Instructions for use: information for the user

Wobenzym enteric-coated tablets

pancreatinum, papainum, bromelainum, trypsinum, lipasum, amylasum, chymotrypsinum, rutosideum trihydricum

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.

- Keep this leaflet. You may need to read it again later.

- If you need more information or advice, ask your pharmacist.

- If you get any side effects, talk to your doctor, pharmacist or nurse. This also applies to possible side effects not listed in this leaflet.

See section 4.

- If you do not feel better after 14 days or if you feel worse, you should talk to your doctor.

In this leaflet you can find out:

1. What Wobenzym is and what it is used for

2. What you need to know before you take Wobenzym

3. How to take Wobenzym

4. Possible side effects

5. How to store Wobenzym

6. Contents of the pack and other information

1. What Wobenzym is and what it is used for

Wobenzym is a combined enzyme-containing product with anti-inflammatory, anti-swelling, immune-regulating and blood-thinning effects. Enzymes are involved in virtually all life processes in the body, including regulating immunity (immunity). Many diseases are associated with insufficient amounts of enzymes in the body.

Use

As an alternative (optional) medicine:

• traumatic edema and hematomas (swelling and bruising);

• lymphedema of various etiologies (lymphatic edema of various origins);

• fibrocystic breast disease (chronic breast disease characterized by the formation of cavities and ligaments).

As an adjuvant therapy:

• inflammation and postoperative condition in surgery;

• superficial thrombophlebitis and post-thrombotic syndrome (inflammation of superficial veins, inflammation of blood vessels and condition after vascular occlusion);

• herpetic infection (herpes virus infection);

• rheumatoid arthritis (inflammatory joint disease).

As an additional therapy:

• chronic and recurrent (repeated) inflammations of the oral cavity, ears, throat and nose (sinuses), respiratory tract, digestive tract organs, pancreas, liver, urogenital organs, joints and other organs;

• to increase the effectiveness of pharmacotherapy (treatment) of infections insensitive to antibiotics.

2. What you need to know before you take Wobenzym Do not take Wobenzym:

- If you are allergic to the active substances or any of the other ingredients of this medicine (listed in section 6);

- If you are hypersensitive to fruits such as pineapple or papaya.

Warnings and precautions for use

Consult your doctor or pharmacist before using Wobenzym.

If allergic reactions occur, treatment with Wobenzym should be discontinued immediately.

If you are scheduled for surgery, consult your doctor. Wobenzym should be discontinued 4 days before dental or other operations.

Wobenzym is not recommended if you have severe kidney or liver problems.

If you have severe acquired or congenital blood clotting disorders, your doctor will monitor you closely. In the case of chronic diseases, pain-related symptoms may initially worsen after taking Wobenzym.

Children and adolescents

For children and adolescents, unless otherwise prescribed, the dosage is calculated based on body weight: 1 tablet of Wobenzym for every 6 kg of body weight per day, divided into 2 or 3 doses, for all the above indications.

Due to the risk of choking and/or suffocation, the tablets are not recommended for children under 6 years of age.

Other medicines and Wobenzym

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. It should be noted that taking Wobenzym at the same time as antibiotics may increase the concentration of antibiotics in the area of inflammation.

Consult your doctor if you are taking anticoagulants and/or antiplatelet agents (medicines to thin the blood).

Wobenzym with food

- Do not take Wobenzym with food. The tablets should be taken at least 30 minutes before or 90 minutes after a meal, with sufficient (250 ml) liquid.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

There are limited (less than 300 pregnancy outcomes) or no data from the use of Wobenzym in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. As a precautionary measure, it is recommended to avoid the use of Wobenzym during pregnancy.

Breastfeeding

Information on the excretion of the active substances/metabolites in human milk is insufficient. A risk to the infant cannot be excluded. Your doctor will decide whether to discontinue breast-feeding or to discontinue/abstain from Wobenzym therapy.

Fertility

There are no data on the effect on human fertility.

Driving and using machines

Wobenzym has no or negligible influence on the ability to drive and use machines.

Wobenzym contains lactose and sucrose. The medicinal product contains up to 0.149 g of lactose monohydrate per tablet and also contains sucrose (only as an enzyme carrier). This should be taken into account in patients with diabetes. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Wobenzym.

Wobenzym contains the dyes sunset yellow (E110) and cochineal red (E124) - may cause allergic reactions.

3. How to take Wobenzym

Always take this medicine exactly as described in this leaflet or as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

The recommended dose for adults is 6 tablets per day (3 tablets 2 times a day). The maximum daily dose is 30 tablets.

The tablets should be taken at least 30 minutes before a meal or 90 minutes after a meal, with sufficient (250 ml) liquid.

Enteric-coated tablets should not be chewed, divided or crushed, as only an intact tablet coating protects against pH-sensitive effects in the intestine.

As alternative (optional) medicines

It is recommended to start treatment with 10 tablets 3 times a day. If the treatment is effective and the symptoms of the disease decrease, the dose can be reduced to 3-5 tablets 3 times a day.

Traumatic edema and hematomas (swelling and bruising) - 10 tablets 3 times a day, 10-14 days.

Lymphedema of various etiologies (lymphatic edema of various origins) – 10 tablets 2 times a day, up to 7 weeks, if necessary longer.

Fibrocystic breast disease (chronic breast disease characterized by the formation of cavities and ligaments) – 10 tablets 3 times a day, 6 weeks.

