Instructions for Ermital 36000 capsules No. 20
Composition
active ingredient: pancreatin;
1 capsule of 36,000 IU contains pancreatin from the pancreas of pigs with enzymatic activity of lipase 36,000 IU, amylase 18,000 IU, protease 1200 IU;
Excipients: microcrystalline cellulose, crospovidone, colloidal anhydrous silica, magnesium stearate, methacrylate copolymer dispersion, triethyl citrate, talc, simethicone, montan glycol wax, gelatin, red iron oxide (E 172), black iron oxide (E 172), titanium dioxide (E 171), sodium lauryl sulfate.
Dosage form
Gastro-resistant hard capsules.
Main physicochemical properties:
HERMITAL 36,000: oblong hard gelatin capsule size 00, brown cap, opaque, colorless, transparent body; capsule contents: whitish-gray round biconvex microtablets, film-coated, with a characteristic odor.
Pharmacotherapeutic group
Preparations that improve digestion, including enzymes. Polyenzyme preparations. ATX code A09A A02.
Pharmacological properties
Pharmacodynamics
The preparation contains pancreatin from the pancreas of pigs in the form of enteric-coated (acid-resistant) microtablets in gelatin capsules. The capsules dissolve rapidly in the stomach, releasing microtablets in a multi-dose manner, which ensures good mixing with the stomach contents, transport from the stomach together with its contents and, after release, sufficient distribution of enzymes within the intestinal contents. When the microtablets enter the small intestine, the coating dissolves rapidly (at pH > 5.5), releasing enzymes with lipolytic, amylolytic and proteolytic activity, which ensures the breakdown of fats, carbohydrates and proteins. The products of pancreatic digestion are then absorbed either immediately or after further hydrolysis by intestinal enzymes.
Pharmacokinetics
Animal studies have not shown any evidence of absorption of the enzymes in their unchanged form, and therefore classical pharmacokinetic studies have not been performed. Pancreatic enzyme supplements do not require absorption to achieve their effect. On the contrary, their full therapeutic effect is exerted in the lumen of the gastrointestinal tract. Moreover, as proteins, they undergo proteolytic digestion as they pass through the gastrointestinal tract before being absorbed as peptides and amino acids.
Non-clinical data do not indicate relevant acute, subchronic or chronic toxicity. No genotoxicity, carcinogenicity or reproductive toxicity studies have been conducted.
Indication
Treatment of exocrine pancreatic insufficiency in adults and children caused by various diseases, including but not limited to the following:
chronic pancreatitis; pancreatectomy; gastrectomy; operations with gastrointestinal anastomosis (e.g. Billroth II gastroenterostomy); Shwachman-Diamond syndrome; condition after an attack of acute pancreatitis and resumption of enteral or oral nutrition.
Contraindication
Hypersensitivity to the active substance pancreatin, pig/pork proteins or any other component of the drug.
Interaction with other medicinal products and other types of interactions
Folic acid: Folic acid absorption may be reduced in patients taking pancreatic enzyme preparations, therefore monitoring of folic acid levels is recommended during concomitant use.
Acarbose, miglitol. It cannot be excluded that pancreatic enzyme preparations may reduce the effect of these antidiabetic agents. Therefore, monitoring of the effect of antidiabetic agents on the patient's blood sugar level is recommended during concomitant treatment with pancreatin.
Application features
Pancreatin preparations contain active proteins that may cause mucosal damage (e.g. mouth ulcers) when released into the oral cavity (e.g. by chewing). Therefore, care should be taken to ensure that the preparations are taken without chewing.
ERMITAL 36,000 should not be taken in acute pancreatitis and during the exacerbation phase of chronic pancreatitis.
Like other porcine pancreatin preparations currently on the market, ERMITAL 10,000, ERMITAL 25,000, ERMITAL 36,000 are produced from pancreatic tissue of pigs intended for food purposes. Although the risk of the drug introducing an infectious agent into the human body is reduced by testing and inactivating certain viruses during the manufacturing process, there is a theoretical risk of transmission of viral infections, including those caused by new or unidentified viruses. The presence of porcine viruses that can infect humans cannot be completely ruled out.
However, no case of transmission of infectious disease due to the use of porcine pancreatin preparations has been reported to date, although they have been used for a long time.
