FAKOVIT

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT FAKOVIT

Composition:

Active substances: The preparation consists of two types of tablets:

1 enteric-coated tablet contains L-glutamic acid 200 mg, glycine 100 mg, pyridoxine hydrochloride 25 mg;

Excipients: potato starch, calcium stearate, monohydrate lactose;

1 coated tablet, enteric-coated, contains L-cysteine 200 mg, ascorbic acid 175 mg;

Excipients: potato starch, calcium stearate, monohydrate lactose, Eudragit L-100-55, macrogol 4000, azo dye 0, talc.

Pharmaceutical form. Enteric-coated tablets and coated enteric-coated tablets.

Main physicochemical properties: enteric-coated tablets are white or almost white, flat cylindrical, with a score line and bevel; tablets, coated, enteric-coated, are from yellow-orange to brown, biconvex. Marbling on the surface of the tablets is permissible. Two layers are visible in cross-section.

Pharmacotherapeutic group. Agents used in ophthalmology. Trophic agents.

ATC code S01XA.

Pharmacological Properties

Pharmacodynamics

A drug for regulation of metabolic processes in the lens, possessing antioxidant and detoxifying properties.

In the eye lens, the tripeptide glutathione is synthesized from glutamic acid, glycine, and cysteine with the participation of adenosine triphosphate (ATP). Glutathione serves as a central component of the enzymatic antioxidant defense system of proteins and detoxification of toxic metabolites. The phosphorylated form of pyridoxine hydrochloride (pyridoxal phosphate) facilitates the transport of these amino acids into the lens through the capsule. Ascorbic acid acts as a regulator of redox processes in the lens and participates in the reduction of disulfide bonds.

The drug reduces the intensity of free radical processes in the lens, thereby decreasing the formation of cross-links and polymerization of lens proteins, which results in slowing down or halting lens opacification.

Pharmacokinetics

Not studied.

Clinical characteristics.

Indications. Prevention and treatment of early stages of cataract formation in the lens in elderly individuals or under chronic low-intensity radiation exposure.

Contraindications. Hypersensitivity to the components of the drug, severe hepatic/renal insufficiency, nephrotic syndrome, febrile conditions, increased excitability with pronounced psychotic reactions, peptic ulcer of the stomach/duodenum in the stage of exacerbation, hematopoietic organ disorders with anemia/leukopenia, pronounced arterial hypotension.

Interaction with other medicinal products and other types of interactions. Reduces toxicity of anticonvulsants, neuroleptics, and antidepressants. When combined with sedatives, enhances the inhibitory effect on the central nervous system. Increases detoxification and total clearance of ethyl alcohol, and elevates blood concentrations of salicylates, sulfonamides, benzylpenicillin, and tetracyclines; decreases concentrations of oral contraceptives. Weakens anticoagulant effects of coumarin derivatives and heparin. The efficacy of the drug is reduced by isoniazid, cycloserine, and penicillamine. When used concomitantly with levodopa, inhibitors of dopa-decarboxylase must be administered simultaneously, as the action of levodopa is inhibited.

Special precautions.

Use with caution in patients with a history of gastric or duodenal ulcer, diabetes mellitus, or predisposition to thrombosis.

During treatment, regular blood and urine tests are required.

Patients prone to arterial hypotension should have their blood pressure monitored; if necessary, dosage adjustment should be performed (use a lower dose and ensure regular monitoring of blood pressure). If blood pressure remains below normal levels despite dose reduction, discontinuation of the drug is recommended.

If a patient has known intolerance to certain sugars, medical advice should be sought before taking this medicinal product.

Use during pregnancy or breastfeeding. The effect of the drug during pregnancy or breastfeeding has not been studied; therefore, its use is not recommended.

Effect on reaction speed when driving or operating machinery. When used according to the recommended dosage regimen, the drug does not affect the ability to drive or operate machinery. However, it cannot be ruled out that concentration may be impaired in individuals highly sensitive to the drug's components. Therefore, caution should be exercised during potentially hazardous activities until individual response to the drug is established.

Method of administration and dosage. For adults, take orally during meals.

Take simultaneously one enteric-coated tablet and one film-coated, delayed-release tablet; frequency of administration – twice daily.

Treatment duration – 20–30 days. Conduct 3–4 treatment courses per year.

Children. The efficacy and safety of the drug in children have not been studied.

Overdose. There are no reported cases of overdose. In theory, an overdose may lead to an increase in adverse effects.

In case of accidental overdose, induce vomiting; subsequent treatment should be symptomatic.

Side effects.

Possible increase in gastric juice acidity, allergic reactions including urticaria, rash, itching, hyperemia.

Other adverse reactions have not been reported to date; however, the following theoretically possible reactions associated with the active ingredients of the drug may occur: nausea, vomiting, diarrhea, abdominal pain, rhinitis, conjunctivitis, sore throat, impaired concentration, headache, tension, irritability, insomnia, weakness, decreased hemoglobin levels and/or leukopenia with prolonged use.

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. Enteric-coated tablets № 10x3 + film-coated tablets, enteric-coated № 10x3 in blisters in a box; enteric-coated tablets № 30 + film-coated tablets, enteric-coated № 30 in blisters with an insert containing special eye exercises in a box.

Availability category. Over-the-counter.

Manufacturer. Limited liability company "Pharmaceutical Company "Zdorovye".

Manufacturer's address and place of business.
Ukraine, 61013, Kharkiv region, city of Kharkiv, Shevchenko Street, building 22.