Pancreatin Forte (pancreatin) coated enteric tablets №50

Description

Pancreatin Forte composition
active substance: pancreatin;
1 tablet contains pancreatin, which corresponds to the minimum enzymatic activity: 4500 amylolytic IU.; 6000 lipolytic IU .; 300 proteolytic IU .;
excipients: lactose monohydrate; sodium chloride; calcium stearate; croscarmellose sodium; povidone; colloidal anhydrous silica; triethyl citrate; acrylic-white 9ZA18597 (mixture of dry substances: methacrylate copolymer (type C); talc; titanium dioxide (E 171); colloidal anhydrous silica; sodium bicarbonate; sodium lauryl sulfate).

Dosage form
Coated tablets are enteric-coated.

Pharmacological properties
Pancreatin Forte is an enzyme preparation from the pancreas of cattle and pigs. Pancreatic enzymes that are part of the drug – lipase, amylase and protease – facilitate the process of digestion of proteins, carbohydrates and fats of food, promoting a more complete absorption of nutrients in the small intestine. In diseases of the pancreas, the drug compensates for the lack of its exocrine function and improves digestion.

Indication:

• Diseases that are accompanied by indigestion 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 the passage of food through the intestines, intestinal disorders, simultaneous consumption of indigestible plant, fatty and unusual foods.
• Flatulence.
• Preparation for X-ray or ultrasound diagnostic tests.

Contraindication
Hypersensitivity to pancreatin or to other components of the drug. Acute pancreatitis, chronic pancreatitis in the acute phase, acute hepatitis, mechanical jaundice, intestinal obstruction.

Children
The drug is recommended for use in children over 6 years of age.

Use during pregnancy or breastfeeding
During pregnancy or breastfeeding, the drug should be taken as prescribed by a physician if the expected benefit to the mother outweighs the potential risk to the fetus / child.

Method of application and dosage
The dose of Pancreatin Forte depends on the deficiency of pancreatic enzymes in the duodenum and is set by the doctor individually.
If there are no other recommendations, as well as in cases of consumption of indigestible plant foods, fatty or unusual foods, take 1-2 tablets. In other cases, in case of indigestion, the recommended dose is 2-4 tablets. If necessary, the dose can be increased. Dose escalation to reduce the symptoms of the disease, such as steatorrhea or abdominal pain, should only be performed under the supervision of a physician. The daily dose of lipase should not exceed 15000–20000 lipolytic IU per 1 kg of body weight.
The tablets should be swallowed whole without chewing, drinking plenty of fluids, such as 1 glass of water.
The duration of treatment is determined by the nature of the disease and is set by the doctor individually.
The question of drug dosage and duration of treatment for children is decided by the doctor.
The drug is prescribed in the daily dose required to normalize bowel movements, but not more than 1500 lipolytic IU 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 15,000-200,000 lipolytic IU per 1 kg of body weight.

Overdose
Symptoms. At reception of extremely high doses of drug of a pancreatin hyperuricemia and a hyperuricosuria, increase in level of uric acid in a blood plasma were observed.
Treatment. Withdrawal of the drug, symptomatic therapy, adequate hydration.

Side effects:

• From the digestive system: diarrhea, abdominal pain, bloating, vomiting, nausea, changes in the nature of bowel movements, possible development of intestinal obstruction, constipation, discomfort in the epigastrium.
• Narrowing of the ileocecal intestine and colon (fibrosing colonopathy) as well as colitis were observed in patients taking high doses of pancreatin. In case of unusual abdominal symptoms or changes 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 IU  lipase / kg / day.
• On the part of the immune system: allergic reactions, including itching, skin rash, runny nose, urticaria, sneezing, tearing, bronchospasm, anaphylactic reactions, angioneurotic edema.

Expiration date
2 years.

Storage conditions
In the original packaging at a temperature not exceeding 25 ºC.
Keep out of reach of children.