Mezim forte tablets p / o 20000ED, No. 20

• Lack of exocrine pancreatic function (chronic pancreatitis, cystic fibrosis, etc.);

• Chronic inflammatory-dystrophic diseases of the stomach, intestines, liver of the gallbladder;

• Conditions after resection or irradiation of the gastrointestinal tract, accompanied by impaired digestion of food, flatulence, diarrhea (as part of combination therapy);

• To improve the digestion of food in patients with normal gastrointestinal tract function in case of nutritional inaccuracies;

• Preparation for X-ray and ultrasound examination of the abdominal organs;

• Disorders of the gastrointestinal tract of a functional nature (with acute intestinal infections, irritable bowel syndrome, etc.).

The dose of MezimЃ 20000 is set individually, depending on the disease and the severity of symptoms.

Unless otherwise instructed, adults should take 1-2 tablets of MezimЃ 20000 with meals. The drug is taken orally without breaking or chewing the tablet (the effectiveness of MezimЃ 20000 may decrease when chewed and when released, pancreatic enzymes can irritate the oral mucosa) with a sufficient amount of liquid (for example, a glass of water).

It is not recommended to exceed the daily dose of pancreatic enzymes corresponding to 15000-20000 IU of lipase / kg of body weight.

An increase in the dose should be carried out only under the supervision of a physician, while focusing on symptoms (for example, a decrease in steatorrhea and abdominal pain).

The duration of treatment is determined by the doctor and can vary from several days (in case of indigestion due to an error in the diet) to several months or even years (if constant substitution 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 selected taking into account the severity of the symptoms of the disease, the control of steatorrhea and the maintenance of an adequate nutritional status (see section 'Special instructions').

The dose should not exceed 10,000 units of lipase / kg of body weight per day.

In children, the dosage regimen and duration of treatment is determined by the doctor depending on the severity of digestive disorders and the composition of the diet at the rate of 1000 U of lipase / kg of the child's body weight for each meal for children under 4 years of age and 500 U of lipase / kg of the child's body weight for each meal food for children over 4 years old.

If after treatment there is no improvement or the symptoms worsen or new symptoms appear, you should consult your doctor.

Use the drug only according to the indications for the method of use and in the doses indicated in the instructions.

For one tablet:

Core:

Active substance:

Pancreatin * with minimal activity

amylase 12000 units

lipase 20,000 units

protease 900 U

Excipients: microcrystalline cellulose (type 12), crospovidone (type A), colloidal anhydrous silicon dioxide, magnesium stearate, lactose monohydrate.

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

* obtained from pork pancreas.

• Hypersensitivity to any component of the drug;

• Acute pancreatitis or chronic pancreatitis in the acute stage. Nevertheless, it is possible to use it in the phase of a damping exacerbation with the expansion of the diet if there are signs of indigestion;

• Hereditary galactose intolerance, lactase deficiency or glucose-galactose malabsorption syndrome;

• Children under 3 years of age (for this dosage form).

Trade name of the drug

MezimЃ 20000

International non-proprietary name

Pancreatin

Dosage form

pills

Composition

For one tablet:

Core:

Active substance:

Pancreatin * with minimal activity

amylase 12000 units

lipase 20,000 units

protease 900 U

Excipients: microcrystalline cellulose (type 12), crospovidone (type A), colloidal anhydrous silicon dioxide, magnesium stearate, lactose monohydrate.

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

* obtained from pork pancreas.

Description

Round, biconvex film-coated tablets, from white to white with a grayish shade, with a smooth surface, with a specific odor, brown blotches are possible on the fracture.

Pharmacotherapeutic group

Digestive Enzyme Remedy

ATX code

A09AA

Pharmacodynamics:

Pancreatin is a powder from the pancreas of pigs. Pancreatic enzymes that are part of pancreatin have a proteolytic amylolytic and lipolytic effect and promote the breakdown of proteins, fats and carbohydrates, improve the functional state of the gastrointestinal tract (GIT), thus normalizing digestion processes.

Pharmacokinetics:

MezimЃ 20000 tablets are coated with an acid-resistant membrane that is resistant to gastric hydrochloric acid and thereby protects the pancreatic enzymes contained in the preparation from inactivation. Dissolution of the enteric coat and release of enzymes occurs at neutral or slightly alkaline pH values.

Indications:

• Lack of exocrine pancreatic function (chronic pancreatitis, cystic fibrosis, etc.);

• Chronic inflammatory-dystrophic diseases of the stomach, intestines, liver of the gallbladder;

• Conditions after resection or irradiation of the gastrointestinal tract, accompanied by impaired digestion of food, flatulence, diarrhea (as part of combination therapy);

• To improve the digestion of food in patients with normal gastrointestinal tract function in case of nutritional inaccuracies;

• Preparation for X-ray and ultrasound examination of the abdominal organs;

• Disorders of the gastrointestinal tract of a functional nature (with acute intestinal infections, irritable bowel syndrome, etc.).

