Expiration date: 08/2025

The composition and form of issue:

Tablets, enteric coated tablets, 1 tablet contains:

Pancreatin 345 FR. Heb.Farm. — ED

papain 90 F. I. P — ED

of rutin trihydrate 50 mg

bromelain 225 F. I. p. UNITS

trypsin 360 F. I. P — ED

lipase 34 F. I. P — ED

amylase 50 F. I. P — ED

chymotrypsin 300 F. I. p. — UNITS

inactive ingredients: lactose monohydrate corn starch magnesium stearate stearic acid purified water silicon dioxide highly dispersed talc calcium carbonate methacrylic acid and methyl methacrylate copolymer (1:1) resin titanium dioxide white colorant yellow-orange S dye (E110) colorant Ponceau 4 R (E124) povidone macrogol 6000 triethylcitrate vanilla wax bleached wax Carnauba 

blistere in 20 PCs., in box 2, or 10 blisters, or in vials of high density polyethylene at 800 PCs.

Description pharmaceutical form:

Round biconvex tablets (pills) with a smooth surface, with a characteristic odor, painted in red-orange color. Permitted variations in intensity of the color of the outer shell from red-orange to red.

Description pharmacological action:

WOBENZYM is a combination of highly active proteolytic enzymes (proteases) of plant and animal origin, showing stable pharmacological activity. In combination enzymes have pleiotropic (multiple) effects, having different effects on different target organs and biochemical processes. Protease drug implement their systemic effects through immunomodulatory, anti-inflammatory, antiplatelet, fibrinolytic, antiedematous, a higher thrombolytic effect and secondary analgesic action. An important ability of the immobilized endogenous antiprotease enzymes of the drug is able to move in the bloodstream and be present in various organs and tissues, which has important therapeutic value in systemic inflammatory processes and injuries. In the product is implemented the ability of the enzymes to co-operation and synergies, thereby enhanced and complementary of their action.

By doing the body, drops drug, coated with a protective acid sheath, are transiently upper GI tract, not participating in the digestion or trauma to the stomach. Protective shell tablets dissolves in the small intestine, and the enzymes interact with M-cells and enterocytes of the intestine.

Part of the proteolytic enzymes are absorbed through the resorption of intact molecules (endocytosis, pinocytosis) and forms complexes with transport proteins of blood — antiprotease (alpha-2-macroglobulin and alpha-1-antitrypsin). When connecting to antiprotease proteolytic enzymes alter the conformational structure of the transport of macromolecules, resulting in antiprotease transformed into an active form.

The formation of a complex "protease-antiprotease" can slow the excretion of exogenous proteolytic enzymes of the drug from the body and increase their circulation time in the bloodstream. The complex does not occur irreversible inactivation of enzymes, they retain their activity and reactivity in relation to some specific substrates.

Antiprotease (alpha-2-macroglobulin) masks the antigenic determinants of macromolecules protease of the drug, allowing enzymes to the bloodstream without an allergic reaction, the immune system and their delivery in remote areas to the site of inflammation, regardless of the localization of the pathological process in the body.

Under the influence of enzymes activated form of alpha-2-macroglobulin acquires the ability to regulate the level of proinflammatory cytokines and growth factors, exercising their sorption, transport and clearance. Thus, enzymes of the drug indirectly through the activation of endogenous antiprotease, can regulate the transition of Pro-inflammatory immune response in anti-inflammatory. Proteolytic enzymes to interrupt the pathological cascade of inflammation and prevent the transition of the inflammatory process in the chronic stage.

Activated antiprotease regulate the level of transforming growth factor (TGF-&beta) in the circulatory direction due to its absorption and elimination. TGF-&beta is an autocrine regulation and is responsible for the fibrosis and replacement of damaged areas of organs connective tissue. The enzymes of the drug indirectly through antiprotease reduce the level of TGF-&beta, thus regulating the reparative processes, the growth of connective tissue and the formation of physiological rumen, preventing the formation of keloid scar and the development of adhesive disease.

