Wobenzym gastro-resistant tablets

Wobenzym gastro-resistant tablets. Indications: for the supportive treatment of swelling, inflammation, or pain resulting from injuries, superficial thrombophlebitis, inflammation of the urinary and genital tract (urogenital tract), painful and activated osteoarthritis (chronic joint wear and tear), soft tissue rheumatism (a condition with symptoms affecting muscles, tendons, and ligaments).

For risks and side effects, read the package leaflet and ask your doctor or pharmacist.


PACKAGE LEAFLET: INFORMATION FOR THE USER

Wobenzym gastro-resistant tablets for use in adults
Active ingredients: Bromelain, Trypsin, Rutoside trihydrate

Read the entire package leaflet carefully before you start taking this medicine because it contains important information. Always take this medicine exactly as described in this leaflet or exactly as your doctor or pharmacist has told you.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
• If you do not feel better or even feel worse after a few days, consult your doctor.

What this leaflet contains:

1. WHAT IS WOBENZYME AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE TAKING WOBENZYME?
3. HOW SHOULD WOBENZYME BE TAKED?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD WOBENZYME BE STORED?
6. PACKAGE CONTENTS AND FURTHER INFORMATION.

1. WHAT IS WOBENZYME AND WHAT IS IT USED FOR?

Wobenzym is an anti-inflammatory medicine. Wobenzym is used in adults as supportive treatment for:

• Swelling, inflammation, or pain as a result of injuries.
• superficial thrombophlebitis (inflammation of a vein).
• Inflammation of the urinary and genital tract (urogenital tract).
• Painful and activated osteoarthritis (chronic joint wear and tear).
• Soft tissue rheumatism (a disease characterized by symptoms affecting muscles, tendons, and ligaments).

Wobenzym has anti-inflammatory effects. This medicine contains active ingredients that also reduce swelling and fluid retention (edema) in the tissues caused by inflammation or injury. The enzymes contained in Wobenzym also reduce blood clotting by prolonging the time it takes for a blood clot to form.

2. WHAT YOU SHOULD KNOW BEFORE TAKING WOBENZYME:

Wobenzym must not be taken if:

• if you are hypersensitive (allergic) to the active substances, pineapple or any of the other ingredients of this medicine listed in section 6.
• by children and young people under 18 years of age.
• during pregnancy and breastfeeding.
• if you suffer from congenital or acquired blood clotting disorders such as hemophilia.
• if you suffer from severe liver and/or kidney damage.
• if you are about to undergo surgery.
• Warnings and precautions when taking medications that affect blood clotting at the same time.

Please talk to your doctor or pharmacist before taking Wobenzym. Before surgery, the anticoagulant activity of the medication should be taken into account, and the patient should be monitored accordingly. The medication should be discontinued 4 days before the operation in any case.

Children and adolescents:
There is insufficient experience with the use

of Wobenzym in children and adolescents under 18 years of age for the stated indications (see section "Wobenzym must not be taken"). Taking Wobenzym with other medicines:
Please inform your doctor or pharmacist if you are taking, have recently taken, or intend to take any other medicines, including those obtained without a prescription. When Wobenzym is administered concurrently with antibiotics, the plasma and urine levels of antibiotics, especially tetracyclines, sulfonamides, and amoxicillin, are increased. Your doctor will adjust the dosage of the antibiotics accordingly. You must not take Wobenzym if you are using other medications that affect blood clotting. When taken concurrently with medications that affect blood clotting, the inhibition of blood clotting may be intensified.

Pregnancy, breastfeeding, and fertility:
If you are pregnant or breastfeeding, or if you suspect you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine, as with any other medicine. There are insufficient studies on the use of Wobenzym during pregnancy and breastfeeding. Therefore, Wobenzym must not be used by pregnant or breastfeeding women. Studies on the safety of Wobenzym have not revealed any risks to human fertility.

Driving and using machines:
No effects on the ability to drive or use machines are known.

Wobenzym contains lactose monohydrate (milk sugar):
(Approximately 0.15 g per gastro-resistant tablet). This is used to adjust the enzyme content, and therefore the amount varies slightly. Please only take Wobenzym after consulting your doctor if you know you have an intolerance to certain sugars.

3. HOW TO TAKE WOBENZYME?

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The recommended daily dose is 6 tablets, unless otherwise prescribed by your doctor. The maximum dose of 12 tablets per day should not be exceeded. Treatment should be continued until symptoms disappear. If symptoms have not subsided after 14 days, you should consult a doctor, as it may be a condition requiring medical treatment. It is recommended to take the tablets throughout the day (e.g., 3 tablets twice a day) or as a single dose, swallowed whole with plenty of liquid at least 30 minutes before a meal or 90 minutes after a meal.

If you have taken more Wobenzym than you should:
Mild diarrhea may occur, which usually does not require additional treatment and disappears after stopping the medication. If diarrhea persists after stopping the medication, contact a doctor immediately.

If you forget to take Wobenzym:
Do not take a double dose, but continue your dosing schedule as usual.

If you stop taking Wobenzym:
Please talk to your doctor about the reasons for doing so. If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Wobenzym can cause side effects, although not everybody gets them. The following side effects have been reported in clinical trials and/or after marketing:

Rare (affect up to 1 in 1,000 users):
Allergic reactions such as skin rash, itching, skin reddening, various types of gastrointestinal discomfort such as stomach cramps.
If you experience signs of a hypersensitivity reaction (difficulty breathing, skin rash with itching or skin reddening, allergic reaction), stop taking Wobenzym and consult a doctor.

Occasionally (affect up to 1 in 100 users):
Asthma-like symptoms, bloating, flatulence, changes in stool consistency, color, or odor.

Very rarely (affect up to 1 in 10,000 users):
Diarrhea, nausea, vomiting, sweating, headache, flatulence, increased appetite.

Undesirable reactions after taking Wobenzym are usually temporary, but can also be a sign of an excessive dose. Gastrointestinal discomfort can be avoided by dividing the dose throughout the day and by strictly adhering to the time of administration (at least 30 minutes before a meal or 90 minutes after a meal). Taking Wobenzym may cause changes in stool consistency, color, or odor.

Reporting of side effects:
If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. Pharmacovigilance, Kurt-Georg-Kiesinger-Allee 3, D-53175 Bonn, Germany, website: www.bfarm.de. By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE WOBENZYME

Store below 25°C and in the original packaging to protect the contents from light. Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton and blister after "EXP". The expiry date refers to the last day of that month. Do not use this medicine if you notice any of the following: damaged tablets with cracks in the surface or fragments in the packaging. These tablets should not be taken because their effectiveness may be impaired. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment. For the 800-tablet container: Use within 6 months of first opening the container.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Wobenzym contains The active ingredients are:
Bromelain 67.5–76.5 mg standardized to 450 FIP units, Trypsin 32–48 mg standardized to 24 µkat, Rutoside trihydrate 100 mg. The other ingredients are: Lactose monohydrate, pregelatinized starch (maize), magnesium stearate [vegetable], stearic acid, purified water, colloidal anhydrous silica, maltodextrin, talc, methacrylic acid-methyl methacrylate copolymer (1:1), titanium dioxide (E 171), macrogol 6000, triethyl citrate, vanillin.

What Wobenzym looks like and contents of the pack:
Gastro-resistant, round, white tablet.

(Apo) Usually dispatched within 3-4 business days