Expiration date: 10/2027

Compound

For one tablet:

Active ingredient :

Tilorone dihydrochloride

125,0000 mg

Excipients :

microcrystalline cellulose 101

120,0000 mg

potato starch

46,0000 mg

povidone K 30

3.0000 mg

calcium stearate

3.0000 mg

croscarmellose (croscarmellose sodium)

3.0000 mg

Shell composition:

VIVACOAT® PC-3P-386[hypromellose

6.8100 mg

titanium dioxide

3.5630 mg

macrogol 4000

0.9130 mg

Sunset Yellow dye (E 110)

0.3530 mg

quinoline yellow dye (E 104)

0.2470 mg

polysorbate 80 (tween 80)]

0.1140 mg

Dosage form

film-coated tablets

Description

Round, biconvex, orange film-coated tablets. When viewed cross-sectionally, the core is orange, with minor darker or lighter inclusions permitted.

Pharmacodynamics

A low-molecular-weight synthetic interferon inducer that stimulates the production of all types of interferons (alpha, beta, gamma, and lambda) in the body. The main interferon producers in response to tilorone are intestinal epithelial cells, hepatocytes, T-lymphocytes, neutrophils, and granulocytes. After oral administration, maximum interferon production is observed in the intestine-liver-blood sequence within 4-24 hours. Tilorone has immunomodulatory and antiviral effects. According to experimental studies, after a single oral administration of tilorone at a dose equivalent to the maximum daily dose for humans, the maximum concentration of interferon lambda in lung tissue is observed after 24 hours, and interferon alpha after 48 hours. Induction of interferon lambda in lung tissue helps enhance antiviral protection of the respiratory tract during influenza and other respiratory viral infections. Tilorone induces interferon synthesis in human leukocytes. It stimulates bone marrow stem cells, increases antibody production, reduces immunosuppression, and restores the T-suppressor/T-helper cell ratio, depending on the dose. It is effective against various viral infections, including influenza viruses, other acute respiratory viral infections, hepatitis viruses, and herpes viruses. Its antiviral action is associated with the inhibition of the translation of virus-specific proteins in infected cells, thereby suppressing viral reproduction.

Pharmacokinetics

After oral administration, tilorone is rapidly absorbed from the gastrointestinal tract. Bioavailability is 60%. Approximately 80% of tilorone is bound to plasma proteins. Tilorone is eliminated virtually unchanged through the feces (70%) and the kidneys (9%). The half-life (T1/2) is 48 hours. Tilorone does not undergo biotransformation and does not accumulate in the body.

Indications for use

As part of complex therapy in adults: treatment of influenza and other acute respiratory viral infections; treatment of herpes infection. Prevention of influenza and other acute respiratory viral infections in adults.

Contraindications

Hypersensitivity to tilorone or other components of the drug; pregnancy and breastfeeding; children under 18 years of age.

Use during pregnancy and breastfeeding

The use of Flogardin® during pregnancy is contraindicated. If the drug must be prescribed during lactation, breastfeeding should be discontinued.

Side effects

Allergic reactions, dyspepsia, and short-term chills are possible. If any of the side effects listed in the instructions worsen, or you notice any other side effects not listed in the instructions, notify your doctor.

Interaction

Compatible with antibiotics and medications for viral and bacterial infections. No clinically significant interactions between tilorone and antibiotics or conventional treatments for viral and bacterial infections have been identified. If you are taking any of the above-mentioned medications or other medications (including over-the-counter medications), consult your doctor before using Flogardin®.

Method of administration and dosage

Orally, after meals. For adults: For the treatment of influenza and other acute respiratory viral infections - 125 mg per day for the first 2 days of treatment, then 125 mg after 48 hours. The course dose is 750 mg (6 tablets). For the prevention of influenza and other acute respiratory viral infections - 125 mg once a week for 6 weeks. The course dose is 750 mg (6 tablets). For the treatment of herpes infection - 125 mg for the first two days, then 125 mg after 48 hours. The course dose is 1.25-2.5 g (10-20 tablets). When treating influenza and other acute respiratory viral infections, if symptoms persist for more than 4 days, consult a doctor. Use the drug only as directed, as directed, and in the doses specified in the instructions.

Overdose

There are no known cases of overdose with Flogardin®.

Special instructions

The product contains sunset yellow dye (E 110), which may cause allergic reactions.

Impact on the ability to drive vehicles and operate machinery

The drug Flogardin® does not have a negative effect on the ability to drive vehicles and engage in other potentially dangerous activities that require increased concentration and speed of psychomotor reactions.

Release form

Film-coated tablets, 125 mg.

Conditions of dispensing from pharmacies

Over the counter

Storage conditions

In a package at a temperature not exceeding 25°C. Keep out of reach of children.

Best before date

3 years. Do not use after expiration date.

Manufacturer and organization accepting consumer complaints

UPDATE OF PFC, JSC Russia