Rabeprazole (Tablets, Capsules, Lyophilisate) Instructions for Use

Instructions
Dosage forms

ATC Code

A02BC04 (Rabeprazole)

Active Substance

Rabeprazole (Rec.INN registered by WHO)

Clinical-Pharmacological Group

H⁺-K⁺-ATPase inhibitor. Antiulcer drug

Pharmacotherapeutic Group

Acid-related disorder treatment agents; antiulcer agents and agents for the treatment of gastroesophageal reflux disease (GERD); proton pump inhibitors

Pharmacological Action

Proton pump inhibitor. Rabeprazole belongs to the class of antisecretory agents that are chemically substituted benzimidazoles.

Rabeprazole inhibits the activity of the H+/K+ ATPase enzyme (proton pump), thereby blocking the final stage of hydrochloric acid synthesis.

This effect is dose-dependent and leads to the inhibition of both basal and stimulated secretion of hydrochloric acid, regardless of the stimulus.

It does not possess anticholinergic properties.

Pharmacokinetics

After oral administration, it is absorbed from the gastrointestinal tract.

At a dose of 20 mg, C_max is reached in 3.5 hours.

Changes in C_max and AUC are linear (in the dose range from 10 to 40 mg).

The absolute bioavailability is about 52% due to the first-pass effect through the liver.

The bioavailability of rabeprazole does not increase with repeated administration.

Food intake and time of administration during the day do not affect the absorption of rabeprazole.

Plasma protein binding is 97%.

Rabeprazole sodium undergoes a first-pass effect. It is metabolized in the liver with the participation of CYP isoenzymes.

Main metabolites (thioether and carboxylic acid) and minor metabolites (sulfone, dimethyl thioether, and mercapturic acid conjugate) are present in low concentrations.

Indications

Adults aged 18 years and older: gastric ulcer in the acute phase and anastomotic ulcer; duodenal ulcer in the acute phase; erosive and GERD or reflux esophagitis, maintenance therapy for GERD, non-erosive GERD; Zollinger-Ellison syndrome and other conditions characterized by pathological hypersecretion; in combination with antibacterial therapy for the eradication of Helicobacter pylori in patients with peptic ulcer disease.

Adolescents aged 12 years and older: GERD.

ICD codes

Open the list of ICD codes

ICD-10 code	Indication
B98.0	Helicobacter pylori as the cause of diseases classified elsewhere
K21	Gastro-esophageal reflux
K25	Gastric ulcer
K26	Duodenal ulcer

ICD-11 code	Indication
DA22.Z	Gastro-esophageal reflux disease, unspecified
DA60.Z	Gastric ulcer, unspecified
DA63.Z	Duodenal ulcer, unspecified
XN3DY	Helicobacter pylori (H. pylori)

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Administer orally. Swallow tablets or capsules whole with water; do not crush or chew.

For erosive GERD or reflux esophagitis, take 20 mg once daily for 4 to 8 weeks. For maintenance therapy, use 10 mg or 20 mg once daily.

For duodenal ulcer, take 20 mg once daily after breakfast for 4 weeks.

For gastric ulcer, take 20 mg once daily for 6 weeks.

For Zollinger-Ellison syndrome, start with 60 mg once daily. Adjust dose individually; some patients require divided doses. Doses up to 100 mg daily or 60 mg twice daily may be used.

For Helicobacter pylori eradication, use in combination therapy. One regimen is 20 mg twice daily with amoxicillin 1000 mg twice daily and clarithromycin 500 mg twice daily for 7 days.

For adolescents aged 12 years and older with GERD, take 10 mg or 20 mg once daily for up to 8 weeks.

Take doses in the morning, before a meal. The duration of therapy is determined by the indication and clinical response.

No dose adjustment is required for elderly patients or those with mild to moderate hepatic impairment. Use with caution in patients with severe hepatic impairment.

Adverse Reactions

Immune system disorders: rarely – acute systemic allergic reactions.

Blood and lymphatic system disorders: rarely – thrombocytopenia, neutropenia, leukopenia.

Metabolism and nutrition disorders: rarely – hypomagnesemia.

Hepatobiliary disorders: infrequently – increased activity of liver enzymes; rarely – hepatitis, jaundice, hepatic encephalopathy.

Renal and urinary disorders: very rarely – interstitial nephritis.

Skin and subcutaneous tissue disorders: rarely – bullous eruptions, urticaria; very rarely – erythema multiforme, toxic epidermal necrolysis, Stevens-Johnson syndrome;

Musculoskeletal and connective tissue disorders: rarely – myalgia, arthralgia.

Reproductive system and breast disorders: very rarely – gynecomastia.

Contraindications

Hypersensitivity to rabeprazole or substituted benzimidazoles; pregnancy, breastfeeding period; children under 12 years of age (for all indications), children and adolescents under 18 years of age (except for indications for adolescents over 12 years of age).

With caution severe renal failure.

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy and lactation (breastfeeding).

Use in Hepatic Impairment

No dose adjustment is required for patients with impaired liver function; however, Rabeprazole should be used with caution in patients with severe liver impairment.

Use in Renal Impairment

Should be used with caution in patients with severe renal impairment.

Pediatric Use

Contraindicated for use for all indications in children under 12 years of age.

Contraindicated for use in children and adolescents under 18 years of age (except for indications for adolescents over 12 years of age).

Geriatric Use

Patients aged 55 years and older should consult a doctor if symptoms appear or change during therapy with rabeprazole.

Special Precautions

Before starting therapy, it is necessary to exclude malignant neoplasms of the stomach, because the use of rabeprazole may mask symptoms and delay correct diagnosis.

No dose adjustment is required for patients with impaired liver or kidney function; however, Rabeprazole is recommended to be used with caution in patients with severe liver impairment.

Therapy with proton pump inhibitors may lead to an increased risk of gastrointestinal infections caused by Clostridium difficile.

When used concomitantly with rabeprazole, doses of ketoconazole and digoxin should be adjusted.

Patients with long-term recurring symptoms of indigestion or heartburn should be regularly monitored by a doctor.

Patients over 55 years of age who daily take over-the-counter medications to relieve symptoms of heartburn and indigestion should inform their doctor about this.

Rabeprazole should not be used simultaneously with other acid-reducing agents, such as H₂-receptor blockers or proton pump inhibitors.

In experimental studies, no carcinogenic effect of rabeprazole was established; however, ambiguous results were obtained in mutagenicity studies.

Tests on mouse lymphoma cells were positive, while the in vivo micronucleus test and in vivo and in vitro DNA repair tests were negative.

Drug Interactions

With simultaneous use with digoxin, a slight to moderate increase in the plasma concentration of digoxin is possible.

With simultaneous use with ketoconazole, its bioavailability decreases.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

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.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Rabeprazole [Izvarino Pharma LLC (Russia)]
Enteric-coated tablets, 10 mg: 7, 10, 14, 20, 28, 30, 50, 56, 60, 90, or 100 pcs.
Enteric-coated tablets, 20 mg: 7, 10, 14, 20, 28, 30, 50, 56, 60, 90, or 100 pcs.

Marketing Authorization Holder

Izvarino Pharma LLC (Russia)

Dosage Forms

	Rabeprazole	Enteric-coated tablets, 10 mg: 7, 10, 14, 20, 28, 30, 50, 56, 60, 90, or 100 pcs.
		Enteric-coated tablets, 20 mg: 7, 10, 14, 20, 28, 30, 50, 56, 60, 90, or 100 pcs.

Dosage Form, Packaging, and Composition

Enteric-coated tablets from pink to brownish-pink in color, round, biconvex.

