Penzital tablets p / o, No. 80

Replacement therapy for exocrine pancreatic insufficiency: chronic pancreatitis, pancreatectomy, condition after irradiation, dyspepsia, Remheld syndrome (gastrocardial syndrome), cystic fibrosis; flatulence, diarrhea of ??non-infectious genesis.
Impaired assimilation of food (condition after resection of the stomach and small intestine); to improve the digestion of food in persons with normal gastrointestinal tract function in case of errors in nutrition (consumption of fatty foods, large amounts of food, irregular nutrition) and in case of impaired chewing function, a sedentary lifestyle, prolonged immobilization.
Preparation for X-ray examination and ultrasound of the abdominal organs.

Inside. The drug is taken during or after meals, without chewing and drinking a non-alkaline liquid (water, fruit juices).
The dose is determined individually depending on the degree of indigestion. Adults usually take 1-2 tablets 3 times a day.
In children, the drug is used as directed by a doctor.
The duration of treatment can vary from several days (if the digestive process is disturbed due to dietary errors) to several months or years (if constant replacement therapy is necessary)

Each tablet contains:

Pancreatin 212.5 mg with enzyme activity:
lipase 6000 U FIP
amylase 4500 U FIP
protease 300 U FIP
Excipients: lactose, microcrystalline cellulose, sodium starch glycolate, povidone, talc, colloidal silicon dioxide, methacrylic acid copolymer, titanium dioxide

Hypersensitivity to the components of the drug, acute pancreatitis, exacerbation of chronic pancreatitis.

Trade name: Penzital

International non-proprietary name:
pancreatin

Dosage form:
enteric-coated tablets

Composition:
Each tablet contains:

Pancreatin 212.5 mg with enzyme activity:
lipase 6000 U FIP
amylase 4500 U FIP
protease 300 U FIP
Excipients: lactose, microcrystalline cellulose, sodium starch glycolate, povidone, talc, colloidal silicon dioxide, methacrylic acid copolymer, titanium dioxide

Description:
White round biconvex film-coated tablets.

Pharmacotherapeutic group:
digestive enzyme agent

ATX code: ј09јј02

Pharmacological properties:
Compensates for the insufficiency of the exocrine function of the pancreas, has a proteolytic, amylolytic and lipolytic effect.
The enzymes included in pancreatin (lipase, alpha-amylase, trypsin, chymotrypsin) promote the breakdown of proteins to amino acids, fats to glycerol and fatty acids, starch to dextrins and monosaccharides.
Improves the functional state of the gastrointestinal tract, normalizes digestion processes.
Trypsin inhibits the stimulated secretion of the pancreas, providing an analgesic effect.
Pancreatic enzymes are released from the dosage form in the alkaline environment of the small intestine, because protected from the action of gastric juice by the membrane.
The maximum enzymatic activity is observed 30-45 minutes after oral administration.

Indications for use:
Replacement therapy for exocrine pancreatic insufficiency: chronic pancreatitis, pancreatectomy, condition after irradiation, dyspepsia, Remheld syndrome (gastrocardial syndrome), cystic fibrosis; flatulence, diarrhea of ??non-infectious genesis.
Impaired assimilation of food (condition after resection of the stomach and small intestine); to improve the digestion of food in persons with normal gastrointestinal tract function in case of errors in nutrition (consumption of fatty foods, large amounts of food, irregular nutrition) and in case of impaired chewing function, a sedentary lifestyle, prolonged immobilization.
Preparation for X-ray examination and ultrasound of the abdominal organs.

Contraindications:
Hypersensitivity to drug components, acute pancreatitis, exacerbation of chronic pancreatitis.

Method of administration and dosage:
Inside. The drug is taken during or after meals, without chewing and drinking a non-alkaline liquid (water, fruit juices).
The dose is determined individually depending on the degree of indigestion. Adults usually take 1-2 tablets 3 times a day.
In children, the drug is used as directed by a doctor.
The duration of treatment can vary from several days (if the digestive process is disturbed due to dietary errors) to several months or years (if constant replacement therapy is necessary)

Side effect:
Allergic reactions. In some cases - diarrhea, constipation, a feeling of discomfort in the stomach, nausea (the cause-and-effect relationship of the development of these reactions with the action of pancreatin has not been established, since these phenomena refer to symptoms of exocrine pancreatic insufficiency). With prolonged use in high doses, the development of hyperuricosuria, an increase in the level of uric acid in the blood plasma are possible. With cystic fibrosis, if the required dose of pancreatin is exceeded, strictures (fibrous colonopathy) may develop in the ileocecal region in the ascending colon.
When using pancreatin in high doses in children, perianal irritation and irritation of the oral mucosa may occur.

Overdose:
Symptoms: hyperuricosuria, hyperuricemia. Children have constipation.
Treatment: drug withdrawal, symptomatic therapy.

Interaction with other medicinal products:
With the simultaneous use of pancreatin with iron preparations, it is possible to reduce the absorption of the latter. The simultaneous use of antacids containing calcium carbonate and / or magnesium hydroxide can lead to a decrease in the effectiveness of pancreatin.

Special instructions: The
safety of using pancreatin during pregnancy has not been studied enough. Application is possible in cases where the expected benefit to the mother outweighs the potential risk to the fetus.
In case of cystic fibrosis, the use of high doses of pancreatin is not recommended due to the increased risk of developing strictures (fibrous colonopathy).
With prolonged use, iron supplements are prescribed at the same time.

Release form:
10 enteric-coated tablets in strips. 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 strips in a cardboard box with instructions for use.

Storage conditions:
Store in a dry place at temperatures between 2 ? C and 25 ? C.
Keep out of the reach of children.

Expiration date:
3 years. Do not use after the expiration date printed on the package.

Terms of dispensing from pharmacies:
Without prescription.