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Panzinorm ®10000 21’s caps.




The instruction for medical use

of ПАНЗИНОРМ® 10,000 medicine

the Trade name
Панзинорм® 10,000

International unlicensed

name Pancreatinum Dosage Form

of the Structure One Capsule Capsule contains
active agents – a lipase of 10,000 PIECES,
amylase of 7200 PIECES,
protease of 400 PIECES,
excipients – 30% suspension of a kopolimer methacrylic acid – ethyl acrylate (1:1), triethyl citrate, talc, 20% an emulsion of a simetikon,
structure of a cover of the capsule: gelatin, the titan dioxide (E171), sodium lauryl sulfate

the Description
Solid gelatin capsules with the transparent colourless body and an opaque lid of brown color. Capsule contents – whitish-gray microspheres, film coated, with a characteristic smell.

Pharmacotherapeutic group
Drugs, digestant, (including fermental drugs)
the Code of automatic telephone exchange A09AA02

the Pharmacological

Pharmacokinetics Pancreatic Enzymes properties – the natural substances promoting digestion and digestion of food. The film cover of the microspheres which are contained in drug capsules protects active enzymes from influence of acidic environment of a stomach. Digestive enzymes are activated and split in intestines as a result of an autolysis and proteolysis. A small amount of the enzymes accepted with drug is removed with excrements.
A pharmacodynamics
of Panzinorm Capsule 10000 compensate vneshnesekretorny insufficiency of a pancreas, accelerate catabolism of food and eliminate clinical manifestations of the broken digestion. Active enzymes are released in a small intestine. At treatment of the disturbances of digestion caused by vneshnesekretorny insufficiency of a pancreas, the most important point is the high activity of a lipase. The lipase hydrolyzes fats to fatty acids and a gditserin, providing their absorption and absorption of oil-soluble vitamins. Amylase hydrolyzes carbohydrates to dextrins and sugars, and protease splits proteins.
Panzinorm 10,000 promotes fuller absorption of all main components of food and improves the patient’s food. Drug prevents or reduces development of a steatorrhea and other symptoms of the broken digestion.
Pancreatinum is capable to reduce severity of pain in chronic pancreatitis. This effect is caused by effect of proteases which suppress secretion of own enzymes of a pancreas though it is up to the end not studied.

– chronic vneshnesekretorny insufficiency of a pancreas
– treatment and/or prevention of the symptoms caused reduced absrbtsiy
food at vneshnesekretorny insufficiency of a pancreas

the Route of administration and doses
the Dose is defined individually depending on disease severity and from a diet.
Treatment is begun with small doses: one or two capsules three times a day with the main meals. If the applied dose is not enough for digestion disturbance elimination, the dose of drug can be increased gradually.
It is necessary to apply the smallest effective doses, especially at patients with a mucoviscidosis.
Capsules are swallowed entirely, without chewing. If necessary (for example, small children and elderly patients) the capsule can be opened carefully and to add a microsphere to liquid food or to accept with liquid.

Side effect
– skin syp, an itching, obstruction of airways
– diarrhea, a constipation, sensation of discomfort in a stomach, nausea
– a hyperuricemia, a hyper uricosuria, deficiency of folic acid (at
prolonged use in high doses)

– hypersensitivity to drug components
– acute pancreatitis
– exacerbation of chronic pancreatitis

Medicinal interactions
Pancreatic enzymes suppress absorption of folic acid. At a concomitant use of other drugs with similar action (a naprmer, bicarbonates or Cimetidinum) or at long-term treatment the high doses of Pancreatinum, recommended periodic control of level of folates in blood serum and/or additional intake of folic acid.
Pancreatinum can reduce efficiency of acarbose and a miklitol.
Steady microspheres in acidic environment in the Panzinorma capsules 10000 break up to a duodenum. If contents of a duodenum have very acidic environment, enzymes can be released at the wrong time.
Simultaneous use of the drugs reducing secretion of hydrochloric acid in a stomach such as blockers histamine H2 – receptors or inhibitors of a proton pomp, allow to reduce at some patients Panzinorm’s dose 10000.
Pancreatinum can reduce iron absorption, however clinical value of this interaction not ustanvleno.

Special instructions
In a mucoviscidosis in case of reception of high doses of pancreatic enzymes (more than 10000 PIECES of a lipase/kg of weight bodies/day) development of strictures in ileocecal department and the ascending part of a colon (fibrous colonopathy) is seldom possible. If at reception of the Panzinorma capsules 10000 there are signs of intestinal impassability, it is necessary to exclude a fibrous colonopathy.
Pregnancy and a lactation
pregnant women should appoint Drug with care. Enzymes of a pancreas are not soaked up from digestive tract, however the potential risk cannot be excluded completely. Pregnant women and the feeding women can take the drug, only if the potential advantage for mother exceeds potential risk for the child.
Features of influence of An ability to run the vehicle or potentially dangerous mechanisms.

The Overdose
Symptoms does not influence: nausea, vomiting, diarrhea, hyperuricemia and hyperuricemia.
Treatment: drug withdrawal, symptomatic treatment.

A form of release and packing
of the Capsule
On 7 capsules in the blister.

Storage conditions
to Store 3.8 or 12 blisters in a cardboard pack together with the instruction for use in the dry place, at a temperature not above +25 °C.
To store out of children’s reach!

3 years
not to apply a period of storage after an expiration date.

Prescription status
Without prescription

the Producer
of KRK, of, the place, Slovenia Is new

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