Part of the proteolytic enzymes of the drug remains in the small intestine, reacts digestion, improves metabolism of protein, fats and other substrates, and also helps to restore the ecology of the intestine and the microbial balance between allochthonous (related) and conditionally pathogenic microflora.

The enzymes of the drug have a positive effect on the inflammatory process, limit the pathological manifestations of autoimmune and immunocomplex processes, restoring the immunological reactivity of the organism. The enzymes of the drug accelerate the decay of inflammatory mediators, carry out the stimulation and regulation of functional activity of monocytes-macrophages, natural killer cells and stimulate antitumor immunity. The drug reduces the level of proinflammatory cytokines (IL-1&beta, IL-6, IL-8, TNF-&alpha, INF-&gamma) and promotes production of anti-inflammatory cytokines (IL-4, IL-10) regulates the level of immunoglobulins and antibodies, thus providing multilateral immunomodulatory effect, increasing the activity of phagocytes and stimulating the interferonogenesis.

Under the influence of proteases of the drug is reducing the number of circulating immune complexes (antigen-antibody) and membranous deposits of immune complexes with the acceleration of excretion (elimination) from the tissues.

The drug reduces the infiltration of interstitium plasma proteins, increases the elimination of protein detritus (cell fragments) and deposits of fibrin in the area of inflammation, accelerates the lysis of toxic products and necrotic tissue.

The enzymes of the drug to optimize physiological reparative processes, accelerate resorption of hematomas and swelling, normalizes the permeability of vascular walls, improve microcirculation and trophic processes in the area of damage tissue, speeding up healing and recovery.

WOBENZYM reduces the concentration of thromboxane and aggregation (sticking together) of platelets, reduces the expression of adhesion molecules and adhesion of blood cells on the endothelium, increases the ability of erythrocytes to alter their shape (deformability), improving their plasticity and ability to deliver oxygen to the tissues. The drug activates the anticoagulant system of blood, restores the number of discocytes, reduces the number of activated forms of platelets, reduces the total number of microaggregates platelets, normalizes blood viscosity, thus improving blood rheology and microcirculation. Proteolytic enzymes increases fibrinolytic activity of plasma, the supply of oxygen to tissues, improve metabolism.

The drug reduces the risk of side effects associated with hormonal therapy (hypercoagulability, platelet activation, thrombosis, blood clots).

WOBENZYM has a pronounced antioxidant effect, reduce lipid peroxidation and normalizes the lipid metabolism. Proteolytic enzymes of the drug reduced the level of endogenous cholesterol, increase the content of HDL, reduce LDL, thus showing anti-atherogenic effect. The drug improves the metabolism of polyunsaturated fatty acids increases the antioxidant activity of plasma and reduces oxidative stress.

Proteolytic enzymes of the drug to interrupt intercellular communication and the interaction between bacteria, disrupt the growth of microbial colonies (in vitro). Thus, enzymes enhance the penetration of antibiotics in microbial communities (biofilms), increasing the efficiency of antibiotic therapy. Protease drugs have the important property to interrupt the transmission factors of resistance to antibiotics between bacteria in microbial colonies, while reducing the risk of resistance (resistance) to antibiotics.

WOBENZYM increases the concentration of antibiotics in the inflammation, which increases the effectiveness of antibiotic therapy.

Enzymes drug reduce unwanted side effects of antibiotic therapy (dysbiosis, irritable bowel syndrome) by improving digestion, cleavage of substrates, normalization of microflora and recovery of endoecology of the intestine.

WOBENZYM activates the natural mechanisms of nonspecific protection, increases the production of interferon, immunoglobulin A, thus realizing antiviral and antimicrobial action.

