Instructions Pancreatin Forte film-coated tablets blister pack No. 60
Composition
active ingredient: pancreatin;
1 tablet contains pancreatin corresponding to the minimum enzymatic activity: 4500 amylolytic U Ph. Eur.; 6000 lipolytic U Ph. Eur.; 300 proteolytic U Ph. Eur.;
excipients: lactose, monohydrate; sodium chloride; calcium stearate; croscarmellose sodium; povidone; colloidal anhydrous silicon dioxide; triethyl citrate; acrylic white 93A18597 (mixture of dry substances: methacrylate copolymer (type C); talc; titanium dioxide (E 171); colloidal anhydrous silicon dioxide; sodium bicarbonate; sodium lauryl sulfate).
Dosage form
The film-coated tablets are enteric-coated.
Main physicochemical properties: tablets, round, coated, with a smooth biconvex surface, white in color, a specific odor is allowed. When broken, when viewed under a magnifying glass, a core surrounded by one continuous layer is visible.
Pharmacotherapeutic group
Digestive aids, including enzymes. Polyenzyme preparations. ATX code A09A A02.
Pharmacological properties
Pharmacodynamics.
Enzyme preparation from the pancreas of cattle and pigs. The pancreatic enzymes included in the preparation – lipase, amylase and protease – facilitate the process of digestion of proteins, carbohydrates and fats of food, contributing to a more complete absorption of nutrients in the small intestine. In diseases of the pancreas, the preparation compensates for the insufficiency of its exocrine function and helps to improve the digestive process.
Pharmacokinetics.
Due to the acid-resistant coating, the enzymes are not inactivated by the hydrochloric acid of the stomach. The dissolution of the shell and the release of enzymes begins in the duodenum. The enzymes are poorly absorbed in the digestive tract, acting in the intestinal lumen.
Indication
- Diseases that are accompanied by disturbances in 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 pancreatin or to any of the components of the drug. Acute pancreatitis, chronic pancreatitis in the acute phase, acute hepatitis, mechanical jaundice, obstructive intestinal obstruction.
Interaction with other medicinal products and other types of interactions
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.
Simultaneous use of the drug Pancreatin forte with iron and folic acid preparations may lead to a decrease in their absorption and a decrease in the hypoglycemic effect of acarbose.
Simultaneous use of antacids containing calcium carbonate and/or magnesium hydroxide, with tannin, alcohol-containing agents may lead to a decrease in the effectiveness of pancreatin.
Application features
The drug contains active enzymes that can damage the oral mucosa, so the tablets should be swallowed whole, without chewing.
To avoid the formation of uric acid stones in intestinal obstruction, the uric acid content in the urine should be monitored.
The drug reduces iron absorption, so with prolonged use, iron preparations should be prescribed simultaneously. Digestive system disorders may occur in patients with hypersensitivity to pancreatin or in patients after intestinal resection in history.
The use of drugs containing pancreatin may reduce the absorption of folic acid, which may require its additional intake into the body.
The medicine contains lactose, therefore, if the patient has been diagnosed with intolerance to some sugars, you should consult your doctor before taking this medicine.
The medicine contains croscarmellose sodium.
Use during pregnancy or breastfeeding
During pregnancy or breastfeeding, the drug should be taken as prescribed by a doctor if the expected benefit to the mother outweighs the potential risk to the fetus/child.
Ability to influence reaction speed when driving vehicles or 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 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, 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 lipolytic U Ph. Eur. per 1 kg of body weight.
The tablets should be swallowed whole, without chewing, with plenty of liquid, for example 1 glass of water.
The duration of treatment is determined by the nature of the disease and is set by the doctor individually.
The dosage and duration of treatment for children is decided by the doctor.
The drug should be prescribed in a daily dose necessary to normalize bowel movements, but not more than 1500 lipolytic U Ph. Eur. per 1 kg of body weight of a child under 12 years of age. For children over 12 years of age, the daily dose of enzymes should not exceed 15,000–20,000 lipolytic U Ph. Eur. per 1 kg of body weight.
Children.
The medicine is recommended for use in children aged 6 years and over.
Overdose
Symptoms: When taking extremely high doses of pancreatin, hyperuricemia and hyperuricosuria, an increase in the level of uric acid in the blood plasma were observed.
Treatment: Discontinuation of the drug, symptomatic therapy, adequate hydration.
Adverse reactions
On the part of the digestive system: diarrhea, abdominal pain, bloating, vomiting, nausea, change in the nature of stools, possible development of intestinal obstruction, constipation, discomfort in the epigastrium.
In patients taking high doses of pancreatin, narrowing of the ileocecal part of the intestine and colon (fibrosing colonopathy) and colitis have been observed. In the event of unusual abdominal symptoms or a change in the nature of the symptoms of the underlying disease, it is necessary to exclude the possibility of colon damage, especially if the patient uses more than 10,000 Ph.Eur. lipase units/kg/day.
On the part of the immune system: allergic reactions, including itching, skin rashes, runny nose, urticaria, sneezing, lacrimation, bronchospasm, anaphylactic reactions, angioedema.
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 a medicinal product via the Automated Information System for Pharmacovigilance at the link: https://aisf.dec.gov.ua.
Expiration date
2 years.
Storage conditions
In the original packaging at a temperature not exceeding 25 ºС.
Keep out of reach of children.
Packaging
10 tablets in a blister, No. 10×2 or No. 10×4, or No. 10×5, or No. 10×6 blisters in a cardboard pack.
Vacation category
Without a prescription.
Producer
JSC "VITAMINS".
Location of the manufacturer and its business address.
Ukraine, 20300, Cherkasy region, Uman city, Uspenska st., 31.
Applicant.
JSC "VITAMINS".
Location of the applicant.
Ukraine, 20300, Cherkasy region, Uman city, Uspenska st., 31.
