Moviprep set powder for oral solution, sachet 111.9g 2pcs + sachet 10.6g 2pcs

Composition

Sachet A:

Active ingredients: Macrogol-3350 100,00 g, sodium sulfate anhydrous 7,500 g, sodium chloride 2,691 g, potassium chloride 1,015 g.

Auxiliary substances: aspartame (E 951) 0.233 g, acesulfame potassium 0.117 g, lemon flavor V3938-1 N1 0.340 g.

Sachet B:

Active ingredients: ascorbic acid 4,700 g, sodium ascorbate 5,900 g.

Pharmacological action

Pharmacotherapeutic group: laxative

ATX code: A06AD65

Pharmacological properties

Pharmacodynamics

Oral use of an electrolyte solution based on macrogol causes moderate diarrhea, which results in rapid emptying of the contents of the colon.

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

Macrogol-3350 increases the volume of fecal matter, which leads to increased intestinal motility.

The electrolytes that make up the drug, as well as the additional intake of liquid, prevent the violation of the water-electrolyte balance.

Pharmacokinetics

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

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

After oral use of high doses of ascorbic acid and if its plasma concentration exceeds 14 mg/l, absorbed ascorbic acid is mainly excreted unchanged through the kidneys.

Indications

Preparation for diagnostic tests (for example, endoscopic, X-ray, and other bowel examinations) and surgical procedures that require bowel movement.

Use during pregnancy and lactation

Experience with MOVIPREP during pregnancy and lactation is limited. MOVIPREP should only be used if the intended benefit to the mother exceeds the potential risk to the fetus or child (medical advice is required).

Contraindications

• hypersensitivity to any of the components of the drug
• violation of gastric emptying (gastroparesis)
• 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, which is a complication of severe inflammatory bowel diseases, including Crohn’s disease and ulcerative colitis
• age up to 18 years
• unconsciousness.

With caution

• impaired gag reflex, tendency to aspiration or regurgitation
• impaired consciousness
• dehydration
• severe heart failure (NYHA functional Class III-IV)
• severe renal failure (creatinine clearance
• severe acute inflammatory bowel diseases
• abdominal pain of unclear etiology
• risk of arrhythmia (in patients receiving treatment for cardiovascular diseases or with thyroid diseases).

If you have any of these conditions, be sure to consult your doctor before taking MOVIPREPR®P.

Side effects

Diarrhea is the expected effect of bowel preparation. Due to the nature of the drug’s effects during bowel preparation for the procedure, undesirable effects are observed in most patients. Despite some differences in specific cases, the most common adverse effects for a macrogol-containing drug are: nausea, vomiting, bloating, abdominal pain, anal irritation, and sleep disturbances. Dehydration may occur as a result of diarrhea and/or vomiting.

As with other products containing macrogol, a variety of allergic reactions are possible, including rash, urticaria, pruritus, dyspnoea, angioedema, and anaphylactic shock.

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 based on the data obtained)

Immune system disorders:

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

Mental disorders:

Frequent ones: sleep disorders.

Nervous system disorders:

Frequent ones: dizziness, headache.

Frequency unknown: seizures 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.

Disorders of the cardiovascular system:

Frequency unknown: short-term increase in blood pressure, arrhythmia, rapid heartbeat.

Disorders of the gastrointestinal tract:

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

Frequent ones: vomiting, dyspepsia.

Infrequent: difficulty swallowing.

Frequency unknown: flatulence, vomiting.

Liver and biliary tract disorders:

Infrequent: abnormal liver function tests.

Skin and subcutaneous tissue disorders:

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

Common disorders:

Very frequent ones: malaise, increased body temperature.

Frequent ones: chills, thirst, hunger.

Infrequent ones: discomfort.

If any of the undesirable effects listed in the instructions get worse, or you notice any other undesirable effects not listed in the instructions, tell your doctor.

Interaction

Diarrhea caused by taking MOVIPREPR®P may lead to impaired absorption of other medications taken at the same time. Medications taken orally within one hour before the start of the laxative effect of the drug (for example, oral contraceptives) can be eliminated from the gastrointestinal tract without being absorbed.

How to take, course of use and dosage

Before performing a diagnostic examination (for example, endoscopic, X-ray and other bowel examination) and surgery, it is necessary to go through an important process of bowel preparation, which includes 3 stages:

Detailed information on each stage is provided below.

3 days before the study or surgery, it is important to follow a special diet:

Before surgical interventions, a one-stage evening regimen of MOVIPREP®is used.

Before conducting a diagnostic study, it is necessary to choose with the attending physician the most appropriate regimen for taking MOVIPREP®, depending on the time of the procedure and the patient’s daily activity:

* If necessary, the time of taking MOVIPREP® can be adjusted by the attending physician depending on the daily activity of the patient and the time to get to the clinic, observing the specified time intervals.

The package of MOVIPREP® contains two sachets A and two sachets B, from which a solution is prepared for oral use. Regardless of the patient’s weight, the total dose of MOVIPREP® for high-quality bowel cleansing is 2 liters of the drug solution.

• Preparation of the first liter of MOVIPREP®solution:

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

• Preparation of the second liter of MOVIPREP®solution:

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

The prepared solution of MOVIPREP should be drunk within 1-2 hours, for example,1 glass every 15-30 minutes.

