Ermital caps 25000 #50

Instruction for Ermital

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Ermital is a drug that replenishes the deficiency of pancreatic enzymes.

Release form and composition

Ermital dosage form - capsules (enteric capsules): hard gelatinous, oblong, with a brown opaque lid and a transparent colorless body; the capsules contain convex, whitish-gray film-coated microtablets; the presence of a characteristic smell is permissible; size No. 2, No. 0el or No. 00 (10, 25 or 36 thousand units, respectively) (20, 50 or 100 capsules in dark glass jars, in a cardboard box of 1 can).
The active substance in 1 capsule: pancreatin from the pancreas of a pig - 87.28-112.96 (Ermital 10000 U); 218.2–282.4 (Ermital 25,000 U) or 272.02–316.68 mg (Ermital 36,000 U), which corresponds to the following enzyme activity (according to the European Pharmacopoeia):
    lipase - 10 thousand; 25 thousand or 36 thousand units (action units);
    amylase - 9 thousand; 22.5 thousand or 18 thousand units;
    protease - 0.5 thousand; 1.25 thousand or 1.2 thousand units
Auxiliary components:
    microtablet: microcrystalline cellulose, crospovidone, anhydrous colloidal silicon dioxide, magnesium stearate;
    film coating of microtablets: simethicone, talc, copolymer of ethyl acrylate and methacrylic acid (1: 1), triethyl citrate;
    polishing agent: montan glycol wax;
    capsule: cap - gelatin, sodium lauryl sulfate, titanium dioxide (E 171), red and black iron oxide (E 172); body - sodium lauryl sulfate, gelatin.

Pharmacodynamics

Ermital is one of the digestive enzyme preparations that compensate for the deficiency of pancreatic enzymes. It has lipolytic, amylolytic and proteolytic effects.
Ermital contains microtablets resistant to gastric juice, containing standard highly active pancreatin, which is obtained from the pancreas of a pig.
The enzymes included in the preparation (chymotrypsin, lipase, trypsin, alpha-amylase) improve the functional state of the digestive system, promote the breakdown of fats to fatty acids and glycerol, proteins to amino acids, starch to monosaccharides and dextrins. Cleavage products by pancreatic enzymes are absorbed in the intestine either directly or after digestion by intestinal enzymes.

Pharmacokinetics

Ermital's dosage form ensures complete release in the stomach of microtablets resistant to the action of gastric juice from the capsule, followed by their fine mixing with intestinal contents and chyme and rapid release of enzymes from the microtablets in the duodenum.
Pancreatic enzymes are not absorbed into the blood. They, like proteins, are inactivated and digested in the intestine by proteolysis and autolysis.

Indications for use

    errors in nutrition (in order to improve the digestion of food with normal function of the gastrointestinal tract);
    replacement therapy for exocrine pancreatic insufficiency, including chronic pancreatitis, cystic fibrosis, pancreatectomy, pancreatic cancer, ductal obstruction associated with neoplasms (including obstruction of the common bile duct, pancreatic ducts), Shwachman-Diamond syndrome, nutrition and attacks of acute pancreatitis;
    digestive disorders, including the condition after cholecystectomy, partial gastrectomy (Billroth - I / II), total gastrectomy, duodeno- and gastrostasis, biliary obstruction, dysbiosis, cholestatic hepatitis, Crohn's disease, liver cirrhosis (symptomatic therapy).

Contraindications

A contraindication to taking Ermital is the presence of hypersensitivity to its components.
Taking the drug by pregnant and lactating women is possible only after a doctor has assessed the balance of benefits and risks.

Instructions for the use of Ermital: method and dosage

According to the instructions, Ermital is taken orally, during meals, with a large amount of liquid (water, juices) (about 200 ml).
The capsules must be swallowed whole. If swallowing is difficult, they can be opened and the contents added to liquid food with a sour taste (pH <5.5). Also, the contents of the capsules can be poured into the mouth and swallowed with plenty of liquid without chewing. Make sure there are no microtablets left in your mouth.
Chewing / crushing microtablets or adding them to food with a pH> 5.5 leads to the destruction of the membrane that protects them from the effects of gastric juice, which can cause early release of enzymes in the oral cavity and, as a result, irritation of the mucous membranes and a decrease in the effectiveness of the drug ...
The dose should be selected individually by the physician based on the severity of the disease and diet. The calculation is carried out in terms of units of lipase activity.
In patients with cystic fibrosis, the dose is determined by weight. For children under 4 years of age at the beginning of therapy, it should be 1,000 lipase units / kg for each meal, for adults and children from 4 years old - 500 lipase units / kg.
The dose is determined depending on the severity of the symptoms of the disease, maintaining an adequate nutritional status and the results of steatorrhea control. In most cases, it should be ≤ 10 thousand lipase units / kg per day or 4 thousand lipase units / g of fat consumed.
The recommended dose during each meal for other conditions accompanied by exocrine pancreatic insufficiency is 1 capsule of Ermital 36 thousand units, or 1-2 capsules of Ermital 25 thousand units, or 2–4 capsules of Ermital 10 thousand units.
If necessary, it is possible to increase a single dose (should be carried out under medical supervision). The maximum daily dose is 15–20 thousand lipase units / kg. Therapy should be carried out against the background of abundant fluid intake.
Children should take Ermital as prescribed by their doctor.

Side effects

Possible adverse reactions (> 10% - very often;> 1% and <10% - often;> 0.1% and <1% - infrequently;> 0.01% and <0.1% - rarely; <0, 01% - very rarely; with an unspecified frequency - in cases where it is impossible to determine the frequency of occurrence of the violation):
    digestive system (usually side effects are associated with the underlying disease): very often - pain in the abdomen; often - vomiting, nausea, constipation, diarrhea, bloating; with an unknown frequency - strictures of the colon, cecum and ileum (fibrosing colonopathy);
    immune system: with an unknown frequency - hypersensitivity (anaphylactic reactions);
    skin / subcutaneous tissue: infrequently - rash; with an unknown frequency - urticaria, itching.

Overdose

The main symptoms are hyperuricosuria and hyperuricemia (especially in cystic fibrosis).
In case of an overdose, the cancellation of Ermital is indicated, symptomatic treatment.

Special instructions

With a prolonged course with the use of high doses, patients with cystic fibrosis may experience colitis, the development of constipation, and strictures of the cecum / ileum.
In cases of taking high doses (from 10 thousand lipase units / kg per day), it is necessary to carefully monitor unusual symptoms and side reactions from the organs of the gastrointestinal tract. To exclude fibrosing colonopathy, a medical examination is performed if necessary.

Application during pregnancy and lactation

Before prescribing Ermital, pregnant and lactating women should assess the benefit-risk ratio. Pancreatin has a low systemic absorption, and therefore a negative effect on the woman's body, as well as the fetus / child, is not expected.

Drug interactions

Possible interactions:
    folic acid: a decrease in its absorption;
    acarbose, miglitol (oral hypoglycemic drugs): decreased effectiveness.

Terms and conditions of storage

Store at temperatures up to 25 ° C. Keep out of the reach of children.
The shelf life is 3 years.

Reviews about Ermital

According to reviews, Ermital is an effective drug that replenishes the deficiency of pancreatic enzymes. Helps to get rid of heaviness and discomfort in the abdomen, prevents the recurrence of acute pancreatitis. They also note the possibility of its use by young children. Of the shortcomings, they indicate the high exchange rate of the drug.

Terms of sell

A prescription is not required to buy Ermital.