Expiration date: 07/2025

Trade name: Rezalut® Pro

International nonproprietary name or grouping name: Phospholipids

Dosage form: capsules

Composition for 1 capsule:

Active substance: ppl 600 – 600 mg Lipoid consisting of:

phospholipids polyunsaturated from soy lecithin-300, 0 mg, glycerol mono / dialconate (C14-C18) - 120, 0 mg, medium chain triglycerides-40, 5 mg, refined soybean oil-138, 5 mg,?- tocopherol-1, 0 mg.

Auxiliary substance: refined soy oil-100, 0 mg.

Capsule shell: gelatin (in terms of dry matter) – 220, 5 mg, glycerol 95% - 107, 8 mg.

Description:

Transparent colorless gelatin capsules of an oblong shape. Contents of capsules: viscous liquid from Golden yellow to yellow-brown color.

Pharmacotherapeutic group: Hepatoprotective agent

ATX code: A05B.

Pharmacological properties:

Pharmacodynamics. Soy phospholipid extract consists of phosphatidylcholine and phosphoglycerides (on average by 76 %), with linoleic acid prevailing among the fatty acids. The hepatoprotective effect of the drug is due to the acceleration of the process of liver cell regeneration and stabilization of cell membranes, inhibition of the process of lipid oxidation and suppression of collagen synthesis in the liver. The drug normalizes lipid metabolism, reducing the level of cholesterol by increasing the formation of its esters and linoleic acid.

Pharmacokinetics. Studies of the pharmacokinetics of phosphatidylcholine have shown that it breaks down in the intestine to lyso-phosphatidylcholine and is absorbed mainly in the same form. In the intestinal wall, it partially resynthesizes to phospholipid, which then passes through the lymphatic vessels into the circulatory channel, part of the lyso-phosphatidylcholine breaks down in the liver to fatty acids, choline and glycerol-3-phosphate. In plasma, phosphatidylcholine and other phosphoglycerides bind strongly to lipoproteins and / or albumin. Most of the introduced soy phospholipids with a high content of (3-sn-phosphatidyl) choline combine as metabolites with the body's own phospholipids within a few hours. Their excretion corresponds to the excretion of the body's own phospholipids or their metabolites.

Indications for use:

• fatty liver degeneration of various etiologies,
• chronic hepatitis,
• toxic liver damage,
• cirrhosis,
• hypercholesterolemia, when the diet and other non-drug measures (physical activity and measures to reduce body weight) are ineffective.

Contraindications:

• hypersensitivity to phospholipids, peanuts, soy and other components of the drug,
• antiphospholipid syndrome.

Use during pregnancy and lactation

There are no data on the safety of the drug during pregnancy. Therefore, Rezalut® Pro should only be used if the intended benefit to the mother exceeds the possible risk to the fetus.

There is no data on the penetration of Rezalut® Pro into breast milk, so if you need to use Rezalut® Pro during lactation, breastfeeding should be discontinued for the period of taking the drug.

Dosage and administration

The drug is intended for oral administration.

If there are no other instructions, you should take 2 capsules of Rezalut® Pro 3 times a day before meals, without chewing and with a sufficient amount of liquid.

The duration of treatment depends on the course of the disease.

Side effect

From the gastrointestinal tract: sometimes there may be discomfort in the epigastric region, diarrhea.

Allergic reactions: in rare cases, skin rash, urticaria.

From the hematopoietic system: extremely rare-petechial rashes, bleeding in women during the intermenstrual period.

Overdose:

There have been no reports of overdose or intoxication with the drug to date.

Interaction with other medications

Cases of incompatibility are still unknown.

However, we cannot exclude the interaction Rezalut® Pro with coumarin anticoagulants (e.g. phenprocoumon, warfarin). If appropriate combination therapy is unavoidable, it may be necessary to adjust the dosage of the drug.

Special instruction:

In one capsule Rezalut® contains less than About 0, 1 XE (bread units).

The effect of the drug on the ability to drive vehicles and manage mechanisms is not known.

Form release

Capsules. 10 or 20 capsules in a contour cell package (blister) [PVC/pvdh/aluminum foil]. 1, 3, 5 blisters of 10 capsules together with the instructions for use in a cardboard pack.

Storage conditions

At a temperature no higher than 25°C.

Keep the medicine out of the reach of children!

Shelf life

2 years.

Do not use after the expiration date indicated on the package.

Conditions of release from pharmacies

Without a prescription.