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Enzirem ® Neo – capsules

INSTRUCTIONS FOR MEDICAL USE

ENZIREM® NEO

Trade name of the drug: Enzirem® Neo

Active substance (INN): Pancreatin

Dosage form: capsules.

Contents:

1 capsule contains:

The active substance:

For dosage of 10000 IU: pancreatin with enzymatic activity of lipase 10000 IU Eur.F, amylase 8000 IU Eur.F, protease 600 IU Eur.F

For dosage of 25000 IU: pancreatin with enzymatic activity of lipase 25000 IU Eur.F, amylase 18000 IU Eur.F, protease 1000 IU Eur.F

Excipients: triethylcitrate, talc, copolymer of methacrylic acid.

Description: Solid gelatin capsules, color orange, size “0”. Capsule contents – pellets from light beige to dark brown in color.

Pharmacotherapeutic group: Digestive enzymes.

ATX code: A09AA02.

Pharmacological properties

Enzyme preparation. It compensates the lack of pancreatic enzymes (lipase, amylase and protease) which hydrolyze vegetable and animal fats (to glycerol and fatty acids), polysaccharides (to dextrins and monosaccharides) and proteins (to dipeptides and amino acids) respectively, contributing to more complete absorption of food substances in small intestine. Improves digestion.

Pharmacokinetics

The drug is not absorbed from the gastrointestinal tract and acts locally.

Special dosage form of the drug enables to avoid decrease in enzyme activity due to inactivation by gastric juice.

Granules of the drug contained in a capsule with acid-resistant coating are evenly mixed with the contents of the stomach and enter the duodenum. Rapid release and activation of the enzymes begins in its slightly acidic or neutral environment, where the coating of the granules disintegrates.

Granules are stable in gastric medium at pH below 5.5. Stable in the presence of gastric juice for 45 min. The release of enzymatic activity at pH 6 is 75-100% within 1 h, at pH 6.8-100% within 30 min, at pH 8 – complete release in 15 min.

After interaction with substrates protease, lipase and amylase in lower intestine lose activity and are excreted together with intestinal contents.

Indications for use

Substitutive therapy for insufficiency of exocrine pancreatic function in children and adults. Lack of exocrine function of the pancreas is associated with a variety of gastrointestinal tract diseases and is most commonly seen in:

  • cystic fibrosis,
  • chronic pancreatitis,
  • After pancreatic surgery,
  • after gastrectomy,
  • pancreatic cancer,
  • partial resection of the stomach (e.g., Bilroth II),
  • pancreatic duct or common bile duct obstruction (e.g., due to a neoplasm),
  • Schwachman-Daimond syndrome.

To avoid complications, use only after consultation with physician.

Dosage and administration

Inside.

Doses of the drug chosen individually depending on the severity of the disease and the composition of the diet.

Capsules should be taken during or immediately after each meal (including snacks), swallowed as a whole, do not break or chew, drinking plenty of fluids.

If it is difficult to swallow (e.g., in young children or elderly patients) capsules should be opened carefully, and microgranules should be added to liquid food that does not require chewing and has a sour taste, such as apple puree or fruit juice (pH < 5.5). It is not recommended to add the contents of the capsules to hot food. Any mixture of microgranules with food or liquid should not be stored and should be taken immediately after preparation.

It is important to ensure adequate continued fluid intake by the patient, especially if there is increased fluid loss. Inadequate fluid intake may cause or exacerbate constipation.

Dose for adults and children with cystic fibrosis

  • The dose depends on body weight and should be 1000 lipase units/kg at the start of treatment per meal for children less than four years of age, and 500 lipase units/kg at meal times for children over four years of age.
  • The dose should be determined according to the severity of symptoms, the results of steatorrhea control, and maintenance of adequate nutritional status.
  • In most patients the dose should remain less or not exceed 10000 lipase units/kg body weight per day or 4000 lipase units/g of fat consumed.

Dose in other conditions accompanied by exocrine pancreatic insufficiency

The dose should be adjusted to the patient’s individual characteristics, which include the degree of digestive insufficiency and the fat content of the food. The dose required by the patient along with the main meal ranges from 25,000 to 80,000 IU of lipase, and half the individual dose during a light snack.

Side effects

When used in moderate therapeutic doses, side effects occur in less than 1% of cases.

Digestive system: in some cases – diarrhea, constipation, feeling of discomfort in the stomach, nausea.

Allergic reactions: in some cases – skin manifestations.

Metabolism: development of hyperuricosuria in case of long-term use in high doses; in excessive doses – increase in plasma uric acid level.

Other: when using the drug in high doses in children it may cause anal irritation.

Contraindications:

  • Hypersensitivity to pancreatin or to one of the excipients
  • acute pancreatitis
  • exacerbation of chronic pancreatitis.

Special indications

Dosage of the drug in cystic fibrosis must be adequate to the quantity of enzymes required for hydrolysis of fats with regard to the quality and quantity of food consumed. Children receiving long-term treatment with the drug for cystic fibrosis should be regularly examined by a specialist. In cystic fibrosis, if the required dose of pancreatin is exceeded, structures may form in the ascending part of the colon.

The safety of using the drug in pregnancy has not been studied sufficiently. Administration during pregnancy and lactation is possible only by physician’s prescription in cases when the expected effect of therapy for a mother exceeds the potential risk for a fetus or child.

The drug should be used only after consultation with a physician in order to prevent complications.

The drug has no effect on the ability to drive and operate machines and mechanisms.

Drug interactions

Reduces iron absorption (especially with long-term use). Simultaneous use of histamine H2-receptor blockers, proton pump inhibitors or antacid drugs can increase the effectiveness of pancreatin. When concomitant use with cimetidine, bicarbonates, it is recommended to periodically monitor folate levels and/or folic acid administration. Pancreatin may reduce the effectiveness of acarbose and miglitol.

Overdose

If extremely high doses are taken, hyperuricemia and hyperuricosuria are possible, constipation in children.

Treatment: Discontinue the drug and if necessary, conduct symptomatic therapy.

Form of production

Capsules of 10000 and 25000 units in carton packs.

Storage conditions

Store in a dry, dark place at temperatures not exceeding 25°C. Keep away from children!

Shelf life

2 years. Do not use after the expiration date.

Conditions of dispensing from pharmacies

Released without a prescription.

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