Ermital caps. 25tys.ed 50 pc

Description

Composition
Active substance:
One capsule resistant to gastric juice contains microtablets 218.2 – 282.4 mg of pancreatin from porcine pancreas, which corresponds to a lipase activity of 25,000 IU, 22,500 IU of amylase, protease 1250 U (according to European Pharmacopoeia).
Excipients:
Microcrystalline cellulose, crospovidone, colloidal anhydrous silica, magnesium stearate; microtablets film coating: Methacrylic acid-ethyl acrylate copolymer (1: 1), triethyl citrate, talc, simethicone; polishing agent: montan glycol wax. The cap of the capsule: gelatin, red iron oxide (E 172), black iron oxide (E 172) Titanium dioxide (E 171), sodium lauryl sulfate; Capsule Shell: gelatin, sodium lauryl sulfate.
Description:
Solid elongated gelatin capsule, size 0 № el, lid brown opaque, colorless, transparent body. The contents of the capsules: white-gray convex film-coated microtablets; tolerance of micro-tablets in the characteristic smell.
Product form:
Capsules 25 000 units. 50 capsules in a glass vial dark glass, a sealed plastic cap vial equipped with a sealing disc consisting of two parts held together by wax dots. When you first open the disc is divided into two parts. Part 1 (glassine paper / aluminum foil / wax dots) remains on the bottle neck and part 2 (aluminum foil / paper / cardboard) remains in the cap. 1 bottle in cardboard box, together with instructions for medical use of the drug.
Contraindications
Known hypersensitivity to any component of the drug.
Dosage
25 thousand units
Indications
In adults and children: to improve food digestion in patients with normal function of the gastrointestinal tract in the case of errors in the diet; substitution therapy in exocrine pancreatic insufficiency: cystic fibrosis, chronic pancreatitis, pancreatectomy, pancreatic cancer, ductal obstruction from neoplasm (including obstruction of the pancreatic duct, common bile duct), Shvahmana-Diamond syndrome, conditions after an attack of acute pancreatitis and resumption of power; symptomatic therapy of digestive disorders: condition after cholecystectomy, partial gastrectomy (Billroth-I / II), total gastrectomy, and duodeno- gastrostasis, biliary obstruction, cholestatic hepatitis, cirrhosis, Crohn’s disease, goiter.
Interaction with other drugs
Before the drug Ermital® may decrease the absorption of folic acid. On the background of treatment Ermital® may decrease the effect of oral hypoglycemic drugs acarbose and miglitol.
Overdose
When receiving a pancreatin in high doses may develop hyperuricosuria and hyperuricemia, particularly in patients with cystic fibrosis.
Treatment: removal of the drug, symptomatic therapy.
pharmachologic effect
Pharmacological group:
Digestive enzymatic means
Pharmacodynamics:
Ermital® comprises a standard high activity pancreatin, obtained from pig pancreas in the form of micro-tablets resistant to gastric juices. Digestive enzymatic means compensates deficiency of pancreatic enzymes, having proteolytic, amylolytic and lipolytic action. Included in the enzymes (lipase, alpha-amylase, trypsin, chymotrypsin) contribute to the breakdown of proteins to amino acids, fats – to glycerol and fatty acids, starch – into dextrins and sugars, improve the functional state of the gastrointestinal tract, normalize digestion. Products splitting pancreatic enzymes are absorbed in the gut, either directly or after digestion by intestinal enzymes.
Pharmacokinetics:
Product form provides a drug release complete resistant to gastric juice microtablets of capsules in the stomach, followed by stirring microtablets particulate with intestinal contents and chyme and rapid release of enzymes from the micro-tablets in the duodenum kishke.Fermenty pancreas is not absorbed into the bloodstream. The enzymes are inactivated and digested in the gut as proteins by autolysis and proteolysis.
Pregnancy and breast-feeding
Use of the drug Ermital® during pregnancy and lactation is possible only after careful evaluation of the ratio of benefits to the mother and the risk to the fetus or infant. Due to the low systemic absorption of pancreatin, the negative impact on the mother and the fetus and the baby is not expected.
Conditions of supply of pharmacies
Without a prescription.
side effects
Disorders of the gastrointestinal tract
Very common (> 1/10): abdominal pain.
Often (> 1/100,
Frequency unknown: stricture of the ileum, cecum and colon (fibrosing colopathy).
Gastrointestinal disorders are mainly related to the underlying disease. The frequency of occurrence of adverse reactions such as an abdominal pain and diarrhea was lower or similar to that with placebo. Stricture of the ileum, cecum and colon (fibrosing colopathy) were observed in patients with mukovistsidzom receiving high doses of pancreatin preparations (see. Section “Special Instructions”).
Violations of the skin and subcutaneous tissue
Infrequently (> 1/1000,
Violations by the immune system
Frequency unknown: hypersensitivity (anaphylactic response). Allergic reactions were observed mainly on the part of the skin, but were also noted and other manifestations of allergy. Reports of these adverse events were received during post-marketing use and were spontaneous. For an accurate assessment of the incidence of insufficient data are available. In the application in children has not been noted any specific adverse reactions. Frequency, type and severity of adverse reactions in children with cystic fibrosis were similar to those in adults.
special instructions
With prolonged use of high doses of pancreatin in patients with cystic fibrosis may develop constipation, stricture ileum and cecum (fibrosing colopathy), colitis. Before the drug at high doses (over 10,000 lipase units / kg body weight per day) should be carefully monitored unusual symptoms and side effects of the gastrointestinal tract and, if necessary, to carry out the medical examination to exclude fibrosing colonopathy. Ermital® preparation comprises active enzymes which when released in the oral cavity (e.g., upon chewing) can cause irritation and ulceration of the mucosa. Therefore, micro-tablets should be swallowed without chewing.
The drug does not affect the ability to drive vehicles, machinery.
Storage conditions
At a temperature of not higher than 25 degrees. Keep out of the reach of children!
Dosing and Administration
Inside, dose picked individually, depending on the severity of the disease and diet. dose calculation is carried out, based on the units of lipase activity. Capsules should be swallowed whole during meals, with plenty of liquid (water, juice); with difficulty swallowing capsules can be opened and the contents added to a liquid food having a sour taste (pH
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist