Mezim 20000ed pills coated №20

Trade name: Mezim ^® 20000

International non-proprietary name or chemical name: Pancreatin

Dosage Form: enteric coated tablets

The composition of one tablet

Core:
Active substance:
Pancreatin - 220.00 - 293.34 mg
with minimal activity:

Excipients: lactose monohydrate - 83.34 mg, microcrystalline cellulose - 72.66 mg, colloidal silicon dioxide - 1.60 mg, crospovidone (type A) - 10.40 mg, Magnesium stearate - 2.00 mg;

Shell:
hypromellose - 6.25 mg, methacrylic acid and ethyl acrylate copolymer (1: 1), dispersion 30% (dry weight) - 15.89 mg, triethyl citrate - 5.07 mg, talc - 9.60 mg, titanium dioxide, E 171 - 6.58 mg, simethicone emulsion 30% (dry weight) - 0.43 mg, macrogol 6000 - 0.25 mg, carmellose sodium - 0.55 mg, polysorbate 80 - 0.88 mg, flavoring with the smell of vanilla - 0, 34 mg, flavoring with the smell of bergamot - 0.16 mg

Description: round, biconvex tablets, covered with an enteric coating, from white to white with a grayish tint color with a smooth surface, with a specific odor, on a fracture possible brown patches.

Pharmacological properties:

Pharmacodynamics. Pancreatin is a powder from the pancreas glands of pigs. Pancreatic enzymes,constituent of pancreatin, have a proteolytic, amylolytic and lipolytic effect and promote the breakdown of proteins, fats, carbohydrates, improve the functional state of the gastrointestinal tract (GIT), normalize the processes of digestion.
Pharmacokinetics. pills mezim^® 20,000 are covered with an acid-resistant coating that does not dissolve under the action of the hydrochloric acid of the stomach and, thus, protects the enzymes contained in the preparation from inactivation. The dissolution of the shell and the release of enzymes occurs at pH values ​​close to neutral or slightly alkaline.

Indications for use

- Lack of exocrine pancreatic function, (chronic pancreatitis, cystic fibrosis, etc.)
- Chronic inflammatory-dystrophic diseases of the stomach, intestines, liver, gallbladder.
- Conditions after resection or irradiation of these organs, accompanied by impaired digestion of food, flatulence, diarrhea (as part of combination therapy).
- To improve the digestion of food in patients with normal function of the gastrointestinal tract in case of errors in nutrition.
- Preparation for X-ray and ultrasound examination of the abdominal cavity organs.
- Gastrointestinal disorder of a functional nature (with intestinal infectious diseases, irritable bowel syndrome, etc.).

Contraindications

- Hypersensitivity to the drug.
- Acute pancreatitis or chronic pancreatitis in the acute stage. Nevertheless, the prescription is acceptable in the phase of damped exacerbation during the expansion of the diet, if there are signs of impaired digestion.
- Hereditary intolerance to galactose, lack of lactase or glucose-galactose malabsorption syndrome.
- Children's age up to 3 years (for this dosage form).

Use during pregnancy and during breastfeeding

Data on the use of digestive enzyme preparations during pregnancy and during breastfeeding are not available. During pregnancy and during breastfeeding, you can take the drug Mezim^® 20,000 as prescribed by a doctor.

Dosage and administration

Dose of the drug Mezim^® 20,000 is set individually depending on the composition and the severity of the disease.
Unless otherwise indicated for adults should take 1-2 pills of the drug Mezim^® 20,000 while eating. The drug is taken orally, without chewing and drinking a sufficient amount of liquid (for example, a glass of water). You may increase the dose, which should be carried out only under the supervision of a physician, focusing on the weakening of symptoms (for example, steatorrhea, abdominal pain).
The daily dose of enzymes, which is 15000-20000 IU of lipase / kg of body weight, is not recommended to exceed.
For children The dosage regimen and duration of treatment are determined by the doctor depending on the severity of the disease and the composition of the food at the rate of 1000 U of lipase / kg of body weight of the child for each meal.The duration of treatment can vary from several days (in case of digestive disorders, errors in diet) to several months and even years (if necessary, constant replacement therapy).

Adverse effects

Allergic reactions are possible, with prolonged use in high doses may develop hyperuricuria. In case of cystic fibrosis, if the required dose of pancreatin is exceeded, it is possible to develop strictures (fibrous colonopathy) in the ileocecal region and in the ascending colon.

Overdosage

Data on cases of overdose and intoxication drug no.

Interaction with other drugs

When taking drugs containing pancreatin, may decrease the absorption of folic acid. The action of hypoglycemic agents for oral administration (acarbose, miglitol) may decrease with simultaneous use with the drug Mezim^® 20000.
With the simultaneous use of the drug Mezim^® 20,000 with iron preparations may decrease the absorption of the latter. The simultaneous use of antacids containing Calcium carbonate and / or magnesium hydroxide, can lead to a decrease in the effectiveness of the drug.

Special notes

In acute pancreatitis or exacerbation of chronic pancreatitis (at the stage of attenuation of exacerbation), during a restorative diet, it is advisable to prescribe the drug Mezim^® 20,000 on the background of existing or remaining inadequate pancreatic function.

The influence of the drug on the ability to drive vehicles and control mechanisms
Mezim^® 20,000 does not affect the speed of psychomotor reactions and the ability to perceive or assess the situation.

Storage conditions

At a temperature not higher than 25 ° C.
Keep the medicine out of the reach of children!