Mezim forte 10 000 20 caps (Mezym forte)

Description

Composition
Active substance:
1 tablet contains:
Pancreatin powder -137.500 mg with a minimum enzymatic activity: 10,000 U lipase Ph. Eur. amylase 7500 U Ph. Eur. protease 375 U Ph. Eur.
Excipients:
Lactose monohydrate – 89.100 mg microcrystalline cellulose – 52.000 mg Colloidal silicon dioxide – 1,533 mg, crospovidone – 18,000 mg magnesium stearate – 1,867 mg; sheath: hypromellose (~ 5 mPas) – 4,800 mg, methacrylic acid-ethyl acrylate copolymer (1: 1) dispersion of 30% (dry weight) of 12,200 mg triethyl citrate – 3,900 mg titanium dioxide (E 171) – 5,050 mg talc – 6,780 mg, cimetikona emulsion 30% (dry weight) of 0.049 mg macrogol 6000 – 0.210 mg, sodium carmellose (~ 30 mPa · s) – 0.440 mg of polysorbate 80 – 0.690 mg azorubinovy ​​lacquer (E 122) 0.232 mg sodium hydroxide – 0,035 mg.
Description:
Pink Valium tablets, coated with an almost plane-parallel surfaces and sloping edges on the fracture possible brown blotches.
Product form:
The tablets coated with enteric coating.
10 tablets in blisters (blister) [Aluminum / PVC / polyamide]. 1 or 2 blisters together with instructions for use in a cardboard package.
Contraindications
Acute pancreatitis; exacerbation of chronic pancreatitis; Hypersensitivity to pancreatin or other components of the formulation; hereditary galactose intolerance, the lack of lactase, or syndrome of glucose-galactose malabsorption; Children up to age 3 years (indivisible dosage form).
Indications
Replacement therapy in exocrine pancreatic insufficiency (including chronic pancreatitis, cystic fibrosis); chronic inflammatory and degenerative diseases of the stomach, intestine, liver, gall bladder; state after resection or irradiation of the digestive tract, accompanied by violation of the digestion of food, flatulence, diarrhea (in combination therapy); gastrointestinal disorder is a functional nature (for intestinal infectious diseases, irritable bowel syndrome, etc.); to improve food digestion in patients with normal function of the digestive tract in the case of errors in the diet; preparations for X-ray and ultrasound examination of the abdominal cavity.
Interaction with other drugs
Upon receiving the preparations containing pancreatin may decrease the absorption of folic acid. Action antidiabetic drugs (acarbose, miglitol) can be reduced while reception with pancreatin.
With simultaneous application of pancreatin with iron supplementation may decrease the absorption of the latter. The simultaneous use of antacids containing calcium carbonate and / or magnesium hydroxide, can reduce the effectiveness of the drug.
Overdose
Data on cases of overdose and toxic drug not.
Possible: hyperuricosuria, hyperuricemia in children – constipation.
Treatment: removal of the drug, symptomatic therapy.
pharmachologic effect
Pharmacological group:
Digestive enzymatic means.
Pharmacodynamics:
Enzyme preparation, which improves digestion.
Pancreatin is a powder made from porcine pancreatic glands, which along with the pancreatic exocrine enzymes – lipase, amylase, protease, trypsin and chymotrypsin contains other enzymes.
Pancreatic enzymes included in the formulation, facilitate cleavage of proteins, fats and carbohydrates, which leads to more complete absorption in the small intestine. Trypsin inhibits stimulated secretion of the pancreas, providing an analgesic effect. Maximum enzyme activity of the drug observed after 30-45 minutes after oral administration.
Pharmacokinetics:
Tablets Mezim® forte 10,000 acid-coated shell that does not dissolve under deystviemsolyanoy gastric acid and thus prevents the enzymes contained in the product from inactivation. Dissolution of the shell and release of enzyme occurs at a value of pH close to neutrality or slightly alkaline.
Pregnancy and breast-feeding
Due to the lack of adequate data on the use of pancreatic enzymes in humans during pregnancy and lactation, the use of the drug Mezim® forte 10000 is possible only if the expected benefit to the mother outweighs the potential risk to the fetus or child.
Conditions of supply of pharmacies
Without recipe.
side effects
Revealed no side effects or complications, even with prolonged and regular use of the drug Mezim® forte 10000 in patients with impaired function of the pancreas.
In some cases, upon receiving a pancreatin may develop allergic reactions, rare-diarrhea or constipation, nausea, discomfort in the epigastrium.
In rare cases, patients suffering from cystic fibrosis, prolonged use of high doses of the drug may develop hyperuricosuria (increase of uric acid level in blood plasma), formation of strictures in the ileocecal region and the ascending colon.
special instructions
In acute pancreatitis or chronic pancreatitis exacerbation (worsening on attenuation stage), while reducing diet, it is advisable to assign Mezim® forte 10000 amid occurring or remaining hereinafter pancreatic insufficiency. Mezim® forte 10000, taking into account the solid indivisible dosage form is contraindicated in children under 3 years old.
Effect on ability to drive vehicles and management mechanisms Mezim® forte 10000 does not affect the speed of psychomotor reactions and the ability to perceive and assess the situation.
Storage conditions
At a temperature of not higher than 25 C.
Drug store out of reach of children !.
Dosing and Administration
Dose Mezim® forte 10000 is determined 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 10,000 on food reception.
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.
May increase the dose, which should be done only under medical supervision, in line with the weakening of symptoms (eg steatorrhea, abdominal pain). The maximum daily dose of 15,000-20,000 IU Ph. Eur. lipase / kg body weight.
Children batch is a doctor, depending on the severity of the disease and the composition of the food at the rate of 500-1000 IU Ph. Eur. lipase / kg body weight per meal.
Duration of treatment may vary from a few days (in violation of the digestive system, errors in diet) to several months or even years (permanent replacement therapy if necessary).
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist