Panzinorm Forte 20000 coated intestine-soluble pills N10
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Active ingredients
Pancreatin
Release form
Uncoated Tablets
Composition
Pancreatin with minimal enzymatic activity: lipases 20,000 IU Ph.Eur, amylases 12,000 IU Ph.Eur, proteases 900 IU Ph.Eur. Auxiliary substances: lactose monohydrate, microcrystalline cellulose, crospovidone, anhydrous colloidal silicon dioxide, magnesium stearate.S. : hypromellose, copolymer of methacrylic acid and ethyl acrylate, triethyl citrate, titanium dioxide (E171), talc, simethicone emulsion, vanilla flavoring 54286С, bergamot flavoring 54253Т, macrogol 6000, carmellose sodium, polysorbate 80.
Pharmacological effect
Enzyme preparation. The drug compensates for the insufficiency of the exocrine function of the pancreas. High lipase activity plays an important role in the treatment of maldigestia caused by pancreatic enzyme deficiency. Lipase breaks down fats by hydrolysis to fatty acids and glycerol, thus, contributes to their absorption and absorption of fat-soluble vitamins. Amylase breaks down carbohydrates into dextrins and sugars, while protease breaks down proteins. The enzymes lipase, amylase and protease, which are part of pancreatin, facilitate the digestion of fats, carbohydrates and proteins, which contributes to their more complete absorption in the small intestine. Eliminates the symptoms resulting from digestive disorders (feeling of heaviness and overfilling of the stomach, flatulence, feeling of lack of air, shortness of breath due to gas accumulation in the intestines, diarrhea). Improves the process of digestion in children; stimulates the secretion of its own enzymes of the pancreas, stomach and small intestine, and bile. The capsule has a protective sheath, due to which active enzymes are released in the small intestine, where pancreatic enzymes operate.
Pharmacokinetics
Panzinorm 10 000 is produced in the form of a capsule, inside which contains film-coated pellets. The film shell of the pellets protects the active enzymes from the acidic environment of the stomach, which allows the enzymes to be released in the small intestine. Most enzymes are inactivated as a result of autolysis and proteolysis. A minor part of the digestive enzymes is secreted through the intestines.
Indications
- insufficiency of the exocrine pancreatic function — to improve the digestion of food in patients with normal gastrointestinal function in the event of errors in nutrition.
Contraindications
- acute pancreatitis; - exacerbation of chronic pancreatitis; - children's age up to 3 years (for this dosage form); - children with cystic fibrosis under the age of 15 years; - hypersensitivity to porcine protein or other components of the drug. .
Use during pregnancy and lactation
Use of Panzinorm 10,000 during pregnancy and lactation (breastfeeding) is possible only if the expected positive effect of therapy outweighs the possible risk, due to the lack of clinical data confirming the safety of the use of pancreatic enzymes in this category of patients.
Dosage and administration
The drug is taken orally during a meal or snack. Capsules should be taken whole, without chewing, drinking plenty of liquids. The dose and duration of therapy is determined individually, depending on age, degree of pancreatic function insufficiency and diet. Adults at the beginning of treatment are recommended to take the minimum dose - 1-2 capsules 3 times / day, during each main meal (breakfast, lunch, dinner) and 1 capsule - during each snack. If necessary, a single dose is gradually increased. The effective daily dose is 4 to 15 capsules. The smallest effective dose should be prescribed, especially in patients with cystic fibrosis. In children, the drug is used only on prescription. Children over the age of 3 should be given 1-2 capsules with a meal or snack. The duration of treatment can vary from a single dose or several days (if the digestive process is disturbed due to errors in the diet) to several months or years (if necessary, constant replacement therapy).
Side effects
Panzinorm 10,000 rarely causes undesirable effects. On the part of the digestive system: when taking large doses of the drug - nausea, vomiting, abdominal pain (including intestinal colic), diarrhea, constipation, perianal irritation, irritation of the oral mucosa.In case of cystic fibrosis in case of exceeding the required dose of pancreatin (more than 10,000 IU Ph.Eur. Lipase / kg body weight), it is rarely possible to develop strictures (fibrous colonopathy) in the ileocecal region and in the ascending colon. Allergic reactions: hypersensitivity reactions, including skin flushing, skin rash, pruritus; airway obstruction. Other: hyperuricemia, hyperuricuricuria, folate deficiency.
Overdose
An overdose of Panzinorm 10 000 does not cause systemic intoxication. Symptoms: nausea, vomiting, diarrhea, hyperuricosuria, hyperuricemia, perianal irritation; rarely develops fibrous colonopathy (with cystic fibrosis). Treatment: drug withdrawal, hydration, symptomatic therapy.
Interaction with other drugs
With simultaneous long-term use of pancreatin in high doses may decrease the absorption of iron preparations (clinically insignificant) and folic acid. It is recommended to periodically monitor the level of folate and / or the appointment of folic acid. When used simultaneously with cimetidine, bicarbonate, it is also recommended to periodically monitor the level of folate and / or the appointment of folic acid. Pancreatin may decrease the effectiveness of acarbose and miglitol. The acid-resistant panzinorm pellet shell 10,000 dissolves in the duodenum. At low pH in the duodenum, pancreatin is not released. The simultaneous use of histamine H2-receptor blockers (cimetidine), hydrocarbons, proton pump inhibitors can lead to an increase in the effectiveness of pancreatin, which allows to reduce the dose of Panzinorm 10,000.
special instructions
In case of cystic fibrosis, if the required dose of pancreatin is exceeded (more than 10,000 IU Ph.Eur. Lipase / kg of body weight), strictures (fibrous colonopathy) may develop in the ileocecal region and in the ascending colon. Therefore, in cystic fibrosis, the dose must be adequate to the amount of enzymes that are necessary for the absorption of fat, taking into account the quality and quantity of food consumed. If you receive symptoms of intestinal obstruction while taking Panzinorm 10,000 capsules, fibrous colonopathy should be excluded. With prolonged use at the same time prescribed iron supplements.Influence on ability to drive motor vehicles and control mechanisms Unknown about the negative impact on the ability to drive and work with other mechanisms.