Mezim Neo 10000,10000 units 20 pcs

Pharmacotherapeutic group: digestive enzyme drug

ATX code: A09AA02

Pharmacological properties

Pharmacodynamics

The active ingredient of the drug Mesim® neo 10000 is pancreatin, which is powder from pig pancreas glands. The enzymes contained in pancreatin help to break down fats, carbohydrates and proteins from food. Pancreatin having proteolytic, amylolytic and lipolytic action compensates enzymatic insufficiency of the pancreas, improves functional condition of the gastrointestinal tract (GIT) and normalizes digestive processes.

Pharmacokinetics

The gelatin capsules of the drug Mesim® neo 10000 quickly dissolve in the stomach, releasing mini-tablets covered with an enteric-soluble (acid-resistant) coating. Thus, the enzymes remain protected from inactivation in the acidic environment of the stomach. The form of the drug ensures that the mini-tablets are mixed with the intestinal contents and that the enzymes are evenly distributed. Dissolution of the shell of the mini-tablets and enzyme activation occurs at neutral or slightly alkaline pH in the small intestine. Pancreatin is not absorbed in the gastrointestinal tract and is excreted with the feces.

Indications

Replacement therapy for pancreatic exocrine function insufficiency in adults and children with the following conditions:

Active ingredient

Composition

On one capsule:

The contents of the capsule (enteric-coated mini tablets):

The core:
Active ingredient: Pancreatin – 153.5 mg
with minimal activity:
lipase 10000 IU
amylase 9000 IU
protease 500 IU

Excipients: croscarmellose sodium – 5.12 mg, microcrystalline cellulose – 8.52 mg, hydrogenated castor oil – 1.709 mg, colloidal anhydrous silica – 0.849 mg, magnesium stearate – 0.849 mg.

The shell: methacrylic acid and ethyl acrylate copolymer (1:1), 30% dispersion -25.0 mg, triethylcitrate – 2.51 mg, simethicone 30% emulsion (dry weight) – 0.015 mg; talc – 5.01 mg;

Capsule: casing: Gelatin – 36.20 mg, titanium dioxide (E 171) – 0.20 mg; iron oxide yellow dye (E 172) – 0.20 mg; iron oxide red dye (E 172) – 0.01 mg;
cap: Gelatin, 23.800 mg; titanium dioxide (E 171), 0.400 mg; quinoline yellow dye (E 104), 0.200 mg; indigo carmine (E 132), 0.002 mg.

How to take, the dosage

The dose of the drug Mesim® Neo 10000 is adjusted individually depending on the severity of the disease and the volume and composition of the food taken.

Unless otherwise stated, it is recommended that adults take 2-4 capsules of Mesim® neo 10000 with each meal, swallowing the capsules whole (not chewed), with plenty of fluid (e.g. a glass of water).

If the whole capsule is too difficult for the patient to swallow (e.g. in young children or the elderly) you may pour the entire capsule into a glass, for example by opening the cap, and then take the content (mini-tablets) with some fluid or add to a liquid food which does not require chewing (e.g. applesauce or fruit juice). The mixture of mini-tablets with food or liquid should not be stored (take immediately after preparation).

Increasing the dose of the drug should only be done under the supervision of a physician, with reference to the dynamics of symptoms (e.g., decrease in steatorrhea, less abdominal pain).

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

The duration of treatment is determined by the doctor and depends on the course of the disease.

In children the dosage regimen and duration of treatment are determined by the doctor depending on the disease severity and food composition at the rate of 500 to 1000 lipase units/kg of body weight per each meal.

Per use in cystic fibrosis

The dose of Mesim® neo 10000 depends on the body weight and should be 1000 lipase units/kg at every meal for children under 4 years old at the beginning of treatment and 500 lipase units/kg at every meal for children older than 4 years old.

The dose of the drug should be adjusted individually depending on the severity of the disease, with monitoring of steatorrhea and support for an optimal diet. In most patients, the dose should not exceed 10000 lipase units/kg body weight per day or 4000 lipase units/g fat consumed.

Special Instructions

Strictures of the ileum, cecum and colon (fibrosing colonopathy) have been described in patients with cystic fibrosis who have received high doses of pancreatin preparations. As a precautionary measure, if unusual symptoms occur or the nature of symptoms of the underlying disease changes, medical evaluation should be performed to rule out colon involvement, especially if the drug is used at doses greater than 10,000 lipase units per kg body weight per day.

The effect of the drug on the ability to drive motor transport and other mechanisms

Mesim® neo 10000 has no effect on performance of potentially dangerous activities requiring particular attention and speed of reaction.

Contraindications

Side effects

Possible side effects are listed below in descending frequency of occurrence: frequently (> 1/100, < 1/10), infrequently (> 1/1000, < 1/100), rarely (> 1/10000, < 1/1000), very rarely (< 1/10000), including individual reports.

Gastrointestinal disorders:
Often:Nausea, vomiting, and bloating.
Gastrointestinal disorders are mainly related to the underlying disease. The incidence of the following adverse reactions was lower or similar to that of placebo:
Very common: abdominal pain;
Frequent: diarrhea.

Skin and subcutaneous tissue disorders:
Rarely: rash;
Itching, urticaria – data are insufficient to estimate the incidence.

Overdose

Pregnancy use

Pregnancy

There are no clinical data on the treatment of pregnant women with preparations containing pancreatic enzymes. In animal studies no absorption of porcine pancreatic enzymes was found; therefore, toxic effects on reproductive function and fetal development are not expected.

The use of the preparation Mesim® neo 10000 during pregnancy is possible if the expected benefits for mother exceed the possible risk for fetus.

Breast-feeding period

Based on animal studies in which no negative effects of pancreatic enzymes were found, no harmful effects of the drug on the baby through breast milk are expected. Pancreatic enzymes can be taken while breastfeeding.

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