ENZYMTAL

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT ENZYMTAL (ENZYMTAL)

Composition:

Active substances: 1 tablet contains: 50 mg fungal diastase (1:1200), 30 mg papain, 50 mg simethicone, 75 mg activated charcoal, 25 mg nicotinamide;

Excipients: lactose monohydrate, microcrystalline cellulose (E 460), calcium hydrogen phosphate, light magnesium carbonate, povidone, gelatin, talc, indion 234, magnesium stearate, sodium croscarmellose;

Coating: shellac, hypromellose, titanium dioxide (E 171), talc, macrogol 6000, aspartame (E 951).

Pharmaceutical form. Coated tablets.

Main physico-chemical properties: white, biconvex, round, smooth coated tablets.

Pharmacotherapeutic group.

Digestive enzymes and other agents used to improve digestion. Enzyme preparations.

ATC code A09AA.

Pharmacological Properties

Pharmacodynamics

Enzymtal is a combination preparation containing essential components for rapid relief of dyspepsia and control of flatulence and abdominal discomfort.

Enzymtal contains fungal diastase (α- and ß-amylase) and papain, which act as enzymes. Fungal diastase promotes digestion of carbohydrate-rich foods. The amylolytic enzyme fungal diastase has specific activity in converting starch into dextrose and maltose. When this enzyme is deficient, the hydrolysis process slows down, promoting carbon dioxide gas formation (causing unpleasant abdominal sensations). The amylolytic activity level of fungal diastase contained in Enzymtal dragees is 1:1200. This means that 1 part of fungal diastase breaks down 1200 parts of dietary cooked starch.

Papain is a plant-derived substance—a mixture of enzymes extracted from the juice of unripe papaya fruit (Carica Papaya)—consisting of a mixture of papain and chymopapain, exhibiting broad proteolytic activity. It can be used by patients with reduced or preserved gastric acid secretion.

The combined action of the enzymes in Enzymtal exceeds the effect produced by each enzyme individually.

Simethicone (dimethylpolysiloxane) is a nontoxic, inert surfactant with anti-foaming properties based on silicon. Simethicone reduces gas formation in the intestine. It acts by decreasing the surface tension of gas bubbles formed in the intestine during flatulence. The released gas is absorbed or eliminated naturally. Simethicone does not affect gastric secretion or nutrient absorption. It reduces bloating and pain caused by excessive flatulence. Simethicone significantly improves the condition in cases of flatulence, aerophagia, and digestive, absorptive, and excretory disorders. Thus, this component is a beneficial addition to the enzymatic components of the drug.

Activated charcoal is an enterosorbent. Specially processed charcoal has high surface activity, adsorbing gases, alkaloids, endo- and exotoxins, and other chemical compounds. Activated charcoal in Enzymtal acts as an enterosorbent and detoxifying agent, adsorbing gases and toxins produced during digestive disturbances, adsorbing poorly soluble substances, reducing the volume of intestinal contents, and thereby alleviating symptoms of bloating and dyspepsia, acting synergistically with the enzymes.

Nicotinamide participates as a coenzyme in carbohydrate metabolism. Nicotinamide coenzymes (NAD and NADP) are essential for the viability of all cells. Their important function includes participation in tissue respiration (the first step of the respiratory chain) and cellular energy metabolism. Deficiency of this compound usually occurs with unbalanced diets in elderly patients. A lack of nicotinamide may lead to reduced gastric acid, affecting digestion and intestinal absorption; lactose intolerance may also develop due to nicotinamide deficiency, which is one of the mechanisms underlying diarrhea caused by deficiency of this compound.

Thus, Enzymtal promotes normalization of digestive processes and alleviation of symptoms of dyspepsia and abdominal bloating.

Pharmacokinetics

In the stomach, active components of Enzymtal are released within 30 minutes after oral administration and begin interacting with food. Fungal diastase, papain, simethicone, and activated charcoal are not absorbed following oral intake. Of all Enzymtal components, only nicotinamide is well absorbed in the gastrointestinal tract. The absorption process is impaired in the absence of gastric acid, during enteritis, and in peptic ulcer disease. Nicotinamide penetrates all tissues and is excreted unchanged via renal excretion or after biotransformation in the liver, primarily as methylnicotinamide.

Clinical characteristics.

Indications.

Symptomatic treatment of dyspepsia and meteorism.

Contraindications.

Hypersensitivity to any component of the medicinal product.

Intestinal obstruction, presence of gastrointestinal ulcers and gastrointestinal bleeding. Obstructive gastrointestinal disorders. Liver function impairment.

Interaction with other medicinal products and other forms of interaction.

Activated charcoal contained in the medicinal product may reduce the absorption of medicinal drugs in the digestive system when used simultaneously; therefore, other medications should be taken 2 hours before or 1 hour after taking Enzymital.

Special precautions.

Activated charcoal may blacken stool.

Women taking oral contraceptives should use additional contraceptive methods during treatment with this medicinal product.

Due to the adsorptive properties of activated charcoal, Enzymtal should be taken 1–1.5 hours before or after food intake when used concomitantly with other medications. The product should be administered with caution to patients with a history of gastric and/or duodenal ulcer, as well as to patients suffering from diabetes mellitus or gout.

Excipients

The medicinal product contains aspartame, a phenylalanine derivative, which is hazardous for patients with phenylketonuria.

The product contains lactose. If you have been diagnosed with intolerance to certain sugars, consult your doctor before taking Enzymtal.

Use during pregnancy or lactation.

The use of this medicinal product is not recommended during pregnancy or breastfeeding.

Ability to influence reaction rate when driving or operating machinery.

Enzymtal does not affect the ability to drive a vehicle or perform tasks requiring increased attention.

Dosage and Administration.

For adults and children aged 14 years and older: take 2 tablets three times a day during meals. For children aged 7 to 14 years: take 1 tablet three times a day during meals.

Do not chew the tablets; swallow them whole with a small amount of liquid.

The duration of treatment is determined individually by a physician and depends on the course of the disease.

Children.

Enzymital is contraindicated in children under 7 years of age.

Overdose.

There are no reports of cases of intentional or accidental overdose.

Niacinamide overdose may cause abdominal pain, increased intestinal peristalsis, nausea, and occasionally vomiting.

In case of overdose, perform gastric lavage and administer symptomatic therapy.

Adverse reactions.

Caused by nicotinamide: in individual cases, allergic reactions may occur, such as skin hyperemia, rashes (petechial, macular, urticarial), sometimes itching, increased sensitivity, or idiosyncratic reactions. When high doses are used, abdominal pain, exacerbation of gastric and duodenal ulcers, nausea, vomiting, diarrhea, sensation of warmth in extremities, dry skin, arterial hypotension, transient headache, arrhythmia, and impaired glucose tolerance may occur.

Caused by activated charcoal: constipation, diarrhea, nausea, vomiting are possible; with prolonged use, deficiency of vitamins, hormones, fats, and proteins may develop, requiring appropriate medicinal correction.

No adverse effects of fungal diastase, papain, and simethicone have been observed.

Shelf life.

2 years.

Storage conditions.

Store in original packaging at a temperature not exceeding 25 °C, in a place inaccessible to children.

Packaging.

10 dragees per strip; 1 or 10 strips per cardboard box.

Prescription status.

Over-the-counter.

Manufacturer.

Genome Biotech Pvt. Ltd.

Manufacturer's address and location of business activity.

Plot No. D-121, 122, 123, MIDC Malegaon, Tal. Sinnar, Nashik 422103, Maharashtra State, India.