Instructions Pancreatin 8000 gastro-resistant tablets blister No. 50
Composition
active ingredients: 1 tablet contains pancreatin with enzymatic activity of at least 8000 lipolytic U Ph. Eur., 5600 amylolytic U Ph. Eur., 370 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, coated tablets, pink in color, with a faint specific odor, convex on the upper and lower surfaces. When broken, a core surrounded by a single solid layer is visible under a magnifying glass.
Pharmacotherapeutic group
Means that improve digestion, including enzymes. Polyenzyme preparations (lipase, protease, amylase).
ATX code A09A A02.
Pharmacological properties
Pharmacodynamics.
A multi-enzyme preparation. Pancreatic enzymes (lipase, amylase and protease) that 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 preparation compensates for the insufficiency of its exocrine function and helps improve the digestive process.
Pharmacokinetics.
The coating covering the tablets 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 coating 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 distension and preparation for X-ray or ultrasound diagnostic examinations.
Contraindication
Hypersensitivity to the components of the drug. Acute pancreatitis or chronic pancreatitis in the acute stage. The drug should not be used in patients with obstructive intestinal obstruction.
Interaction with other medicinal products and other types of interactions
With simultaneous use of pancreatin with iron preparations, a decrease in the absorption of the latter is possible.
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 treatment with pancreatin.
Application features
Intestinal obstruction – if symptoms suggestive of this condition 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 drug 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 proteins of pork origin.
This medicinal product contains 0.024 mmol (or 0.55 mg) sodium/dose. Caution should be exercised when administered 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.
The ability to influence the reaction speed when driving or working with other mechanisms
Does not affect.
Method of administration and doses
If there are no other recommendations, as well as in cases of consumption of difficult-to-digest plant foods, fatty or unusual foods, take 1-2 tablets. In other above-mentioned cases, when 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, for example, 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 with meals, swallow them whole and drink plenty of liquid, for example, 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 for use in this age group of patients.
Overdose
Hyperuricemia and hyperuricosuria have been observed when taking extremely high doses of pancreatin. Treatment is symptomatic.
Side effects
The following classification is used to assess the frequency of adverse reactions:
very common: ≥ 1/10;
common: ≥ 1/100 - < 1/10;
sometimes: ≥ 1/1000 – < 1/100;
rare: ≥ 1/10,000 – < 1/1,000;
very rare: < 1/10,000,
frequency unknown (cannot be estimated from the available data).
Immune system disorders: Very rare: immediate allergic reactions (skin rash, itching, sneezing, lacrimation, bronchospasm), anaphylactic reactions (urticaria, angioedema)
Frequency unknown: carmoisine (E 122) may cause allergic reactions.
Skin: Frequency unknown: urticaria, hyperemia, itching.
From the digestive tract. When using high doses of pancreatin, narrowings may form in the ileocecal region and in the ascending part of the colon. Very rarely: diarrhea, abdominal pain, nausea, change in the nature of stools; possible development of intestinal obstruction, constipation, vomiting, bloating.
On the part of the genitourinary system. Increased excretion of uric acid in the urine is possible, especially when using high doses of pancreatin. To avoid the formation of uric acid stones in such patients, its content in the urine should be monitored.
Reporting of suspected adverse reactions.
Reporting suspected adverse reactions after a medicine has been authorised plays an important role. This allows for continued monitoring of the benefit-risk balance of the medicine. Healthcare professionals should report any suspected adverse reactions.
Expiration date
3 years
Storage conditions
Store at a temperature not exceeding 25 °C.
Keep out of reach of children.
Packaging
10 tablets in a blister; 2 or 5 blisters in a cardboard pack.
10 tablets in a blister; 90 blisters in a cardboard box.
Vacation category
Without a prescription.
Producer
Technolog PJSC.
Address
Ukraine, 20300, Cherkasy region, Uman city, Stara Prorizna Street, building 8.
