SOLIZYM®

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT SOLIZYM®

Composition:

Active substance: microbial lipase;

1 tablet contains microbial lipase in an amount corresponding to an enzymatic activity of 20,000 LU;

Excipients: sugar; lactose monohydrate; povidone; stearic acid; methylcellulose; acrylic yellow 93O38159 (a mixture of substances: methacrylate copolymer type C, talc, titanium dioxide (E 171), triethyl citrate, colloidal anhydrous silicon dioxide, sodium bicarbonate, sodium lauryl sulfate, quinoline yellow (E 104), iron oxide yellow (E 172), Ponceau 4R (E 124)).

Pharmaceutical form. Enteric-coated tablets.

Main physicochemical properties: round-shaped, coated tablets with smooth, biconvex surfaces, light yellow to dark yellow in color.

Pharmacotherapeutic group. Agents affecting the digestive system and metabolism. Enzyme preparations.

ATC code A09AA.

Pharmacological Properties

Pharmacodynamics

Solizym® is a microbial-derived enzyme preparation. It compensates for the deficiency of pancreatic lipase.

The lipase contained in the preparation hydrolyzes plant and animal fats (into glycerol and fatty acids), thereby promoting more complete absorption of nutrients in the small intestine. The enzyme fully retains its activity at a pH of 7.0–8.0 and a temperature of 30–40 °C. It is resistant to proteases and inhibitors of pancreatic enzymes and does not require activation by bile acids. It possesses broad substrate specificity. Dissolution of the coating and release of the enzyme begin in the duodenum. The enzyme acts within the intestinal lumen, participating in luminal digestion (hydrolysis of fats). At therapeutic doses, Solizym® does not affect evacuatory function of the gastrointestinal tract. The effect of the drug manifests as disappearance or reduction of pain syndrome, meteorism, and bowel disturbances; and leads to positive changes in coprological examinations (marked decrease in the content of neutral fat and fatty acids in feces). Lipase improves pancreatic function. The use of this drug carries no risk of zoonotic infections (unlike pancreatin-containing preparations).

Pharmacokinetics

Not studied.

Clinical characteristics.

Indications.

Chronic pancreatitis with impaired exocrine function of the pancreas and reduced pancreatic lipase activity; digestive disorders occurring against the background of decreased exocrine pancreatic function; after consumption of fatty foods that are difficult to digest.

Contraindications.

Hypersensitivity to the components of the drug. Acute pancreatitis.

Interaction with other medicinal products and other forms of interaction.

The drug should not be used concomitantly with iron-containing preparations and antacids containing aluminum, magnesium, or calcium ions.

Special precautions for use

The medicine contains sugar and lactose; therefore, if the patient has been diagnosed with an intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

The medicine contains the colouring agent Ponceau 4R, which may cause allergic reactions.

Use during pregnancy or breastfeeding.

The efficacy and safety of the medicine during pregnancy or breastfeeding have not been established; therefore, the medicine may be used only if, in the opinion of the physician, the expected benefit to the mother outweighs the potential risk to the fetus/child.

Ability to influence reaction rate while driving or operating machinery.

No influence.

Dosage and Administration.

Take tablets orally during or immediately after a meal. Swallow tablets whole, without chewing, with a small amount of liquid.

The dosage and duration of Solizym® treatment are determined individually by a physician for each patient depending on the nature and course of the disease, functional state of the pancreas, degree of digestive impairment, and dietary composition. The single therapeutic dose is 20,000–40,000 LU (1–2 tablets). Administer 3–4 times daily. The daily dose of the drug is 120,000–160,000 LU (6–8 tablets). Maximum daily dose: 8 tablets. The treatment course lasts 2–4 weeks.

Children.

There is no experience with the use of the drug in children; therefore, the drug should not be used in pediatric practice.

Overdose.

Symptoms.

Possible intensification of adverse effects.

Treatment.

Symptomatic.

Side effects.

Gastrointestinal system: in individual cases, nausea may occur or intensify, diarrhea may develop.

Immune system: allergic reactions, including itching and urticaria.

Shelf life. 2 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging.

10 tablets per blister, 2 or 5 blisters per carton.

Availability category. Over-the-counter.

Manufacturer.

JSC "VITAMINS".

Manufacturer's address.

31 Uspenska Street, Uman, Cherkasy region, 20300, Ukraine.

Marketing Authorization Holder.

JSC "VITAMINS".

Address of the Marketing Authorization Holder and/or its representative.

31 Uspenska Street, Uman, Cherkasy region, 20300, Ukraine.