INFORMATION FOR USE, READ CAREFULLY!

WOBENZYM

gastro-resistant tablets

Marketing authorisation holder:

MUCOS Pharma GmbH& Co.KG., Berlin, Germany

Manufacturer:

MUCOS Emulsionsgesellschaft mbH, Berlin, Germany

Components of 1 gastro-resistant tablet:

Pancreatinum 300 Protease Ph. Eur.-j., papainum 90 F.I.P.-j., bromelaina 225 F.I.P.-j., lipasum 34 F.I.P.-j., amylasum 50 F.I.P.-j, trypsinum 360 F.I.P.-j., chymotrypsinum 300 F.I.P.-j., rutosidum trihydricum 50 mg.

total proteolytic activity: 570 F.I.P.-u.

total amylolytic activity: 4030 F.I.P.-u.

total lipolytic activity: 4525 F.I.P.-u.

Excipients:

Core: lactose monohydrate, maize starch, magnesium stearate, 95% stearic acid, colloidal anhydrous silica, talc.

Coating layer: talc, MA/MMA copolymer 1:1, sodium lauryl sulfate, triethyl citrate, hypromellose, hyprolose, microcrystalline cellulose, glycerol 85%, Ponceau 4R (E124), orange yellow (E110), titanium oxide, macrogol 6000.

Indication group: Other drugs for disorders of the musculoskeletal system, enzymes

Characteristics:

Wobenzym contains suitably assembled enzymes (proteins catalysing chemical reactions) that have the ability to affect immunity purposefully, inhibit inflammation and swelling, and to some extent dissolve blood clots. They accelerate the course of inflammation and mitigate its effects, alleviate symptoms of illnesses caused by harmful immunocomplexes resulting from antibody reactions. The metabolic products harmful to the human body and dead tissue material are rapidly degraded. Swelling and bruises are better absorbed. Rutin normalises the permeability of the vessel wall. Wobenzym reduces blood viscosity and thus improves blood circulation in the smallest blood vessels. Inflammation, pain and swelling quickly disappear and healing is facilitated. Tablets are resistant to gastric juice.

Indication:

1. As an alternative to existing therapeutic procedures, Wobenzym can be used in the following conditions:

• Post-traumatic swelling
• Lymphoedema (swelling caused by lymph outflow disorder) of various aetiology
• Fibrocystic mastopathy (chronic breast disease characterised by the formation of cavities and connective tissue)

1. As a supportive treatment, Wobenzym is suitable in the following conditions:

• Certain postoperative conditions in surgery
• Inflammation of superficial veins
• Post-thrombotic syndrome of lower limbs (conditions after the occlusion of lower limb veins by a blood clot)
• Rheumatoid arthritis (inflammatory joint disease)
• Rheumatism of soft tissues
• Arthritis (degenerative joint disease) – advanced stages
• Multiple cerebrospinal sclerosis
• Chronic and recurrent inflammations (in the area of the nose, ears and throat, upper and lower respiratory tract, urinary and genital tract, digestive tract, skin, etc.), supportive treatment during the use of antibiotics.

Wobenzym can only be given to children after consultation with a paediatrician who will also determine the dosage.

Contraindications: Wobenzym should not be used in situations that are associated with increased bleeding tendencies or increased fibrinolysis (dissolving of blood clots). The product should not be used in case of known hypersensitivity to the active substances or excipients.

Pregnancy and breast-feeding:

You should always consult your Medical Doctor about the use of Wobenzym during pregnancy and breast-feeding, even if you become pregnant during the treatment.

Side effects: Wobenzym is usually well tolerated, and no adverse reactions have been observed even with long-term administration of high doses. Occasionally, slight changes may occur in consistency, color and smell of stool. The use of higher single doses has been reported to lead to flatulence, rarely nausea. These feelings can be avoided by dividing the dose throughout the day. If these symptoms persist after dose reduction, talk to your Medical Doctor. Rarely occurring allergic reactions (skin rash) resolve after discontinuation of the drug. In case of these reactions, stop taking Wobenzym and talk to your Medical Doctor. Ask your Medical Doctor about further use of Wobenzym also in the event of any unusual reactions.

Interaction: Undesirable interactions of Wobenzyme with other concomitant medications is not known.

Dosage: Treatment is started at the dose of 3x5 to 3x10 tablets a day. When disease symptoms improve, the dose is gradually decreased to the maintenance dose of 3x3 tablets a day.