	1 tab.
Rabeprazole sodium	10 mg,
Equivalent to rabeprazole content	9.24 mg

Excipients: magnesium oxide, hypromellose (hydroxypropylcellulose), mannitol, hypromellose, sodium stearyl fumarate.

Composition of tablet coating 1: Opadry colorless 03K19229 (hypromellose, triacetin, talc), magnesium oxide.
Composition of tablet coating 2 Surelease colorless E-7-19040 (ethylcellulose, ammonium hydroxide, medium-chain triglycerides, oleic acid).
Composition of tablet coating 3 Acryl-EZE II pink 393Z240000 (methacrylic acid and ethyl acrylate copolymer (1:1), talc, titanium dioxide, poloxamer 407, calcium silicate, sodium bicarbonate, sodium lauryl sulfate, iron oxide red dye, iron oxide yellow dye).

7 pcs. – blister packs (1) – cardboard packs.
7 pcs. – blister packs (2) – cardboard packs.
7 pcs. – blister packs (4) – cardboard packs.
7 pcs. – blister packs (8) – cardboard packs.
10 pcs. – blister packs (1) – cardboard packs.
10 pcs. – blister packs (2) – cardboard packs.
10 pcs. – blister packs (3) – cardboard packs.
10 pcs. – blister packs (5) – cardboard packs.
10 pcs. – blister packs (6) – cardboard packs.
10 pcs. – blister packs (9) – cardboard packs.
10 pcs. – blister packs (10) – cardboard packs.
14 pcs. – blister packs (1) – cardboard packs.
14 pcs. – blister packs (2) – cardboard packs.
14 pcs. – blister packs (4) – cardboard packs.
14 pcs. – jars (1) – cardboard packs.
28 pcs. – jars (1) – cardboard packs.
30 pcs. – jars (1) – cardboard packs.
60 pcs. – jars (1) – cardboard packs.

Enteric-coated tablets from light yellow to yellow in color, round, biconvex.

	1 tab.
Rabeprazole sodium	20 mg,
Equivalent to rabeprazole content	18.85 mg

Excipients: magnesium oxide, hypromellose (hydroxypropylcellulose), mannitol, hypromellose, sodium stearyl fumarate.

Composition of tablet coating 1: Opadry colorless 03K19229 (hypromellose, triacetin, talc), magnesium oxide.
Composition of tablet coating 2 Surelease colorless E-7-19040 (ethylcellulose, ammonium hydroxide, medium-chain triglycerides, oleic acid).
Composition of tablet coating 3 Acryl-EZE II yellow 493Z220000 (methacrylic acid and ethyl acrylate copolymer (1:1), talc, titanium dioxide, poloxamer 407, calcium silicate, sodium bicarbonate, sodium lauryl sulfate, iron oxide yellow dye).

Rabeprazole [Tatkhimpharmpreparaty, JSC (Russia)]
Enteric-coated tablets 10 mg: 14 or 28 pcs.
Enteric-coated tablets, 20 mg: 14 or 28 pcs.

Marketing Authorization Holder

Tatkhimpharmpreparaty, JSC (Russia)

Dosage Forms

	Rabeprazole	Enteric-coated tablets 10 mg: 14 or 28 pcs.
		Enteric-coated tablets, 20 mg: 14 or 28 pcs.

Dosage Form, Packaging, and Composition

Enteric-coated tablets pink in color, round, biconvex; roughness of the tablet surface is allowed.

	1 tab.
Rabeprazole sodium	10 mg

Excipients: calcium carbonate, lactose monohydrate, corn starch, hypromellose, magnesium stearate.

Excipients of the separating layer Opadry white.
Excipients of the enteric coating Acryl-EZE pink, macrogol 6000 (polyethylene glycol).

14 pcs. – blister packs (1) – cardboard packs.
14 pcs. – blister packs (2) – cardboard packs.

Enteric-coated tablets yellow with a brownish tint, round, biconvex; roughness of the tablet surface is allowed.

