Release form and composition
The drug is released in 2 forms:
- capsules: one blister contains 7 capsules (1 package can contain 3, 8, 12 blisters, instructions are included);
- tablets: one blister contains 10 tablets (1 package may contain 1.3 blisters, instructions are included).
The drug contains the enzymes amylase, lipase, and protease. In 1 tablet of the main active ingredient lipase – 20,000 units, in 1 capsule – 10,000 units. Based on the volume of the component, the trade names of the drug are distinguished: Panzinorm 10,000 and Panzinorm 20,000. The content of amylase in 1 tablet is 12,000 units, protease – 900 units.
Among the auxiliary components of the drug:
- lactose monohydrate;
- microcrystalline cellulose;
- crospovidone;
- colloidal dioxide anhydrous;
- magnesium stearate;
- hypromellose;
- methacrylic acid and ethyl acrylate copolymer (1:1);
- triethyl citrate;
- titanium dioxide (E 171);
- talc;
- simethicone – emulsion;
- vanillin flavor 54 286 C;
- bergamot flavor 54 253 T;
- macrogol 6000;
- carmellose sodium and polysorbate 80.
The tablets have a smooth and rounded surface, biconvex sides, and are white or light gray in color.
pharmachologic effect
The drug is prescribed in the treatment of diseases of the pancreas and stomach that occur with enzyme deficiency. In this case, the tablets stimulate the breakdown of complex substances into simpler ones and improve their absorption in the gastrointestinal tract. The release of active enzymes of the drug occurs in the duodenum, where their active action is observed.
Lipase is the main enzyme that the body requires when there is a deficiency of such substances in the pancreas. This enzyme is involved in the hydrolysis of fats into fatty acids and glycerol, which contributes to their better absorption. Amylase ensures the hydrolysis of carbohydrates into dextrins and sugars. Protease is involved in the digestion of protein compounds.
Indications for use
The instructions for use of the drug Panzinorm indicate that the drug can be taken if the following conditions develop:
- insufficient secretory activity, which in most cases is caused by chronic pancreatitis and cystic fibrosis (a systemic hereditary disease caused by a mutation of a certain gene);
- chronic inflammatory pathology in any organ involved in the digestive process (stomach, intestines, gall bladder, liver);
- post-traumatic condition in the digestive organ, including a history of surgery or radiation;
- functional disorder of digestive function caused by problems with chewing or prolonged lying down;
- digestive dysfunction caused by eating food that is difficult for the gastrointestinal tract;
- development of cystic fibrosis in the pancreas.
This is not an exhaustive list of indications for taking the drug. Panzinorm is also prescribed in the preparatory period before an ultrasound or x-ray examination of the abdominal organs.
Contraindications
In most cases, the drug Panzinorm is well tolerated by the body, however, there are some contraindications that limit the use of the drug in the treatment of any gastrointestinal disease. These include:
- the presence of individual intolerance to any component of the drug, including pork protein;
- development of pancreatitis (inflammatory process in the pancreas) in the acute stage;
- development of chronic pancreatic inflammation in the acute stage;
- age factor (the drug is not prescribed for the treatment of pathologies for children and adolescents under 15 years of age whose medical history is aggravated by cystic fibrosis);
- development of liver failure;
- precoma and coma;
- development of obstructive jaundice;
- presence of intestinal obstruction;
- development of hyperbilirubinemia.
In addition, the drug is not prescribed for cholelithiasis and hepatitis.
Interactions of the drug Panzinorm forte
Pancreatic enzymes inhibit the absorption of folic acid. When taking bicarbonates and cimetidine simultaneously with large doses of pancreatic enzymes, it is recommended to periodically analyze the concentration of folic acid salts in the blood plasma and, if necessary, prescribe additional folic acid to the patient. Pancreatic enzymes may decrease iron absorption, but the clinical significance of this interaction is unknown. Concomitant use of H2 receptor inhibitors or proton pump inhibitors may increase the effectiveness of pancreatic enzymes and allow some patients to take lower doses of Panzinorm forte-N.
Instructions for use
It is recommended to take the drug in the dosage determined by the attending physician. In any case, self-medication is prohibited, as it can not only slow down recovery, but also cause additional harm to health.
There is no need to double the dosage if you manage to miss taking pills. The next dose is in the dosage prescribed by the doctor. The daily volume of the drug taken is determined by the doctor, taking into account the individual characteristics of the body, the state of the gastrointestinal tract, and the composition of the food consumed.
Swallow the tablet whole, without chewing, with a sufficient amount of water. If it is not possible to take the tablet as a whole, it can be crushed, mixed with liquid and swallowed without chewing. In most cases, the drug is prescribed to be taken during meals.
