Panzinorm 10000 (Diseases of the gastrointestinal tract)

Compound

Each Panzinorm Forte tablet contains pork pancreatin . The active substance contains active enzymes:

• lipase content 20,000 units;
• amylase containing 12,000 units;
• protease containing 900 units.

In addition to the active substance, the tablets contain auxiliary components:

• lactose monohydrate;
• microcrystalline cellulose;
• carmellose sodium;
• magnesium stearate;
• crospovidone;
• hypromellose;
• colloidal silicon dioxide;
• titanium dioxide;
• talc;
• macrogol 6000.

The tablet shell consists of:

• hypromellose;
• methacrylic acid;
• ethyl acrylate copolymer;
• triethyl citrate;
• titanium dioxide (E171);
• talc;
• simethicone emulsion;
• vanilla flavoring 54286 C;
• bergamot flavoring 54253 T;
• macrogol 6000;
• carmellose sodium;
• polysorbate 80.

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.

pharmachologic effect

Panzinorm Forte 20000 is an enzyme preparation with an effect aimed at stimulating catabolic processes and replenishing the deficiency of enzymes (protein molecules, RNA molecules or their complex) of the pancreas.

Prescribed as an additional remedy for the treatment of diseases caused by a deficiency of the enzyme pancreatin .

The active substances included in the drug have a targeted effect on compensating for dysfunction of the excretory process of pancreatic fluid into the duodenum. lipase activity is of great importance in the treatment of maldigestion , a disease caused by pancreatic enzyme deficiency. By hydrolysis, lipase breaks down into its components - glycerol and fatty acids. This stimulates the absorption of glycerol and fatty acids , as well as isoprenoids .

Amylase breaks down carbohydrates into dextrins and sugars, and protease breaks down proteins.

The active substance of this drug is pork pancreatin , which contains enzymes that facilitate the digestion of fats, proteins and carbohydrates, and thus ensure their almost absolute absorption in the small intestine.

When taken correctly, the drug neutralizes the symptoms that arise as a result of digestive disorders:

• feeling of heaviness;
• feeling of fullness in the stomach;
• flatulence;
• feeling of lack of air.

Pharmacological properties of the drug Panzinorm forte

The drug contains highly active natural pancreatic enzymes: lipase, amylase and protease. Lipase hydrolyzes fats into fatty acids and glycerol, thereby ensuring their absorption and absorption of fat-soluble vitamins. Amylase takes part in the conversion of carbohydrates into dextrins and glucose. Proteases take part in the digestion of proteins. The ingredients included in the drug are obtained from the pig pancreas and are similar to similar human enzymes. The film coating of the tablet protects enzymes sensitive to the action of gastric juice during passage through the stomach from inactivation by acid. Dissolution of the shell occurs in the intestine, where enzymes take part in the processes of autolysis and proteolysis. Enzymes are not absorbed in the gastrointestinal tract and act in the intestines. A small part of the enzymes is excreted from the body along with feces.

Indications for use

Panzinorm Forte 20000 is indicated for use for:

• chronic disruption of the production of pancreatic juice in an amount insufficient for normal digestion of food;
• cystic fibrosis;
• diseases of the hepatobiliary system;
• dyspepsia associated with eating food that is difficult to digest;
• flatulence;
• preparation for x-ray examination or ultrasound.

Side effects

Side effects of Panzinorm Forte 20000 are expressed in the manifestation of such reactions as:

• allergic skin rashes, redness and itching;
• bronchospasm;
• nausea;
• urge to vomit;
• pain in the abdominal area;
• constipation;
• diarrhea;
• colitis;
• abdominal symptoms of an unusual nature;
• increased pain;
• hyperuricemia;
• phthalate deficiency.

Instructions for use Panzinorm Forte 20000

The instructions for using this drug have some peculiarities, so you should read it before taking the drug for the first time.

The tablets are taken with meals. They should not be chewed, and to make it easier to take, it is better to take the tablets with plenty of water.

The dosage and duration of treatment using this drug is determined by a specialist individually, depending on the patient’s age and the severity of his disease.

