Instructions Movinase-10 mg enteric-coated tablets 10 mg blister No. 30
Composition
active ingredients: 1 tablet contains 10 mg or 20 mg of serratiopeptidase in the form of granules (equivalent to enzyme activity of 20,000 U or 40,000 U). 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 activity. 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.
The drug passes through the stomach unchanged and is absorbed in the intestine. The drug is not inactivated by gastric juice. The maximum concentration in the blood plasma is reached after 1 hour. Serratiopeptidase reaches the bloodstream in an enzymatically active form, is also excreted in an active form with bile and is detected in small quantities in the urine.
Indication
Musculoskeletal and surgical diseases: sprains and ligament tears, fractures and dislocations, swelling caused by plastic surgery;
respiratory diseases: reduces the viscosity of sputum and facilitates its discharge from the respiratory tract;
ENT diseases: facilitates the discharge of secretions from the paranasal sinuses;
skin diseases: acute inflammatory dermatoses;
Diseases of the female genital organs and mammary glands: hematomas, stasis in the mammary glands.
Contraindication
Hypersensitivity to serratiopeptidase or to any component of the drug. Blood clotting disorders.
Interaction with other medicinal products and other types of interactions
When used simultaneously, the drug accelerates the penetration of antibiotics and nonsteroidal anti-inflammatory drugs into inflamed tissues. It enhances the effect of anticoagulants (this combination of drugs should be used under close medical supervision).
Application features
Since the drug affects blood clotting, it should be used with caution in patients with a risk of bleeding, impaired blood clotting time, patients taking anticoagulants, and in cases of severe liver and 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 influence reaction speed when driving vehicles or other mechanisms
Does not affect.
Method of administration and doses
The drug is prescribed to adults orally, 1 tablet 1–3 times a day after meals. The tablets should be swallowed without chewing, washed down with 1 glass of water. The maximum daily dose is 30 mg.
The dose and duration of the treatment course depend on the nature and dynamics of the pathological process and are determined in each case individually by the doctor.
Children.
The drug should not be used in children due to the lack of clinical data.
Overdose
Symptoms: nausea, vomiting, anorexia, epigastric discomfort, in some cases – bleeding and streaks of blood in the sputum.
Treatment: therapy is symptomatic.
Adverse reactions
In some cases, diarrhea, nausea, vomiting, anorexia, abdominal pain, and epigastric discomfort may occur when using the drug.
In rare cases, nosebleeds, blood-tinged sputum, acute eosinophilic pneumonia, hypersensitivity reactions, including itching, skin flushing, and rash, may occur.
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 pack.
Vacation category
According to the recipe.
Producer
Valles Pharmaceuticals Pvt. Ltd.
Location of the manufacturer and its business address
India, Bhatian, Nalagarh, Distr. Solan, Ech. Pi.
Applicant
Movie Health GmbH.
Applicant's location
35 Egerischstrasse, Baar, 6340, Switzerland.