	1 tab.
Rabeprazole sodium	20 mg

Excipients: calcium carbonate, lactose monohydrate, corn starch, hypromellose, magnesium stearate.

Excipients of the separating layer Opadry white.
Excipients of the enteric coating Acryl-EZE yellow, macrogol 6000 (polyethylene glycol).

14 pcs. – blister packs (1) – cardboard packs.
14 pcs. – blister packs (2) – cardboard packs.

Rabeprazole [Pharmstandard-Lexredstva OJSC (Russia)]
Enteric-coated tablets, 10 mg: 7, 10, 14, 15, 20, 28, or 30 pcs.
Enteric-coated tablets, 20 mg: 7, 10, 14, 15, 20, 28, or 30 pcs.

Marketing Authorization Holder

Pharmstandard-Lexredstva OJSC (Russia)

Dosage Forms

Rabeprazole		Enteric-coated tablets, 10 mg: 7, 10, 14, 15, 20, 28, or 30 pcs.
Rabeprazole		Enteric-coated tablets, 20 mg: 7, 10, 14, 15, 20, 28, or 30 pcs.

Dosage Form, Packaging, and Composition

Enteric-coated tablets from white to white with a grayish tint or white with a yellowish tint, round, biconvex; on the cross-section, the core is from white to white with a grayish or white with a yellowish tint.

	1 tab.
Rabeprazole sodium	10 mg,
Equivalent to rabeprazole content	9.42 mg

Excipients: mannitol, magnesium oxide, low-substituted hydroxypropylcellulose, hydroxypropylcellulose (hypromellose), magnesium stearate.

Coating composition ethylcellulose, magnesium oxide.
Enteric coating composition hypromellose phthalate, diacetylated monoglyceride, talc, titanium dioxide (E171), carnauba wax.

7 pcs. – blister packs (1) – cardboard packs.
7 pcs. – blister packs (2) – cardboard packs.
7 pcs. – blister packs (4) – cardboard packs.
10 pcs. – blister packs (1) – cardboard packs.
10 pcs. – blister packs (2) – cardboard packs.
10 pcs. – blister packs (3) – cardboard packs.
14 pcs. – blister packs (1) – cardboard packs.
14 pcs. – blister packs (2) – cardboard packs.
15 pcs. – blister packs (1) – cardboard packs.
15 pcs. – blister packs (2) – cardboard packs.

	1 tab.
Rabeprazole sodium	20 mg,
Equivalent to rabeprazole content	18.85 mg

Excipients: mannitol, magnesium oxide, low-substituted hydroxypropylcellulose, hydroxypropylcellulose (hypromellose), magnesium stearate.

Coating composition ethylcellulose, magnesium oxide.
Enteric coating composition hypromellose phthalate, diacetylated monoglyceride, talc, titanium dioxide (E171), carnauba wax.

Rabeprazole PSK [PSK Pharma, LLC (Russia)]
Lyophilizate for preparation of solution for intravenous administration 20 mg: fl.

Marketing Authorization Holder

PSK Pharma, LLC (Russia)

Dosage Form

Rabeprazole PSK

Lyophilizate for preparation of solution for intravenous administration 20 mg: fl.

Dosage Form, Packaging, and Composition

Lyophilizate for preparation of solution for intravenous administration from almost white to light yellow.

	1 fl.
Rabeprazole sodium	20 mg

Excipients: mannitol – 75 mg, sodium hydroxide – to pH 12.0.

95 mg – vials (1) – carton packs.

