Moviprep, sachet 111, 9 g 2 pcs.+ sachet 10.6 g 2 pcs.

Pharmacotherapeutic group:laxative

ATX code: A06AD65

Pharmacological properties

Pharmacodynamics

Oral administration of macrogoal-based electrolyte solution causes moderate diarrhea, which results in rapid emptying of the contents of the large intestine.

Macrogol-3350, sodium sulfate and ascorbic acid have an osmotic effect that causes a laxative effect.

Macrogol-3350 increases the volume of stool masses, which leads to increased intestinal peristalsis.

The electrolytes included in the drug, as well as additional fluid intake, prevent disruption of the water-electrolyte balance.

Pharmacokinetics

Macrogol-3350 does not change while in the intestine. It is practically not absorbed from the gastrointestinal (GI) tract. The absorbed amount of Macrogol-3350 is excreted through the kidneys.

Ascorbic acid is absorbed mainly in the small intestine by active sodium-dependent saturable transport. There is an inverse relationship between the dose received and the absorbed percentage of the dose. When an oral dose of 30 to 180 mg is taken, about 70-85% of the dose taken is absorbed. A subsequent oral dose of up to 12 g of ascorbic acid absorbs only 2 g.

After oral administration of high doses of ascorbic acid and when its plasma concentration exceeds 14 mg/L, the absorbed ascorbic kta is excreted mostly unchanged through the kidneys.

Indications

Preparation for diagnostic proceduresPreparing for diagnostic examinations (e.g., endoscopy, X-rays and other bowel examinations) and surgical interventions that require emptying the bowels.

Composition

Sachet A:

Active substances: Macrogol-3350 100.00 g, sodium sulfate anhydrous 7.500 g, sodium chloride 2.691 g, potassium chloride 1.015 g.

Additives: aspartame (E951) 0.233 g, acesulfame potassium 0.117 g, lemon flavoring V3938-1 N1 0.340 g.

Sachet B:

Active substances:ascorbic acid 4.700 g, sodium ascorbate 5.900 g.

How to take, the dosage

Before a diagnostic study (e.g., endoscopy, X-ray, or other bowel exam) and surgical procedure, there is an important bowel preparation process that includes 3 steps:

1. Maintaining a special diet;
2. Selecting a drug regimen depending on the time of the study or surgery;
3. Having a bowel cleansing process with the drug MOVIPREP^®.

The details of each step are below.

1. Maintaining a special diet:

The special diet is important 3 days before the study or surgery:

2. Choice of MoVIPREP ^® drug regimen depending on the time of study or surgery:

Pre-operative interventions use a one-step evening regimen of MOVIPREP^®.

Previously before a diagnostic test, the most suitable regimen of MOVIPREP ^® must be chosen with the attending physician depending on the time of the procedure and the daily activities of the patient:

* If necessary, the time of administration of MOVIPREP ^® can be adjusted by the physician according to the patient’s daily activities and the time required to get to the clinic, observing the indicated time intervals.

3. Implementation of the colon cleansing process with MOVIPREP^®:

The package of MOVIPREP^® contains two sachets A and two sachets B, from which an oral solution is prepared. Regardless of the patient’s weight, the total dosage of MOVIPREP ^® for a good colon cleansing is 2 liters of the drug solution.

• Preparing the first liter of MOVIPREP^® solution:

The contents of one sachet (sachet) A and one sachet B must be dissolved completely in a small amount of non-carbonated drinking water at room temperature, bring the volume of solution with water to 1 liter and mix.

• Prepare the second liter of MOVIPREP^® solution:

Repeat the algorithm for preparing the drug solution from item 1 (see above), using the remaining sachet A and sachet B.

The prepared solution of MOVIPREP® should be taken over 1-2 hours, for example 1 cup every 15-30 minutes.

WARNING:When taking MOVIPREP® , it is strongly recommended that you drink 1 liter of other fluids in addition: non-carbonated water, broth (clear, strained), fruit juice without pulp, soft drinks, tea without milk (can be with sugar or honey).

Do not eat solid foods from the beginning of the MOVIPREP solution^® and until the end of the diagnostic test or surgical intervention.

In case of procedures under general anesthesia:

In two-step, one-step morning and one-step evening dosing regimens, administration of MOVIPREP^® and other fluids (according to the list of approved – see

^{and other fluids (according to the list of approved fluids – see above) must be stopped at least 2 hours but not more than 4 hours prior to the start of the procedure.}

In case of procedures without anesthesia:

In a two-step dosing regimen, administration of MOVIPREP^® and other fluids (according to the list of approved fluids – see

In a two-step dosing regimen, the administration of MOVIPREP® and other fluids (as listed above) must be stopped at least 1 hour but not more than 4 hours prior to the start of the procedure.

In single-step morning and single-step evening dosing regimens, the administration of MOVIPREP® must be stopped at least 2 hours but not more than 4 hours before starting the procedure and other fluids (according to the list of approved fluids – see above) must be stopped at least 1 hour but not more than 4 hours before starting the procedure.

The criterion for readiness for a diagnostic study or surgical intervention is the appearance of liquid transparent or almost transparent, slightly colored stools.

If you are taking the MOVIPREP® solution at home, consider an appropriate time window to travel to the clinic for the procedure.

Frequent liquid stools usually appear within 1 hour of starting each liter of MOVIPREP^® and usually end 1-2 hours later. The frequency of defecation may increase up to 12-15 times while taking the drug.

If you are taking any medicine, be sure to tell your doctor before taking MOVIPREP^®.

Precautions for use in specific patient groups

Patients with impaired renal function

Caution should be taken when taking this drug in patients with severe renal impairment (creatinine clearance < 30 ml/min).

Patients with impaired renal function or those on a controlled potassium diet should note that the drug contains 14.2 mmol of potassium per liter of solution.

If you have any questions, be sure to ask your physician.

Interaction

Diarrhea caused by taking MOVIPREP®P may lead to impaired absorption of other concomitantly taken drugs. Drugs taken orally within one hour before the beginning of the laxative effect of the drug (e.g., oral contraceptives) may be excreted from the gastrointestinal tract without being absorbed.

Special Instructions

In elderly patients, frail or emaciated patients with various comorbidities, patients prone to aspiration or regurgitation, patients with impaired consciousness, especially if the drug is administered via nasogastric tube, the drug should be used under medical supervision.

The prepared solution of MOVIPREP® is not a substitute for regular fluid intake, so adequate fluid intake should be maintained.

In emaciated, debilitated patients, patients with various comorbidities, with clinically significant renal impairment, arrhythmias, and risk of electrolyte imbalance, consideration should be given to determining electrolyte levels at baseline and after treatment, assessing renal function and performing an ECG study.

Severe arrhythmias, including atrial fibrillation, associated with the use of ionic osmotic laxatives for bowel preparation have been observed in rare cases. These phenomena occur predominantly in patients with existing cardiac risk factors and electrolyte imbalance.

If patients present with any symptoms suggestive of arrhythmias or shifts in water/electrolyte balance (e.g., edema, dyspnea, increased fatigue, heart failure), plasma electrolyte levels should be determined, an ECG performed and all identified abnormalities treated appropriately.

If a patient has symptoms such as marked flatulence, bloating, abdominal pain, or any other reaction that makes it difficult to continue taking the drug, the drug should be slowed or temporarily stopped and a physician should be consulted.

This medication contains 363.2 mmol (8.4 g) sodium per bowel preparation course (a bowel preparation course is two liters of MOVIPREP solution

sup>®), which is equivalent to 420% of the WHO recommended maximum daily sodium dose of 2 g for an adult. This should be considered in patients on a diet with controlled sodium intake. Only part of the sodium (up to 112.4 mmol (2.6 g) per bowel preparation) is absorbed.

This medication contains 28.4 mmol/L (1.1 g) potassium per bowel preparation course (bowel preparation course is two liters of MOVIPREP solution

sup>®), which should be considered in patients with impaired renal function and in patients on a controlled potassium diet.

Influence on the ability to drive and operate vehicles

. During the preparation for medical manipulation with MOVIPREP ^® we recommend that you do not drive or operate any machinery (see “Side effects”).

