Pancreatin tablets 100 mg

Instructions for use for Pancreatin tablets 100 mg

Brand Name: Pancreatin

International Nonproprietary Name: Pancreatin

Dosage Form:  Enteric-coated tablets

Composition per 1 tablet:

Active substance: Pancreatin - 100 mg. The amount of pancreatin is specified for a substance with an amylolytic activity of at least 1700 FIP U; lipolytic activity of at least 3000 FIP U; total proteolytic activity of at least 130 FIP U.

Inactive ingredients (core): Calcium stearate – 3.2 mg, Potato starch - 7.4 mg, Croscarmellose sodium - 1.2 mg, Lactose monohydrate - to obtain a core tablet weighing 320 mg.

Inactive ingredients (coating) to obtain a coated tablet weighing 335 mg: Titanium dioxide - 0.933 mg, Azorubine (Acid Red 2C) - 0.025 mg, Methacrylic acid and ethyl acrylate copolymer (1:1) - 6.948 mg, Macrogol 4000 - 1.044 mg, Talc - 4.184 mg, Povidone - 1.866 mg.

Description:

Pink or dark pink coated tablets with speckles, specific odor, biconvex shape. A cross-section shows two layers.

Pharmacotherapeutic group: Digestive enzyme preparation.

ATC Code: A09AA02.

Pharmacological Properties

Pancreatin compensates for the insufficiency of the exocrine function of the pancreas, exerting proteolytic, amylolytic, and lipolytic effects.

The enzymes included in pancreatin (lipase, alpha-amylase, trypsin, chymotrypsin) facilitate the breakdown of proteins into amino acids, fats into glycerol and fatty acids, and starch into dextrins and monosaccharides.

It improves the functional state of the gastrointestinal tract and normalizes digestive processes.

Trypsin inhibits stimulated pancreatic secretion and has an analgesic effect.

Pancreatic enzymes are released from the dosage form in the alkaline environment of the small intestine, as they are protected from gastric juice by the enteric coating.

The maximum enzymatic activity of the drug is observed 30-45 minutes after oral administration.

Indications for use

Replacement therapy for exocrine pancreatic insufficiency: chronic pancreatitis, pancreatectomy, post-radiation condition, dyspepsia, Roemheld syndrome (gastrocardiac syndrome), cystic fibrosis; flatulence, diarrhea of non-infectious origin.

Impaired food absorption (conditions after resection of the stomach and small intestine); to improve food digestion in individuals with normal gastrointestinal function in cases of dietary errors (consumption of fatty foods, large amounts of food, irregular meals) and in cases of masticatory disorders, sedentary lifestyle, prolonged immobilization.

Preparation for radiographic and ultrasound examinations of the abdominal organs.

Contraindications

Hypersensitivity to the components of the drug, acute pancreatitis, exacerbation of chronic pancreatitis, children under 3 years of age (for this dosage form).

Dosage and administration

The drug is taken orally, without chewing, during or after meals.

Adults: 2-4 tablets 3-4 times a day.

Children – individually, as prescribed by a doctor.

The duration of treatment can vary from several days (in case of digestive disorders due to dietary errors) to several months or years (if constant replacement therapy is necessary).

Adverse effects

Allergic reactions. In some cases – diarrhea, constipation, stomach discomfort, nausea (a causal relationship between the development of these reactions and the action of pancreatin has not been established, as these phenomena are symptoms of exocrine pancreatic insufficiency). With long-term use in high doses, perianal irritation and irritation of the oral mucosa may occur. In patients with cystic fibrosis, the development of strictures in the ileocecal region and ascending colon is possible.

Effect on ability to drive and operate machinery

The drug does not negatively affect the ability to drive vehicles and/or operate machinery.

Overdose

Symptoms: Hyperuricosuria, hyperuricemia. In children - constipation. Treatment: Discontinuation of the drug, symptomatic therapy.

Drug interactions

Concomitant use of pancreatin with iron preparations may reduce the absorption of the latter. Simultaneous use of antacids containing calcium carbonate and/or magnesium hydroxide may reduce the effectiveness of pancreatin.

Special instructions

The safety of pancreatin use during pregnancy has not been sufficiently studied. Use is possible only in cases where the expected benefit to the mother outweighs the potential risk to the fetus.

In cystic fibrosis, the use of pancreatin in high doses is not recommended due to an increased risk of strictures (fibrosing colonopathy). The dose should be adequate to the amount of enzymes required for fat absorption, taking into account the quality and quantity of food consumed.

With long-term use, iron supplements should be prescribed concurrently.

Pharmaceutical form

Enteric-coated tablets.

10 or 15 tablets in a blister pack made of polyvinyl chloride film and printed lacquered aluminum foil.

1, 2, 3, 4, 5, 6, 7, or 8 blister packs of 10 tablets, or 1, 2, 3, 4, 5, or 6 blister packs of 15 tablets, along with the package insert, are placed in a cardboard carton.

Storage conditions

Store in a dry place, protected from light at a temperature not above 25 °C. Keep out of reach of children.

Shelf life

2 years. Do not use the drug after the expiration date.

Regulatory status

Over-the-counter.

Marketing Authorization Holder / Organization for claims:

JSC "AVVA RUS", Russia, 121614,

Moscow, Krylatskie Kholmy St., 30, building 9.

Tel/Fax: (495) 956-75-54.

avva.com.ru

Manufacturing address:

JSC "AVVA RUS", Russia, 610044, Kirov Region, Kirov, Luganskaya St., 53a.

Tel: +7 (8332) 25-12-29; +7 (495) 956-75-54.