Pancreatin Reneval 10000,10000 units 20 pcs

Pharmacotherapeutic group: digestive enzyme. ATX code: A09AA02 Pharmacodynamics

Pancreatin is a powder from the pancreas glands of pigs. Pancreatic enzymes contained in pancreatin have proteolytic, amylolytic and lipolytic effect and contribute to the breakdown of proteins, fats and carbohydrates, improve the functional state of the gastrointestinal tract (GIT), thus normalizing digestion.

Pharmacokinetics

Pancreatin 10 000 tablets are covered with acid-resistant coating, which is resistant to the influence of gastric hydrochloric acid and thus protects the pancreatic enzymes contained in the preparation from inactivation. Dissolution of the enteric membrane and release of enzymes occurs at neutral or slightly alkaline pH values. Pancreatic enzymes are not absorbed from the gastrointestinal tract.

Indications

• To improve digestion in patients with normal gastrointestinal function in case of dietary irregularities;

• insufficiency of external pancreatic secretory function (chronic pancreatitis, cystic fibrosis and others);

• chronic inflammatory-dystrophic diseases of the stomach, intestines, liver, gallbladder;

• conditions following resection or irradiation of the gastrointestinal organs, accompanied by indigestion disorders, flatulence, diarrhea (as part of combined therapy);

• Preparation for X-ray and ultrasound examination of the abdominal cavity;

• Gastrointestinal disorders of functional character (with acute intestinal infections, irritable bowel syndrome and others).

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Active ingredient

Pancreatin

Composition

Active ingredient: Pancreatin1, corresponding to the enzymatic activity: lipase – at least 10000 units, amylase – at least 7500 units, protease – at least 375 units Excipients: Microcrystalline cellulose 102 – 52,000 mg, crosspovidone – 18,000 mg, magnesium stearate – 1,867 mg, colloidal silicon dioxide (aerosil) – 1,533 mg, lactose monohydrate – to obtain a tablet without a shell weight of 300,000 mg Shell composition: methacrylic acid and ethylacrylate copolymer (1:1) – 12.200 mg, talc – 6.780 mg, titanium dioxide – 5.050 mg, hypromellose – 4.800 mg, triethylcitrate – 3.900 mg, polysorbate 80 (tween 80) – 0.690 mg, sodium carmellose (sodium carboxymethylcellulose) – 0.440 mg, macrogol 6000 (polyethylene glycol 6000) – 0,210 mg, simethicone emulsion 30% (dry weight)2 – 0.163 mg, dye azorubin (carmoisine) – 0.022 mg 1 Quantity may vary depending on the lipolytic activity of the parent substance. A substance with lipolytic activity between 80 IU/mg and 44 IU/mg is acceptable. 2 Emulsion consists of simethicone (30%), emulsifiers (5-10%), preservatives (0.5-1.0%), purified water (60-65%).

How to take, the dosage

The dose of the drug Pancreatin Reneval 10 000 is set individually depending on the disease and severity of symptoms.

If there are no other indications, adults should take 2-4 tablets of Pancreatin Reneval 10,000 with meals. The drug is taken orally without breaking or chewing the tablet (the efficacy of Pancreatin Reneval 10 000 may be reduced by chewing, and the pancreatic enzymes may irritate the oral mucosa if released) and with plenty of fluid (e.g. a glass of water).

The daily dose of pancreatic enzymes, which is 15000-20000 units of lipase/kg body weight, should not be exceeded.

Intensification of the dose should only be done under medical supervision, based on symptomatic findings (e.g., decrease in steatorrhea and abdominal pain).

The duration of therapy is determined by the physician, and varies from a few days (if indigestion is caused by poor diet) to a few months or even years (if continued replacement therapy is necessary).

In children the dosage is determined by the doctor.

Dose for children and adults with cystic fibrosis

In patients with cystic fibrosis, the dose should be adjusted for severity of symptoms, results of steatorrhea control and maintenance of adequate nutritional status (see “Special Precautions”).

The dose should not exceed 10000 IU of lipase/kg body weight per day.