Rabeprazole Velpharm [Velpharm, LLC (Russia)]
Enteric-coated capsules 10 mg
Enteric-coated capsules 20 mg

Marketing Authorization Holder

Velpharm, LLC (Russia)

Manufactured By

Velpharm-M, LLC (Russia)

Dosage Forms

Rabeprazole Velpharm		Enteric-coated capsules 10 mg
Rabeprazole Velpharm		Enteric-coated capsules 20 mg

Dosage Form, Packaging, and Composition

Enteric-coated capsules

	1 caps.
Rabeprazole sodium	10 mg

10 pcs. – jars – carton packs (10 pcs.) – Over-the-counter
10 pcs. – blister packs – carton packs (10 pcs.) – Over-the-counter
10 pcs. – blister packs (10 pcs.) – carton packs (100 pcs.) – Over-the-counter
10 pcs. – blister packs (2 pcs.) – carton packs (20 pcs.) – Over-the-counter
10 pcs. – blister packs (3 pcs.) – carton packs (30 pcs.) – Over-the-counter
10 pcs. – blister packs (5 pcs.) – carton packs (50 pcs.) – Over-the-counter
10 pcs. – blister packs (6 pcs.) – carton packs (60 pcs.) – Over-the-counter
10 pcs. – blister packs (9 pcs.) – carton packs (90 pcs.) – Over-the-counter
100 pcs. – jars – carton packs (100 pcs.) – Over-the-counter
14 pcs. – jars – carton packs (14 pcs.) – Over-the-counter
14 pcs. – blister packs – carton packs (14 pcs.) – Over-the-counter
14 pcs. – blister packs (2 pcs.) – carton packs (28 pcs.) – Over-the-counter
15 pcs. – jars – carton packs (15 pcs.) – Over-the-counter
15 pcs. – blister packs – carton packs (15 pcs.) – Over-the-counter
15 pcs. – blister packs (2 pcs.) – carton packs (30 pcs.) – Over-the-counter
15 pcs. – blister packs (4 pcs.) – carton packs (60 pcs.) – Over-the-counter
15 pcs. – blister packs (6 pcs.) – carton packs (90 pcs.) – Over-the-counter
20 pcs. – jars – carton packs (20 pcs.) – Over-the-counter
28 pcs. – jars – carton packs (28 pcs.) – Over-the-counter
30 pcs. – jars – carton packs (30 pcs.) – Over-the-counter
50 pcs. – jars – carton packs (50 pcs.) – Over-the-counter
60 pcs. – jars – carton packs (60 pcs.) – Over-the-counter
7 pcs. – jars – carton packs (7 pcs.) – Over-the-counter
7 pcs. – blister packs – carton packs (7 pcs.) – Over-the-counter
7 pcs. – blister packs (2 pcs.) – carton packs (14 pcs.) – Over-the-counter
7 pcs. – blister packs (4 pcs.) – carton packs (28 pcs.) – Over-the-counter
90 pcs. – jars – carton packs (90 pcs.) – Over-the-counter

Enteric-coated capsules

	1 caps.
Rabeprazole sodium	20 mg

10 pcs. – jars – carton packs (10 pcs.) – Prescription only
10 pcs. – blister packs – carton packs (10 pcs.) – Prescription only
10 pcs. – blister packs (10 pcs.) – carton packs (100 pcs.) – Prescription only
10 pcs. – blister packs (2 pcs.) – carton packs (20 pcs.) – Prescription only
10 pcs. – blister packs (3 pcs.) – carton packs (30 pcs.) – Prescription only
10 pcs. – blister packs (5 pcs.) – carton packs (50 pcs.) – Prescription only
10 pcs. – blister packs (6 pcs.) – carton packs (60 pcs.) – Prescription only
10 pcs. – blister packs (9 pcs.) – carton packs (90 pcs.) – Prescription only
100 pcs. – jars – carton packs (100 pcs.) – Prescription only
14 pcs. – jars – carton packs (14 pcs.) – Prescription only
14 pcs. – blister packs – carton packs (14 pcs.) – Prescription only
14 pcs. – blister packs (2 pcs.) – carton packs (28 pcs.) – Prescription only
15 pcs. – jars – carton packs (15 pcs.) – Prescription only
15 pcs. – blister packs – carton packs (15 pcs.) – Prescription only
15 pcs. – blister packs (2 pcs.) – carton packs (30 pcs.) – Prescription only
15 pcs. – blister packs (4 pcs.) – carton packs (60 pcs.) – Prescription only
15 pcs. – blister packs (6 pcs.) – carton packs (90 pcs.) – Prescription only
20 pcs. – jars – carton packs (20 pcs.) – Prescription only
28 pcs. – jars – carton packs (28 pcs.) – Prescription only
30 pcs. – jars – carton packs (30 pcs.) – Prescription only
50 pcs. – jars – carton packs (50 pcs.) – Prescription only
60 pcs. – jars – carton packs (60 pcs.) – Prescription only
7 pcs. – jars – carton packs (7 pcs.) – Prescription only
7 pcs. – blister packs – carton packs (7 pcs.) – Prescription only
7 pcs. – blister packs (2 pcs.) – carton packs (14 pcs.) – Prescription only
7 pcs. – blister packs (4 pcs.) – carton packs (28 pcs.) – Prescription only
90 pcs. – jars – carton packs (90 pcs.) – Prescription only