IMPORTANT: while taking MOVIPREP®, it is strongly recommended to additionally consume 1 liter of other liquids: still water, broth (clear, filtered), fruit juice without pulp, soft drinks, tea without milk (you can use sugar or honey).

Do not eat solid food from the beginning of taking the MOVIPREP solution until the end of the diagnostic study or surgical intervention.

If the procedure is performed under general anesthesia:

With two-stage, one-stage morning and one-stage evening dosing regimens, the use of MOVIPREP® and other liquids (according to the list of permitted ones – see above) should be stopped at least 2 hours, but no more than 4 hours before the procedure begins.

In case of performing procedures without anesthesia:

With a two-step dosage regimen, the use of MOVIPREP® and other liquids (according to the list of permitted ones – see above) should be stopped at least 1 hour, but no more than 4 hours before the procedure begins.

In the case of one-stage morning and one-stage evening dosing regimens, MOVIPREP® should be discontinued at least 2 hours, but not more than 4 hours before the procedure, and other liquids (according to the list of permitted ones – see above) should be discontinued at least 1 hour, but not more than 4 hours before the procedure.

The criterion of readiness for diagnostic examination or surgical intervention is the appearance of liquid transparent or almost transparent, slightly colored stool.

When taking a solution of MOVIPREP® at home, it is necessary to take into account the appropriate time interval for traveling to the clinic for the procedure.

Frequent loose stools usually appear within 1 hour of the start of taking each liter of MOVIPREP® and usually end after 1-2 hours. During the period of taking the drug, the frequency of defecation may increase up to 12-15 times.

If you are taking any medications, be sure to tell your doctor before taking MOVIPREP.

Features of use in certain groups of patients

Patients with impaired renal function

Precautions should be taken when taking this drug in patients with severe renal insufficiency (creatinine clearance

Patients with impaired renal function or patients who follow a controlled potassium diet should note that the drug contains 14.2 mmol of potassium per 1 liter of solution.

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

Overdose

Symptoms: severe diarrhea, which can lead to a violation of the water-electrolyte balance. Treatment: it is usually sufficient to consume a large amount of liquid, preferably fruit juices. If necessary, intravenous infusion solutions are administered to restore the water-electrolyte balance.

Description

Sachet A: White to yellow powder with a distinctive lemon smell.

Sachet B: White to light brown powder.

Special instructions

Elderly patients, debilitated or emaciated patients with various concomitant diseases, patients prone to aspiration or regurgitation, with impaired consciousness, especially if the drug is administered through a nasogastric tube, the drug should be used under medical supervision.

The prepared solution of MOVIPREP® does not replace regular fluid intake, so it is necessary to maintain sufficient fluid levels in the body.

In emaciated, debilitated patients, patients with various comorbidities, with clinically significant renal impairment, arrhythmia and risk of electrolyte imbalance, the need to determine the level of electrolytes at baseline and after treatment, evaluate renal function and perform an ECG study should be considered.

In rare cases, serious arrhythmia, including atrial fibrillation, has been observed associated with the use of ion osmotic laxatives for bowel preparation. These phenomena occur mainly in patients with existing cardiological risk factors and electrolyte imbalance.

If patients develop any symptoms that indicate an arrhythmia or changes in the water / electrolyte balance (for example, edema, shortness of breath, fatigue, heart failure), the level of electrolytes in the blood plasma should be determined, an ECG should be performed, and all identified abnormalities should be adequately treated.

If the patient experiences symptoms such as severe flatulence, bloating, abdominal pain, or any other reactions that make it difficult to continue taking the drug, it is necessary to slow down or temporarily suspend taking the drug and consult a doctor.

This medicine contains 363.2 mmol (8.4 g) of sodium per bowel preparation course (the bowel preparation course consists of two liters of MOVIPREP® solution), which is equivalent to 420% of the WHO recommended maximum daily dose of 2 g of sodium for an adult. This should be considered in patients on a controlled sodium intake diet. In this case, only part of the sodium (up to 112.4 mmol (2.6 g) per course of bowel preparation) is absorbed.

This medicinal product contains 28.4 mmol / l (1.1 g) of potassium per bowel preparation course (the bowel preparation course consists of two liters of MOVIPREP® solution), which should be considered in patients with impaired renal function, as well as in patients on a diet with controlled potassium intake.

Influence on the ability to drive vehicles and mechanisms

During the course of preparation for medical manipulations with MOVIPREP®, it is recommended to refrain from driving vehicles and other mechanisms (see the section “Side effects”).

Form of production

Powder for the preparation of a solution for oral use.

111.896 g of the drug in a laminated sachet A.

10,600 g of the drug in a laminated sachet B.

One sachet A and one sachet B in a plastic bag. Two packages are placed in a cardboard box together with the instructions for use.

Storage conditions

At a temperature not exceeding 25 ° C.

Store the reconstituted solution at a temperature not exceeding 8 ° C.

Keep out of the reach of children.

Shelf

life is 3 years.

Reconstituted solution – 24 hours.

Do not use after the expiration date.

Active ingredient

Macrogol, ascorbic acid

Dosage form

solution for oral use

Purpose

For adults as directed by your doctor

Indications

Diagnostic procedures