Instructions for Mezim forte 20000 enteric-coated tablets blister No. 20
Composition
active ingredient: powder from pancreas (pigs); 1 enteric-coated tablet contains 160–222.22 mg of powder from pancreas of pigs, which has a minimum lipolytic activity of 20,000 EF units (European Pharmacopoeia units), a minimum amylolytic activity of 12,000 EF units, a minimum proteolytic activity of 900 EF units;
Excipients: lactose monohydrate, microcrystalline cellulose, colloidal anhydrous silica, crospovidone, magnesium stearate, hypromellose, methacrylate copolymer (type A), triethyl citrate, titanium dioxide (E 171), talc, simethicone, polyethylene glycol, polysorbate, carmellose sodium, vanilla flavor, bergamot flavor, sodium hydroxide.
Dosage form
Enteric-coated tablets.
Main physicochemical properties: slightly biconvex tablets, film-coated, white to slightly gray in color with a smooth surface.
Pharmacotherapeutic group
Digestive aids, including enzymes. Polyenzyme preparations.
ATX code A09A A02.
Pharmacological properties
Pharmacodynamics
The active substance of the drug Mezim® forte 20000 is a powder from the pancreas (pancreatin) of mammals, usually pigs, which, in addition to excretory pancreatic enzymes (lipase, alpha-amylase, trypsin and chymotrypsin), contains other enzymes. Pancreatin also contains other accompanying substances that do not have enzymatic activity.
Pharmacokinetics
Absorption
Pancreatic powder is not absorbed in the gastrointestinal tract and is excreted in the feces. Most of it is destroyed or denatured by digestive juices or by bacteria.
Bioavailability
The enteric coating of the tablets, resistant to the action of gastric juice, protects the acid-sensitive enzymes from inactivation during passage through the stomach. Only after reaching a neutral or slightly alkaline environment in the small intestine are the enzymes released after dissolution of the coating. Due to the fact that the pancreatic powder is not absorbed in the digestive tract, there is no information on its pharmacokinetics and bioavailability.
The effectiveness of pancreatic powder is determined by the degree and rate of enzyme release from the dosage form.
Indication
Impairment of the exocrine function of the pancreas, accompanied by digestive disorders.
Contraindication
Hypersensitivity to the active substance, pig meat (pork allergy) or to any of the excipients of the medicinal product.
Acute pancreatitis or chronic pancreatitis in the exacerbation phase (but episodic use is possible in the phase of subsiding exacerbation when expanding the diet in the presence of pancreatic function disorders). The drug should not be used in patients with obstructive intestinal obstruction.
Interaction with other medicinal products and other types of interactions
Folic acid
When using ready-made medicines containing pancreatin, the absorption of folic acid may decrease, which may result in the need for its additional intake into the body.
Acarbose, miglitol
The blood sugar-lowering effect of the oral antidiabetic drugs acarbose and miglitol may be reduced when used simultaneously with the drug Mezim® forte 20000.
Application features
In case of unusual abdominal discomfort or changes in symptoms, it is recommended to undergo an examination to exclude intestinal damage as a precautionary measure, especially if the patient uses a dose of more than 20,000 IU of EF lipase per kilogram of body weight per day.
The drug contains active enzymes that, when released in the oral cavity, for example, when chewing, can damage its mucous membrane, up to the formation of ulcers, therefore
Mezim® forte 20000 should be swallowed whole.
Mezim® forte 20000 should not be used in patients with rare hereditary forms of galactose intolerance, lactase deficiency or glucose-galactose malabsorption syndrome.
Ability to influence reaction speed when driving vehicles or other mechanisms
The effect of Mezim® forte 20000 on the ability to drive vehicles or operate other mechanisms is absent or insignificant.
Use during pregnancy or breastfeeding
There are no adequate data on the use of Mezim® forte 20000 in pregnant women. There is insufficient data on the effects on pregnancy, embryonal/fetal development, parturition or postnatal development obtained in animal experiments, so the potential risk to humans is unknown. Therefore, Mezim® forte 20000 should not be taken during pregnancy and lactation, except in cases where its use is absolutely necessary.
Method of administration and doses
Dosage
The dose of Mezim® forte 20000 is determined according to the severity of the existing pancreatic insufficiency. Usually the recommended dose is a dose of lipase 20000–40000 IU EF per meal, but it may be higher. The goal of treatment with Mezim® forte 20000 is to achieve or maintain normal body weight and normalize the frequency of defecation or stool consistency. Increasing the dose should be carried out only under the supervision of a physician and in order to relieve symptoms (e.g. steatorrhea, stomach pain).
The daily dose of enzymes should not be exceeded, which is 15,000–20,000 U of lipase per kilogram of body weight.
Mezim® forte 20000 tablets should be swallowed whole, washed down with plenty of liquid, during meals, since the effectiveness of the drug Mezim® forte 20000 may decrease when chewed, and the enzymes contained in the drug, when released in the oral cavity, may damage its mucous membrane.
Duration of use
The duration of treatment depends on the course of the disease and is determined by the doctor.
Children
The drug Mezim® forte 20000 is used to treat children aged 3 years and older.
The dosage and duration of treatment are determined by the doctor.
Overdose
The use of very high doses of pancreatic enzymes may be accompanied by hyperuricosuria and hyperuricemia. Treatment is symptomatic.
Adverse reactions
The following classification is used to estimate the frequency of adverse reactions: very common: ≥ 1/10; common: ≥ 1/100 - < 1/10; uncommon: ≥ 1/1000 - < 1/100; rare: ≥ 1/10000 - < 1/1000; very rare: < 1/10000, frequency unknown (cannot be estimated from the available data).
On the part of the immune system
Very rare: immediate-type allergic reactions (skin rash, urticaria, sneezing, lacrimation, bronchospasm, dyspnea), hypersensitivity reactions localized in the gastrointestinal tract.
From the digestive tract
Very rare: diarrhoea, abdominal discomfort, abdominal pain, nausea, vomiting. Formation of strictures in the ileocecal region and in the ascending colon has been described after administration of pancreatic powder in high doses.
Reporting of suspected adverse reactions
Reporting of suspected adverse reactions after the authorisation of a medicinal product plays an important role. This allows for continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals should report any suspected adverse reactions.
Expiration date
3 years.
Do not use the drug after the expiration date indicated on the package.
Storage conditions
Store at a temperature not exceeding 30°C. Keep out of the reach of children.
Packaging
10 tablets in a blister; 2 blisters in a cardboard box.
Vacation category
Without a prescription.
Producer
BERLIN-CHEMI AG
Location of the manufacturer and its business address
Glienicker Weg 125, 12489 Berlin, Germany.
