Enzystal^® (Tablets) Instructions for Use

Marketing Authorization Holder

Torrent Pharmaceuticals, Ltd. (India)

ATC Code

A09AA02 (Polyenzyme preparations (incl. lipase, protease))

Active Substances

Pancreatin (BAN)

Hemicellulase (Group)

Bile (Group)

Dosage Form

Enzystal®

Enteric-coated tablets: 4, 6, 20, 80 or 100 pcs.

Dosage Form, Packaging, and Composition

Enteric-coated tablets white, round, biconvex.

4 pcs. – blisters (1) – cardboard packs.
6 pcs. – blisters (1) – cardboard packs.
10 pcs. – blisters (2) – cardboard packs.
10 pcs. – blisters (8) – cardboard packs.
4 pcs. – strips (1) – cardboard packs.
6 pcs. – strips (1) – cardboard packs.
10 pcs. – strips (10) – cardboard packs.

Clinical-Pharmacological Group

Enzyme preparation

Pharmacotherapeutic Group

Digestive enzyme agent

Pharmacological Action

A combined medicinal product, the action of which is due to the components that make up its composition. It has proteolytic, amylolytic, and lipolytic action.

It promotes rapid and complete digestion of food, eliminates symptoms arising from digestive disorders (feeling of heaviness and fullness in the stomach, flatulence, feeling of lack of air, shortness of breath caused by gas accumulation in the intestines, diarrhea).

It improves the process of food digestion in children; stimulates the secretion of the body’s own enzymes of the pancreas, stomach, and small intestine, as well as bile.

Bile extract acts choleretically, promotes fat emulsification, increases the activity of Lipases, improves the absorption of fats and fat-soluble vitamins A, E, K.

Hemicellulase is an enzyme that promotes the breakdown of plant fiber.

Indications

Exocrine insufficiency of the pancreas, stomach, intestines, liver, gallbladder (chronic inflammatory-dystrophic diseases of these organs, condition after resection or irradiation); flatulence, diarrhea of non-infectious origin; cystic fibrosis.

To improve food digestion in persons with normal gastrointestinal function in case of dietary errors (consumption of fatty foods, large amounts of food, irregular meals); in cases of chewing function impairment (damage to teeth and gums, during the period of adaptation to an artificial jaw); sedentary lifestyle; prolonged immobilization.

Preparation for X-ray examination and ultrasound of the abdominal organs. As an auxiliary medicinal product for faster absorption of certain medicinal products (PAS, sulfonamides, antibiotics).

ICD codes

Dosage Regimen

Orally, 1 single dose 3 times/day during or immediately after meals. Swallow whole, do not chew. If necessary, the single dose can be doubled.

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

Before X-ray examination and ultrasound – 2 single doses 2-3 times/day for 2-3 days before the examination.

Adverse Reactions

Allergic reactions skin hyperemia, sneezing, lacrimation.

From the digestive system diarrhea, nausea, abdominal pain (including intestinal colic). In children (when taken in high doses) – perianal irritation, irritation of the oral mucosa.

From metabolism hyperuricemia, hyperuricouria.

Contraindications

Hypersensitivity; hyperbilirubinemia; acute pancreatitis, chronic pancreatitis (exacerbation), hepatitis, hepatic insufficiency, hepatic coma or precoma, gallbladder empyema, cholelithiasis, mechanical jaundice, intestinal obstruction.

With caution cystic fibrosis, pregnancy; children’s age (under 3 years).

Use in Pregnancy and Lactation

With caution: pregnancy.

Use in Hepatic Impairment

Contraindicated in hepatitis, hepatic insufficiency, hepatic coma or precoma.

Pediatric Use

With caution: children’s age (under 3 years).

Drug Interactions

Reduces the bioavailability of iron preparations.

Increases the absorption of PAS, sulfonamides, antibiotics.

Cimetidine enhances the effect of the drug.

Antacids containing magnesium and/or calcium ions reduce the effectiveness of the drug.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.