At the first stage of treatment, in the absence of other indications, Panzinorm Forte 20000 is prescribed in a minimum dosage - from 1 tablet with a dosage frequency of up to 3 times a day with food or during snacks. At the discretion of the attending physician, the dosage can be increased to 6 tablets per day.

Taking the drug before X-ray examination and ultrasound should begin at least two days before the procedure in a dosage of 2 tablets with a dosage frequency of up to 3 times a day.

Panzinorm 20000 (Diseases of the gastrointestinal tract)

NAME OF THE DRUG

Panzinorm ® forte 20 000, tablets.

QUALITATIVE AND QUANTITATIVE COMPOSITION

Compound

for 1 tablet

Core:

Active substance:

Pancreatin (pork)1 269.12 mg – 279.44 mg2

Excipients: lactose monohydrate 53.90 mg - 64.22 mg, microcrystalline cellulose 72.66 mg, crospovidone 10.40 mg, colloidal silicon dioxide, anhydrous 1.60 mg, magnesium stearate 2.00 mg

Shell: hypromellose 6.25 mg, methacrylic acid and ethyl acrylate copolymer (1:1) 15.89 mg, triethyl citrate 5.07 mg, titanium dioxide (E171) 6.58 mg, talc 9.60 mg, simethicone emulsion 0.43 mg, vanilla flavor (54286 C) 0.34 mg, bergamot flavor (54253 T) 0.16 mg, macrogol-6000 0.25 mg, carmellose sodium 0.55 mg, polysorbate-80 0.88 mg

1C enzymatic activity: lipase 20,000 units. Evr.Pharm., amylase 12,000 units. Eur.Pharm., protease 900 units. EuroPharm.

The 215% excess of pancreatin is due to technical losses during the production process. An excess of 10% pancreatin is used to compensate for losses due to breakdown during the storage period.

PHARMACEUTICAL FORM

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

CLINICAL DATA

Indications for use

Replacement therapy for exocrine (enzyme) pancreatic insufficiency in children and adults, caused by a decrease in the enzyme activity of the pancreas due to impaired production, regulation of secretion, delivery of pancreatic enzymes or their increased destruction in the intestinal lumen, which is caused by a variety of diseases of the gastrointestinal tract, and most often occurring when:

• cystic fibrosis,

• chronic pancreatitis,

• after pancreatic surgery,

• after gastrectomy,

• pancreatic cancer,

• partial gastrectomy (for example, Billroth II),

• obstruction of the pancreatic duct or common bile duct (for example, due to a neoplasm),

• Shwachman-Diamond syndrome,

• condition after an attack of acute pancreatitis and resumption of nutrition.

To avoid complications, use only after consulting a doctor.

Contraindications

Hypersensitivity to the active substance (porcine pancreatin) or to any auxiliary component of the drug,

lactase deficiency, lactose intolerance, glucose-galactose malabsorption syndrome (the drug Panzinorm ® forte 20,000 contains lactose),

· children under 3 years of age (for this dosage form).

Use during pregnancy and breastfeeding

Pregnancy

There are no clinical data on the treatment of pregnant women with drugs containing pancreatic enzymes. Animal studies have not revealed the absorption of pancreatic enzymes of porcine origin, therefore toxic effects on reproductive function and fetal development are not expected.

The drug should be prescribed to pregnant women with caution if the expected benefit to the mother outweighs the potential risk to the fetus.

Breastfeeding period

Based on animal studies, which did not reveal systematic negative effects of pancreatic enzymes, no harmful effects of the drug on the child through breast milk are expected.

Pancreatic enzymes can be taken by women during breastfeeding.

If necessary, during pregnancy or breastfeeding, Panzinorm ® forte 20,000 should be taken in doses sufficient to maintain adequate nutritional status.

Directions for use and doses

Inside, take with meals. Tablets of the drug Panzinorm ® forte 20,000 should be taken without chewing with a sufficient amount of liquid.