Rabeprazole Velpharm [Velpharm-M, LLC (Russia)]
Enteric-coated film-coated tablets 10 mg
Enteric-coated film-coated tablets 20 mg

Marketing Authorization Holder

Velpharm-M, LLC (Russia)

Manufactured By

Velpharm, LLC (Russia)

Velpharm-M, LLC (Russia)

Dosage Forms

Rabeprazole Velpharm		Enteric-coated film-coated tablets 10 mg
Rabeprazole Velpharm		Enteric-coated film-coated tablets 20 mg

Dosage Form, Packaging, and Composition

Enteric-coated film-coated tablets

	1 tab.
Rabeprazole (as rabeprazole sodium)	10 mg

10 pcs. – blister packs – carton packs (10 pcs.) – Over-the-counter
10 pcs. – blister packs (3 pcs.) – carton packs (30 pcs.) – Over-the-counter
10 pcs. – blister packs (6 pcs.) – carton packs (60 pcs.) – Over-the-counter
10 pcs. – blister packs (9 pcs.) – carton packs (90 pcs.) – Over-the-counter
14 pcs. – jars – carton packs (14 pcs.) – Over-the-counter
14 pcs. – blister packs – carton packs (14 pcs.) – Over-the-counter
14 pcs. – blister packs (2 pcs.) – carton packs (28 pcs.) – Over-the-counter
14 pcs. – blister packs (4 pcs.) – carton packs (56 pcs.) – Over-the-counter
28 pcs. – jars – carton packs (28 pcs.) – Over-the-counter
30 pcs. – jars – carton packs (30 pcs.) – Over-the-counter
56 pcs. – jars – carton packs (56 pcs.) – Over-the-counter
60 pcs. – jars – carton packs (60 pcs.) – Over-the-counter
7 pcs. – blister packs – carton packs (7 pcs.) – Over-the-counter
7 pcs. – blister packs (2 pcs.) – carton packs (14 pcs.) – Over-the-counter
7 pcs. – blister packs (4 pcs.) – carton packs (28 pcs.) – Over-the-counter
90 pcs. – jars – carton packs (90 pcs.) – Over-the-counter