Indications:

The drug is used as a part of complex therapy of the following diseases:

• angiology — thrombophlebitis, treatment of postthrombotic disease and acute thrombophlebitis of superficial veins, endarteritis and obliterating atherosclerosis of lower limb arteries, prevention of recurrent phlebitis, lymphoedema
  
• gastroenterology is a chronic inflammatory disease of the gastrointestinal tract, hepatitis, dysbiosis
  
• gynecology acute and chronic infectious-inflammatory diseases of genitals: salpingoophoritis, endometritis, cervicitis, vulvovaginitis preeclampsia, breast, reduction in the frequency and severity of side effects of hormone replacement therapy, complex therapy of miscarriage in the II and III trimester, sexually transmitted infections: chlamydia, ureaplasmosis, mycoplasmosis
  
• dermatology — atopic dermatitis, acne, pruritic dermatoses
  
• cardiology — angina, subacute stage of myocardial infarction (to improve the rheological properties of blood and trophic processes in the myocardium)
  
• neurology — multiple sclerosis, chronic disorders of cerebral circulation
  
• Nephrology — pyelonephritis, glomerulonephritis
  
• Oncology — improving the tolerability of chemotherapy and radiation therapy and to reduce the risk of development of opportunistic complications
  
• ENT — sinusitis, sinusitis, otitis, laryngitis
  
• ophthalmology — uveitis, iridocyclitis, hemophthalmus, diabetic retinopathy, glaucoma, ophthalmic surgery, prevention of complications after operations
  
• Pediatrics — atopic dermatitis, infectious-inflammatory diseases of the respiratory tract (inflammation of the upper and lower respiratory tract, pneumonia), prevention and treatment of postoperative complications (abscess and local edema, poor wound healing, adhesive disease)
  
• pulmonary disease — bronchitis, tracheobronchitis, obstructive bronchitis, pneumonia, tuberculosis
  
• rheumatology — rheumatoid arthritis, reactive arthritis, osteoarthritis, juvenile rheumatoid arthritis
  
• dentistry — infectious-inflammatory diseases of the oral cavity
  
• traumatology — injuries, fractures, distortion, damaged ligaments, bruises, chronic post-traumatic processes, inflammation of soft tissues, burns, injuries in sports medicine
  
• urology — cystitis, cystopyelitis, prostatitis, infections, sexually transmitted infections (in combination with antibiotics)
  
• surgery — prophylaxis of postoperative complications (inflammation, thrombosis, edema), post-traumatic and lymph edema, plastic and reconstructive surgery
  
• endocrinology — diabetic angiopathy, diabetic retinopathy, autoimmune thyroiditis.
  

The prevention of the following conditions:

• the failure of adaptation and acclimatization of post-stress disorders
  
• disturbance of microcirculation, vascular accident
  
• the development of viral infections and their complications
  
• the development of adhesive disease and keloid scar in the postoperative period
  
• side effects of hormone replacement therapy
  
• dysbiotic disorders in antibacterial therapy.
  

Contraindications:

• individual intolerance to the drug
  
• diseases associated with increased likelihood of bleeding (hemophilia, thrombocytopenia)
  
• a kidney dialysis
  
• childhood (to 5 years).
  

Application of pregnancy and breast-feeding:

Pregnancy and lactation are not a contraindication to the use of the drug. Pregnant women the product should be applied as a part of complex treatment of miscarriage in the second trimester of pregnancy.

The dosage and duration of use of the drug in pregnant women it is advisable to check with your doctor.

Side effects:

The drug is well tolerated, subject to the receive mode for 40 minutes before eating or 2 hours after meals with water.

In some cases, there are: nausea, vomiting, diarrhea, heaviness in the stomach, slight changes in the consistency and smell of feces, skin eruptions in the form of urticaria, Allergy on some components of the drug. These side effects disappear at lower doses or drug discontinuation.

Withdrawal syndrome and habituation was not observed even after prolonged treatment with high doses.

With the appearance of other adverse reactions, not noted in the instructions, recommended stop taking the drug and consult a doctor.

Drug interactions:

The simultaneous administration of the drug with other medications the cases of incompatibility is not described.

Method of application and dose:

Inside, don't bite, at least 40 min before or 2 h after meals with water.