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

For adults, Panzinorm ® forte 20,000 is recommended to be taken (in the absence of other prescriptions) at the beginning of treatment, 1 tablet 3 times a day with each main meal. It is possible to take Panzinorm ® forte 20,000 while taking a light snack. If necessary, the single dose is increased by 2 times. The average daily dose is 1-2 tablets 3 times a day.

In children, the drug is used as prescribed by a doctor. Children over 3 years of age – 100,000 units/day (in terms of lipase).

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

Side effects

Gastrointestinal disorders:

very often (≥ 1/10): pain in the abdomen;

often (≥ 1/100, < 1/10): nausea, vomiting, constipation, bloating, diarrhea;

frequency unknown: strictures of the ileum, cecum and colon (fibrosing colonopathy).

Gastrointestinal disorders are mainly associated with the underlying disease. The incidence of adverse reactions such as abdominal pain and diarrhea was lower or similar to that observed with placebo.

Strictures of the ileum, cecum and colon (fibrosing colonopathy) have been observed in patients with cystic fibrosis receiving high doses of pancreatin preparations (see section "Special Instructions").

Disorders of the skin and subcutaneous tissues:

uncommon (≥ 1/1000, < 1/100): skin rash;

frequency unknown: skin itching, urticaria.

Immune system disorders:

frequency unknown: hypersensitivity (anaphylactic reactions).

Allergic reactions were observed mainly from the skin, but other manifestations of allergies were also noted. Reports of these side effects were received during post-marketing use and were spontaneous. There are insufficient data to accurately estimate the incidence of cases.

When used in children, no specific adverse reactions were observed. The frequency, type and severity of adverse reactions in children with cystic fibrosis were similar to those in adults.

Overdose

Symptoms: hyperuricosuria and hyperuricemia.

Treatment: drug withdrawal, symptomatic therapy, ensuring adequate rehydration.

Interaction with other drugs

No interaction studies have been conducted.

special instructions

Strictures of the ileum, cecum, and colon (fibrosing colonopathy) have been described in patients with cystic fibrosis treated with high doses of pancreatin (over 10,000 U lipase/kg/day).

Effect on the ability to drive a car and other mechanisms

The use of the drug Panzinorm ® forte 20,000 does not affect or has an insignificant effect on the ability to drive a car and operate machinery.

PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: digestive enzyme agent

ATX code: A09AA02

Pharmacological properties

Pharmacodynamics

An enzyme preparation that improves food digestion processes in adults and children, and thereby reduces the symptoms of pancreatic enzyme insufficiency (flatulence, changes in stool frequency and consistency). Pancreatic enzymes included in the drug facilitate the breakdown of proteins, fats, and carbohydrates, which leads to their complete absorption in the small intestine.

The drug Panzinorm ® forte 20,000 is a tablet containing porcine pancreatin, coated with an enteric (acid-resistant) coating. When the tablets reach the small intestine, the enteric coating dissolves rapidly (at pH > 5.5), releasing enzymes with lipolytic, amylolytic and proteolytic activity, resulting in the breakdown of fats, carbohydrates and proteins. The resulting substances are then either absorbed directly or further broken down by intestinal enzymes.

Pharmacokinetics

Animal studies have demonstrated a lack of absorption of uncleaved enzymes and, as a result, classical pharmacokinetic studies have not been performed. Preparations containing pancreatic enzymes do not require absorption to produce their effects. On the contrary, the therapeutic activity of these drugs is fully realized in the lumen of the gastrointestinal tract. According to their chemical structure, they are proteins and, in connection with this, when passing through the gastrointestinal tract, enzyme preparations are broken down until absorption occurs in the form of peptides and amino acids.

PHARMACEUTICAL DATA

Release form

Enteric-coated tablets.

10 tablets in a blister made of combined material OPA/Al/PVC and aluminum foil.

1, 3 or 10 blisters along with instructions for use are placed in a cardboard pack.

CARRIER OF REGISTRATION CERTIFICATE

Name of the legal entity in whose name the registration certificate was issued, address

JSC Krka d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer

JSC Krka d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Packer (Primary packaging)

JSC Krka d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

LLC "KRKA-RUS", 143500, Russia, Moscow region, Istra, st. Moskovskaya, 50

Tel.

