Composition, form of production and packaging
? Capsules hard gelatinous, opaque, body and lid white; contents of capsules - pellets of beige-brown color.
1 caps.
pancreatin (in the form of pellets) 96.6-123.9 mg,
which corresponds to the activity:
lipase 10 000 ED Ph.Eur.
amylases not less than 7 200 ED Ph.Eur.
protease not less than 400 units Ph.Eur.
Excipients: methacrylic acid-ethyl acrylate copolymer (1: 1), dispersion 30%, dry weight (sodium lauryl sulfate, polysorbate 80); triethylcitrate, talc, simethicone emulsion 20%, dry weight (23%).
Composition of the cap and capsule body: gelatin, titanium dioxide (E171), sodium lauryl sulfate.
7 pcs. - blisters (3) - packs of cardboard.
7 pcs. - blisters (12) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2015.
PHARMACHOLOGIC EFFECT
Enzyme preparation. The drug compensates for the lack of exocrine function of the pancreas.
High lipase activity plays an important role in the treatment of maldigestii due to pancreatic enzyme deficiency. Lipase breaks fats by hydrolysis into fatty acids and glycerol, thus facilitating their absorption and absorption of fat-soluble vitamins. Amylase splits carbohydrates into dextrins and sugars, while protease cleaves proteins.
The pancreatin enzymes of lipase, amylase and protease facilitate the digestion of fats, carbohydrates and proteins, which contributes to their fuller absorption in the small intestine. Eliminates the symptoms arising from digestive disorders (feeling of heaviness and overflow of the stomach, flatulence, lack of air, shortness of breath due to the accumulation of gases in the intestines, diarrhea). Improves the process of digestion of food in children; stimulates the release of its own enzymes of the pancreas, stomach and small intestine, as well as bile.
The capsule has a protective envelope, through which active enzymes are released in the small intestine where pancreatic enzymes act.
PHARMACOKINETICS
PanzinormВ® В® 10 000 is available in the form of a capsule, inside which are contained pellets, coated with a film sheath. The film membrane of the pellet protects the active enzymes from the action of the acidic environment of the stomach, which allows the enzymes to be released in the small intestine. Most of the enzymes are inactivated, as a result of autolysis and proteolysis. A small part of the digestive enzymes are released through the intestine.
INDICATIONS
- Insufficiency of the exocrine function of the pancreas;
- to improve the digestion of food in patients with normal gastrointestinal function in the event of errors in nutrition.
DOSING MODE
The drug is taken orally during a meal or snack. Capsules should be taken whole, not liquid, squeezed with enough liquid.
The dose and duration of therapy are determined individually, depending on the age, degree of pancreatic function deficiency and diet.
Adults at the beginning of treatment are recommended to take minimum doses - 1-2 capsules 3 times / day, during each main meal (breakfast, lunch, dinner) and 1 capsule - during each snack. If necessary, the single dose is gradually increased. The effective daily dose is from 4 to 15 capsules.
The lowest effective doses should be given, especially in patients with cystic fibrosis.
In children, the drug is used only as directed by a doctor.
Children over the age of 3 years are prescribed 1-2 capsules with meals or snacks.
Duration of treatment can vary from a single dose or several days (if the digestive process is disturbed due to inaccuracies in the diet) to several months or years (if necessary, permanent replacement therapy).
SIDE EFFECT
Pansinorm В® В® 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 excess of the necessary dose of pancreatin (more than 10 000 U. Ph.Eur. lipase / kg of body weight) strictures (fibrous colonopathy) in the ileocecal region and in the ascending colon are rarely possible.
Allergic reactions: hypersensitivity reactions, incl. hyperemia of the skin, skin rash, itchy skin; obstruction of the airways.
Other: hyperuricemia, hyperuricosuria, folate deficiency.
CONTRAINDICATIONS
acute pancreatitis;
- exacerbation of chronic pancreatitis;
- Children under 3 years of age (for this dosage form);
- children with cystic fibrosis before the age of 15;
- Hypersensitivity to the pork protein or other components of the drug.
Caution should be prescribed during pregnancy.
PREGNANCY AND LACTATION
The application of Pansinorm 10 000 during pregnancy and during lactation (breastfeeding) is possible only if the expected positive effect of therapy exceeds the possible risk, due to the lack of clinical data confirming the safety of pancreatic enzymes in this category of patients.
APPLICATION FOR CHILDREN
Contraindication: children under 3 years of age (for this dosage form); children with cystic fibrosis before the age of 15 years. In children, the drug is used only as directed by a doctor.
SPECIAL INSTRUCTIONS
In case of cystic fibrosis in case of excess of the necessary dose of pancreatin (more than 10 000 U. Ph.Eur. lipase / kg of body weight), strictures (fibrous colonopathy) in the ileocecal region and in the ascending colon can be developed. Therefore, in cystic fibrosis, the dose should be adequate to the number of enzymes that are needed to absorb fat, taking into account the quality and quantity of food consumed.
If the symptoms of intestinal obstruction appear on the background of taking PenzinormВ® В® 10,000 capsules, fibrotic colonopathy should be excluded.
With prolonged use, iron preparations are simultaneously prescribed.
Impact on the ability to drive vehicles and manage mechanisms
It is not known about the negative impact on the ability to drive and work with other mechanisms.
OVERDOSE
Overdose of the drug Pansinorm В® 10 000 does not cause systemic intoxication.
Symptoms: nausea, vomiting, diarrhea, hyperuricosuria, hyperuricemia, perianal irritation; rarely develops fibrous colonopathy (with cystic fibrosis).
Treatment: withdrawal of the drug, hydration, symptomatic therapy.
DRUG INTERACTION
With simultaneous long-term use of pancreatin in high doses, it is possible to reduce absorption of iron preparations (clinically insignificant) and folic acid. It is recommended that folate levels and / or folic acid are monitored periodically.
When used simultaneously with cimetidine, bicarbonates, it is also recommended to periodically monitor folate levels and / or the administration of folic acid.
Pancreatin can reduce the effectiveness of acarbose and miglitol.
Acid-resistant pellet shell PansinormВ® В® 10 000 is soluble in the duodenum. At a low pH in the duodenum, pancreatin is not released. Simultaneous use of blockers of histamine H2-receptors (cimetidine), hydrogen carbonates, proton pump inhibitors can lead to an increase in the effectiveness of pancreatin, which allows to reduce the dose of Panzinorm 10,000.
TERMS OF RELEASE FROM PHARMACY
The drug is approved for use as a means of OTC.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored out of reach of children at a temperature of no higher than 30 В° C. Shelf life - 3 years.
