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SOLIZIM® enteric-coated tablets 20,000 LO
Instruction
For medical use of the medicinal product
Solizim®
(Solizymum®)
Composition:
Active ingredient: lipase of microbial origin;
1 tablet contains lipases of microbial origin in an amount corresponding to the enzymatic activity of 20,000 LE;
excipients: sugar; lactose, monohydrate; povidone; stearic acid; methylcellulose; acrylic-z yellow 93O38159 (mixture of substances: methacrylate copolymer type C, talc, titanium dioxide (E 171), triethyl citrate, colloidal anhydrous silica, sodium bicarbonate, sodium lauryl sulfate, quinoline yellow (E 104), iron oxide yellow (E 172), ponceau 4R (E 124)).
Dosage form.
The film-coated tablets are enteric-coated.
Main physicochemical properties: tablets, round in shape, coated, with a smooth, biconvex surface, from light yellow to dark yellow in color.
Pharmacotherapeutic group.
Drugs that affect the digestive system and metabolism. Enzyme preparations.
PBX code A09A A.
Pharmacological properties.
Pharmacodynamics.
Enzyme preparation of microbial origin. Compensates for pancreatic lipase deficiency.
Lipase, which is part of the drug, hydrolyzes vegetable and animal fats (to glycerol and fatty acids), contributing to a 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 ºС, is resistant to protease and pancreatic enzyme inhibitors, does not require its activation by bile acids, and has a wide substrate specificity. The dissolution of the shell and the release of the enzyme begins in the duodenum. The enzyme acts in the intestinal cavity, participating in the process of cavity digestion (hydrolysis of fats). In therapeutic doses, Solizym ® does not affect the evacuation capacity of the digestive tract. The effect of the drug is manifested in the disappearance or reduction of pain syndrome, flatulence, stool disorders; the appearance of positive changes in coprological studies (the content of neutral fat and fatty acids in feces is significantly reduced). Lipase improves pancreatic function. There is no risk of zoonotic infection when using the drug (unlike pancreatin preparations).
Pharmacokinetics.
Not studied.
Clinical characteristics.
Indication.
Chronic pancreatitis with impaired exocrine pancreatic function and decreased pancreatic lipase activity; digestive disorders that occur against the background of decreased pancreatic function; after eating fatty, indigestible food.
Contraindication.
Hypersensitivity to the components of the drug. Acute pancreatitis.
Interaction with other drugs and other types of interactions.
The drug should not be taken simultaneously with iron preparations and antacids containing aluminum, magnesium, or calcium ions.
Application features.
The drug contains sugar and lactose, therefore, if the patient has been diagnosed with intolerance to some sugars, you should consult a doctor before taking this medicine.
The drug contains the dye Ponceau 4R, which may cause allergic reactions.
Use during pregnancy or breastfeeding.
The effectiveness and safety of the drug during pregnancy or breastfeeding have not been established, therefore the drug can be used only if, in the opinion of the doctor, the expected benefit from use for the mother outweighs the potential risk to the fetus/child.
The ability to influence the reaction speed when driving vehicles or other mechanisms.
Does not affect.
Method of administration and doses.
Tablets should be taken orally during or immediately after meals. Swallow the tablets whole, without chewing, with a small amount of liquid.
The dosage and duration of Solizima ® use is determined by the doctor individually for each patient depending on the nature and course of the disease, the functional state of the pancreas, the degree of digestive disorders and the composition of food. A single therapeutic dose is 20,000-40,000 LE (1-2 tablets). Apply 3-4 times a day. The daily dose of the drug is 120,000-160,000 LE (6-8 tablets). The maximum daily dose is 8 tablets. The duration of the treatment course is 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 increased side effects.
Treatment.
Symptomatic.
Adverse reactions.
On the part of the digestive system: in some cases, the appearance or intensification of nausea and diarrhea may occur.
Immune system disorders: allergic reactions, including itching, urticaria.
Expiration date.
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 in a blister, 2 or 5 blisters in a pack.
Vacation category.
Without a prescription.
Producer.
Pao "vitamins".
Location of production and its address of place of business.
20300, Ukraine, Cherkasy region, M uman, Leninsky Iskra St., 31.
Applicant.
Pao "vitamins".
Location of the applicant and/or the applicant's representative.
20300, Ukraine, Cherkasy region, M uman, Leninsky Iskra St., 31.