Fax

JSC "Vector-Medica", 630559, Russia,

Novosibirsk region, urban district working village Koltsovo, rural settlement Koltsovo, Research and Production Zone, building. 38;

Novosibirsk region, urban district, working village of Koltsovo, RP Koltsovo, Research and Production Zone, building 13;

Novosibirsk region, urban district working village Koltsovo, rural settlement Koltsovo, Research and Production Zone, building 15

Tel/fax

Packer (Secondary (consumer) packaging)

JSC Krka d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

LLC "KRKA-RUS", 143500, Russia, Moscow region, Istra, st. Moskovskaya, 50

Tel.

Fax

JSC "Vector-Medica", 630559, Russia,

Novosibirsk region, urban district working village Koltsovo, rural settlement Koltsovo, Research and Production Zone, building. 38;

Novosibirsk region, urban district, working village of Koltsovo, RP Koltsovo, Research and Production Zone, building 13;

Novosibirsk region, urban district working village Koltsovo, rural settlement Koltsovo, Research and Production Zone, building 15

Tel/fax

Issue quality control

JSC Krka d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

LLC "KRKA-RUS", 143500, Russia, Moscow region, Istra, st. Moskovskaya, 50

Tel.

Fax

JSC "Vector-Medica", 630559, Russia,

Novosibirsk region, urban district working village Koltsovo, rural settlement Koltsovo, Research and Production Zone, building. 38;

Novosibirsk region, urban district, working village of Koltsovo, RP Koltsovo, Research and Production Zone, building 13;

Novosibirsk region, urban district working village Koltsovo, rural settlement Koltsovo, Research and Production Zone, building 15

Tel/fax

Name and address of the organization receiving consumer complaints

LLC "KRKA-RUS", 125212, Moscow, Golovinskoe highway, building 5, building 1

Tel., fax

REGISTRATION AUTHORITY NUMBER

P No. 014602/01

Analogues of Panzinorm Forte

Level 4 ATC code matches:
Digestin

Creon

Pancitrate

Mezim

Festal

Pankreoflat

Pancreazim

Enterosan

Panzinorm

Micrasim

Enzistal P

Pancreatin

Penzital

Pangrol

Hermital

Abomin

There are a large number of analogues of Panzinorm Forte on the modern pharmaceutical market. Drugs similar in action and composition are:

• Panzinorm Forte-N;
• Biozyme;
• Gastenorm Forte;
• Creon;
• Mezim;
• Micrasim;
• Pangrol;
• PanziCam;
• Panzim Forte;
• Panzinorm;
• Pancreazim;
• Pancreatin;
• Pancrelipase;
• Pankrenorm;
• Pancitrate;
• Penzital;
• Uni-Festal;
• Festal N;
• Enzistal-P;
• Hermital.

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.

Reviews of Panzinorm Forte 20000

Reviews about Panzinorm Forte 20000 on the Internet are different, but all the opinions of users who have been treated with this drug boil down to the fact that this is one of the best enzyme preparations, which has proven itself well decades ago.

Thanks to the excellent combination of low price and excellent quality, as well as the inevitable effect that occurs at different periods of time depending on the age of the patient and the severity of his disease, Panzinorm 20000 is trusted by doctors and patients in many countries around the world.

Price Panzinorm Forte 20000

The price of Panzinorm Forte is relatively low for drugs of similar quality. You can buy the product in pharmacies for a price starting from 68 rubles.

• Online pharmacies in RussiaRussia
• Online pharmacies in UkraineUkraine

ZdravCity

• Panzinorm Forte 20000 tablets p.p.o.
  enteric solution 30 pcs. KRKA/Krka-Rus LLC 232 rub. order

Pharmacy Dialogue

• Panzinorm forte (table p/o 20000 No. 30)KRKA/KPKA-RUS

  RUB 216 order

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Pharmacy24

• Panzinorm forte 20000 No. 10 tablets KRKA, Slovenia
  77 UAH. order
• Panzinorm forte 20000 No. 30 tablets KRKA, Slovenia

  167 UAH order