Pancreatin 8000 gr

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT PANKREATIN 8000 GR (PANCREATIN 8000 GR)

Composition:

Active substance: pancreatin;

One tablet contains pancreatin with enzymatic activity of not less than 8000 lipolytic IU Ph. Eur., 5600 amylolytic IU Ph. Eur., 370 proteolytic IU 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. Enteric-coated tablets.

Main physicochemical characteristics: round-shaped enteric-coated tablets with convex upper and lower surfaces, pink-colored, with a faint specific odor.

When viewed under a magnifying glass, the cross-section reveals a core surrounded by a single continuous layer.

Pharmacotherapeutic group.

Digestive enzymes and other agents improving digestion. Pancreatic enzyme preparations.

ATC code A09A A02.

Pharmacological properties.

Pharmacodynamics.

Polyenzyme preparation. Pancreatic enzymes (lipase, amylase, and protease) contained in the formulation facilitate the digestion of fats, carbohydrates, and proteins, thereby promoting their complete absorption in the small intestine. In pancreatic disorders, the preparation compensates for the insufficiency of its exocrine function and improves the digestive process.

Pharmacokinetics.

The tablets have a protective coating insoluble in the acidic environment of the stomach, which prevents the degradation of enzymes by gastric juice pH.

Clinical characteristics.

Indications.

• Diseases associated with impaired digestion due to insufficient secretion of pancreatic digestive enzymes, such as chronic pancreatitis.
• Conditions following concomitant resection of the stomach and small intestine, functional acceleration of food passage through the intestine, intestinal disorders, concurrent intake of poorly digestible plant-based, fatty, and unusual food.
• Intestinal bloating and preparation for radiological or ultrasound diagnostic examinations.

Contraindications.

Hypersensitivity to the components of the drug. Acute pancreatitis, exacerbation of chronic pancreatitis.

Interaction with other medicinal products and other types of interactions.

Administration of drugs containing pancreatin may reduce the absorption of folic acid, which may necessitate additional supplementation of folic acid.

Special precautions for use.

The drug contains active enzymes that may damage the oral mucosa; therefore, the tablets should be swallowed whole, without chewing.

Use during pregnancy or breastfeeding.

During pregnancy or breastfeeding, the drug should be used only as prescribed by a physician, when the expected benefit to the mother outweighs the potential risk to the fetus/child.

Ability to influence reaction rate when driving or operating machinery.

Has no effect.

Dosage and Administration.

The dosage of the drug depends on the degree of pancreatic enzyme deficiency in the duodenum and is determined individually.

If there are no other recommendations, and also in cases of consuming poorly digestible plant-based food, fatty or unusual food, take 1–2 tablets. In other cases listed above, when digestive disturbances occur, the recommended dose is 2–4 tablets. The dose may be increased if necessary. Dose escalation aimed at reducing disease symptoms, such as steatorrhea or abdominal pain, should be performed only under medical supervision. The daily dose of lipase should not exceed 15,000–20,000 Ph. Eur. units 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 individually by a physician.

Children.

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

Overdose.

Possible adverse effects include nausea, vomiting, diarrhea, intestinal obstruction, hyperuricemia, uricosuria, and perianal skin irritation.

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

Side effects.

Immune system disorders.

Allergic reactions, including rash, itching, sneezing, urticaria, lacrimation, bronchospasm, anaphylactic reactions.

The dye carmoisine (E 122) may cause allergic reactions.

Gastrointestinal disorders.

Diarrhea, bloating, abdominal pain, nausea, vomiting, changes in bowel movements; intestinal obstruction and constipation are possible.

Shelf life. 3 years.

Storage conditions.

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

Keep out of reach of children.

Packaging.

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

Availability category. Over-the-counter.

Manufacturer.

JSC "Tekhnolog".

Manufacturer's name and address of the place of business.

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