Epicur^® (Capsules) Instructions for Use

Marketing Authorization Holder

FP Obolenskoe, JSC (Russia)

Contact Information

ALIUM JSC (Russia)

ATC Code

A02BC03 (Lansoprazole)

Active Substance

Lansoprazole (Rec.INN registered by WHO)

Dosage Form

Epicur®

Capsules 30 mg: 7, 14, 20, 21, 28, or 30 pcs.

Dosage Form, Packaging, and Composition

Capsules hard gelatin, size No. 1, with a transparent green body and a transparent green cap; the capsule contents are spherical microgranules white or almost white in color.

Excipients : mannitol, hypromellose, methacrylic acid and ethyl acrylate copolymer, magnesium carbonate, sodium phosphate dibasic, diethyl phthalate, sucrose, titanium dioxide, povidone K30, calcium carboxymethylcellulose, talc, sugar spheres [sucrose, starch syrup], polysorbate 80, sodium lauryl sulfate, sodium hydroxide.

Composition of the capsule body and cap quinoline yellow, patent blue

7 pcs. – blister packs (1) – cartons.
7 pcs. – blister packs (2) – cartons.
7 pcs. – blister packs (3) – cartons.
7 pcs. – blister packs (4) – cartons.
10 pcs. – blister packs (2) – cartons.
10 pcs. – blister packs (3) – cartons.

Clinical-Pharmacological Group

H⁺-K⁺-ATPase inhibitor. Antiulcer drug

Pharmacotherapeutic Group

Gastric secretion reducing agent – proton pump inhibitor

Pharmacological Action

Antiulcer drug. A specific proton pump inhibitor (H⁺-K⁺-ATPase).

It is metabolized in the parietal cells of the gastric mucosa to active sulfonamide derivatives, which inhibit the sulfhydryl groups of H⁺-K⁺-ATPase. It blocks the final stage of hydrochloric acid synthesis, reducing basal and stimulated secretion, regardless of the nature of the stimulus.

Using the drug at a dose of 30 mg causes a reduction in gastric secretion of hydrochloric acid by 80-97%. The inhibitory effect increases over 4 days. After discontinuation of the drug, acidity remains below 50% of the basal level for 39 hours, and no “rebound” increase in secretion is observed.

Secretory activity is restored 3-4 days after the end of drug administration.

The drug does not affect gastrointestinal motility.

In patients with Zollinger-Ellison syndrome, the drug acts for a longer duration.

Pharmacokinetics

Absorption and Distribution

After oral administration, Lansoprazole is well absorbed from the gastrointestinal tract. Bioavailability is 80%. Taking the drug simultaneously with food reduces absorption and bioavailability by 50%, but the inhibitory effect on gastric secretion remains the same. After oral administration of a 30 mg dose, C_max is reached in 1.5-2 hours and is 0.75-1.15 mg/L.
Plasma protein binding is 97.7-99.4%.

Metabolism and Excretion

It is actively biotransformed during the “first pass” through the liver. T_1/2 is 1.3-1.7 hours. 14-23% of the administered dose is excreted by the kidneys (as metabolites), the rest through the intestines.

Pharmacokinetics in Special Clinical Cases

In hepatic impairment and in elderly individuals, the elimination of lansoprazole is slowed.

Indications

• Gastric and duodenal ulcer;
• Reflux esophagitis;
• Erosive-ulcerative esophagitis;
• Erosive-ulcerative lesions of the stomach and duodenum associated with NSAID use;
• Stress ulcers;
• Erosive-ulcerative lesions of the stomach and duodenum associated with Helicobacter pylori;
• Zollinger-Ellison syndrome.

ICD codes

Dosage Regimen

Capsules should be taken orally, swallowed whole, without chewing.

For duodenal ulcer in the acute phase, 30 mg/day is prescribed for 2-4 weeks (in resistant cases – up to 60 mg/day).

For gastric ulcer in the acute phase and for erosive-ulcerative esophagitis, 30-60 mg/day is prescribed for 4-8 weeks.

For erosive-ulcerative lesions of the gastrointestinal tract caused by NSAID use, – 30 mg/day for 4-8 weeks.

For Helicobacter pylori eradication – 30 mg twice daily for 10-14 days in combination with antibacterial therapy.

For anti-relapse treatment of gastric and duodenal ulcer – 30 mg/day.

For anti-relapse treatment of reflux esophagitis – 30 mg/day for a long time (up to 6 months).

For Zollinger-Ellison syndrome, the dose is selected individually until a basal secretion level of <10 mmol/hour is achieved.

Adverse Reactions

From the central nervous system headache; rarely – malaise, dizziness, drowsiness, depression, anxiety.

From the digestive system decreased or increased appetite, nausea, abdominal pain; rarely – diarrhea, constipation; in isolated cases – ulcerative colitis, gastrointestinal candidiasis, increased liver transaminase activity, hyperbilirubinemia.

From the respiratory system rarely – cough, pharyngitis, rhinitis, upper respiratory tract infection, flu-like syndrome.

From the hematopoietic system rarely – thrombocytopenia (with hemorrhagic manifestations); in some cases – anemia.

Allergic reactions skin rash; in some cases – photosensitivity, erythema multiforme.

Other extremely rarely – myalgia, alopecia.

Contraindications

• Malignant neoplasms of the gastrointestinal tract;
• First trimester of pregnancy;
• Lactation period (breastfeeding);
• Children and adolescents under 18 years of age;
• Hypersensitivity to the components of the drug.

With caution the drug should be used in hepatic/renal impairment, in the second and third trimester of pregnancy, in elderly patients.

Use in Pregnancy and Lactation

The drug is contraindicated for use in the first trimester of pregnancy and during lactation (breastfeeding). In the second and third trimesters of pregnancy, the drug is prescribed with caution.

Use in Hepatic Impairment

The drug should be used with caution in hepatic impairment.

Use in Renal Impairment

The drug should be used with caution in renal impairment.

Pediatric Use

Contraindication: children and adolescents under 18 years of age.

Geriatric Use

With caution the drug should be used in elderly patients.

Special Precautions

Before starting treatment with Epicur^®, the possibility of a malignant neoplasm in the upper gastrointestinal tract should be excluded, since taking the drug may mask symptoms and delay the correct diagnosis.

Overdose

Data on drug overdose are not provided.

Drug Interactions

Lansoprazole slows the elimination of drugs metabolized in the liver by microsomal oxidation (including diazepam, phenytoin, indirect anticoagulants).

Lansoprazole reduces the clearance of theophylline by 10%.

Lansoprazole slows the pH-dependent absorption of drugs belonging to the groups of weak acids and accelerates the pH-dependent absorption of drugs belonging to the groups of bases.

With simultaneous use, sucralfate reduces the bioavailability of lansoprazole by 30%, so the interval between taking these drugs should be 30-40 minutes.

Antacids slow down and reduce the absorption of lansoprazole, so they should be prescribed 1 hour before or 1-2 hours after taking lansoprazole.

Storage Conditions

List B. The drug should be stored out of the reach of children, in a dry, light-protected place at a temperature not exceeding 25°C (77°F).

Shelf Life

Shelf life – 2 years.

Dispensing Status

The drug is dispensed by prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.