Mezim 20000,20000 units 20 pcs

Pharmacotherapeutic group: Digestive enzyme agent

ATX code: A09AA02

Pharmacological properties

Pharmacodynamics. Pancreatin is a powder from the pancreatic glands of pigs. Pancreatic enzymes contained in pancreatin have proteolytic, amylolytic and lipolytic effects and contribute to the breakdown of proteins, fats and carbohydrates, improving the functional state of the gastrointestinal tract (GIT), thus normalizing digestive processes.

Pharmacokinetics. The tablets of Mesim^® 20000 are coated with an acid-resistant coating, which is resistant to stomach hydrochloric acid and thus protects the pancreatic enzymes contained in the drug from inactivation. Dissolution of the enteric coating and release of the enzymes occurs at neutral or slightly alkaline pH values.

Indications

Active ingredient

Composition

Kernel:

Active substance:Pancreatin* with minimal activity:

amylase 12,000 IU

lipase 20,000 IU

protease 900 IU

Associates: microcrystalline cellulose (type 12), crospovidone (type A), colloidal anhydrous silica, magnesium stearate, lactose monohydrate.

Shell: hypromellose, methacrylic acid and ethyl acrylate copolymer (1:1), 30% dispersion (dry weight), triethylcitrate, titanium dioxide, E 171, talc, simethicone emulsion 30% (dry weight), vanilla-scented flavoring, bergamot-scented flavoring, macrogol 6000, sodium carmellose, polysorbate 80, hydroxide.

*derived from pig pancreatic glands

How to take, the dosage

The dose of the drug Mezim® 20000 is set individually depending on the disease and severity of symptoms.

If there are no other indications, adults should take 1-2 tablets of Mesim® 20000 with meals. The drug is taken orally without breaking or chewing the tablet (effectiveness of the drug Mesim ® 20000 may decrease if chewed, and pancreatic enzymes may irritate the oral mucosa if released), washed with plenty of liquid (e.g. a glass of water).

The daily dose of pancreatic enzymes corresponding to 15000-20000 units of lipase/kg body weight should not be exceeded.

Intensification of the dose should only be done under medical supervision and should be guided by the symptoms (e.g., decrease in steatorrhea and abdominal pain).

The duration of therapy is determined by the physician, and varies from a few days (if digestive problems due to poor diet) to months or even years (if continued replacement therapy is necessary).

In children the dosage is determined by the doctor.

Dose for children and adults with cystic fibrosis

In patients with cystic fibrosis, the dose should be adjusted to the severity of the symptoms, results of steatorrhea control and maintenance of adequate nutritional status (see section “Special Instructions”).

The dose should not exceed 10000 IU of lipase/kg body weight per day.

In children the dosing regimen and duration of treatment are determined by the physician according to the severity of digestive disorders and the composition of the diet, at the rate of 1000 IU of lipase/kg of child body weight at each meal for children under 4 years old and 500 IU of lipase/kg of child body weight at each meal for children over 4 years old.

If there is no improvement after treatment, or if symptoms get worse or new symptoms develop, you should talk to your doctor.

To use the drug only according to the indication, route of administration, and dosage listed in the directions.

Interaction

Possible decrease in absorption of folic acid in concomitant use with pancreatin preparations. The effect of hypoglycemic agents for oral administration (such as acarbose, miglitol) may be reduced when concomitant use with preparations of digestive enzymes containing enzymes that break down carbohydrates (e.g., amylase).

If you are using the above or other medicines (including over-the-counter medications), consult your physician before using Mesim® 20000.

Special Instructions

In acute pancreatitis or exacerbation of chronic pancreatitis (at the stage of waning exacerbation), during the recovery diet, it is advisable to take the drug Mezim® 20000 against the background of existing and/or remaining further exocrine pancreatic insufficiency.

In patients with cystic fibrosis, especially when taking high doses of pancreatin, hyperuricosuria may be observed; therefore, uric acid concentration in urine should be monitored in this group of patients.

Strictures in the ileocecal and ascending colon have been described in this group of patients.

As a precautionary measure, a medical examination is necessary if unusual abdominal discomfort or changes in the nature of complaints occur, especially when taking more than 10,000 units of lipase/kg body weight per day.

The drug Mezim® 20000 contains active enzymes which, if released in the oral cavity, e.g., when chewed, may damage the oral mucosa (up to and including ulceration). This is why the tablet must be swallowed whole.

The drug contains lactose; therefore it is contraindicated in patients with hereditary galactose intolerance, lactase deficiency or glucose-galactose malabsorption syndrome.

Influence on driving and operating ability

The drug Mesim ® 20000 has no or negligible effect on the ability to drive vehicles and other mechanisms.

Synopsis

Contraindications

Side effects

Possible side effects are listed below in descending frequency of occurrence: Very frequently (≥ 1/10), frequently (> 1/100, < 1/10), infrequently (> 1/1000, < 1/100), rarely (> 1/10000, < 1/1000), very rarely (< 1/10000), frequency not determined (cannot be estimated from available data).

Immune system disorders

Very rare: immediate-type allergic reactions (such as skin rash, urticaria, sneezing, lacrimation, bronchospasm, dyspnea), gastrointestinal hypersensitivity.

Gastrointestinal tract disorders

Very rare:Diarrhea, abdominal discomfort, abdominal pain, nausea, vomiting; formation of strictures in the ileocecal and ascending colon in patients with cystic fibrosis when using high doses of pancreatin.

Urogenital system disorders

Frequency unknown:hyperuricosuria (see section “Special Precautions”).

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

Overdose

Symptoms: hyperuricosuria and hyperuricemia (especially in patients with cystic fibrosis taking high doses of enzyme drugs).

Treatment: symptomatic therapy, withdrawal of the drug.

Pregnancy use

Before using Mesim® 20000, if you are pregnant or if you suspect that you may be pregnant or are planning to become pregnant, consult your physician.

When breastfeeding, you should consult your doctor before using Mesim® 20000.

There are no data on the use of pancreatin during pregnancy and during breastfeeding.

Pancreatine may only be prescribed by the physician during pregnancy and breastfeeding if the anticipated benefit to the mother outweighs the possible risk to the fetus or baby.

Similarities