Holder of authorization approval: MUCOS Pharma GmbH & Co., Geretsried, Germany

Composition of 1 coated tablet: Pancreatin 100 mg, Papain 60 mg, Bromelain 45 mg, Lipase 10 mg, Amylase 10 mg, Trypsin 24 mg, Chymotrypsin 1 mg, Rutosid trihydrate 50 mg.

Inactive ingredients: lactose monohydrate, maize starch, magnesium stearate, stearic acid, purified water, highly dispersed silica, talcum, saccharose, calcium carbonate, copolymer of methacrylic acid and methyl methacrylic acid 1:1, dibutyl phthalate, shellac, titanium (IV)-oxide, kaolin, Ponceau 4R, povidon, macrogol 6000, yellow wax, carnauba wax.

Indication group: Varium

Wobenzymâ contains suitably combined enzymes (substances which cleave proteins) that are able to influence immunity efficiently, to reduce inflammations and edemas and partly to dissolve thrombi. They speed up inflammation course and defuse its sequelae, suppress pathological manifestations caused by harmful immune complexes which result from antibody reactions. Degradation of harmful metabolic products and necrotic tissue is accelerated. Edemas and hematomas are better absorbed. Rutin normalizes permeability of vessel walls. Wobenzymâ decreases blood viscosity, thus improving blood circulation in tiny vessels. Inflammations, pains, and edemas quickly disappear and healing is, therefore, facilitated. Coated tablets are resistant to gastric juices..

1. Wobenzymâ may be used in following cases as an alternative to the currently used therapies:
   - posttraumatic edemas
   - lymphedemas (edemas caused by disorder of lymph discharge) of various etiology
   - fibrocystic mastopathy (chronic breast disease with cavities and ligament
   formation)
2. Wobenzymâ is suitable as a supportive therapy in following cases:
   - some postoperative conditions in surgery
   - inflammations of surface veins
   - postthrombotic syndrome of lower extremities (condition after obliteration of lower extremity veins by thrombus)
   - rheumatoid arthritis (inflammatory joint diseases)
   - rheumatism of soft tissue
   - arthrosis (degenerative joint diseases) – advanced stages
   - multiple sclerosis
   - chronic and recurrent inflammations (nose, ear, throat, upper and lower
   respiratory organs, urinary and genital organs, digestive tract, skin etc.), as a supportive
   treatment with antibiotics.

Wobenzymâ may be administered to children only after consultation with a pediatrician who also determines the dosage.

Wobenzymâ should never be used in the case of enhanced tendency to bleeding or increased fibrinolysis (thrombi dissolving). The preparation must not be used in case of known hypersensitivity to active or inactive ingredients. Administration of Wobenzym^® during pregnancy and breastfeeding should be consulted with a physician. The same applies also when getting pregnant during the treatment.

Wobenzym^® is usually well tolerated, there were no observed adverse effects during long-term high-dosage administration. Harmless alteration in the consistency, color and odor of stool may occur. A sensation of flatulence and occasional episodes of nausea are possible during high-dosage administration. They can be avoided by administration of the enzyme preparation in divided doses. If these symptoms continue also after lowering the dosage, consult your physician. Allergic reactions (skin rash) occur rarely and disappear after discontinuation of the drug. In case of skin rash interrupt using Wobenzymâ and consult your physician. Consult your physician also in case of any other unusual reaction.

There is no evidence of incompatibility of Wobenzym^® with other simultaneously administered drugs.

Dosage and administration:

The treatment begins with the dose of 3x5 to 3x10 coated tablets daily. As the signs of the disease recede, dosage decreases gradually to 3x3 coated tablets daily.

• Edemas after injuries (bruises, sprains, dislocations, fractures) – we recommend to start the treatment with 3x10 coated tablets daily, according to the clinical condition (after 7-10 days) the dosage is decreased to 3x3 coated tablets daily until symptoms disappear completely.
• Some postoperative conditions in surgery - treatment starts with the dose of 3x10 coated tablets daily, after remission of the acute condition (7 - 10 days) dosage is decreased to 3x5 to 3x3 coated tablets daily until symptoms completely disappear.
• Lymphedema (edema caused by a disturbed lymph discharge) – a long-term treatment begins with 2x10 or 3x7 coated tablets daily (for 4-5 weeks), then the dosage is decreased to 3x5 to 3x3 coated tablets daily (for at least 8 weeks). It is necessary to consult a physician at this indication.
• Fibrocystic mastopathy (chronic breast disease manifested by cavities and ligament formation) – we recommend 2x10 coated tablets daily for at least 6 weeks. Before starting the treatment it is necessary to consult a physician.
• Postthrombotic syndrome (condition after vein obliteration with thrombus) – 3x10 to 3x5 coated tablets daily for 5-6 weeks.
• Inflammations of surface veins – 3x7 to 3x5 coated tablets daily for 2-3 weeks.
• Rheumatoid arthritis (inflammatory joint disease) – 3x5 coated tablets daily for 5-6 months.
• Rheumatism of soft tissue – 3x5 coated tablets daily for at least 3-4 weeks.
• Arthrosis (degenerative joint diseases) – 3x6 coated tablets daily for 5-6 weeks.
• Multiple sclerosis - day 1-14, 3x10 coated tablets daily followed by the dose of 3x3 coated tablets daily – a long-term therapy, during stress conditions (infection, physical burden, stress, immunization, tanning) increase the dosage to 3x10 coated tablets daily. The treatment is necessary to consult with a physician.
• Chronic and recurrent inflammations (nose, ear, throat, respiratory organs, urinary and genital organs, digestive tract, skin, etc.) – 3x5 coated tablets daily untill disappearance of the symptoms. Although in case of inflammatory diseases Wobenzymâ does not substitute antibiotic treatment, it increases its efficacy. Therefore, a suitable combination with antibiotics is recommended after consultation with a physician.
• Children – dosage is to be determined by a physician.

When an adult uses at a time more than 20 coated tablets or a child more than 5 coated tablets, it is necessary to consult a physician.

Mode of administration:

coated tablets should be swallowed without chewing with plenty of liquid (at least 1/4 liter) 1/2 hour before meals.

This medication does not replace antibiotic treatment of infectious inflammation but it does increase its efficacy.
Before using Wobenzymâ in chronic illness and when using it more than 2 months it is necessary to consult a physician. The symptoms of chronic illness may occasionally increase in severity at the start of therapy. Based on current experience it means a positive reaction of the organism on the treatment. In this case the medication should not be discontinued, although a temporary reduction in dose might be advisable. Under these circumstances it is necessary to consult a physician as in case of occurrence of adverse events or other unusual reactions. In case of taking other medicines on prescription or as OTC, consult Wobenzymâ administration with your physician and do not take it without his recommendation.
If your physician prescribes you another medicine, inform him that you take Wobenzymâ . Without consultation a physician do not take any other OTC medicine at the same time with Wobenzymâ .
The carbohydrate content of 1 coated tablets is equivalent to 39 kJ = 9.3 kcal.

KEEP THE MEDICINE OUT OF THE REACH OF CHILDREN !
The medication must not be administered after expiration date.

Storage: Store at dry, dark place at room temperature.

40 coated tablets and 200 coated tablets
Clinical package 800 coated tablets

Date of the last revision: January 24, 2001

MUCOS Pharma CZ Ltd., Uhříněveská 448, 252 43 Průhonice, Czech Republic