Hermital, capsules 36000 units 50 pcs
Hermital® contains standard highly active pancreatin derived from the pancreas of pigs in the form of micro tablets resistant to gastric juice.
Digestive enzyme, replenishes pancreatic enzyme deficiencies, has proteolytic, amylolytic and lipolytic action.
Enzymes (lipase, alpha-amylase, trypsin, chymotrypsin) help to break down proteins into amino acids, fats into glycerol and fatty acids, starch into dextrins and monosaccharides, improve the functional state of the gastrointestinal tract, normalize digestive processes.
Products are broken down by pancreatic enzymes are absorbed in the intestine either directly or after cleavage by intestinal enzymes.
The drug’s release form ensures complete release of 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.
Pancreatic enzymes are not absorbed into the blood. The enzymes are inactivated and digested in the intestine as proteins by autolysis and proteolysis.
Dysbacteriosis, Gastritis, Preparation for diagnostic procedures, Meteorism, Colic, Digestive disorders, Abdominal bloating, Wrong diet, Abdominal rumbling, Chronic pancreatitis, Pain, Irritable bowel syndrome, Crohn’s disease, Diarrhea, Hepatitis, Liver cirrhosis, Overeating
In adults and children it applies:
- to improve digestion in patients with normal gastrointestinal function in cases of eating disorders;
- 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.
Dosage 36,000 units:
One capsule of gastric juice-resistant microtablets contains 272.02 – 316.68 mg of pancreatin from the porcine pancreas, corresponding to a lipase activity of 36,000 units, amylase 18,000 units, proteases 1,200 units according to the European Pharmacopeia).
Colloidal anhydrous silicon dioxide,
Film coating of the microtable:
Methacrylic acid and ethyl acrylate copolymer (1:1),
Montane glycol wax.
Red iron oxide (E 172),
Black iron oxide (E 172),
How to take, the dosage
Overly, doses are chosen individually depending on the severity of the disease and diet.
The dose is calculated in terms of units of lipase activity.
The capsules should be swallowed whole with plenty of fluid (water, juice); if they are difficult to swallow, the capsules can be opened and the contents added to a liquid diet./p>
Ideal with a sour taste (pH<5.5), or pour the contents into the mouth and swallow without chewing and with plenty of fluid (approximately one cup of water).
Crushing, chewing, or adding the microtablets to foods with a pH of 5.5 will destroy the coating that protects them from the action of gastric juices.
This can lead to early release of enzymes in the mouth, decreased effectiveness, and irritation of the mucous membranes. You should make sure there are no microtablets left in your mouth.
The dose depends on body weight and should be 1000 lipase units/kg at the start of treatment per meal for children younger than four years and 500 lipase units/kg at meal times for children older than four years and adults.
The dose should be determined according to the severity of symptoms, results of steatorrhea control, 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 involving 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 the dose should be supervised by a physician. The daily dose of enzymes should not exceed 15-20,000 units of lipase per kg of body weight. Therapy should be carried out with plenty of fluid intake.
In children, the drug should be used in accordance with the prescription of the doctor.
The absorption of folic acid may be decreased when taking Ermital® .
The effect of oral hypoglycemic drugs acarbose and miglitol may be decreased during treatment with the drug Hermital®.
In long-term use of pancreatin at high doses, patients with cystic fibrosis may develop constipation, strictures of the ileum and cecum (fibrosing colonopathy), and colitis.
When taking the drug at high doses (more than 10,000 lipase units/kg body weight per day), unusual gastrointestinal symptoms and side effects should be monitored closely and, if necessary, medical examination should be performed to rule out fibrosing colonopathy.
The drug Hermital® contains active enzymes which if released in the oral cavity (e.g. by chewing) may cause irritation and mucosal ulceration. Therefore, the microtablets should be swallowed without chewing.
The drug does not affect the ability to drive vehicles, machinery.
Known hypersensitivity to any of the ingredients of the drug.
Very common (≥1/10): abdominal pain.
Often (≥1/100, <1/10): nausea, vomiting, constipation, bloating, diarrhea.
Prevalence unknown: strictures of the ileum, cecum and colon (fibrosing colonopathy).
The gastrointestinal disorders are mainly related to the underlying disease.
The incidence of adverse reactions such as abdominal pain and diarrhea was lower or similar to that of placebo.
Intestinal, cecal and colonic strictures (fibrosing colonopathy) have been observed in patients with cystic fibrosis who received high doses of pancreatin (see section “Special Precautions”).
Skin and subcutaneous tissue disorders
Infrequent (≥1/1000, <1/100): rash.
Infrequent unknown: itching, urticaria.
Immune system disorders
Prevalence unknown: hypersensitivity (anaphylactic reactions).
Allergic reactions have been observed mainly on the skin, but other manifestations of allergy have also been reported.
The reports of these adverse effects have been received during post-marketing use and have been spontaneous. There are insufficient data to make an accurate incidence estimate.
No specific adverse reactions have been reported in children. The frequency, type and severity of adverse reactions in children with cystic fibrosis were similar to those in adults.
When taking pancreatin in high doses, hyperuricosuria and hyperuricemia may develop, especially in patients with cystic fibrosis.
Treatment: drug withdrawal, symptomatic therapy.
The use of Ermital® during pregnancy and lactation is possible only after careful evaluation of the ratio of benefit to the mother and risk to the fetus or infant.
In view of the insignificant systemic absorption of pancreatin, no adverse effects on the mother, as well as on the fetus and the infant, are expected.
Mezim forte, Creon 40000, Pancreatin, Creon 25000, Micrazyme, Hermital, Panzinorm forte 20000, Penzital, Pancreatin Forte, Creon 10000, Creon 25000, Mezim 20000, Enzival-P, Mezim
|Conditions of storage|
At a temperature not exceeding 25 ˚ C. Keep out of reach of children!
Nordmark Pharma GmbH, Germany
Nordmark Pharma GmbH
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