Expiration date: 02/2025

The composition and form of issue:

Capsules (pellet). 1 capsule contains:

Pancreatin powder (pork, in the form of pellets) 96, 6-123, 9 mg

corresponds to: 

activity of lipase — 10000 IU.Heb.F. 

the amylase activity — not less than 7200 Units.Heb.F. 

total proteolytic activity not less than 400 IU.Heb.F. + excess for stability: 

by weight 10% — 9, 6-12, 4 mg 

for enzyme activity: 

only relative activity of the lipase, 10% 

weight active substance in the amount of 106, 2-136, 3 mg

shell pellets: methacrylic acid and ethylacrylate copolymer (1:1) dispersion 30% dry mass (excipients: sodium lauryl sulphate Ph.Eur./NF and Polysorbate 80 Ph.Eur./NF) triethylcitrate talc simethicone emulsion 20% dry weight (23%). 

composition of empty capsule: 

the cap of the capsule: gelatin titanium dioxide (E171) sodium lauryl 

the body of the capsule: gelatin titanium dioxide (E171) sodium lauryl 

in e blisters 7 PC. in the stack cartons 3, 8 or 12 blisters.

Description pharmaceutical form:

Hard, opaque gelatin capsules filled with pellets a beige-brown color. The body and lid capsules white.

Pharmacokinetics:

Panzinorm of 10000 is available in capsule form, in which are contained pellets, film-coated. Film shell pellets protect the active enzymes from exposure to the acidic environment of the stomach, which allows the enzymes released into the small intestine. A large part of the enzymes is inactivated, as a result of autolysis and proteolysis. 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, while protease 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 function of the pancreas.
  
• to improve food digestion in patients with normal function of the gastrointestinal tract in case of errors in the diet.
  

Contraindications:

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

With caution: pregnancy.

Application of pregnancy and breast-feeding:

The use of the drug Panzinorm 10000 during pregnancy and lactation (breastfeeding) is possible only in case if the expected positive effect of therapy exceeds potential risk, in the absence of clinical data confirming the safety of use of pancreatic enzymes in this category of patients.

Side effects:

Panzinorm 10000 rarely causes unwanted effects.

Allergic reactions: hypersensitivity reactions, including flushing of the skin, skin rash, itching airway obstruction.

From the digestive system (when receiving large doses of the drug), 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 10 000 Units.Heb.F. lipase per 1 kg of body weight) rarely may develop strictures (fibrous kolonopatii) in the Department of the ileocecal and ascending colon.

Other: hyperuricemia, hyperuricosuria, lack of folate.

Drug interactions:

Long-term use of Pancreatin in high doses 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.

While the use of cimetidine, bicarbonate is also recommended to periodically monitor the level of folate and/or folic acid.

Pancreatin may reduce the effectiveness of acarbose and miglitol. Acid-resistant shell pellets of Panzinorm 10000 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, which allows to reduce the dose of Panzinorm 10000.

Method of application and dose:

Inside, during a meal or snack. Capsules should be taken whole without chewing with plenty of liquid.

The dose and duration of therapy is determined individually depending on age, degree of insufficiency of pancreatic function and diet. Adult Panzinorm 10000 is recommended to take at the beginning of treatment minimum dose — 1-2 caps. 3 times a day during each main meal (Breakfast, lunch, dinner) and 1 caps. during each snack. If necessary, the dose gradually increased. An effective daily dose is from 4 to 15 caps. drug Panzinorm 10000.

Should take the lowest effective dose, especially in patients with cystic fibrosis.

In children the drug is used by prescription. Children older than 3 years — 1-2 caps. drug Panzinorm 10000 during meals or snacks.

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:

Overdose of Panzinorm 10000 does not cause systemic intoxication.

Symptoms: nausea, vomiting, diarrhea, hyperuricosuria, hyperuricemia, rarely perianal irritation develops fibrous colonopathy (in cystic fibrosis).

Treatment: cancel the drug, hydration, symptomatic therapy.

Special instructions:

Panzinorm of 10000 should be taken without chewing, with enough fluid.

In cystic fibrosis in case of exceeding the necessary dose of Pancreatin (more 10 000 Units.Heb.F. 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.

If on a background of reception of capsules Panzinorm 10000 symptoms of intestinal obstruction should be excluded fibrous kolonopatii.

Long-term use at the same time appoint preparations of iron.

Effects on ability to drive and other mechanical devices: there are no data about negative influence on ability to drive and use machines.