Mezim forte 10000 tablets coated with quiche-sol. shell 20 pcs (Pancreatin)

Latin name

MEZYMВ® FORTE

Release form

Enteric coated tablets.



packaging 20 pcs

Indications

Replacement therapy for exocrine pancreatic insufficiency (including chronic pancreatitis, cystic fibrosis)

chronic inflammatory and dystrophic diseases of the stomach, intestines, liver, gall bladder

disorders after resection of the digestive tract, irradiation or irradiation of food , flatulence, diarrhea (as part of combination therapy)

gastrointestinal tract disorder of a functional nature (with intestinal infectious diseases, irritable syndrome intestines etc. )

to improve the digestion of food in patients with normal gastrointestinal function in case of nutritional errors

preparation for x-ray and ultrasound examination of the abdominal organs.

Contraindications

Acute pancreatitis

exacerbation of chronic pancreatitis

hypersensitivity to pancreatin or other components of the drug

hereditary galactose intolerance, lactase deficiency or glucose-galactose malignant (3-year-old)

Use during pregnancy and lactation

Due to the lack of sufficient data on the use of pancreatic enzymes in humans during pregnancy and lactation, the use of the drug MezimВ® forte 10000 is possible only if the expected benefit to the mother outweighs the possible risk to the fetus or child.

Composition

Active ingredient:

pancreatin 137.5 mg with minimal enzymatic activity: lipase 10,000 PIECES Ph.Eur, amylase 7500 PIECES Ph.Eur, protease 375 PIECES Ph.Eur.

Excipients:

lactose monohydrate,

microcrystalline cellulose,

silicon dioxide colloidal,

crospovidone,

magnesium stearate.

Shell composition:

hypromellose,

copolymer of methacrylic acid and ethyl acrylate (1: 1) dispersion 30% (dry weight),

triethyl citrate,

titanium dioxide (E171),

talcum powder,

simetone 30%,

simetone emulsion macrogol 6000,

carmellose sodium,

polysorbate 80,

azorubine varnish (E122),

sodium hydroxide.

Dosage and administration of

The dose of Mezim® forte 10000 is set individually depending on the severity of the disease and the composition of the food.

Unless otherwise indicated, the average single dose for adults is 2-4 tablets. Mezim® Forte 10000 at a meal. It is recommended to take half or a third of a single dose at the beginning of the meal, and the rest during it.

The drug is taken orally without chewing and drinking plenty of fluids. It is possible to increase the dose, which should be carried out only under the supervision of a doctor, while focusing on the weakening of symptoms (e.g., steatorrhea, abdominal pain). The maximum daily dose is 15000-20000 PIECES Ph.Eur. lipase / kg body weight.

For children, the doctor sets the dosage regimen depending on the severity of the disease and the composition of the food at the rate of 500-1000 PIECES Ph.Eur. lipase / kg body weight of the child at each meal.

The duration of treatment can vary from a few days (with digestive disorders, errors in diet) to several months and even years (if constant replacement therapy is necessary).

Side effects

No side effects or complications were detected even with prolonged and regular use of Mezim ® Forte 10000 in patients with impaired pancreatic function.

In some cases, after taking pancreatin, allergic reactions are rarely possible - diarrhea or constipation, nausea, discomfort in the epigastric region.

In isolated cases in patients suffering from cystic fibrosis, with prolonged use of high doses of the drug, hyperuricosuria (an increase in uric acid in the blood plasma) may develop, strictures may form in the ileocecal region and the ascending colon.

Drug Interaction

When administered with pancreatin-containing drugs, folic acid absorption may be reduced.

The action of sugar-lowering drugs (acarbose, miglitol) may be diminished when co-administered with pancreatin.

With the simultaneous use of pancreatin with iron, it is possible to reduce the absorption of the latter.

Concomitant use of antacids containing calcium carbonate and / or magnesium hydroxide can reduce the effectiveness of the drug.

Overdose

There are no data on overdose and intoxication with the drug.

Possible: hyperuricosuria, hyperuricemia, constipation in children.

Treatment: withdrawal of the drug, symptomatic therapy.

Storage conditions

Keep out of the reach of children at a temperature not exceeding 30 ° C.

Expiration

3 years.

Deystvuyuschee substances

Pancreatin

dosage form

dosage form

tablets

Berlin Chemie / Menarini Germany



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