Enteric-coated film-coated tablets

	1 tab.
Rabeprazole (as rabeprazole sodium)	20 mg

10 pcs. – blister packs – carton packs (10 pcs.) – Prescription only
10 pcs. – blister packs (3 pcs.) – carton packs (30 pcs.) – Prescription only
10 pcs. – blister packs (6 pcs.) – carton packs (60 pcs.) – Prescription only
10 pcs. – blister packs (9 pcs.) – carton packs (90 pcs.) – Prescription only
14 pcs. – jars – carton packs (14 pcs.) – Prescription only
14 pcs. – blister packs – carton packs (14 pcs.) – Prescription only
14 pcs. – blister packs (2 pcs.) – carton packs (28 pcs.) – Prescription only
14 pcs. – blister packs (4 pcs.) – carton packs (56 pcs.) – Prescription only
28 pcs. – jars – carton packs (28 pcs.) – Prescription only
30 pcs. – jars – carton packs (30 pcs.) – Prescription only
56 pcs. – jars – carton packs (56 pcs.) – Prescription only
60 pcs. – jars – carton packs (60 pcs.) – Prescription only
7 pcs. – blister packs – carton packs (7 pcs.) – Prescription only
7 pcs. – blister packs (2 pcs.) – carton packs (14 pcs.) – Prescription only
7 pcs. – blister packs (4 pcs.) – carton packs (28 pcs.) – Prescription only
90 pcs. – jars – carton packs (90 pcs.) – Prescription only

Rabeprazole-KRKA [Krka d.d., Novo mesto (Slovenia)]
Enteric-coated film-coated tablets, 10 mg: 14, 15, 28, 30, 56 or 60 pcs.
Enteric-coated film-coated tablets, 20 mg: 14, 15, 28, 30, 56, or 60 pcs.

Marketing Authorization Holder

Krka d.d., Novo mesto (Slovenia)

Dosage Forms

Rabeprazole-KRKA		Enteric-coated film-coated tablets, 10 mg: 14, 15, 28, 30, 56 or 60 pcs.
Rabeprazole-KRKA		Enteric-coated film-coated tablets, 20 mg: 14, 15, 28, 30, 56, or 60 pcs.

Dosage Form, Packaging, and Composition

Enteric-coated film-coated tablets orange-pink, round, biconvex, with a bevel.

	1 tab.
Rabeprazole sodium* (equivalent to rabeprazole sodium hydrate)	10 mg (10.47 mg)

* the actual amount of rabeprazole sodium is calculated according to its content “as is”; the amount of rabeprazole sodium is compensated by mannitol.

Excipients: mannitol (E421), light magnesium oxide, hypromellose, low-substituted hypromellose, magnesium stearate, ethylcellulose, hypromellose phthalate, diacetylated monoglycerides, talc, titanium dioxide (E171), yellow iron oxide (E172).

14 pcs. – blisters (1) – carton packs.
14 pcs. – blisters (2) – carton packs.
14 pcs. – blisters (4) – carton packs.
15 pcs. – blisters (1) – carton packs.
15 pcs. – blisters (2) – carton packs.
15 pcs. – blisters (4) – carton packs.

Enteric-coated film-coated tablets brownish-yellow, round, biconvex.

	1 tab.
Rabeprazole sodium* (equivalent to rabeprazole sodium hydrate)	20 mg (20.94 mg)

* the actual amount of rabeprazole sodium is calculated according to its content “as is”; the amount of rabeprazole sodium is compensated by mannitol.

Rabeprazole-OBL [FP Obolenskoe, JSC (Russia)]
Enteric-coated capsules 10 mg: 5, 7, 10, 14, 15, 20, 21, 28, 30 or 60 pcs.

Marketing Authorization Holder

FP Obolenskoe, JSC (Russia)

Dosage Form

Rabeprazole-OBL

Enteric-coated capsules 10 mg: 5, 7, 10, 14, 15, 20, 21, 28, 30 or 60 pcs.

Dosage Form, Packaging, and Composition

Enteric-coated capsules	1 caps.
Rabeprazole sodium	10 mg

5 pcs. – blister packs (1) – carton packs.
7 pcs. – blister packs (1) – carton packs.
10 pcs. – blister packs (1) – carton packs.
14 pcs. – blister packs (1) – carton packs.
20 pcs. – blister packs (1) – carton packs.
5 pcs. – blister packs (2) – carton packs.
7 pcs. – blister packs (2) – carton packs.
10 pcs. – blister packs (2) – carton packs.
14 pcs. – blister packs (2) – carton packs.
20 pcs. – blister packs (2) – carton packs.
5 pcs. – blister packs (3) – carton packs.
7 pcs. – blister packs (3) – carton packs.
10 pcs. – blister packs (3) – carton packs.
14 pcs. – blister packs (3) – carton packs.
20 pcs. – blister packs (3) – carton packs.

