Composition, form of production and packaging
? Tablets, covered with enteric coating of brown or dark brown color, round, biconcave, with a specific odor.
1 tab.
pancreatin, corresponding to the enzymatic activity:
amylases not less than 4620 U
lipases not less than 3850 units
proteases 275-500 IU
Excipients: sodium carboxymethyl starch, pregelatinized starch, low molecular weight polyvinylpyrrolidone (povidone), magnesium stearate, microcrystalline cellulose.
60 pcs. - banks of dark glass (1) - packs of cardboard.
10 pieces. - packings cellular planimetric (2) - packs cardboard.
10 pieces. - packings cellular planimetric (3) - packs cardboard.
10 pieces. - packings cellular planimetric (6) - packs cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2011.
PHARMACHOLOGIC EFFECT
Digestive enzyme, compensates for the inadequacy of the secretory function of the pancreas and bile excretory function of the liver, improves the digestion of food, has a proteolytic, amylolytic and lipolytic effect.
Included in the composition of pancreatic enzymes (lipase, alpha-amylase, trypsin, chymotrypsin) promote the breakdown of proteins to amino acids, fats to glycerol and fatty acids, starch to dextrins and monosaccharides.
Trypsin suppresses the stimulated secretion of the pancreas, providing analgesic effect.
The enzyme hemicellulase promotes the cleavage of plant fiber, which also improves digestive processes, reduces the formation of gases in the intestine. Bile extract acts cholagogically, promotes fat emulsification, improves absorption of fats and fat-soluble vitamins, increases lipase activity.
PHARMACOKINETICS
Pancreatic enzymes are released from the dosage form in the alkaline medium of the small intestine. protected from the action of gastric juice with an enteric-soluble coat.
The maximum enzymatic activity of the drug is observed 30-45 minutes after oral administration.
INDICATIONS
- substitution therapy with exocrine pancreatic insufficiency: chronic pancreatitis, pancreatectomy, condition after irradiation, dyspepsia, cystic fibrosis; flatulence, diarrhea of ​​non-infectious genesis;
- a violation of the assimilation of food (a condition after resection of the stomach and small intestine);
- to improve the digestion of food in individuals with normal gastrointestinal function in the event of errors in nutrition (eating fatty foods, large amounts of food, irregular meals) and in cases of malfunctioning, sedentary lifestyle, prolonged immobilization;
- Remkheld's syndrome (gastrocardial syndrome);
- Preparation for X-ray examination and ultrasound examination of the abdominal cavity organs.
DOSING MODE
Inside, swallowing whole (without chewing), during or immediately after eating, with plenty of liquid (if possible alkaline: water, fruit juices). The dose of the drug is set individually (in terms of lipase) depends on the age and degree of pancreatic insufficiency.
Do not exceed the maximum daily dose of enzymes, which is 15 000-20 000 units lipase / kg, especially in patients with cystic fibrosis .
The average dose for adults is 150,000 units / day; with complete deficiency of the exocrine function of the pancreas - 400 thousand units / day, which corresponds to the daily needs of an adult in lipase.
The duration of treatment can vary from a single intake or several days (if the digestive process is disturbed due to inaccuracies in the diet) to several months and even years (if necessary, permanent replacement therapy). Adults - 3-4 tab. 3 times / day. Higher doses are prescribed by the doctor. To 2 tab. 2-3 times / day for 2-3 days before the X-ray or ultrasound examination .
Children older than 3 years - 100 thousand units / day (lipase), divided into 3-4 reception.
SIDE EFFECT
Allergic reactions, rarely diarrhea or constipation, nausea, discomfort in the epigastric region, abdominal pain, decreased endogenous synthesis of bile acids. With long-term use in high doses, hyperuricosuria, when high doses are used in patients with cystic fibrosis, strictures in the ileocecal region and in the ascending colon appear as symptoms of intestinal obstruction.
CONTRAINDICATIONS
acute pancreatitis;
- exacerbation of chronic pancreatitis;
- liver failure;
- Hepatitis;
- mechanical jaundice;
- cholelithiasis;
- Empyema of the gallbladder;
- intestinal obstruction;
- Children's age (up to 3 years);
- Hypersensitivity to the components of the drug.
PREGNANCY AND LACTATION
During pregnancy and lactation, the drug is prescribed only if the expected benefit to the mother exceeds the potential risk to the fetus or the baby.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
Contraindicated in hepatic insufficiency, hepatitis.
APPLICATION FOR CHILDREN
Contraindicated in children under 3 years.
Children older than 3 years - 100 thousand units / day (lipase), divided into 3-4 reception.
SPECIAL INSTRUCTIONS
In cystic fibrosis, the drug should be administered with caution. The dose should be adequate to the quantity and quality of the food consumed.
With prolonged use in cases of digestive disorders (with normal pancreas function), iron preparations should be prescribed simultaneously.
OVERDOSE
Symptoms: With prolonged use in high doses, hyperuricosuria. when high doses are used in patients with cystic fibrosis - strictures in the ileocecal region and in the ascending colon. Hyperuricemia. Children have constipation.
Treatment: withdrawal of the drug, symptomatic therapy.
DRUG INTERACTION
With simultaneous use with Pancreatin forte, absorption of PASC, sulfonamides, antibiotics is enhanced.
Reduces absorption of iron (especially with prolonged use).
Antacid agents containing calcium carbonate and / or magnesium hydroxide may decrease the effectiveness of Pancreatin forte.
TERMS OF RELEASE FROM PHARMACY
The drug is approved for use as a means of OTC.
TERMS AND CONDITIONS OF STORAGE
Store in a dry place at a temperature not exceeding 20 В° C. Keep out of the reach of children.
Shelf life - 2 years.
Do not use after the expiration date.
