BERLIN-CHEMIE

MEZYM FORTE 10.000UI X 10 FILM-COATED TABLETS

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Composition.

The active substance is porcine pancreatic powder. Pancreatic powder is obtained from porcine pancreas. The other components are: core: lactose monohydrate, microcrystalline cellulose, colloidal anhydrous silicon dioxide, crospovidone, magnesium stearate; gastro-resistant film: hypromellose 5 mPa·s, methacrylic acid:ethyl acrylate copolymer 1:1, 250000 suspension 30%, triethyl citrate, titanium dioxide (E 171), talc, simethicone emulsion (as dry substance), macrogol 6000, sodium carmellose 30 mPa·s, polysorbate 80, azorubine lake (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 encountered in people who have:

· cystic fibrosis, a rare genetic disease

· blockage of the pancreatic ducts or the common bile duct

· chronic inflammation of the pancreas (pancreatitis)

· pancreatic cancer

· an operation to remove a portion of the pancreas or the entire pancreas (partial or total pancreatectomy)

· an operation to remove a portion of the stomach or the entire stomach (partial or total gastrectomy)

· after gastrointestinal bypass surgery

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

The enzymes in Mezym 10000 work by digesting food that passes through the intestine.

You should use Mezym 10000 during or immediately after meals or snacks. This allows the enzymes to mix well with the food.

Dosage and administration.

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

If there is no other recommendation, the usual dose is: 2-4 Mezym 10000 gastro-resistant tablets administered during meals (equivalent to 20000 - 40000 lipase units per meal). Higher doses than the above may be needed, as they must be determined according to the severity of your digestive condition (exocrine pancreatic insufficiency). Your doctor may therefore increase your dose to improve your symptoms (e.g., to normalize stool frequency or consistency or to relieve abdominal pain) and to maintain a normal body weight.

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

In patients with cystic fibrosis, in particular, the enzyme dose should not be higher than necessary for adequate lipid absorption.

Mezym 10000 tablets should be swallowed whole with sufficient liquid, during meals. Be careful to swallow Mezym 10000 tablets whole, as their effectiveness is reduced by chewing them, and the contained enzymes can, after release, affect the oral mucosa.

The duration of use of Mezym 10000 is not limited. This depends on the evolution of the condition and is determined by your doctor.

Talk to your doctor if, within 7 - 14 days, your symptoms do not improve or worsen.

Precautions.

Do not use Mezym

-if you are allergic (