BERLIN-CHEMIE

MEZYM FORTE 10.000UI X 10 FILM-COATED TABLETS

Composition.

The active substance is pork pancreas powder. Pancreas powder is obtained from pork pancreas. The other ingredients are: core: lactose monohydrate, microcrystalline cellulose, colloidal anhydrous silicon dioxide, crospovidone, magnesium stearate; gastro-resistant film: hypromellose 5 mPa¿s, methacrylic acid copolymer: ethyl acrylate 1:1, 250000 suspension 30%, triethyl citrate, titanium dioxide (E 171), talc, simethicone emulsion (as dry substance), macrogol 6000, sodium carmeloose 30 mPa¿s, polysorbate 80, azorubine lac (E122), sodium hydroxide.

Therapeutic indications.

Mezym 10000 is used in children and adults with "exocrine pancreatic insufficiency". This occurs when the pancreas does not secrete enough enzymes to digest food.

It is often found in people who have:

· cystic fibrosis, a rare genetic condition

· blockage of the pancreatic ducts or the common bile duct

· chronic inflammation of the pancreas (pancreatitis)

· cancer of the pancreas

· an operation to remove part or all of the pancreas (partial or total pancreatectomy)

· an operation to remove part or all of the stomach (partial or total gastrectomy)

· after gastro-intestinal bypass surgery

· Shwachman-Diamond syndrome, a very rare genetic condition.

The enzymes in Mezym 10000 work by digesting the food as it passes through the gut.

You should take Mezym 10000 during or just after meals or snacks. This will allow the enzymes to mix well with the food.

Dosage and method of administration.

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Unless otherwise prescribed, the usual dose is: 2-4 Mezym 10000 gastro-resistant tablets taken with meals (equivalent to 20000 - 40000 units of lipase per meal). Doses higher than those mentioned above may be required, because they must be established according to the severity of your digestive disorder (exocrine pancreatic insufficiency). Your doctor may therefore increase your dose to relieve your symptoms (for example to normalise the frequency or consistency of your stools or to relieve abdominal pain) and to maintain a normal body weight.

The maximum daily dose depends on body weight. A dose of 15000 ¿ 20000 units of lipase per kilogram of body weight should not be exceeded.

In patients with cystic fibrosis, in particular, the dose of enzymes should not be greater than necessary for adequate fat absorption.

Mezym 10000 tablets should be swallowed whole with sufficient liquid, during meals. Take care to swallow Mezym 10000 tablets whole, because their effectiveness is reduced by chewing them, and the enzymes contained may, after release, affect the mucous membrane of the mouth

The duration of use of Mezym 10000 is not limited. It depends on the course of the disease and is determined by your doctor.

Talk to your doctor if your symptoms do not improve or get worse within 7 ¿ 14 days.

Precautions.

Do not use Mezym

-if you are allergic (hypersensitive) to pancreatic enzymes of porcine origin or to any of the ingredients.

-if you have acute pancreatitis and exacerbations of chronic pancreatitis in the most advanced stage of the disease. However, if acute or chronic but aggravated pancreatitis shows signs of improvement, your doctor may decide to prescribe Mezym occasionally.

Special warnings.

Pregnancy and breast-feeding

You can use Mezym during pregnancy and breast-feeding after consulting your doctor. Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

No special precautions are necessary.

Packaging. Box with an Al/Al blister of 10 gastro-resistant tablets

 

Page updated on: 09.06.2021