Adults

Traditionally, the drug is prescribed in the minimum therapeutic dosage for 3 table. 3 times a day rate of from 2 to 5 weeks.

The average disease activity WOBENZYM is prescribed in a dose of 5 tab. 3 times a day course of 2 to 4 weeks. The improvement in the patient's dose over 2 weeks may be reduced to 3 tables. 3 times a day. To achieve long-term effect, it is recommended to repeat courses of the drug 1.5–2 months with a 2-week break.

Under high disease activity WOBENZYM is prescribed in a dose table 7. 3 times daily course of 3 weeks. The improvement in the dose may be reduced from 2 weeks to 3 table. 3 times a day with a continuation of the course up to 1.5 months. The duration of treatment determined by the doctor.

In chronic long-term current diseases WOBENZYM can be used by readings courses 3 to 6 months with intervals of 2-4 weeks.

Used in the operations

During routine operations, the drug is used to prevent the development of complications of keloid scar and adhesive disease. The drug is administered before surgery 3 table. 3 times a day course 5 days. 3 days before the operation, cancel the drug.

The use of antibiotics

To improve the efficacy of antibiotics and reduce the severity of side effects, and prevention of dysbacteriosis drug prescribed for the entire course of antibiotic therapy at a dose of 5 tab. 3 times a day. After completing a course of antibiotics to restore microflora of the intestine 3 PL. 3 times a day for 7-14 days.

The use of chemotherapy

For the prevention of infectious complications, improve portability and improve the quality of life the drug is prescribed as therapy "cover" during chemotherapy and radiation therapy for 5 table. 3 times a day to complete the course of chemo - and radiotherapy. After chemotherapy to restore the immune system on the 3 table. 3 times daily course of 3 weeks.

To prevent

If you are using WOBENZYM prophylactically to increase resistance to disease and reduce the risk of diseases the drug is recommended to apply 2-3 table. 3 times a day. Course — from 3 weeks to 1,5 months with repetition 2-3 times per year.

Children

At an early age children have trouble swallowing tablets, WOBENZYM therefore, it is recommended to appoint to children from 5 years of age. The drug is prescribed at the rate of 1 tabl. 6 kg of body weight of the child. Taking the drug above 40 minutes before meals or 2 hours after meals with water. The duration of treatment may be from 2 to 5 weeks depending on diagnosis and condition and is determined by the doctor.

The dose should be calculated individually for each child up to 12 years. With 12 years the drug is prescribed under the scheme for adults: 2-3 table. 3 times a day course — from 2 to 5 weeks. The duration of treatment determined by the doctor and depends on the severity of the disease.

In infectious diseases in children: the drug should be taken in conjunction with antibiotics with the aim of increasing their efficiency during the whole course of antibiotics in the dosage according to age and body weight of the child.

To restore the ecology of the gut and improve immunity after etiotropic antibacterial and antiparasitic therapy, the preparation appoint 1 tab. 2 times a day children up to 7 years from 7 years — 2 table. 2 times a day from 12 years the drug is prescribed under the scheme for adults of 2-3 table. 3 times a day. The recommended course of 1 to 3 weeks. The duration of the drug determined by the physician. If recurrent inflammatory diseases in frequently and long ill children: the drug should be taken in the course of 3-6 weeks for 2 table. 2 times a day or in a dosage according to age and body weight of the child.

To achieve remission and improve the condition in frequently and long ill children recommended several repeated courses of the drug a year for 3-6 weeks with a break of 1-2 weeks. Dosage and duration of treatment of frequently ill children depends on the severity of the disease and is determined by a physician.

Overdose:

The cases of drug overdose are unknown.

Special instructions:

It should be borne in mind that in the beginning of the drug symptoms may be aggravated. In such cases, the treatment should not be interrupted, and recommended a temporary reduction of the dose.

The drug is not a drug and has no negative impact on driving and work requiring high speed mental and physical reactions.

In infectious diseases the drug does not replace antibiotics, but improves their efficiency, increasing the concentration of antibiotics in the tissues, bacterial colonies and inflammation.