See side effects).

Synopsis

Sachet A: Powder from white to yellow in color with a characteristic odor of lemon.

Sachet B: Powder from white to light brown in color.

Contraindications

• hypersensitivity to any of the ingredients
• disordered gastric emptying (gastroparesis)
• intestinal obstruction
• perforation or risk of gastrointestinal perforation

Intestinal obstruction

• perforation or risk of gastrointestinal perforation
• phenylketonuria (due to aspartame content)
• glucose-6-phosphate dehydrogenase deficiency (due to ascorbic acid content)
• toxic megacolon, a complication of severe inflammatory bowel disease, including Crohn’s disease and ulcerative colitis
• age under 18 years
• conscious.

With caution

• disordered gag reflex, tendency to aspiration or regurgitation
• impaired consciousness
• dehydration
• severe heart failure (NYHA functional class III-IV)
• severe renal insufficiency (creatinine clearance < 30 ml/min)
• acute inflammatory bowel disease of severe
• abdominal pain of unclear etiology
• risk of arrhythmia (in patients treated for cardiovascular disease or with thyroid disease).

If you have any of the conditions listed above, always check with your doctor before taking MOVIPREP®P.

Side effects

Diarrhea is an expected effect of bowel preparation. Because of the nature of the drug’s effects during bowel preparation for the procedure, undesirable effects are noted in most patients. Although there is some variation in specific cases, the most common undesirable effects for macrogol-containing medication are: nausea, vomiting, abdominal bloating, abdominal pain, anus irritation, and sleep disturbances. Dehydration may occur as a result of diarrhea and/or vomiting.

As with other products that contain macrogoal, various allergic reactions are possible, including rash, urticaria, itching, dyspnea, Quincke’s edema, and anaphylactic shock.

The undesirable effects are classified according to the frequency of occurrence:

Very frequent: >1/10

Frequent: >1/100, <1/10

Infrequent: >1/1000, < 1/100

Rare: >1/10000, < 1/1000

Very Rare: < 1/10000

Frequency unknown (cannot be estimated from the data obtained)

Immune system disorders:

Frequency unknown: allergic reactions, including anaphylactic reactions, dyspnea, and skin reactions (see below).

Mental disorders:

Frequent:sleep disturbances.

Nervous system disorders:

Frequent:dizziness, headache.

Frequent unknown:convulsions associated with severe hyponatremia.

Metabolic and nutritional disorders:

Frequency unknown: dehydration, electrolyte disturbances, including decreased blood bicarbonate levels, hypercalcemia and hypocalcemia, hypophosphatemia, hypokalemia and hyponatremia, and changes in blood chloride levels.

Cardiovascular disorders:

Frequency unknown: transient increase in blood pressure, arrhythmia, palpitations.

Gastrointestinal tract disorders:

Very frequent: abdominal pain, nausea, abdominal bloating, irritation in the anus area.

Frequent:vomiting, dyspepsia.

Infrequent:painful swallowing.

Frequent unknown: meteorism, urges to vomit.

Liver and biliary tract disorders:

Infrequent: deviations from normal liver function tests.

Skin and subcutaneous tissue disorders:

Frequency unknown: allergic skin reactions, including angioedema, urticaria, pruritus, rash, and reddening of the skin.

General disorders:

Very frequent:malaise, elevated body temperature.

Frequent:chills, thirst, hunger.

Infrequent:discomfort.

If any of the unwanted effects listed in the instructions worsen, or if you notice any other unwanted effects not listed in the instructions, tell your doctor.

Overdose

Symptoms: severe diarrhea, which can lead to a water-electrolyte imbalance. Treatment: it is usually sufficient to consume plenty of fluids, preferably fruit juices. If necessary, intravenous infusion of infusion solutions to restore water-electrolyte balance.

Pregnancy use

Experience with the use of MOVIPREP® during pregnancy and breastfeeding is limited. MOVIPREP® should be used only in cases when the expected benefits to the mother exceed the potential risk to the fetus or child (medical consultation is necessary).