Instructions for Fibrinase-10 tablets 10 mg No. 30
Composition
active ingredient: serratiopeptidase;
1 tablet contains serratiopeptidase in the form of granules of 10 mg or 20 mg (equivalent to enzyme activity of 20,000 U or 40,000 U);
Excipients: microcrystalline cellulose, povidone, magnesium stearate, talc, sodium starch glycolate (type A), croscarmellose sodium, hypromellose, titanium dioxide (E 171), hydragit L 100, red iron oxide (E 172), castor oil, diethyl phthalate, polyethylene glycol (PEG 6000).
Dosage form
The film-coated tablets are enteric-coated.
Main physicochemical properties: enteric-coated tablets of pink color, round shape, biconvex, coated.
Pharmacotherapeutic group
Means used in the pathology of the musculoskeletal system. Enzymes. ATX code M09 AB.
Pharmacological properties
Pharmacodynamics.
The active substance of the drug - serratiopeptidase - is a proteolytic enzyme isolated from the non-pathogenic intestinal bacterium Serratia E15. It has fibrinolytic, anti-inflammatory and anti-edematous effects and reduces pain by blocking the release of pain amines from inflamed tissues.
Serratiopeptidase directly reduces capillary dilation and controls capillary permeability by hydrolyzing bradykinin, histamine, and serotonin. It also blocks plasmin inhibitors, thereby enhancing its fibrinolytic activity. In chronic inflammation, serratiopeptidase reduces the levels of polypeptide inflammatory mediators (bradykinin) and fibrin, but has no significant effect on living proteins such as albumin and α- and γ-globulin.
The enzymatic activity of serratiopeptidase is 10 times higher than that of α-chymotrypsin. The drug penetrates well into the sites of inflammation, lyses necrotic tissues and their decomposition products, reduces hyperemia, and accelerates the penetration and activity of antibiotics.
By proteolysis of sputum structural proteins, the enzyme improves the rheological properties of sputum and promotes its excretion.
Serratiopeptidase also reduces the viscosity of saliva and nasal secretions, thereby facilitating their removal.
Pharmacokinetics.
After oral administration, the drug is absorbed unchanged in the intestine. It is not inactivated by gastric juice and enters the bloodstream in an enzymatically active form. The maximum concentration in blood plasma is reached after 1 hour. It binds to blood alpha-2-macroglobulin in a 1:1 ratio, which masks the antigenicity of the enzyme, but retains its enzymatic activity. It is not metabolized in the body. It is excreted in active form with bile and in small quantities by the kidneys.
Indication
Surgical diseases: sprains and ligament tears, fractures and dislocations, swelling caused by plastic surgery.
Respiratory diseases: reducing the viscosity of sputum and facilitating its discharge from the respiratory tract.
ENT diseases: facilitating the discharge of sinus secretions.
Skin diseases: acute inflammatory dermatoses.
Diseases of the female genital organs and mammary glands: hematomas, congestion in the mammary glands.
Contraindication
Hypersensitivity to the active substance or to other components of the medicinal product.
Violation of the blood clotting system.
Interaction with other medicinal products and other types of interactions
The drug accelerates the penetration of antibiotics and nonsteroidal anti-inflammatory drugs into inflamed tissues.
When used simultaneously, the drug enhances the effect of anticoagulants; the combination of drugs should be used with caution and under the supervision of a physician.
Application features
Due to its effect on the blood coagulation system, the drug should be used with caution in patients with:
with the threat of bleeding;
when used simultaneously with anticoagulants;
in case of impaired blood clotting time;
in severe liver diseases;
in severe kidney diseases.
Use during pregnancy or breastfeeding
Due to the lack of clinical data, the drug is not recommended for use during pregnancy or breastfeeding.
Ability to influence reaction speed when driving vehicles or other mechanisms
The drug does not affect the reaction speed when driving vehicles or other mechanisms.
Method of administration and doses
The drug is administered orally to adults in a dose of 10–20 mg after meals. The maximum daily dose is 30 mg. The tablets should be swallowed without chewing and washed down with one glass of water.
The dose and duration of the treatment course depend on the nature and dynamics of the pathological process and are determined by the doctor individually in each case.
Children.
Due to the lack of clinical data, the drug should not be used in pediatric practice.
Overdose
Symptoms: nausea, vomiting, anorexia, epigastric discomfort, in some cases – bleeding and streaks of blood in the sputum.
Treatment: symptomatic therapy.
Side effects
Respiratory, thoracic and mediastinal disorders: epistaxis, bloody sputum, acute eosinophilic pneumonia.
On the part of the digestive system: abdominal pain, nausea, vomiting, diarrhea, epigastric discomfort, anorexia.
Immune system, skin and subcutaneous tissue disorders: hypersensitivity reactions, including rash, itching, hyperemia.
Reporting adverse reactions after the registration of a medicinal product is important. This allows monitoring of the benefit/risk ratio when using this medicinal product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, should report all cases of suspected adverse reactions and lack of efficacy of the medicinal product via the automated pharmacovigilance information system at the following link: https://aisf.dec.gov.ua
Expiration date
2 years.
Storage conditions
Store out of the reach of children at a temperature not exceeding 25 °C.
Packaging
10 tablets in a blister; 1 or 3 or 10 blisters in a cardboard pack.
Vacation category
According to the recipe.
Producer
Evertogen Life Sciences Limited.
Location of the manufacturer and its business address.
Plot No.: S-8, S-9, S-13/P and S-14/P T E C I A C, S I Z Pharma, Green Industrial Park, Polepally (V), Yedcherla (M), Mahabubnagar, Telangana, IH-509 301, India /
Plot No: S-8, S-9, S-13/P & S-14/P TSIIC, Pharma SEZ, Green Industrial Park, Polepally (V), Jadcherla (M), Mahabubnagar, Telangana, IN-509 301, India
