Hermital, Capsules 10000 units 50 pcs

Ermital contains standard highly active pancreatin derived from the pancreas of pigs in the form of micro tablets resistant to gastric juice.

A digestive enzyme, replenishes pancreatic enzyme deficiencies, has proteolytic, amylolytic and lipolytic action.

Included enzymes (lipase, alpha-amylase, trypsin, chymotrypsin) help to breakdown proteins into amino acids, fats into glycerol and fatty acids, starch into dextrins and monosaccharides, improves the functional state of the gastrointestinal tract and normalizes digestive processes.

Pharmacodynamics

The form of the drug ensures complete release of the gastric juice-resistant microtablets from the capsule in the stomach, followed by fine mixing of the microtablets with

intestinal contents and chyme and rapid release of enzymes from the microtablets in the duodenum at pH>5.

Pancreatic enzyme breakdown products are absorbed in the intestine either directly or after breakdown by intestinal enzymes.

Pharmacokinetics

The pancreatic enzymes contained in Hermital are not absorbed into the blood. The enzymes are inactivated and digested in the intestine as proteins by autolysis and proteolysis. Residual enzymatic activity can be determined in the stool.

Indications

Bloating, Diarrhoea, Dietary irregularities, Overeating, Digestive disorders, Preparation for diagnostic procedures, Pain, Crohn’s disease, Cirrhosis, Meteorism, Irritable bowel syndrome, Chronic pancreatitis, Hepatitis, Colic, Dysbacteriosis, Stomach rumble In adults and children it is used:

• to improve digestion in patients with normal gastrointestinal function in case of nutritional errors;
• replacement therapy in external pancreatic insufficiency: cystic fibrosis, chronic pancreatitis, pancreatectomy, pancreatic cancer, ductal obstruction due to neoplasm (incl.ч. pancreatic duct obstruction, common bile duct obstruction, Schwachman-Daimond syndrome, conditions after an attack of acute pancreatitis and resumption of feeding, advanced age;
• symptomatic therapy for digestive disorders: Condition after cholecystectomy, partial gastric resection (Bilroth-I/II), total gastrectomy, duodeno- and gastrostasis, biliary obstruction, cholestatic hepatitis, cirrhosis of the liver, Crohn’s disease, dysbacteriosis.

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Active ingredient

Pancreatin

Composition

Dosage 10,000 units:

One capsule of gastric juice-resistant microtablets contains 87.28 – 112.96 mg of pancreatin from the porcine pancreas, corresponding to the activity of lipase 10,000 units, amylase
9,000 units, proteases 500 units (according to the European Pharmacopoeia).

Auxiliary substances:

Microcrystalline cellulose,

Crospovidone,

Colloidal anhydrous silicon dioxide,

Magnesium stearate;

Film-coated microtable:

Methacrylic acid and ethyl acrylate copolymer (1:1),

Triethylcitrate,

Talc,

Simethicone;

Polishing agent:

Montane glycol wax.

Capsule cap:

Gelatin,

Red iron oxide (E 172),

Black iron oxide (E 172),

How to take, the dosage

Doses are adjusted individually depending on the severity of the disease and diet.

Dose is calculated in recalculation for units of lipase activity.

Capsules should be swallowed whole during meals with plenty of liquid (water, juices), if swallowing is difficult, the capsules can be opened and their contents added to liquid food that has

sour taste.br>
sour taste (pH<5.5), or pour the contents of capsules into the mouth and swallow them without chewing and with plenty of liquid (about a glass of water).

Crushing, chewing the micro tablets or adding them to foods with pH>5.5 leads to the destruction of their coating, which protects them from the action of gastric juice.

This can lead to early release of enzymes in the mouth, decreased effectiveness and irritation of the mucous membranes. Make sure there are no micro tablets left in the mouth.

Mucoviscidosis

The dose depends on body weight and should be 1000 lipase units/kg per meal for children under four years old and 500 lipase units/kg during meals for children over four years and adults at the beginning of treatment.

The dose should be determined according to the severity of disease symptoms, results of steatorrhea monitoring, and maintenance of adequate nutritional status.

In most patients, the dose should remain less than or less than 10,000 lipase units/kg body weight per day or 4,000 lipase units/g fat consumed.

Other conditions accompanied by exocrine pancreatic insufficiency

The recommended dose is 2-4 capsules of Hermital® 10,000 units, or 1-2 capsules of Hermital® 25,000 units, or 1 capsule of Hermital® 36,000 units with each meal.

The dose may be increased if necessary. Increasing of the dose should be under the control of a physician. The daily dose of enzymes within 15-20,000 lipase units per kg of body weight should not be exceeded.

Therapy should be carried out against abundant fluid intake.

In children the drug should be used in accordance with the prescription.

Interaction

The absorption of folic acid may be decreased when taking Ermital® .

The effect of the oral hypoglycemic drugs acarbose and miglitol may be decreased during treatment with Ermital® .

Special Instructions

Prolonged use of pancreatin in high doses in patients with cystic fibrosis may result in constipation, strictures of the ileum and cecum (fibrosing colonopathy), colitis.

When taking the drug in high doses (more than 10,000 lipase units/kg body weight per day), unusual symptoms and side effects from the gastrointestinal tract should be carefully monitored and, if necessary, medical examination should be conducted to rule out fibrosing colonopathy.

Hermital® contains active enzymes that when released in the oral cavity (e.g. during chewing) may cause irritation and ulceration of the mucous membrane. Therefore, the microtablets should be swallowed without chewing.

The drug does not affect the ability to drive vehicles and mechanisms.

Contraindications

• Known hypersensitivity to pancreatic enzymes;
• acute pancreatitis;
• acute chronic pancreatitis;
• pregnancy.

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Side effects

Gastrointestinal disorders

Very common (≥1/10): abdominal pain.

Frequent (≥1/100, < 1/10): nausea, vomiting, constipation, abdominal bloating, diarrhea.

Frequency unknown: strictures of the ileum, cecum, and colon (fibrosing colonopathy).

Gastrointestinal disorders are primarily related to the underlying disease. The incidence of adverse reactions such as abdominal pain and diarrhea was lower or similar to that of placebo.

ileal, cecum and colon strictures (fibrosing colonopathy) were observed in patients with cystic fibrosis who received high doses of pancreatin preparations (see section “Indications.

Skin and subcutaneous tissue disorders

Infrequent (≥1/1000, < 1/100): rash.

Frequency unknown: itching, urticaria.

Immune system disorders

Frequency unknown: hypersensitivity (anaphylactic reactions).

Allergic reactions were observed primarily on the skin, but other manifestations of allergy were also observed.

No specific adverse reactions have been observed during use in children. The frequency, type and severity of adverse reactions in children with cystic fibrosis were similar to those in adults.

Overdose

Symptoms: hyperuricosuria, hyperuricemia.

Treatment: drug withdrawal, symptomatic therapy.

Pregnancy use

Do not use during pregnancy.

The risk/benefit ratio should be considered while breastfeeding.

Similarities

Mezim forte, Creon 40000, Pancreatin, Creon 25000, Micrazyme, Hermital, Panzinorm forte 20000, Penzital, Pancreatin Forte, Creon 10000, Creon 25000, Mezim 20000, Enzival-P, Mezim