Contraindications:

• Hypersensitivity to any component of the drug;

• Acute pancreatitis or chronic pancreatitis in the acute stage. Nevertheless, it is possible to use it in the phase of a damping exacerbation with the expansion of the diet if there are signs of indigestion;

• Hereditary galactose intolerance, lactase deficiency or glucose-galactose malabsorption syndrome;

• Children under 3 years of age (for this dosage form).

Pregnancy and lactation:

Before using MezimЃ 20000, if you are pregnant or think that you might be pregnant or are planning to become pregnant, you should consult your doctor.

During the period of breastfeeding, before using the drug MezimЃ 20000, you should consult your doctor.

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

During pregnancy and during breastfeeding, the appointment of pancreatin by the attending physician is possible only if the intended benefit to the mother outweighs the possible risk to the fetus or child.

Method of administration and dosage:

The dose of MezimЃ 20000 is set individually, depending on the disease and the severity of symptoms.

Unless otherwise instructed, adults should take 1-2 tablets of MezimЃ 20000 with meals. The drug is taken orally without breaking or chewing the tablet (the effectiveness of MezimЃ 20000 may decrease when chewed and when released, pancreatic enzymes can irritate the oral mucosa) with a sufficient amount of liquid (for example, a glass of water).

It is not recommended to exceed the daily dose of pancreatic enzymes corresponding to 15000-20000 IU of lipase / kg of body weight.

An increase in the dose should be carried out only under the supervision of a physician, while focusing on symptoms (for example, a decrease in steatorrhea and abdominal pain).

The duration of treatment is determined by the doctor and can vary from several days (in case of indigestion due to an error in the diet) to several months or even years (if constant substitution 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 selected taking into account the severity of the symptoms of the disease, the control of steatorrhea and the maintenance of an adequate nutritional status (see section 'Special instructions').

The dose should not exceed 10,000 units of lipase / kg of body weight per day.

In children, the dosage regimen and duration of treatment is determined by the doctor depending on the severity of digestive disorders and the composition of the diet at the rate of 1000 U of lipase / kg of the child's body weight for each meal for children under 4 years of age and 500 U of lipase / kg of the child's body weight for each meal food for children over 4 years old.

If after treatment there is no improvement or the symptoms worsen or new symptoms appear, you should consult your doctor.

Use the drug only according to the indications for the method of use and in the doses indicated in the instructions.

Side effects:

Possible side effects are listed below in descending frequency of occurrence: very often (? 1/10) often (? 1/100 <1/10) infrequently (? 1/1000 <1/100) rarely (? 1/10000 <1/1000 ) very rarely (<1/10000) the frequency has not been established (it is impossible to estimate from the available data).

Immune system disorders

Very rare: immediate allergic reactions (such as skin rash, hives, sneezing, lacrimation, bronchospasm, dyspnea) hypersensitivity of the gastrointestinal tract.

Gastrointestinal disorders

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

Violations of the genitourinary system

Frequency unknown: hyperuricosuria (see section 'Special instructions').

If you have any side effects indicated in the instructions or they are aggravated or you notice any other side effects not specified in the instructions, inform your doctor.

Overdose:

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

Treatment: symptomatic therapy, drug withdrawal.

Interaction:

It is possible to reduce the absorption of folic acid when used simultaneously with pancreatin preparations. The effect of hypoglycemic agents for oral administration (such as acarbose miglitol) may be reduced when used simultaneously with preparations of digestive enzymes containing enzymes that break down carbohydrates (for example, amylase).

If you are using the above or other drugs (including over-the-counter), consult your doctor before using MezimЃ 20000.

Special instructions:

In acute pancreatitis or exacerbation of chronic pancreatitis (at the stage of exacerbation attenuation) during the period of restorative dietary nutrition, it is advisable to take MezimЃ 20000 against the background of existing and / or remaining exocrine pancreatic insufficiency in the future.

In patients with cystic fibrosis, especially when taking high doses of pancreatin, hyperuricosuria can be observed, therefore, in this group of patients, it is necessary to control the concentration of uric acid in the urine.

In the above group of patients, strictures in the ileocecal and ascending colon are described.

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

MezimЃ 20000 contains active enzymes that, when released in the oral cavity, for example when chewed, can damage the oral mucosa (up to the formation of ulcers). Therefore, the tablet must be swallowed whole.

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

Impact on the ability to drive vehicles. Wed and fur .:

MezimЃ 20000 does not affect or has a slight effect on the ability to drive vehicles and other mechanisms.

Release form / dosage:

Enteric coated tablets 20,000 IU.

Packaging:

10 tablets in a blister strip [aluminum foil / aluminum foil].

1 2 or 5 blisters with instructions for use of the drug in a cardboard box.

Storage conditions:

At a temperature not exceeding 30 ? C.

Keep out of the reach of children!

Shelf life:

3 years.

Do not use after the expiration date indicated on the package.

Vacation conditions

Without recipe

Manufacturer

Berlin-Chemie AG, Glienicker Weg 125, 12489, Berlin, Germany, Germany