Pancreatin forte enteric-coated tablets

Pancreatin forte enteric-coated tablets

International nonproprietary name

Pancreatin

Pharmacological group

Желчегонные средства и ферменты

Composition

Pancreatin corresponding to the enzymatic activity:
- amylase - not less than 4620 units ЕР
- lipase - not less than 3850 units ЕР
- protease - (275 - 500) units ЕР
Excipients:
carboxymethyl starch (primogel) - 21.5 mg
pregelatinized starch (starch 1500) - 16.5 mg
povidone (low molecular medical polyvinylpyrrolidonum) - 5 mg
magnesium stearate - 3.3 mg
silicium dioxide colloidal (aerosil) - 3.3 mg
microcrystalline cellulose - to obtaine a tablet without coating with weight 330 mg
Composition of the coating:
acetylphthalic cellulose - 2.847 mg
polysorbate 80 (tween -80) - 0.85 mg
liquid paraffin (vaseline oil) - 0.5 g
brown ferric oxide dye (sikovite 70 Е172, ferronate Е172) - 0.803 mg

Pharmacological action

Digestive enzyme, compensates for the secretory dysfunction of the pancreas, improves digestion of food, has a proteolytic, amylolytic and lipolytic effect.
The pancreatic enzymes (lipase, alpha-amylase, trypsin, chymotrypsin) in the composition of the drug promote 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 breakdown of plant fiber, which also improves digestive processes, reduces formation of gases in the intestine.

Pharmacokinetics

The pancreatic enzymes are released from the dosage form in the alkaline medium of the small intestine protected from the effect of gastric juice with enteric coating.
The maximum enzymatic effect of the drug is observed 30-45 minutes after oral administration.

Indications for Use

Substitution therapy with exocrine pancreatic failure: chronic pancreatitis, pancreatectomy, condition after irradiation, dyspepsia, cystic fibrosis; flatulence, diarrhea of non-infectious genesis.
Digestion disorders (state after resection of the stomach and small intestine); to improve digestion in persons with normal gastrointestinal function in case of nutrition errors (eating fatty foods, large amounts of food, irregular meals) and in cases of malfunctioning, sedentary lifestyle, long-term immobilization. Remkheld's syndrome (gastrocardial syndrome).
Preparation for X-ray examination and ultrasound examination of the abdominal organs.

Contraindications

Hypersensitivity to the components of the drug, acute pancreatitis, acute phase of chronic pancreatitis.
Children at the age under 3 years old.
Pregnancy and lactation period
During pregnancy and lactation period administration of the drug is possible only when potential benefit to the mother outweighs any potential risk to the fetus and the baby.

Cautions

For cystic fibrosis, the drug shall be administered with care, because the dose shall be adequate to quantity and quality of the consumed food. Long-term administration in cases of digestive disorders (with normal pancreas function), iron agents shall be administered simultaneously.
Effects on ability to drive and use machines
The drug does not affect the ability to drive and operate machines.

Dosing and Administration

Oral administration by swallowing a whole tablet (without chewing), during or immediately after eating with plenty of liquid (if possible alkaline: water, fruit juices).

The dose of the drug is set on an individual basis (equivalent to lipase) based on the age and degree of pancreatic failure.
The maximum daily dose of enzymes shall not exceed 15,000-20,000 units of 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 lipase demand in adults.
The treatment duration can vary from a single dose or several days (if the digestive process is disturbed due to inadequate diet) to several months and even years (if required, permanent substitution therapy).
In adults 3-4 tablets 3 times per day. Higher doses are prescribed by a doctor.
2 tablets 2-3 times per day during 2-3 days before x-ray or ultrasonic examination.
For children from 3 years old - 100 thousand units/day (lipase), divided into 3-4 doses.

Side effect

Allergic reactions, rare diarrhea or constipation, nausea, discomfort in the epigastric region, abdominal pain, decreased endogenous synthesis of bile acids. Long-term administration at high doses - hyperuricosuria, administration of high doses in patients with cystic fibrosis - strictures in the ileocecal region and in the ascending colon appear as symptoms of intestinal obstruction.
Overdose
Symptoms: Long-term administration at high doses - hyperuricosuria, administration of high doses in patients with cystic fibrosis - strictures in the ileocecal region and in the ascending colon. Hyperglycemia. In children - constipation.
Treatment: withdrawal of the drug, expectant therapy.

Interaction with other medicines

Simultaneous administration with pancreatin increase absorption of para-aminosalicylic acid, sulfonamides, antibiotics.
The drug reduces absorption of iron (especially during long-term administration).
Antacid agents containing calcium carbonate and/or magnesium hydroxide can reduce efficacy of pancreatin.

Form release

Storage conditions

In a dry place at temperature maximum 20 °С.

Expiration date

2 years