Mezim Neo 25000,25000 units 50 pcs

Pharmacotherapeutic group: digestive enzyme drug

ATX code: A09AA02

Pharmacological properties

Pharmacodynamics

The active ingredient of the drug Mesim® neo 25000 is pancreatin, which is powder from pig pancreas glands. 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 25000 quickly dissolve in the stomach, releasing mini-tablets covered with an enteric-soluble (acid-resistant) coating. This way, 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:

The active ingredient:

Pancreatin – 356.10 mg
with minimal activity:
lipase 25000 IU
amylase 22500 IU
protease 1250 IU

Excipients: croscarmellose sodium – 11.87 mg, microcrystalline cellulose – 19.77 mg, hydrogenated castor oil – 3.96 mg, colloidal anhydrous silica – 1.97 mg, magnesium stearate – 1.97 mg;

Shell: methacrylic acid and ethyl acrylate copolymer (1:1), 30% dispersion – 57.9 mg, triethylcitrate – 5.82 mg, simethicone 30% emulsion (dry weight) – 0.036 mg; talc – 11.63 mg;

Capsule:
Case: Gelatin – 65.40 mg, titanium dioxide (E 171) – 0.30 mg; iron oxide yellow dye (E 172) – 0.30 mg; iron oxide red dye (E 172) – 0.02 mg;
Cap: Gelatin, 42.900 mg; titanium dioxide (E 171), 0.800 mg; quinoline yellow dye (E 104), 0.300 mg; indigo carmine (E 132), 0.003 mg.

Description: opaque hard gelatin capsules of cylindrical shape with hemispherical ends № 0: capsule body is light orange, capsule cap is yellowish-green.

The contents of the capsules: mini-tablets of cylindrical shape, covered with enteric-soluble coating, light beige color with a shiny surface.

How to take, the dosage

The dose of the drug Mezim® neo 25000 is adjusted individually depending on the severity of the disease and the volume and composition of the food taken.

Unless otherwise stated, adults should take 1-2 capsules of Mesim® neo 25000 with each meal, swallowed 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 capsule contents into a glass, for example by opening the cap, and then take the entire capsule (mini-tablets) with some liquid or added to a liquid food which should not require chewing (e.g. mashed potatoes 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 degree of disease and the food composition at the rate of 500 to 1000 lipase units/kg of body weight per meal.

Per use in cystic fibrosis

The dose of Mesim® neo 25000 depends on body weight and should be 1000 lipase units/kg at each meal for children under 4 years of age at the start of treatment and 500 lipase units/kg at each meal for children older than 4 years.

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 and operate vehicles

Mesim® Neo 25000 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

Symptoms: Use of high doses of pancreatic enzymes may be accompanied by hyperuricosuria and hyperuricemia in patients with cystic fibrosis.

Treatment: withdrawal of the drug, symptomatic therapy.

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, no toxic effect on reproductive function and fetal development was expected.

The use of the preparation Mesim® neo 25000 during pregnancy is possible in case 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 preparation on the child through breast milk are expected. Pancreatic enzymes can be taken while breastfeeding.

Similarities