• Post-traumatic swelling (blunt injury, distortion, disarticulations, fractures) – we recommend starting the treatment with a dose of 3x10 tablets a day; depending on the clinical condition (after 7-10 days), the dose is reduced to 3x3 tablets a day until symptoms completely disappear.
• Certain post-operative surgical conditions – the treatment begins with a dose of 3x10 tablets a day; after the acute condition resolves (7-10 days), continue with a dose of 3x5 to 3x3 tablets a day until the symptoms disappear.
• Lymphoedema (oedema caused by disturbed lymph outflow) – the treatment is long-term and starts with a dose of 2x10 or 3x7 tablets a day (4-5 weeks); the dose is then reduced to 3x5 to 3x3 tablets a day (at least 8 weeks). In this indication, it is necessary to consult your Medical Doctor.
• Fibrocystic mastopathy (chronic breast disease characterised by the formation of cavities and connective tissue) - we recommend a dose of 2x10 tablets daily for at least 6 weeks. Talk to your Medical Doctor before you start the treatment.
• Post-thrombotic syndrome (condition after the occlusion of vein by a blood clot) – 3x10 to 3x5 tablets daily for 5-6 weeks.
• Inflammation of superficial veins – 3x7 to 3x5 tablets daily for 2-3 weeks.
• Rheumatoid arthritis (inflammatory joint disease) – 3x5 tablets daily for 5-6 months.
• Soft tissue rheumatism – 3x5 tablets daily for at least 3-4 weeks.
• Arthritis (degenerative joint disease) – 3x6 tablets daily for 5-6 weeks.
• Multiple cerebrospinal sclerosis – from day 1 to day 14: take 10 tablets 3 times daily, then switch to a maintenance dose of 3 tablets 3 times daily on a long-term basis, in special situations (infectious disease, physical stress, mental stress, vaccination, sunbathing), the dose should be increased to 10 tablets 3 times daily. Treatment should be consulted with your Medical Doctor.
• Chronic and recurrent inflammation (in the area of the nose, ears and throat, upper and lower respiratory tract, urinary and genital tract, digestive tract, skin, etc.) – 3x5 tablets a day until the clinical signs disappear. In inflammatory diseases, Wobenzym does not replace antibiotic therapy, but increases its effect, so we recommend that you consult your Medical Doctor and combine it with antibiotics.
• The Medical Doctor will determine the dosage for children.

If an adult uses more than 20 tablets or a child uses more than 5 tablets at the same time, a Medical Doctor should be consulted.

Method of use: It is recommended to swallow the tablets unchewed, ½ hour before eating, with plenty of liquid (at least ¼ litre).

Caution: This drug does not replace antibiotic treatment for infectious inflammation but increases its efficacy!

If you have been told by your Medical Doctor that you are intolerant of some sugars, talk to your him/her before starting this medicine.

Wobenzym contains Ponceau 4R dyes and orange yellow which can cause allergic reactions.

Without consulting your Medical Doctor, you may use Wobenzym only in post-traumatic swelling. Before using Wobenzym in other illnesses and for longer periods than two months, consult your Medical Doctor. Occasionally, the symptoms in chronic illnesses may worsen after the initiation of the treatment with Wobenzym, which, in the vast majority of cases, is considered to be a positive response by the body to the treatment. In this case, the drug should not be discontinued but a possible temporary reduction of the dose should be considered. Under such circumstances, it is necessary to consult your Medical Doctor. The same steps are to be taken in case of any undesirable effects or other unusual reactions. If you are using other medicines, whether prescription-based or OTC drugs, check the suitability of Wobenzym with your Medical Doctor and do not take it without recommendation.

If your Medical Doctor prescribes another medicine, please let him/her know that you use Wobenzym. Also, do not take any other medicines without a prescription together with Wobenzym unless consulted by your Medical Doctor.

Warning: Keep out of the reach and sight of children!

Do not use after the expiry date stated on the package.

Method of storage: Store below 25°C.

Packaging:

40, 200, and 300 gastro-resistant tablets

Clinical pack of 800 gastro-resistant tablets

40 or 200 gastro-resistant tablets in PVC/PE/PVDC/Al blister;

300 gastro-resistant tablets in a wide neck plastic bottle (HDPE), volume of 200 ml, sealed with aluminium foil and a screw cap;

clinical pack of 800 gastro-resistant tablets in a wide neck plastic bottle (HDPE), volume of 500 ml, sealed with aluminium foil and a screw cap;

Date of last revision: March 20, 2018