In children, the dosing regimen and duration of treatment are determined by the physician depending on the severity of digestive disorders and the composition of the diet at the rate of 1000 IU of lipase/kg of child body weight at each meal for children under 4 years old and 500 IU of lipase/kg of child body weight at each meal for children over 4 years old.

If there is no improvement after treatment, or if symptoms worsen, or if new symptoms develop, you should consult a physician.

To use the drug only according to the indication, route of administration, and dosage listed in the directions.

Interaction

Absorption of folic acid may be decreased when concomitant use with pancreatin preparations. The effect of hypoglycemic agents for oral administration (such as acarbose, miglitol) may be reduced when concomitant use with preparations of digestive enzymes containing enzymes that break down carbohydrates (eg, amylase).

If you use the above or other drugs (including over-the-counter), consult your doctor before using Pancreatin 10 000.

Special Instructions

In acute pancreatitis or exacerbation of chronic pancreatitis (at the stage of exacerbation attenuation), during the recovery diet, it is reasonable to take the drug Pancreatin 10 000 against the background of existing and/or remaining in the future exocrine pancreatic insufficiency.

In patients with cystic fibrosis, especially when taking high doses of Pancreatin, hyperuricosuria may be observed, so uric acid concentration in urine should be monitored in this group of patients.

Strictures in the ileocecal and ascending colon have been described in the above group of patients.
As a precautionary measure, a medical examination should be performed if there is unusual abdominal discomfort or changes in the nature of complaints, especially when taking more than 10,000 IU of lipase/kg body weight per day.

The drug Pancreatin 10 000 contains active enzymes that when released in the oral cavity, such as when chewing, can damage the oral mucosa (up to ulcer formation). Therefore, the tablet should be swallowed whole.

Effect on the ability to drive vehicles and mechanisms
Pancreatin 10 000 does not affect the ability to drive vehicles and other mechanisms.

Synopsis

Round biconvex, coated tablets from light pink to dark pink in color, characteristic odor is allowed. Roughness of the surface is allowed. On cross-section the core is light beige in color with flecks of almost white to light brown color.

Contraindications

– Hypersensitivity to any of the drug components;
– Acute pancreatitis or chronic pancreatitis in the acute phase. Nevertheless, it is possible to use in the phase of subsiding exacerbation during dietary expansion, if there are signs of digestive disorders;
– hereditary galactose intolerance, lactase deficiency or glucose-galactose malabsorption syndrome;
– childhood under 3 years (for this dosage form).

Side effects

Possible side effects are listed below in descending frequency of occurrence: very common (≥ 1/10), common (≥ 1/100 to < 1/10), infrequent (≥ 1/1000 to < 1/100), rare (≥ 1/10000 to < 1/1000), very rare (< 1/10000), frequency not determined (cannot be estimated from available data).

Immune system disorders

Very rare: immediate-type allergic reactions (such as skin rash, urticaria, sneezing, lacrimation, bronchospasm, dyspnea), GI hypersensitivity.

Gastrointestinal tract disorders

Very rare: diarrhea, abdominal discomfort, abdominal pain, nausea, vomiting; formation of strictures in the ileocecal and ascending colon in patients with cystic fibrosis when high-dose pancreatin is used.

Urogenital system disorders

Frequency unknown:hyperuricosuria (see section “Special Precautions”).

If you experience or worsen the side effects listed in the instructions, or if you notice any dother side effects not listed in the instructions, tell your doctor.

Overdose

Symptoms: hyperuricosuria, hyperuricemia (especially in patients with cystic fibrosis taking high doses of enzyme preparations).
Treatment: symptomatic therapy, withdrawal of the drug.

Pregnancy use

The safety of pancreatin administration during pregnancy and during breastfeeding has not been adequately studied. Use is possible in cases when the expected benefit to the mother exceeds the potential risk to the fetus or infant.

Similarities

Mezim forte, Creon 40000, Pancreatin, Creon 25000, Micrazyme, Hermital, Panzinorm forte 20000, Penzital, Pancreatin Forte, Creon 10000, Creon 25000, Mezim 20000, Enzival-P, Mezim