For cystic fibrosis, the amount of medication taken for children under 4 years of age (if the appropriateness of such treatment is determined by a doctor) is 1000 IU of EF lipase per 1 kg of weight at each meal. For children over 4 years of age, the volume is 500 IU of EP lipase per 1 kg of weight at each meal.
For an adult patient, the dosage is selected individually, taking into account the severity of the disorders. At the beginning of therapy, the minimum daily dosage is used - 1 tablet three times a day, which is increased gradually.
Use of the drug Panzinorm forte
The dose is determined individually for each patient depending on the individual characteristics of the patient, the state of functioning of the pancreas and the composition of the food. Panzinorm forte-N is taken orally during meals with plenty of liquid. The tablets should be swallowed whole without chewing. Cystic fibrosis. The recommended starting dose is 1 tablet with meals 3 times a day. The dose may be increased if necessary. It is not recommended to exceed the dose of 10,000 IU lipase/kg/time. Chronic pancreatitis and other types of exocrine pancreatic insufficiency. Treatment begins with 1 tablet during the main meal. For patients with more severe cases of exocrine pancreatic insufficiency, higher doses are used to reduce steatorrhea and maintain proper nutritional status: up to 40,000 units of lipase (2 tablets) with the main meal and 20,000 units of lipase (1 tablet) with an additional meal . If the tablet is not taken with food in a timely manner, you must wait until the next meal and continue the usual use of the tablets (without doubling the dose). It is not recommended to exceed a dose of 75,000 IU of lipase per meal. The duration of treatment with the drug is not limited.
Children, pregnancy and breastfeeding
To date, there is not enough information about whether the drug Panzinorm can be used during pregnancy. Special studies on animals were carried out, the results of which did not reveal the absorption of enzymes, which allows us to say that there is no toxic effect on reproductive function and intrauterine development of the fetus.
However, despite such conclusions, only a doctor can determine the advisability of using the pills by pregnant women. The drug is prescribed during this period if the potential benefit outweighs the possible harm.
As for the use of tablets during breastfeeding, there is no harmful effect on the child’s body, which allows you to take the drug even during lactation.
The ability of children to take the medicine is determined by the attending physician.
Special instructions for the use of the drug Panzinorm forte
In some patients with cystic fibrosis, large doses of pancreatic enzymes (10,000 units/kg/day) caused strictures of the colon or ileocecal part of the intestine (fibrosing colonopathy). If patients taking Panzinorm forte-N develop symptoms of colon obstruction, they should be examined for fibrosing colonopathy as a possible cause. Do not exceed the recommended doses and duration of prescribed treatment. Use during pregnancy or breastfeeding . There is no data on the effect of Panzinorm forte-N during pregnancy or breastfeeding. Enzymes are not absorbed from the gastrointestinal tract. But the drug is recommended to be used only when the expected benefit to the mother outweighs the potential risk to the fetus or child. Influence on reaction speed when driving vehicles or operating other mechanisms. The drug does not affect the reaction rate when driving vehicles or operating other mechanisms. But it must be taken into account that the side effect of the drug, dizziness, can affect the ability to drive vehicles and other mechanical means. Children. The use of the drug is not recommended for children under 15 years of age, since the Panzinorm forte-N tablet is film-coated and cannot be divided.
special instructions
The simultaneous use of the drug Panzinorm and drugs with folic acid causes a decrease in the effect of the latter, which can be explained by inhibition of acid absorption.
In some cases, the active components of Panzinorm interfere with the normal absorption of iron supplied to the body with other drugs or food.
Taking the tablets does not have a negative effect on concentration and visual acuity, which allows therapy to be carried out while driving vehicles and working at work that requires increased mental activity.
Side effects of the drug Panzinorm forte
Severe side effects are very rare. Hypersensitivity reactions may occur, such as swelling of the face, mouth, lips, or throat, which may cause difficulty breathing or swallowing; swelling of the limbs; skin rash, dizziness, jaundice. In such cases, the use of Panzinorm forte-N should be stopped, and the patient should be provided with immediate medical assistance. If the patient experiences pain and bloating in the abdomen, severe cramps, the possibility of developing fibrosing colonopathy should be considered. When taking high doses, loose stools or constipation, hyperuricemia, hyperuricosuria and folic acid deficiency may occur. In isolated cases, in patients with cystic fibrosis, taking the drug in high doses (more than 10,000 units/kg/day) can cause the formation of strictures of the large intestine or ileocecal part of the intestine. More common side effects are weakness, vomiting and abdominal pain.