As an adjuvant therapy

Inflammation and postoperative condition in surgery – 10 tablets 3 times a day, 10-14 days. Therapy is recommended 1-3 days after a planned operation.

Superficial thrombophlebitis (inflammation of the superficial veins associated with the formation of blood clots), post-thrombotic syndrome (condition after vascular occlusion), vasculitis (inflammation of blood vessels) – 5-10 tablets 3 times a day, 4-8 weeks.

Herpetic infection (herpes virus infection) – 2-5 tablets 3 times a day, 3 months.

Rheumatoid arthritis (inflammatory joint disease) – 10 tablets 3 times a day for the first 2 weeks, then 5 tablets for 6-12 months.

As an additional therapy

Chronic and recurrent (repeated) inflammations of the oral cavity, ears, throat and nose (sinuses), respiratory tract, digestive tract organs, pancreas, liver, urogenital organs, joints and other organs – 3-5 tablets 3 times a day, usually 3-4 weeks.

To increase the effectiveness of pharmacotherapy (treatment) of infections insensitive to antibiotics – 3-5 tablets 3 times a day, usually 3-4 weeks.

Use in children and adolescents

For children under 15 years of age, unless otherwise prescribed, the dose is calculated in all cases based on body weight: 1 tablet of Wobenzym for every 6 kg of body weight per day, dividing the daily dose into 2 or 3 doses. Due to the risk of choking and/or suffocation, tablets are not recommended for use in children under 6 years of age.

Treatment should be continued until the signs or complaints of the disease disappear.

Wobenzym is mainly used to treat acute or chronic inflammation. The analgesic effect of Wobenzym is based on the edema-reducing effect of the enzymes it contains, therefore its use does not provide an immediate analgesic effect.

If you take more Wobenzym than you should

The maximum daily dose for adults is 30 tablets, higher doses may cause dyspeptic complaints (digestive or stomach disorders), which resolve without special treatment.

If you forget to take Wobenzym

If you miss a single dose, treatment can be continued as before. Do not take a double dose to make up for a forgotten dose.

If you stop taking Wobenzym

If you have any questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Wobenzym enteric-coated tablets are generally well tolerated.

The frequency of side effects is estimated using the following criteria:

Very common: ≥1/10 people

Common: ≥1/100 to <1/10 people

Uncommon: ≥1/1,000 to <1/100 people

Rare: ≥1/10,000 to <1/1,000 people

Very rare: <1/10,000 people

Not known: frequency cannot be estimated from the available data

Skin and subcutaneous tissue disorders:

- rare – rash, itching, redness;

- very rare – increased sweating.

Gastrointestinal disorders:

- uncommon – diarrhoea, nausea, decreased appetite, changes in stool consistency, smell and colour, abdominal distension, feeling of fullness;

- rare – vomiting, abdominal cramps;

- very rarely - abnormal hunger.

Nervous system disorders:

- very rarely - dizziness, headache.

Immune system disorders:

- rarely - anaphylactic reactions, hypersensitivity.

Investigations:

- very rarely - increased liver enzymes.

Respiratory, thoracic and mediastinal disorders:

- rarely - asthma-like condition.

Description of selected adverse reactions

The use of Wobenzym may cause adverse reactions in patients with allergic reactions to fruits such as pineapple or papaya.

Gastrointestinal side effects (such as diarrhea and abdominal pain) can be reduced by taking the medicine after meals and dividing the daily dose into several doses.

In case of side effects or allergic reactions, the medicine should be discontinued and a doctor should be consulted.

Reporting side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This also applies to possible side effects not listed in this leaflet. You can also report

side effects directly to the State Medicines Agency, Jersikas Street 15, Riga, LV 1003. Website: www.zva.gov.lv.

By reporting side effects, you can help to provide much more information on the safety of this medicine.

5. How to store Wobenzym

Keep out of the sight and reach of children. Store below 25oC.

Do not use this medicine after the expiry date which is stated on the carton and plastic container after “EXP” or on the blister after “EXP”.

The expiry date refers to the last day of that month.

Once opened, use within 3 months and store at 15oC - 25oC. Do not throw away medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information What Wobenzym contains

The active substances are pancreatin 300 Prot.U., papain 90 FIP-U, bromelain 225 FIP-U, trypsin 360 FIP-U,

lipase 34 FIP-U, amylase 50 FIP-U, chymotrypsin 300 FIP-U, rutoside trihydrate 50 mg.

The other ingredients are lactose monohydrate, pregelatinized starch, magnesium stearate, stearic acid, colloidal anhydrous silica, talc, methacrylic acid-methyl methacrylate copolymer (1:1), sodium lauryl sulfate, macrogol 6000, triethyl citrate, hypromellose, hydroxypropyl cellulose, microcrystalline cellulose, glycerol, titanium dioxide, talc 4R (E 124), sunset yellow (E 110).

What Wobenzym looks like and contents of the pack

Orange-red, round, biconvex film-coated tablet. Primary packaging:

- PVC/PE/PVDF/Al foil blister

- HDPE container with 800 tablets Secondary packaging:

- Cardboard box with 40 or 200 tablets in blisters.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

MUCOS Pharma GmbH & Co. KG, Miraustrasse 17, D-13509 Berlin, Germany

Manufacturer

MUCOS Emulsionsgesellschaft mbH, Miraustrasse 17, D-13509 Berlin, Germany

This leaflet was last revised in 03/2025

WOBENZYM