hours.

After 22 hours, the meal is not shown.

hypersensitivity to macrogol (polyethylene glycol) or any of the components of the drug,

serious inflammatory bowel diseases (ulcerative colitis, Crohn's disease) or toxic dilation of the colon, combined with symptomatic stenosis,

perforation or threat of perforation of the gastrointestinal tract,

intestinal obstruction or suspected intestinal obstruction,

abdominal pain of unclear etiology,

children under 8 years of age.

hypersensitivity to polyethylene glycol, as there are reports of very rare allergic reactions (rash, edema, in isolated cases-anaphylactic shock) to the use of drugs containing polyethylene glycol,

a serious condition of the patient (for example, dehydration or severe heart failure),

the presence of a malignant tumor or other disease of the colon, accompanied by extensive damage to the intestinal mucosa,

complete or partial intestinal obstruction,

age up to 15 years (due to lack of clinical data).

severe disorders of the general condition of the patient (including dehydration, heart failure),

intestinal obstruction,

toxic expansion of the colon,

stenosis of the stomach,

perforation of the stomach or intestines,

erosive and ulcerative lesions of the gastrointestinal tract,

impaired renal function.

Adults

Side effects observed in clinical trials on 600 patients were transient in nature, and were observed with the following frequency.

From the gastrointestinal tract: often (more than 1/100, less than 1/10) - bloating and / or pain, nausea, diarrhea, rarely (more than 1/1000, less than 1/100) - vomiting, urgent urge to defecate and fecal incontinence.

Additional information obtained from post-marketing observations. Very rare (less than 1/10000) - cases of hypersensitivity: pruritus, urticaria, transient rash, facial edema, Quincke's edema, and in some cases-anaphylactic shock, frequency unknown-occurrence of diarrhea leading to electrolyte imbalance (hyponatremia, hypokalemia) and/or dehydration, especially in adult patients.

Children

Side effects related to the gastrointestinal tract were minimal and transient in clinical studies involving 147 children aged 6 months to 15 years, were detected with the following frequency.

From the gastrointestinal tract: often (more than 1/100, less than 1/10) — diarrhea and abdominal pain, rarely (more than 1/1000, less than 1/100) - flatulence, nausea and vomiting, frequency unknown-hypersensitivity reactions.

Diarrhea can cause pain in the perianal area.

Nausea and vomiting were reported at the beginning of the drug, which stopped with continued use.

Possible bloating.

There were very rare cases of skin allergic reactions in the form of rashes and edema. Isolated cases of anaphylactic shock have also been reported.

In rare cases, nausea and vomiting, a feeling of heaviness and discomfort when taking the first doses of the drug are possible.

Symptoms: diarrhea.

Treatment: dose reduction or discontinuation of therapy. Excessive fluid loss due to diarrhea or vomiting may require correction of electrolyte disturbances.

No data available.

The high-molecular compound macrogol 4000 is a linear polymer that holds water molecules by means of hydrogen bonds. Due to this, after oral administration of the drug, the volume of intestinal contents increases.

The volume of unabsorbed fluid in the intestinal lumen supports the laxative effect of the solution.

The high-molecular compound macrogol 4000 is a linear polymer that holds water molecules by means of hydrogen bonds. This increases the osmotic pressure and the volume of intestinal contents.

The electrolytes contained in the preparation prevent the violation of the water-electrolyte balance in the body.

Macrogol 4000 is not absorbed in the gastrointestinal tract and is not metabolized.

The action of the drug is based on the combination of a high-molecular polymer with an isotonic solution of electrolytes. Polyethylene glycol MM 4000 prevents the absorption of water from the stomach and intestines and promotes the accelerated evacuation of intestinal contents by frequent defecation. The electrolytes contained in the preparation prevent the violation of the water-electrolyte balance of the body.

Not described. It is possible to slow the absorption of drugs taken simultaneously with the drug ClearLax^®. Therefore, it is recommended to assign ClearLax^® at least 2 hours after the administration of other drugs.

Diarrhea caused by taking ClearLax^® may lead to violation of the absorption of other drugs taken at the same time.