Instructions Pancreazim 10000 gastro-resistant tablets blister No. 50
Composition
active ingredient: pancreatin;
1 gastro-resistant tablet contains pancreatin with enzymatic activity of at least 10,000 lipolytic U Ph. Eur., 7,500 amylolytic U Ph. Eur., 400 proteolytic U Ph. Eur.;
excipients: sodium chloride, colloidal anhydrous silicon dioxide, microcrystalline cellulose, crospovidone, croscarmellose sodium, povidone 25, magnesium stearate, methacrylate copolymer dispersion, talc, propylene glycol, titanium dioxide (E 171), carmoisine (E 122).
Dosage form
Gastro-resistant tablets.
Main physicochemical properties: round, film-coated tablets with convex upper and lower surfaces, pink in color, with a faint specific odor. When broken, a core surrounded by one continuous layer is visible under a magnifying glass.
Pharmacotherapeutic group
Drugs that affect the digestive system and metabolism. Drugs that improve digestion, including enzymes. Polyenzyme drugs (lipase, protease, etc.).
ATX code A09A A02.
Pharmacological properties
Pharmacodynamics
Polyenzyme preparation. Pancreatic enzymes (lipase, amylase and protease), which are part of it, facilitate the digestion of fats, carbohydrates, proteins, which contributes to their complete absorption in the small intestine. In diseases of the pancreas, the drug compensates for the insufficiency of its exocrine function and helps improve the digestive process.
Pharmacokinetics
The shell covering the tablet does not dissolve under the action of gastric juice and protects the enzymes from their inactivation by gastric juice. Only under the action of the neutral or slightly alkaline environment of the small intestine does the shell dissolve and the enzymes are released.
Indication
Diseases that are accompanied by a violation of the process of food digestion due to insufficient secretion of digestive enzymes by the pancreas, such as 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 vegetable, fatty and unusual foods.
Intestinal bloating.
Preparation for X-ray or ultrasound diagnostic examinations.
Contraindication
Hypersensitivity to the active substance or other components of the drug. Acute pancreatitis, exacerbation of chronic pancreatitis, intestinal obstruction.
Interaction with other medicinal products and other types of interactions
When using pancreatin, iron absorption may be reduced, so if necessary, iron preparations should be additionally prescribed.
Concomitant use of antacids containing calcium carbonate and/or magnesium hydroxide may reduce the effectiveness of pancreatin.
Simultaneous use with tannin and alcohol-containing products may lead to a decrease in the effectiveness of pancreatin.
When bicarbonates and cimetidine are taken simultaneously with large doses of pancreatic enzymes, it is recommended to periodically analyze the concentration of folic acid salts in the blood serum and provide additional folic acid intake, if necessary.
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 is possible 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 use with pancreatin.
Application features
If symptoms suggestive of intestinal obstruction are present, 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.
There is a theoretical risk of transmission of viral infections of pigs, including infections 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 has been reported to date due to the use of porcine pancreatin preparations.
The medicine contains active enzymes that can damage the oral mucosa, so the tablets should be swallowed whole, without chewing.
The drug should be used with caution in patients with renal failure, hyperuricemia, and patients with allergies to pork proteins.
This medicinal product contains approximately 0.024 mmol (or 0.55 mg) sodium/dose. Caution should be exercised when administering this medicinal product to patients on a controlled sodium diet.
The medicine contains propylene glycol.
Use during pregnancy or breastfeeding
Security is not established.
The use of the drug should be avoided during pregnancy or breastfeeding.
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 the drug depends on the deficiency of pancreatic enzymes in the duodenum and is set individually.
If there are no other recommendations, as well as in the case of eating hard-to-digest plant foods, fatty or unusual foods, take 1–2 tablets. In other cases mentioned above, if digestive disorders occur, the recommended dose is 2–4 tablets. If necessary, the dose of the drug can be increased. Increasing the dose to reduce the symptoms of the disease, such as steatorrhea or abdominal pain, should be carried out only under the supervision of a doctor. The daily dose of lipase should not exceed 15,000–20,000 Ph. Eur. units per 1 kg of body weight.
Take the tablets during meals, swallowing them whole and drinking plenty of liquid, such as 1 glass of water.
The duration of treatment depends on the course of the disease and is determined by the doctor on an individual basis.
Children
There is no experience with the use of the drug in children, therefore it is not recommended to prescribe it to this age group of patients.
Overdose
Symptoms: Possible increase in side effects. Hyperuricemia and hyperuricosuria have been observed when taking extremely high doses of other pancreatic powder preparations.
Treatment: Discontinuation of the drug, adequate hydration, and symptomatic therapy.
Adverse reactions
The following classification is used to estimate the frequency of adverse reactions: very common: ≥ 1/10; common: ≥ 1/100 and < 1/10; uncommon: ≥ 1/1000 and < 1/100; rare: ≥ 1/10000 and < 1/1000; very rare: < 1/10000, frequency unknown (cannot be estimated from the available data).
Cardiovascular system: frequency unknown: tachycardia.
Immune system disorders: very rare: immediate allergic reactions (skin rash, itching, sneezing, lacrimation, bronchospasm), anaphylactic reactions. Frequency unknown: the dye carmoisine (E 122) may cause allergic reactions.
From the gastrointestinal tract: very rarely: when using high doses of pancreatin (more than 10,000 Ph. Eur. lipase units / kg body weight / day), narrowings may form in the ileocecal region and in the ascending part of the colon; diarrhea, abdominal pain, nausea, vomiting, change in the nature of stools; possible development of intestinal obstruction, constipation.
Skin and subcutaneous tissue disorders: frequency unknown: urticaria, hyperemia, itching, angioedema.
On the part of the genitourinary system: frequency unknown: increased urinary excretion of uric acid is possible, especially when using high doses of pancreatin. To avoid the formation of uric acid stones in such patients, the content of uric acid in the urine should be monitored.
General disorders: frequency unknown: feeling hot, general weakness.
Reporting adverse reactions after registration of a medicinal product is of great importance. This allows monitoring of the benefit/risk ratio when using this medicinal product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, should report all cases of suspected adverse reactions and lack of efficacy of the medicinal product through the Automated Information System for Pharmacovigilance at the link: https://aisf.dec.gov.ua/”.
Expiration date
3 years.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 ºС.
Keep out of reach of children.
Packaging
10 tablets in a blister. 1 or 2 or 5 blisters in a cardboard pack.
Vacation category
Without a prescription.
Producer
Technolog PJSC.
Location of the manufacturer and address of its place of business
Ukraine, 20300, Cherkasy region, Uman city, Stara Prorizna Street, building 8.
