Pancreatin for children

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT PANCREATIN FOR CHILDREN

Composition:

Active substance: pancreatin;

1 tablet contains pancreatin corresponding to a minimum enzymatic activity of:
750 amylolytic units Ph. Eur., 1000 lipolytic units Ph. Eur., 75 proteolytic units Ph. Eur.;

Excipients: lactose monohydrate; povidone; calcium stearate; acrylic-IZ green 93O31213 [a mixture of dry substances: methacrylic acid copolymer (type C), talc, titanium dioxide (E 171), triethyl citrate, yellow iron oxide (E 172), colloidal anhydrous silicon dioxide, sodium bicarbonate, sodium lauryl sulfate, brilliant blue (E 133)].

Pharmaceutical form. Enteric-coated tablets.

Main physicochemical characteristics: round, coated tablets with smooth, biconvex surfaces, light green to green in color; a specific odor may be present. When broken and examined under a magnifying glass, a core surrounded by a single continuous layer is visible.

Pharmacotherapeutic group. Digestive enzymes and other agents improving digestion. Pancreatic enzyme preparations. ATC code A09AA02.

Pharmacological properties.

Pharmacodynamics.

Pancreatin contains exocrine enzymes from the pancreas of pigs and cattle: lipase, amylase, trypsin, and chymotrypsin – which participate in the digestion of fats, carbohydrates, and proteins, promoting more complete absorption of these nutrients in the small intestine. When administered, pancreatin normalizes the digestive process and improves the functional state of the intestine.

Pharmacokinetics.

Due to the acid-resistant coating, the enzymes are not inactivated by gastric hydrochloric acid. Dissolution of the coating and release of enzymes begins in the duodenum. The enzymes are poorly absorbed in the gastrointestinal tract, exert their action within the intestinal lumen, and are excreted in the feces.

Clinical characteristics.

Indications.

Dyspepsia; simultaneous intake of hard-to-digest plant-based, fatty, and unusual food; flatulence associated with the aforementioned disorders; accelerated intestinal transit of functional origin.

Contraindications.

Individual hypersensitivity to pancreatic enzymes of animal origin or to any component of the medicinal product. Acute pancreatitis, chronic pancreatitis in the acute phase. Obstructive intestinal obstruction.

Interaction with other medicinal products and other forms of interaction.

When pancreatin is used concomitantly with antithrombotic agents, vitamin K antagonists, and acetylsalicylic acid, the effect of these drugs is reduced. The efficacy of non-selective inhibitors of neuronal reuptake of monoamines is also reduced when used simultaneously with pancreatin.

Concomitant use with M-cholinoblockers enhances the anticholinergic effect.

Administration of pancreatin may lead to reduced absorption of iron and folic acid.

Simultaneous use of antacid agents containing calcium carbonate and/or magnesium hydroxide, tannin, or alcohol-containing agents may result in decreased efficacy of pancreatin.

Special precautions.

Gastrointestinal disturbances may occur in patients with increased sensitivity to pancreatin or in patients with a history of meconium ileus or intestinal resection.

It should be noted that the presence of a methacrylic acid derivative in the drug formulation may pose a risk of developing fibrosing colonopathy when high doses are used. If signs of large bowel obstruction occur during treatment with this drug, the patient should be evaluated for fibrosing colonopathy as a possible underlying cause.

To prevent the formation of uric acid stones, urinary uric acid levels should be monitored.

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

When taking the drug before meals, it should be taken with alkaline liquids (e.g., "Borjomi" mineral water or 0.5–1% sodium bicarbonate solution).

During prolonged use, concomitant administration of iron preparations is recommended.

The drug contains lactose; therefore, if the patient has been diagnosed with an intolerance to certain sugars, medical advice should be sought before taking this medication.

Use during pregnancy or breastfeeding.

This drug is not intended for use in patients of reproductive age.

Ability to affect reaction rate when driving or operating machinery.

No precautions are necessary.

Method of Administration and Dosage

Take tablets before or during each meal without chewing, swallowing them with a large amount of liquid. The dosage of the medicinal product is determined individually by a physician depending on age and degree of enzyme deficiency, and may be adjusted.

For children aged 3–5 years, the single dose is 1 tablet; for children aged 6–7 years, 1–2 tablets; for children aged 8–9 years, 2 tablets; for children aged 10–14 years, 2–4 tablets.

The duration of treatment with the medicinal product is determined individually by a physician.

Children

The drug is intended for use in children aged 3 to 14 years (see section "Method of Administration and Dosage").

Overdose

Symptoms: in case of overdose, adverse effects may be intensified.

When extremely high doses of the drug are taken, hyperuricemia and hyperuricosuria may occur. Fibrosing colonopathy may develop with the use of high doses of the drug.

Treatment: discontinue the drug; symptomatic therapy.

Side effects.

Gastrointestinal system: diarrhea, constipation, flatulence, stomach discomfort, abdominal pain, nausea, vomiting, changes in bowel habits, development of stricture in the colon or ileocecal region. In case of unusual abdominal symptoms or worsening pain, fibrosing colonopathy should be ruled out.

Immune system: allergic reactions, including skin itching, rash, rhinitis, sneezing, lacrimation, bronchospasm, urticaria, anaphylactic reactions, angioedema.

Metabolism: with high-dose administration in children, perianal skin irritation may occur.

Shelf life.

2 years.

Storage conditions.

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

Keep out of reach of children.

Packaging. 10 tablets per blister, 10×2 or 10×6 blisters per pack.

Prescription status. Over-the-counter.

Manufacturer.

JSC "VITAMINS".

Manufacturer's address and place of business.

31 Uspenska Street, Uman, Cherkasy region, 20300, Ukraine.

Marketing authorization holder.

JSC "VITAMINS".

Address of the marketing authorization holder.

31 Uspenska Street, Uman, Cherkasy region, 20300, Ukraine.