Instructions for Panzinorm forte 20000 film-coated tablets No. 30
Composition
active ingredient: 1 tablet contains 269.12–279.44 mg of pancreatin (porcine) with enzymatic activity of lipase – 20,000 U, amylase – 12,000 U, protease – 900 U;
Excipients: lactose monohydrate, microcrystalline cellulose, crospovidone, colloidal anhydrous silica, magnesium stearate, hypromellose, methacrylate copolymer (type A), triethyl citrate, titanium dioxide (E 171), talc, simethicone emulsion, vanillin flavor, bergamot flavor, macrogol 6000, carmellose sodium, polysorbate 80.
Dosage form
Film-coated tablets.
Main physicochemical properties: white to light gray, smooth, round, convex, flavored tablets, film-coated.
Pharmacotherapeutic group
Means that improve digestion, including enzymes. Polyenzyme preparations. ATX code A09A A02.
Pharmacological properties
Pharmacodynamics
Pancreatin is a powder from the pancreas of a pig, which contains enzymes such as lipase, amylase, trypsin and chymotrypsin, which contribute to the digestion of proteins, fats and carbohydrates in the digestive tract. The key is the enzymatic activity of lipase, as well as the content of trypsin, since even with a significant decrease in the secretory activity of the pancreas, amylase exhibits sufficient activity.
Pharmacokinetics
The acid-resistant shell protects the active enzymes from the action of gastric juice. Only under the influence of the neutral or slightly alkaline environment of the small intestine does the shell dissolve and the enzymes are released.
Indication
Chronic pancreatitis.
Conditions after simultaneous resection of the stomach and small intestine, functional acceleration of food passage through the intestines.
Intestinal disorders, simultaneous consumption of difficult-to-digest plant, fatty and unusual foods.
Panzinorm® forte 20,000 is also used for intestinal bloating and in preparation for X-ray or ultrasound diagnostic examinations.
Contraindication
Panzinorm® forte 20000 is contraindicated:
with hypersensitivity to pork or other ingredients of the drug;
with acute pancreatitis or exacerbation of chronic pancreatitis;
Obstructive intestinal obstruction.
Interaction with other medicinal products and other types of interactions
Pancreatic enzymes inhibit the absorption of folic acid, which may result in the need for additional intake of it into the body.
Pancreatic enzymes may reduce iron absorption, but the clinical significance of this interaction is unknown.
The acid-resistant film coating of Panzinorm® forte 20,000 tablets is destroyed in the duodenum. If the duodenal contents are too acidic, the enzymes will be released untimely. Reducing gastric acid secretion, achieved by using H2-receptor inhibitors or proton pump inhibitors, improves the effectiveness of enzyme intake in some patients and makes it possible to reduce the dose of Panzinorm® forte 20,000.
Acarbose, miglitol.
The blood sugar-lowering effect of the oral antidiabetic drugs acarbose and miglitol may be reduced when used simultaneously with Panzinorm® forte 20,000.
Application features
The drug contains active enzymes that can damage the oral mucosa, so the tablets should be swallowed whole, without chewing, with sufficient liquid.
In case of unusual abdominal discomfort or change in symptoms, it is recommended to undergo an examination to exclude intestinal damage as a precautionary measure, especially if the patient is using a dose of more than 10,000 U of lipase per kilogram of body weight per day.
Panzinorm® forte 20,000 contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Use during pregnancy or breastfeeding
Panzinorm® forte 20,000 is recommended to be used only as prescribed by a doctor in cases where the expected benefit to the mother outweighs the potential risk to the fetus or child.
Ability to influence reaction speed when driving vehicles or other mechanisms
No effect on the ability to drive or use machines was observed.
Method of administration and doses
The dose of Panzinorm® forte 20,000 is determined individually, depending on the severity of pancreatic insufficiency. The usual initial dose is 1–2 tablets with each meal. The tablet is not chewed and washed down with a sufficient amount (a glass) of liquid. Depending on the type of food, as well as the severity of the digestive disorder, the dose can be gradually increased. The dose should be increased under the supervision of a doctor and at the same time be focused on reducing the manifestations of the disease, for example, steatorrhea or pain syndrome. The maximum daily dose of the drug for adults and children over 15 years of age is 9 tablets. The question of increasing the dosage of the drug and the duration of treatment is decided by the doctor individually.
Children
It is not recommended for use in children under 15 years of age, as the Panzinorm® forte 20,000 tablet is film-coated and cannot be divided.
Overdose
There are no data on systemic intoxication in case of overdose. Overdose may cause nausea, vomiting, diarrhea, hyperuricemia, hyperuricosuria and uricosuria, perianal irritation and, very rarely, fibrosing colonopathy. In case of overdose, the tablets should be discontinued, hydration of the body and symptomatic treatment are recommended.
Side effects
When using large doses of the drug, increased excretion of uric acid in the urine may be observed, therefore, to prevent the formation of uric acid stones in such patients, the level of uric acid in the urine should be monitored.
On the part of the immune system. In some cases, immediate allergic reactions (skin rash, urticaria, sneezing, lacrimation, bronchospasm, dyspnea), hypersensitivity reactions localized in the gastrointestinal tract were observed after taking pancreatin.
Gastrointestinal: Very rarely, diarrhea, abdominal discomfort, abdominal pain, nausea, vomiting have been observed.
When using very high doses of pancreatin, strictures may form in the ileocecal and ascending parts of the large intestine.
Expiration date
3 years.
Storage conditions
Store in original packaging.
Keep out of reach of children.
Packaging
10 film-coated tablets in a blister; 1, 3 or 10 blisters in a box.
Vacation category
Without a prescription.
Producer
KRKA, dd, Novo mesto, Slovenia.
Address
Smarjeska cesta 6, 8501 Novo mesto, Slovenia.
