Expiration date: 06/2025

The composition and form of issue:

Tablets, film-coated, soluble in the intestine. One tablet contains:

Pancreatin (pork), with enzyme activity: 

lipase 20,000 IU Heb.Farm.

amylase 12000 IU Heb.Farm.

protease 900 IU Heb.Farm.

weight active substance in the amount of 269, 12-279, 44 mg

(15% excess Pancreatin is due to technical losses in the production process with a 10% excess of Pancreatin is used to compensate losses in the decay during the storage period) 

excipients: lactose monohydrate, the MCC crospovidone silicon dioxide colloidal anhydrous magnesium stearate 

shell: hypromellose methacrylic acid and a copolymer of ethylacrylate triethyl citrate titanium dioxide (E171) talc simethicone emulsion flavoring vanilla flavoring 54286 With bergamot 54253 T macrogol 6000 carmellose sodium Polysorbate 80 

blistere in 10 PCs in a pack a cardboard 1, 3 or 10 blisters, or in dark glass bottles of 10, 30 or 100 PL. in the paper cartons 1 a bottle.

Description pharmaceutical form:

Smooth, round biconvex tablets, film-coated white or light gray in color with a smell of vanilla and bergamot.

Pharmacokinetics:

Pancreatic enzymes are released from the dosage form in the alkaline environment of the small intestine, because it is protected from the action of gastric juice film cover. A minor part of the digestive enzymes secreted through the intestines.

Description pharmacological action:

Combination drug whose action caused by components that are part of it. The preparation compensates the deficiency of exocrine function of the pancreas.

High lipase activity plays an important role in the treatment of maldigestion due to pancreatic enzyme deficiency.

Lipase breaks down fats by hydrolysis to fatty acids and glycerol, thus, promotes their absorption and absorption of fat-soluble vitamins.

Amylase breaks down carbohydrates to dextrins and sugars, then kampotiana breaks down proteins.

The drug has a protective sheath, through which active enzymes are released in the small intestine, where pancreatic enzymes. Included in the Pancreatin enzymes lipase, amylase and protease facilitates the digestion of fats, carbohydrates and proteins, which makes them more complete absorption in the small intestine. Eliminates the symptoms arising from digestive disorders (a feeling of heaviness and fullness, bloating, feeling short of breath, shortness of breath caused by intestinal gas, diarrhea).

Improves process of digestion in children stimulates the secretion of own enzymes of the pancreas, stomach and small intestines, and bile.

Indications:

• insufficiency of exocrine pancreatic function (chronic pancreatitis, cystic fibrosis)
  
• chronic inflammatory-dystrophic diseases of stomach, intestines, liver, gall bladder condition after resection or irradiation of these organs, accompanied by violations of digestion, flatulence, diarrhea (combination therapy)
  
• to improve food digestion in patients with normal function of the gastrointestinal tract in case of errors in the diet, disorders of the chewing function (damage to teeth and gums, in a period of adjustment to dentures), sedentary lifestyle, prolonged immobilization
  
• preparing for x-ray and ultrasound of the abdominal organs.
  

Contraindications:

• hypersensitivity to pork protein or other components of the drug
  
• acute pancreatitis, exacerbation of chronic pancreatitis
  
• children up to age 3 years (for this dosage form) and 15 years (for children suffering from cystic fibrosis).
  

Application of pregnancy and breast-feeding:

The use of the drug Panzinorm Forte 20000 during pregnancy and lactation (breastfeeding) is possible only in case if the expected positive effect of therapy exceeds potential risk (due to the lack of clinical data confirming the safety of the use of pancreatic enzymes in this category of patients).

Side effects:

Allergic reactions: hyperemia skin, skin rashes, itchy skin, sneezing, stuffiness, watery eyes.

From the digestive system (in the long admission in high doses): nausea, vomiting, abdominal pain (including intestinal colic), diarrhea, constipation, perianal irritation, irritation of the mucous membrane of the oral cavity. In cystic fibrosis in case of exceeding the necessary dose of Pancreatin (more than 10,000 IU Heb.Farm. lipase per 1 kg of body weight) may develop strictures (fibrous kolonopatii) in the Department of the ileocecal and ascending colon.

Other: hyperuricemia, hyperuricosuria, lack of folate.

Drug interactions:

While the use of Pancreatin may reduce the absorption of iron supplements (clinically insignificant) and folic acid. We recommend that you periodically monitor the level of folate and/or folic acid.

Acid-resistant shell tablets Panzinorm Forte 20000 dissolves in the duodenum. At low pH in the duodenum Pancreatin is not released.

The simultaneous use of blockers of H2-histamine receptors (cimetidine), bicarbonates, proton pump inhibitors may lead to improving the effectiveness of Pancreatin.

Method of application and dose:

Inside, during a meal. Tablets should be taken whole without chewing, with enough fluid.

The dose and duration of therapy is determined individually depending on the age and degree of pancreatic insufficiency.

Adult Panzinorm Forte 20000 is recommended to take (in the absence of other requirements) at the beginning of treatment, 1 table. 3 times a day during each main meal. Possible the pills of Panzinorm Forte 20000 while taking a light snack. If necessary, the dose increase 2 times. Average daily dose — table 1-2. 3 times.

Before x-ray and ultrasound studies, 2 tablets 2-3 times a day for 2-3 days before the test.

In children the drug is used by prescription. Children under the age of 3 — 100 thousand IU/day (in terms of the lipase).

The duration of treatment can vary from a single dose or a few days (in violation of the digestive process due to errors in the diet) to several months or years (if required constant replacement therapy).

Overdose:

Symptoms: nausea, vomiting, diarrhea, hyperuricosuria, hyperuricemia, perianal irritation, fibrous colonopathy (if mukoviszidose).

Treatment: cancel the drug, hydration, symptomatic therapy.

Special instructions:

Panzinorm  Forte 20000 should primatine chewing, with a sufficient quantity of liquid.

In cystic fibrosis in case of exceeding the necessary dose of Pancreatin (more than 10,000 IU Heb.Farm. lipase per 1 kg of body weight) may develop strictures (fibrous kolonopatii) in the Department of the ileocecal and ascending colon. Therefore, in cystic fibrosis dose should be adequate amounts of enzymes necessary for fat absorption by the quality and quantity of food intake. Capsule hydrosorbent not to swallow!

Influence on ability to driving and other mechanical devices. No data about negative influence on ability to driving and operating other mechanisms.