Instructions Movinase-20 mg enteric-coated tablets 20 mg blister No. 30
Composition
active ingredient: serratiopeptidase;
1 tablet contains 10 mg or 20 mg of serratiopeptidase in the form of granules (equivalent to enzyme 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, red iron oxide (E 172), castor oil, diethyl phthalate, polyethylene glycol 6000.
Dosage form
The film-coated tablets are enteric-coated.
Main physicochemical properties: pink, round, biconvex, film-coated, enteric-coated tablets.
Pharmacotherapeutic group
Means used in pathologies of the musculoskeletal system. Enzymes.
ATX code M09A B.
Pharmacological properties
Pharmacodynamics
Serratiopeptidase is a proteolytic enzyme isolated from the non-pathogenic intestinal bacterium Serratia E15. It has fibrinolytic, anti-inflammatory and anti-edematous effects. In addition to reducing inflammation, serratiopeptidase reduces pain by blocking the release of pain amines from inflamed tissues.
Serratiopeptidase binds in a 1:1 ratio to blood alpha-2-macroglobulin, which masks its antigenicity but retains its enzymatic activity. Then, gradually, at the site of inflammation, it passes into the exudate and, accordingly, its level in the blood decreases.
Serratiopeptidase directly reduces capillary dilation and controls capillary permeability by hydrolyzing bradykinin, histamine, and serotonin. Serratiopeptidase also blocks plasmin inhibitors, thereby enhancing the fibrinolytic activity of plasmin. By proteolysis of sputum structural proteins, it improves the rheological properties of sputum and promotes its clearance.
The enzymatic activity of the drug is 10 times higher than that of α-chymotrypsin. In the focus of chronic inflammation, serratiopeptidase helps reduce the level of mediators of inflammation and pain; hydrolyzes fibrin, preventing the formation of adhesions, improves microcirculation in the focus of chronic inflammation, thereby improving the bioavailability of antibiotics, nonsteroidal anti-inflammatory drugs and other drugs.
It has no significant effect on proteins of the living organism, such as albumin and α- and γ-globulin. The drug does not break down fibrinogen, therefore it has no significant effect on blood clotting processes.
The drug penetrates well into the areas of inflammation, lyses necrotic tissues and their decomposition 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 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 is excreted in an 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 - to reduce the viscosity of sputum and facilitate its discharge from the respiratory tract.
ENT diseases – to facilitate the drainage 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 drug. Violations of the blood coagulation 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, serratiopeptidase 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
The use of the drug during pregnancy or breastfeeding is not recommended due to the lack of clinical data.
Ability to influence reaction speed when driving vehicles or other mechanisms
Does not affect.
Method of administration and doses
The dose and duration of the treatment course depend on the nature and dynamics of the pathological process and are determined individually by the doctor 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 blood in the sputum.
Treatment: symptomatic therapy.
Adverse reactions
Immune system, skin and subcutaneous tissue disorders: hypersensitivity reactions, including rash, itching, hyperemia.
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.
Expiration date
3 years.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 °C.
Keep out of reach of children.
Packaging
10 tablets in a blister; 1 or 3 blisters in a cardboard box.
Vacation category
According to the recipe.
Producer
Sava Helskea Ltd.
Location of the manufacturer and address of its place of business
India, GIDC Estate, 507-B-512, Wadhwan City - 363 035, Surendranagar.
Applicant
Movie Health GmbH.
Applicant's location
Bleichstrasse 25 6340 Baar, Switzerland.
