PANCREAZIM 10000

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT PANCREAZIM 10000 (PANCREAZIM 10000)

Composition:

Active substance: pancreatin;

One gastro-resistant tablet contains pancreatin with enzymatic activity of not less than 10,000 lipolytic units Ph. Eur., 7,500 amylolytic units Ph. Eur., and 400 proteolytic units Ph. Eur.;

Excipients: sodium chloride, colloidal anhydrous silicon dioxide, microcrystalline cellulose, crospovidone, sodium croscarmellose, povidone 25, magnesium stearate, methacrylic acid copolymer dispersion, talc, propylene glycol, titanium dioxide (E 171), carmoisine (E 122).

Pharmaceutical form. Gastro-resistant tablets.

Main physicochemical properties: round-shaped tablets, coated, with convex upper and lower surfaces, pink in color, with a slight specific odor. When broken, the core surrounded by a single continuous layer is visible under magnification.

Pharmacotherapeutic group.

Agents affecting the digestive system and metabolism. Digestive aids, including enzymes. Pancreatic enzyme preparations (lipase, protease, etc.).

ATC code A09AA02.

Pharmacological Properties

Pharmacodynamics

A polyenzyme preparation. Pancreatic enzymes (lipase, amylase, and protease) contained in the formulation facilitate the digestion of fats, carbohydrates, and proteins, promoting their complete absorption in the small intestine. In pancreatic diseases, the medicinal product compensates for exocrine insufficiency of the pancreas and improves the digestive process.

Pharmacokinetics

The coating covering the tablet does not dissolve under the action of gastric juice and protects the enzymes from inactivation by gastric acid. The coating dissolves only under the influence of the neutral or slightly alkaline environment of the small intestine, resulting in the release of enzymes.

Clinical characteristics.

Indications.

Diseases associated with impaired digestion due to insufficient secretion of pancreatic digestive enzymes, such as chronic pancreatitis.

Conditions following simultaneous resection of the stomach and small intestine, functional acceleration of intestinal transit, intestinal disorders, consumption of poorly digestible plant-based, fatty, or unusual food.

Intestinal bloating.

Preparation for radiological or ultrasound diagnostic examinations.

Contraindications.

Hypersensitivity to the active substance and other components of the medicinal product. Acute pancreatitis, exacerbation of chronic pancreatitis, intestinal obstruction.

Interaction with other medicinal products and other types of interactions.

When using pancreatin, absorption of iron may be reduced; therefore, if necessary, iron supplements should be additionally prescribed.

Concomitant use of antacids containing calcium carbonate and/or magnesium hydroxide may lead to reduced efficacy of pancreatin.

Concomitant use with tannins or alcohol-containing agents may lead to reduced efficacy of pancreatin.

When bicarbonates and cimetidine are taken simultaneously with high doses of pancreatic enzymes, periodic monitoring of serum folate concentration is recommended, and additional folic acid supplementation should be provided if necessary.

Folic acid. Absorption of folic acid may be reduced in patients taking pancreatic enzyme preparations; therefore, monitoring of folic acid levels is recommended during concomitant use.

Ac arbose, miglitol. It is not excluded that pancreatic enzyme preparations may reduce the effect of these antidiabetic agents. Therefore, during concomitant use with pancreatin, monitoring of the effect of antidiabetic agents on the patient's blood glucose levels is recommended.

Special precautions for use.

In the presence of symptoms suggestive of intestinal obstruction, the possibility of intestinal strictures should be considered. Unusual symptoms should be monitored, especially when the dose exceeds 10,000 units of lipase/kg/day.

There is a theoretical risk of transmission of porcine viral infections, including infections caused by new or undefined viruses. The possibility of porcine viruses capable of infecting humans cannot be entirely excluded. However, to date, no cases of infectious disease transmission have been reported following the use of porcine pancreatin products.

The medicinal product contains active enzymes that may damage the oral mucosa; therefore, tablets should be swallowed whole and not chewed.

The product should be used with caution in patients with renal insufficiency, hyperuricemia, and in patients allergic to porcine-derived proteins.

This medicinal product contains approximately 0.024 mmol (or 0.55 mg)/dose of sodium. Caution should be exercised when administering to patients on a sodium-restricted diet.

The medicinal product contains propylene glycol.

Use during pregnancy or lactation.

Safety has not been established.

The use of this medicinal product during pregnancy or breastfeeding should be avoided.

Ability to influence the speed of reactions while driving or operating machinery.

No effects on the ability to drive or operate machinery have been observed.

Dosage and Administration

The dose of the medicinal product depends on the deficiency of pancreatic enzymes in the duodenum and is determined individually.

If there are no other recommendations, and also when consuming hard-to-digest plant-based food, fatty or unusual food, take 1–2 tablets. In other aforementioned cases, when digestive disturbances occur, the recommended dose is 2–4 tablets. If necessary, the dose may be increased. Dose escalation aimed at reducing disease symptoms, such as steatorrhea or abdominal pain, should be performed only under physician supervision. The daily dose of lipase should not exceed 15,000–20,000 IU Ph. Eur. per 1 kg of body weight.

Take tablets during meals, swallowing them whole with a sufficient amount of liquid, for example, one glass of water.

The duration of treatment depends on the course of the disease and is determined by the physician individually.

Children.

There is no experience with the use of the medicinal product in children; therefore, its administration to this age group of patients is not recommended.

Overdose.

Symptoms: Possible intensification of adverse effects. During intake of extremely high doses of other pancreatic enzyme powder preparations, hyperuricemia and hyperuricosuria have been observed.

Treatment: Discontinue the drug, ensure adequate hydration, and provide symptomatic therapy.

Adverse reactions

The following classification is used to assess the frequency of adverse reactions: very common: ≥ 1/10; common: ≥ 1/100 to < 1/10; uncommon: ≥ 1/1000 to < 1/100; rare: ≥ 1/10,000 to < 1/1000; very rare: < 1/10,000; frequency not known (cannot be estimated from the available data).

Cardiovascular system: frequency not known: tachycardia.

Immune system: very rare: immediate-type allergic reactions (skin rash, itching, sneezing, lacrimation, bronchospasm), anaphylactic reactions. Frequency not known: carmoisine dye (E 122) may cause allergic reactions.

Gastrointestinal system: very rare: with administration of high doses of pancreatin (more than 10,000 Ph. Eur. units of lipase/kg body weight/day), strictures may develop in the ileocecal region and ascending colon; diarrhea, abdominal pain, nausea, vomiting, changes in stool characteristics; intestinal obstruction and constipation may occur.

Skin and subcutaneous tissue: frequency not known: urticaria, hyperemia, itching, angioneurotic edema.

Urinary and reproductive system: frequency not known: increased urinary excretion of uric acid may occur, especially with high-dose pancreatin. In such patients, urinary uric acid levels should be monitored to prevent formation of uric acid calculi.

General disorders: frequency not known: sensation of warmth, general weakness.

Reporting of adverse reactions after drug registration is of great importance. It enables ongoing monitoring of the benefit-risk balance of the medicinal product. Healthcare and pharmaceutical professionals, as well as patients or their legal representatives, are encouraged to report all suspected adverse reactions and lack of efficacy via the Automated Pharmacovigilance Information System at the following link: https://aisf.dec.gov.ua/.

Shelf life. 3 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 ºC.

Keep out of reach of children.

Packaging.

10 tablets in a blister. 1, 2, or 5 blisters per cardboard box.

Prescription status.

Over-the-counter.

Manufacturer.

JSC "Tekhnolohiia".

Manufacturer's address and place of business.

8 Stara Prorizna Street, Uman, Cherkasy region, 20300, Ukraine.