The drug should be used with caution in patients with renal failure, hyperuricemia, and patients with allergies to proteins of pork origin.
Ability to influence reaction speed when driving vehicles or other mechanisms
The drug has no or negligible influence on the ability to drive or operate other mechanisms.
Use during pregnancy or breastfeeding
Due to the lack of clinical data on the effects of pancreatic enzymes on pregnancy, the drug should be administered with caution to pregnant women. Animal studies have shown no signs of absorption of pancreatic enzymes. Therefore, no toxic effects on reproduction and fetal development are expected.
Since animal studies indicate no systemic exposure of the nursing mother to pancreatic enzymes, no effects on the breastfed infant are anticipated. Therefore, pancreatic enzymes can be administered to breastfeeding women.
If necessary, pregnant or breastfeeding women can take the drug in doses sufficient to ensure adequate nutritional status.
Method of administration and doses
The dosage of the drug is based on the individual needs of the patient and depends on the degree of digestive disorders and the composition of the food. To select an adequate individual dose, there are three doses of the drug - HERMITAL 10,000, HERMITAL 25,000, HERMITAL 36,000.
It is recommended to take the drug during or immediately after meals.
Capsules and microtablets should be swallowed whole, without breaking or chewing, and washed down with sufficient liquid or consumed with a light snack. If the capsule cannot be swallowed whole (children and the elderly), it can be opened and the microtablets added to liquid food that does not require chewing, such as applesauce, to a liquid with a neutral or slightly acidic environment (yogurt, grated apple). This mixture should be taken immediately and not stored.
During treatment with ERMITAL 10,000, ERMITAL 25,000, ERMITAL 36,000, it is very important to drink enough fluids, especially during periods of increased fluid loss. Fluid deficiency can worsen constipation.
Dosage for exocrine pancreatic insufficiency: the dose should be selected individually, depending on the degree of digestive disorders and the fat composition of the food.
The usual starting dose is 10,000 to 25,000 IU of lipase with each main meal. However, it is possible that some patients may require higher doses to eliminate steatorrhea and maintain adequate nutritional status. According to generally accepted clinical practice, at least 20,000 to 50,000 IU of lipase should be taken with meals. The dose for administration during main meals (breakfast, lunch or dinner) can be 25,000 to 80,000 IU of lipase, and for additional light meals between main meals, half the individual dose should be taken.
Children
The medicine can be used in children.
Overdose
Cases of hyperuricosuria and hyperuricemia have been reported in association with extremely high doses of pancreatin.
Adverse reactions
Classification of undesirable effects by frequency: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1000 to < 1/100), rare (≥ 1/10000 to < 1/1000), very rare (< 1/10000), unknown (frequency cannot be estimated from the available data).
When studying the effects of pancreatin-containing drugs on patients, gastrointestinal disorders were most often reported, mainly of mild to moderate severity.
Adverse reactions observed during the study of the drug are listed below.
Infrequently:
Metabolism and nutrition disorders: anorexia.
Gastrointestinal: abdominal pain (gastrointestinal disorders were mainly associated with the underlying disease); nausea, vomiting, constipation, abdominal distension, diarrhea, stomatitis.
Skin and subcutaneous tissue disorders: rash; itching, urticaria, erythema.
Immune system disorders: hypersensitivity (anaphylactic reactions).
Most allergic reactions, including but not limited to skin reactions, have been identified as adverse reactions during post-marketing use.
General disorders: malaise.
Not known (frequency cannot be estimated from the available data):
On the part of the immune system: immediate type I hypersensitivity (urticaria, sneezing, lacrimation, bronchospasm), gastrointestinal hypersensitivity.
Gastrointestinal: adverse events that may be symptoms of prolonged digestive disorders and therefore may require dosage adjustment by a doctor: anorexia, diarrhea, abdominal pain, nausea, vomiting, dyspepsia (pyrosis, heartburn), malaise.
Children
No specific adverse reactions were identified in children.
Expiration date
3 years.
Storage conditions
Store out of the reach of children at a temperature not exceeding 25 °C.
Packaging
20 capsules in a dark glass bottle; 1 bottle in a cardboard box.
Vacation category
Without a prescription.
Producer
Nordmark Artzneimittel GmbH & Co. KG.
Location of the manufacturer and its business address
Pinnauwallee 4, Uetersen, Schleswig-Holstein, 25436, Germany.
