COMPOSITION:

Active substance:

serratiopeptidase;

1 tablet contains serratiopeptidase 10 mg.

Excipients:

lactose monohydrate

corn starch

magnesium carbonate light

sodium starch glycolate

magnesium stearate

cover Оpadry White

cover Оpadry Enteric White.

INDICATIONS:

Surgery:

sprain and rupture of ligaments

fractures and dislocations

edemas caused by operation; Upper airways diseases

It reduces the sputum viscosity and facilitates its excretion from respiratory tracts;

ENT organs diseases:

it facilitates excretion of accessory sinuses secretion.

Dermatology:

Acute inflammatory dermatosis.

Obstetrics and gynecology:

Haematomas

galactostasis.

DOSAGE:

The preparation is administered in dose of 1 tablet 2 – 3 times per day after meal.

Tablets should be swallowed without chewing

following with 1 glass of water.

Maximal daily dose is 30 mg.

The duration of the treatment course depends on the character and dynamics of pathology and is determined individually.

ADVERSE REACTIONS:

In isolated cases during the preparation administration it can be observed:

Gastro-intestinal disorders:

Diarrhoea

nausea

vomiting

anorexia

and epigastric discomfort.

Respiratory tract disorders:

Very rare it may be nasal bleeding and streaks of blood in sputum; in literature it was reported about the case of acute eosinophil pneumonia.

In persons with hypersensitivity allergic reactions and skin rash are possible.

Drug interactions:

In concurrent usage with anticoagulants the preparation intensifies their activity. Such combination should be used under careful medical supervision.

Pregnancy and lactation:

The preparation use during pregnancy and lactation periods is not recommended due to absence of clinical data.

Children:

The experience of the preparation use in children is absent; therefore it should not be used in this age group.

PRECAUTIONS:

The preparation should be administered with caution in patients with risk of bleeding and with disorders of blood coagulation time and in patients used anticoagulants because of the drug influence on blood coagulation.

In case of severe liver and kidneys diseases the preparation should be used with caution.

Overdose:

Symptoms:

Nausea

vomiting

anorexia

epigastric discomfort

in some cases – bleed streaks in sputum and bleeding.

Treatment:

The treatment is symptomatic.

Ability to influence reaction velocity while driving or operating any other mechanisms. It does not influence.

CONTRAINDICATIONS:

Hypersensitivity to Serratiopeptidase or other drugs components. Blood coagulation impairment.

PHARMACOLOGICAL PROPERTIES:

Pharmacodynamics:

Serratiopeptidase is a proteolytic enzyme

which is extracted from nonpathogenic intestinal bacteria Serratia E15. It has a fibrinolytic

anti-inflammatory and anti-edema activity. Except decreasing of inflammatory process serratiopeptidase reduces a pain as a result of blocking of painful amine release from inflamed tissues.

Serratiopeptidase binds with blood alfa-2-macroglobulin in ratio 1:1

that masks its antigenicity

but it retains its enzyme activity. Then gradually it penetrates into exudate at the inflammation site and its level in blood is gradually decreased.

Serratiopeptidase directly reduces the capillaries dilatation and controls theirs penetrability via hydrolysis of bradykinin

histamine and serotonin. Serratiopeptidase also blocks plasmin inhibitors and therefore promotes plasmin fibrinolytic activity. Due to edema reducing and microcirculation improvement serratiopeptidase makes the expectoration easier.

Enzyme activity of the preparation is 10 times more than α-chemotrypsin. It very effectively hydrolises inflammatory mediators of polypeptide nature (bradykinin etc.)

fibrin

but it does not influence on living organism proteins

such as albumin and α- and γ-globulin. The preparation does not split fibrinogen; therefore it does not have a significant influence on blood coagulation processes.

The preparation well penetrates into inflammatory sites

lyses necrotizing tissue and their disintegration product

eliminates hyperemia and enhances antibiotics penetration and activity. The preparation reduces viscosity of saliva and nasal discharge

therefore enhancing their extraction.

Pharmacokinetics: The preparation passes through stomach in unchanged form and is absorbed in intestine. Maximal concentration in plasma is reached in 1 hour. Serratiopeptidase is detected in urine in insignificant quantity.

PHARMACEUTICAL CHARACTERISTICS:

General physico-chemical properties: white

circular

biconvex enteric film coated tablets.

Shelf-life:

3 years.

Storage:

Store in dry

protected from sun light place at the temperature not more than 25°c.

Keep it out of reach of children.

Package:

№10:

10 tablets are in a strip

1 strip is in a carton box;

№10×10:

10 tablets are in a strip

1 strip is in a carton box

10 packs in a carton pack;

№10×3:

10 tablets are in a strip

3 strips are in a carton box;

№30:

30 tablets are in a blister or in a strip

1 blister or strip is in a carton box.

Conditions of supply:

By prescription.