Mezim 20000 - instructions for use, dose, side effects, contraindications

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;

Sheath:

Hypromellose - 6.25 mg of methacrylic acid ethyl acrylate copolymer (1: 1) dispersion of 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 vanilla flavoring - 0 , 34 mg, aroma with the smell of bergamot - 0.16 mg.

Description:

Round, biconcave tablets, film-coated,from white to white with a grayish shade of color with a smooth surface, with a specific smell, brown inclusions are possible at the break.

Pharmacotherapeutic group:Digestive enzyme agent

ATX: & nbsp

A.09.A.A Enzyme preparations

A.09.A.A.02 Pancreatin

Pharmacodynamics:Pancreatin is a powder from the pancreas of pigs. Pancreatic enzymes, which are part 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 digestive process.

Pharmacokinetics:

Mezim® 20000 tablets are coated with an acid-resistant coating that does not dissolve under the action of hydrochloric acid in the stomach and, thus, protects the enzymes contained in the preparation from inactivation. Dissolution of the membrane and the release of enzymes occur at pH values close to neutral or slightly alkaline.

Indications:

- Insufficiency of exocrine functions of the pancreas, (chronic pancreatitis, cystic fibrosis, etc.)

- Chronic inflammatory-dystrophic diseases of the stomach, intestines, liver, gall bladder.

- States after resection or irradiation of these organs, accompanied by

disturbances in the digestion of food, flatulence, diarrhea (as part of combination therapy).

- To improve the digestion of food in patients with normal gastrointestinal function in the event of errors in nutrition.

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

- Disorder of the gastrointestinal tract of a functional nature (with intestinal infectious diseases, irritable bowel syndrome, etc.).

Contraindications:

- Hypersensitivity to the components of the drug.

- Acute pancreatitis or chronic pancreatitis in the acute stage. Nevertheless, the appointment is acceptable in the phase of fading exacerbation with the expansion of the diet, if there are signs of digestion disorders.

- Hereditary intolerance to galactose, a lack of lactase or a syndrome of glucose-galactose malabsorption.

- Children up to 3 years (for this dosage form).

Pregnancy and lactation:

Data on the use of digestive enzyme preparations during pregnancy and during breastfeeding are absent.

During pregnancy and during breastfeeding, you can take Mezim® 20000 as directed by a doctor.

Dosing and Administration:

The dose of Mezim® 20000 is determined individually depending on the composition and severity of the disease.

If there is no other indication, adults take 1-2 tablets of Mezim® 20000 with meals. The drug is taken orally, without chewing and washing down with a sufficient amount of liquid (for example, a glass of water). It is possible to increase the dose, which should be carried out only under the supervision of a doctor, while focusing on reducing symptoms (for example, steatorrhea, abdominal pain).

The daily dose of enzymes, amounting to 15000-20000 units of lipase / kg body weight, is not recommended.

Children the dosing regimen and the 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 units of lipase / kg of body weight of the child for each meal.

The duration of treatment can vary from several days (for digestion,inaccuracies in the diet) up to several months and even years (if necessary permanent replacement therapy).

Side effects:

Allergic reactions are possible, with prolonged use in high doses, the development of hyperuricosuria is possible. In case of cystic fibrosis, in case of exceeding the necessary dose of pancreatin, development of strictures (fibrous colonopathy) in the ileocecal region and in the ascending colon can be possible.

Overdose:

There are no data on cases of overdose and intoxication with the drug.

Interaction:

When taking medications containing pancreatin, it is possible to reduce the absorption of folic acid. The effect of hypoglycemic agents for oral administration (acarbose, miglitol) may decrease with simultaneous use with Mezim® 20000.

With the simultaneous use of Mezim® 20000 with iron preparations, it is possible to reduce absorption of the latter. The simultaneous use of antacid agents containing calcium carbonate and / or magnesium hydroxide, can lead to a decrease in the effectiveness of the drug.

Special instructions:

In acute pancreatitis or exacerbation of chronic pancreatitis (at the stage of exacerbation of exacerbation),during a restorative dietary diet, it is advisable to prescribe Mezim® 20000 against the background of pancreatic function that is or remains inadequate.

Effect on the ability to drive transp. cf. and fur:

Mezim® 20000 does not affect the speed of psychomotor reactions and the ability to perceive or assess the situation.

Form release / dosage:

Tablets coated with enteric coating, 20000 units.

Packaging:

For 10 tablets, coated with an enteric coating in a contour squamous package (blister) [aluminum foil / aluminum foil].

For 1, 2 or 5 blisters together with the instructions for use are placed in a cardboard box.

Storage conditions:

At a temperature of no higher than 25 ° C.

Keep the medicine out of the reach of children!

Shelf life:

3 years.

Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:Without recipe

Registration number:LP-001619

Date of registration:02.04.2012

The owner of the registration certificate:BERLIN-PHARMA, CJSC BERLIN-PHARMA, CJSC Russia

Manufacturer: & nbsp

BERLIN-CHEMIE, AG Germany

Information update date: & nbsp15.08.2015

Illustrated instructions

Instructions

Mezim® 20000 (Mezym® 20000)