Instructions for Enzystal enteric-coated tablets No. 80
Composition
active ingredients: 1 tablet contains pancreatin 192 mg (lipase 6000 IU MPF, amylase 4500 IU MPF, protease 300 IU MPF), hemicellulase 50 mg, bile extract 25 mg;
excipients: lactose monohydrate, magnesium stearate, colloidal anhydrous silicon dioxide, cellulose acetyl phthalate, diethyl phthalate, sugar, calcium carbonate, talc, acacia, gelatin, titanium dioxide (E 171), yellow wax.
Dosage form
Sugar-coated, enteric-coated tablets.
Main physicochemical properties: round biconvex tablets, coated with a white sugar coating.
Pharmacotherapeutic group
Preparations that improve digestion, including enzymes. Polyenzyme preparations.
ATX code A09A A02.
Pharmacological properties
Pharmacodynamics
Combined drug. The enzymes contained in the drug facilitate the digestion of proteins, fats, carbohydrates and contribute to their more complete absorption in the small intestine. Bile extract promotes the emulsification of fats, increases lipase activity, improves the absorption of fats and fat-soluble vitamins. The enzyme hemicellulase promotes the breakdown of plant fiber. These properties of the drug help to improve the functional state of the gastrointestinal tract, normalize the digestive process.
Pharmacokinetics
The drug is not absorbed and acts in the lumen of the intestinal tract. The contents of the tablet are protected by an acid-resistant shell, which prevents the inactivation of enzymes (which are part of the drug) by hydrochloric acid in the stomach. The dissolution of the shell and the release of enzymes occurs in the small intestine, i.e. in an alkaline environment, which is optimal for the manifestation of enzyme activity.
Indication
Replacement therapy for mild and moderate pancreatic exocrine dysfunction in chronic pancreatitis (except in cases of exacerbation of chronic pancreatitis), to improve digestion in ulcerative colitis, irritable bowel syndrome, and after gastric resection; for flatulence and some cases of diarrhea of non-infectious origin; to improve food digestion in individuals with normal digestive tract function in case of violations of the rational diet (eating large amounts of food, eating fatty, fried or unusual foods, irregular meals, etc.); in case of impaired chewing function, in conditions leading to prolonged immobilization; preparation for X-ray and ultrasound examination of the abdominal organs; as an aid for the effective absorption of fat-soluble vitamins and certain drugs (PAK, sulfonamides, antibiotics).
Contraindication
Hypersensitivity to the components of the drug, to pancreatic enzymes of animal origin, acute hepatitis, mechanical jaundice, obstructive intestinal obstruction, acute pancreatitis, exacerbation of chronic pancreatitis.
Interaction with other medicinal products and other types of interactions
Enzystal promotes the effective absorption of fat-soluble vitamins, sulfonamides, antibiotics, and para-aminosalicylic acid (PASA).
When pancreatin is used simultaneously with antithrombotic agents, vitamin K antagonists and acetylsalicylic acid, the effect of these drugs is reduced. The effectiveness of non-selective inhibitors of neuronal monoamine reuptake is also reduced when used simultaneously with pancreatin.
When used simultaneously with M-cholinoblockers, the anticholinergic effect is enhanced.
When using the drug, the absorption of folic acid may be reduced. Pancreatin may reduce the effect of acarbose, so these drugs should not be used simultaneously.
The drug reduces the absorption of iron with prolonged use, so if necessary, iron preparations should be prescribed simultaneously. Simultaneous use of antacids containing calcium carbonate and/or magnesium hydroxide may reduce the effectiveness of Enzystal. Simultaneous use with tannin, alcohol-containing products may reduce the effectiveness of pancreatin.
Cimetidine may enhance the effect of the drug.
Application features
The drug should not be used in acute pancreatitis or chronic pancreatitis in the acute stage. During the recovery period or when expanding the diet, the drug can be taken only as prescribed by a doctor.
In the presence of symptoms similar to intestinal obstruction, the possibility of intestinal strictures should be considered. It is recommended to monitor any unusual symptoms, especially when taking more than 10,000 lipase units/kg/day.
To avoid the formation of uric acid stones, the uric acid content in the urine should be monitored.
The medicinal product contains lactose, therefore patients with rare hereditary forms of galactose intolerance, lactase deficiency or glucose-galactose malabsorption syndrome should not use it. The medicinal product contains sugar, therefore it should be used with caution in patients with diabetes mellitus.
The drug contains purines, so it should be used with caution in patients with the following conditions:
gout; hyperuricemia; renal failure.
Ability to influence reaction speed when driving vehicles or other mechanisms
Does not affect.
Use during pregnancy or breastfeeding
The safety of pancreatin in pregnant women has not been established. Therefore, the use of the drug during pregnancy should be avoided.
The safety of pancreatin in breastfeeding women has not been established, so the drug should be avoided during breastfeeding.
Method of administration and doses
Adults are prescribed 1 tablet with a small amount of liquid during or immediately after each meal. The tablet should not be chewed. If necessary, the dose can be increased to 2 tablets.
The duration of treatment can range from several days (in case of digestive disorders due to eating disorders) to several months and even years (if permanent replacement therapy is necessary).
Children
The drug is not used in children.
Overdose
With prolonged use in high doses, the development of hyperuricemia, hyperuricosuria is possible. The manifestation of adverse reactions is possible.
Treatment: drug withdrawal, adequate hydration, symptomatic therapy.
Adverse reactions
The following classification is used to assess the frequency of side effects: very common: ≥ 10%; common: ≥ 1% and < 10%; uncommon: ≥ 0.1% and < 1%; rare: ≥ 0.01% and < 0.1%; very rare: < 0.01%; frequency unknown (cannot be estimated from the available data).
Immune system disorders: Frequency unknown: anaphylactic reactions, including urticaria and angioedema.
Hypersensitivity reactions may occur, including skin rashes, itching, redness of the skin, tearing and sneezing.
From the genitourinary system. Frequency unknown: hyperuricosuria, especially when using high doses of the drug.
Gastrointestinal disorders: Frequency unknown: vomiting, oral mucosal irritation. Abdominal pain, diarrhea, perianal irritation, constipation, extensive intestinal stenosis, fibrosing colonopathy.
Very rarely, nausea, a feeling of discomfort in the epigastric region of the stomach, flatulence, changes in the nature of stools, intestinal colic, intestinal obstruction may occur.
Adverse reactions from the digestive tract may also be caused by the underlying disease.
Metabolism and nutrition disorders: Frequency not known: hyperuricemia.
The use of very high doses of the drug may lead to an increase in uric acid levels in the blood.
Expiration date
3 years.
Storage conditions
Store at a temperature not exceeding 25 °C in the original packaging.
Keep out of reach of children.
Packaging
10 tablets in a blister, 8 blisters in a cardboard box.
Vacation category
Without a prescription.
Producer
TORRENT PHARMACEUTICALS LTD.
Location of the manufacturer and its business address
Baddi Plant, Village Bhad and Makhnu Majra, Baddi – 173205, Tehsil Dist. Solan (H.P.), India.
