Movinaza®-10 mg

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT MOVINAZA® – 10 mg, MOVINAZA® – 20 mg (MOVINAZA – 10 mg, MOVINAZA – 20 mg)

Composition:

Active substance: serrapeptidase;

1 tablet contains 10 mg or 20 mg of serrapeptidase in the form of granules (equivalent to an enzymatic activity of 20,000 IU or 40,000 IU, respectively). The tablet and each granule are coated with an enteric coating;

Excipients: microcrystalline cellulose, povidone, magnesium stearate, talc, sodium starch glycolate (type A), croscarmellose sodium, hypromellose, titanium dioxide (E 171), Eudragit L 100, iron oxide red (E 172), castor oil, diethyl phthalate, polyethylene glycol 6000.

Pharmaceutical form. Enteric-coated tablets.

Main physicochemical properties: pink-colored, round, biconvex enteric-coated tablets.

Pharmacotherapeutic group.

Agents used in disorders of the musculoskeletal system. Enzymes.

ATC code M09A B.

Pharmacological Properties.

Pharmacodynamics.

Serratiopeptidase is a proteolytic enzyme isolated from the non-pathogenic intestinal bacterium Serratia E15. It possesses fibrinolytic, anti-inflammatory, and anti-edematous properties. In addition to reducing the inflammatory process, serratiopeptidase alleviates pain by blocking the release of pain mediators (pain amines) from inflamed tissues.

Serratiopeptidase binds in a 1:1 ratio with alpha-2-macroglobulin in blood, which masks its antigenicity while preserving its enzymatic activity. Subsequently, it gradually migrates to the site of inflammation and enters the exudate, thereby decreasing its concentration in the bloodstream.

Serratiopeptidase directly reduces capillary dilation (expansion) and controls capillary permeability through hydrolysis of bradykinin, histamine, and serotonin. It also blocks plasmin inhibitors, thus promoting the fibrinolytic activity of plasmin. By proteolysis of structural proteins in sputum, it improves the rheological properties of sputum and facilitates its expectoration.

The enzymatic activity of the drug is 10 times higher than that of α-chymotrypsin. At the site of chronic inflammation, serratiopeptidase reduces levels of inflammatory and pain mediators, hydrolyzes fibrin preventing adhesion formation, and improves microcirculation at the site of chronic inflammation. This enhances the bioavailability of antibiotics, nonsteroidal anti-inflammatory drugs, and other medicinal agents.

It has no significant effect on proteins of the living organism, such as albumin, α- and γ-globulins. The drug does not cleave fibrinogen and therefore has no significant impact on blood coagulation processes.

The medicinal product penetrates well into sites of inflammation, lyses necrotic tissues and their degradation products, reduces hyperemia, and accelerates the penetration and activity of antibiotics. The drug reduces the viscosity of saliva and nasal secretions, thereby facilitating their removal.

Pharmacokinetics.

After oral administration, the drug is absorbed from the intestine in its unchanged form. It is not inactivated by gastric juice and enters the systemic circulation in enzymatically active form. Maximum plasma concentration is reached within 1 hour. The drug is excreted in active form via bile and, to a minor extent, through the kidneys.

Clinical characteristics.

Indications.

Surgical conditions: ligament sprains and ruptures, fractures and dislocations, swelling caused by plastic surgery.

Respiratory tract diseases – to reduce sputum viscosity and facilitate its elimination from the respiratory tract.

Otorhinolaryngological diseases – to facilitate drainage of sinus secretions.

Skin diseases: acute inflammatory dermatoses.

Diseases of female genital organs and mammary glands: hematomas, congestion in mammary glands.

Contraindications.

Hypersensitivity to the active substance or to other components of the medicinal product. Coagulation disorders.

Interaction with other medicinal products and other types of interactions.

The medicinal product enhances penetration of antibiotics and nonsteroidal anti-inflammatory agents into inflamed tissues.

When used concomitantly, serrapeptidase enhances the effect of anticoagulants; such combination should be used with caution and under medical supervision.

Special precautions for use.

Due to its effect on the blood coagulation system, the medicinal product should be used with caution in patients:

• at risk of bleeding;
• when used concomitantly with anticoagulants;
• with impaired blood coagulation time;
• with severe liver disease;
• with severe kidney disease.

Use during pregnancy or breastfeeding.

The use of the drug during pregnancy or breastfeeding is not recommended due to the lack of clinical data.

Ability to affect reaction speed when driving or operating machinery.

Does not affect.

Dosage and Administration

The medicinal product Movinaza® - 10 mg should be administered to adults at a dose of 1 tablet 2–3 times daily. The medicinal product Movinaza® - 20 mg should be administered to adults at a dose of 1 tablet once daily. Tablets should be taken after meals, without chewing, and swallowed with a glass of water. The maximum daily dose is 30 mg.

The dosage and duration of treatment depend on the nature and progression of the pathological process and must be determined individually by a physician in each case.

Children

Due to lack of clinical data, the medicinal product is not recommended for use in pediatric practice.

Overdose

Symptoms: nausea, vomiting, anorexia, epigastric discomfort; in some cases, bleeding and blood admixtures in sputum.

Treatment: symptomatic therapy.

Adverse reactions.

Immune system, skin and subcutaneous tissue disorders: hypersensitivity reactions, including rash, pruritus, hyperemia.

Respiratory, thoracic and mediastinal disorders: epistaxis, hemoptysis, acute eosinophilic pneumonia.

Gastrointestinal disorders: abdominal pain, nausea, vomiting, diarrhea, epigastric discomfort, anorexia.

Reporting of suspected adverse reactions

Reporting of suspected adverse reactions after registration of the medicinal product is important. It allows continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals and patients, as well as their legal representatives, are encouraged to report any suspected adverse reactions and lack of efficacy via the Automated Pharmacovigilance Information System at the following link: https://aisf.dec.gov.ua.

Shelf life. 3 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of reach and sight of children.

Packaging.

10 tablets in a blister; 1 or 3 blisters per cardboard box.

Prescription status.

Prescription-only medicine.

Manufacturer.

Sava Helskea Ltd.

Manufacturer's address and place of business.

GIDC Estate, 507-B-512, Vadodwan City - 363 035, Surendranagar, India.

Marketing Authorization Holder: LLC "Movi Hels"

Address of the Marketing Authorization Holder:

162 A, Shevchenka Street, Shevchenkove village, Kyiv-Sviatoshyn district, Kyiv region, 08140, Ukraine.

INSTRUCTION

for medical use of the medicinal product

MOVINAZA® – 10 mg, MOVINAZA® – 20 mg

(MOVINAZA – 10 mg, MOVINAZA – 20 mg)

Composition:

Active substance: serratiopeptidase;

1 tablet contains 10 mg or 20 mg of serratiopeptidase in the form of granules (equivalent to an enzymatic activity of 20,000 IU or 40,000 IU). The tablet and each granule are coated with an enteric coating;

Excipients: microcrystalline cellulose, povidone, magnesium stearate, talc, sodium starch glycolate (type A), croscarmellose sodium, hypromellose, titanium dioxide (E 171), Eudragit L 100, iron oxide red (E 172), castor oil, diethyl phthalate, polyethylene glycol 6000.

Pharmaceutical form. Enteric-coated tablets.

Main physico-chemical properties: pink-colored, round, biconvex, coated, enteric tablets.

Pharmacotherapeutic group.

Agents used in musculoskeletal disorders. Enzymes.

ATC code M09A B.

Pharmacological Properties

Pharmacodynamics

Serratiapeptidase is a proteolytic enzyme isolated from the non-pathogenic intestinal bacterium Serratia E15. It exhibits fibrinolytic, anti-inflammatory, and anti-edematous effects. In addition to reducing the inflammatory process, serratiapeptidase reduces pain by blocking the release of pain mediators (pain amines) from inflamed tissues.

Serratiapeptidase binds in a 1:1 ratio to alpha-2-macroglobulin in blood, which masks its antigenicity while preserving its enzymatic activity. Subsequently, it gradually migrates to the site of inflammation, entering the exudate, and consequently its concentration in the blood decreases.

Serratiapeptidase directly reduces capillary dilation and controls capillary permeability by hydrolyzing bradykinin, histamine, and serotonin. It also blocks plasmin inhibitors, thereby promoting the fibrinolytic activity of plasmin. By proteolysis of structural proteins in sputum, it improves the rheological properties of sputum and facilitates its expectoration.

The enzymatic activity of the drug is 10 times higher than that of α-chymotrypsin. At the site of chronic inflammation, serratiapeptidase reduces levels of inflammatory and pain mediators, hydrolyzes fibrin (thus preventing adhesion formation), and improves microcirculation in the area of chronic inflammation. This enhances the bioavailability of antibiotics, nonsteroidal anti-inflammatory drugs, and other medicinal agents.

It has no significant effect on vital body proteins such as albumin and α- and γ-globulins. The drug does not cleave fibrinogen and therefore has no significant impact on blood coagulation processes.

The medicinal product effectively penetrates into sites of inflammation, lyses necrotic tissues and their degradation products, reduces hyperemia, and accelerates the penetration and activity of antibiotics. The drug reduces the viscosity of saliva and nasal secretions, thereby facilitating their removal.

Pharmacokinetics

After oral administration, the drug is absorbed from the intestine in its unchanged form. It is not inactivated by gastric juice and enters the systemic circulation in enzymatically active form. Maximum plasma concentration is reached within 1 hour. The drug is excreted in active form via bile and, to a minor extent, via the kidneys.

Clinical characteristics.

Indications.

Surgical conditions: ligament sprains and ruptures, fractures and dislocations, edema caused by plastic surgery.

Respiratory tract diseases: to reduce sputum viscosity and facilitate its elimination from the respiratory tract.

ENT diseases: to facilitate drainage of sinus secretions.

Skin diseases: acute inflammatory dermatoses.

Diseases of female genital organs and mammary glands: hematomas, congestion in mammary glands.

Contraindications.

Hypersensitivity to the active substance or to other components of the medicinal product. Coagulation disorders.

Interaction with other medicinal products and other types of interactions.

The medicinal product enhances penetration of antibiotics and nonsteroidal anti-inflammatory drugs into inflamed tissues.

When used concomitantly, serratiopeptidase enhances the effect of anticoagulants; such combination should be used with caution and under medical supervision.

Special precautions for use.

Due to its effect on the blood coagulation system, the medicinal product should be used with caution in patients:

• at risk of bleeding;
• when used concomitantly with anticoagulants;
• in case of coagulation time disorders;
• in severe liver diseases;
• in severe kidney diseases.

Use during pregnancy or breastfeeding.

The use of the drug during pregnancy or breastfeeding is not recommended due to lack of clinical data.

Ability to influence reaction rate when driving or operating machinery.

Does not affect.

Method of Administration and Dosage

The medicinal product Movinaza® - 10 mg should be administered to adults at a dose of 1 tablet 2–3 times daily. The medicinal product Movinaza® - 20 mg should be administered to adults at a dose of 1 tablet once daily. Tablets should be taken after meals, without chewing, and swallowed with a glass of water. The maximum daily dose is 30 mg.

The dosage and duration of treatment depend on the nature and course of the pathological process and are determined individually by a physician in each case.

Children

Due to the lack of clinical data, the medicinal product should not be used in pediatric practice.

Overdose

Symptoms: nausea, vomiting, anorexia, epigastric discomfort, in some cases gastrointestinal bleeding and blood in sputum.

Treatment: symptomatic therapy.

Adverse reactions.

Immune system, skin and subcutaneous tissue disorders: hypersensitivity reactions, including rash, pruritus, hyperemia.

Respiratory, thoracic and mediastinal disorders: nasal hemorrhage, hemoptysis, acute eosinophilic pneumonia.

Gastrointestinal disorders: abdominal pain, nausea, vomiting, diarrhea, epigastric discomfort, anorexia.

Reporting of suspected adverse reactions

Reporting of suspected adverse reactions after authorization of the medicinal product is of great importance. It allows continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals and patients, as well as their legal representatives, should report all suspected adverse reactions and lack of efficacy via the Automated Pharmacovigilance Information System at the following link: https://aisf.dec.gov.ua.

Shelf life. 3 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of reach and sight of children.

Packaging.

10 tablets per blister; 1 or 3 blisters per cardboard box.

Prescription status.

Prescription only.

Manufacturer.

MediTop Pharmaceutical Ltd.

Manufacturer's address and location of its business operations.

Edő Endre u. 1., Pilisborosjenő, 2097, Hungary.

Marketing Authorization Holder. MOVI Health LLC

Address of the Marketing Authorization Holder.

162 A, Shevchenka Street, Shevchenkove, Kyiv-Sviatoshynskyi District, Kyiv Oblast, 08140, Ukraine