Rabeprazole-OBL [FP Obolenskoe, JSC (Russia)]
Enteric-coated capsules 20 mg: 5, 7, 10, 14, 15, 20, 21, 28, 30, or 60 pcs.

Marketing Authorization Holder

FP Obolenskoe, JSC (Russia)

Dosage Form

Rabeprazole-OBL

Enteric-coated capsules 20 mg: 5, 7, 10, 14, 15, 20, 21, 28, 30, or 60 pcs.

Dosage Form, Packaging, and Composition

Enteric-coated capsules	1 caps.
Rabeprazole sodium	20 mg

Rabeprazole-Teva [Teva Pharmaceutical Industries, Ltd. (Israel)]
Enteric-coated tablets 10 mg
Enteric-coated tablets 20 mg

Marketing Authorization Holder

Teva Pharmaceutical Industries, Ltd. (Israel)

Manufactured By

Balkanpharma-Dupnitsa, AD (Bulgaria)

Dosage Forms

Rabeprazole-Teva		Enteric-coated tablets 10 mg
Rabeprazole-Teva		Enteric-coated tablets 20 mg

Dosage Form, Packaging, and Composition

Enteric-coated tablets

	1 tab.
Rabeprazole sodium	10 mg

7 pcs. – blisters (2 pcs.) – carton packs (14 pcs.) – Over-the-counter
7 pcs. – blisters (4 pcs.) – carton packs (28 pcs.) – Over-the-counter

Enteric-coated tablets

	1 tab.
Rabeprazole sodium	20 mg

7 pcs. – blisters (2 pcs.) – carton packs (14 pcs.) – Prescription only
7 pcs. – blisters (4 pcs.) – carton packs (28 pcs.) – Prescription only

Rabeprazole-Vertex [Vertex, JSC (Russia)]
Enteric-coated capsules 10 mg: 14, 15, 28, or 30 pcs.

Marketing Authorization Holder

Vertex, JSC (Russia)

Dosage Form

Rabeprazole-Vertex

Enteric-coated capsules 10 mg: 14, 15, 28, or 30 pcs.

Dosage Form, Packaging, and Composition

Enteric-coated capsules hard gelatin No. 3, green; capsule contents – spherical pellets from almost white to white with a brownish or yellowish tint.

	1 caps.
Rabeprazole sodium (in the form of rabeprazole pellet substance)*	10 mg

* Rabeprazole pellet substance (Rabeprazole sodium 8.5%) – 117.65 mg.

Excipients: sugar pellets (sucrose – 85.91%, starch – 13.64%, povidone K30 – 0.45%) – 71.24 mg, sodium carbonate – 1.65 mg, talc – 1.76 mg, titanium dioxide – 0.82 mg, hypromellose – 14.71 mg.

Pellet coating composition hypromellose phthalate (hydroxypropylmethyl phthalate cellulose) – 15.88 mg, cetyl alcohol – 1.59 mg.
Hard gelatin capsule composition titanium dioxide – 1%, yellow iron oxide – 0.27%, patent blue – 0.015%, gelatin – up to 100%.

7 pcs. – blister packs (2) – cardboard packs.
7 pcs. – blister packs (4) – cardboard packs.
14 pcs. – blister packs (1) – cardboard packs.
14 pcs. – blister packs (2) – cardboard packs.
15 pcs. – blister packs (1) – cardboard packs.
15 pcs. – blister packs (2) – cardboard packs.
30 pcs. – blister packs (1) – cardboard packs.
14 pcs. – high-density polyethylene jars (1) – cardboard packs.
30 pcs. – high-density polyethylene jars (1) – cardboard packs.

Rabeprazole-Vertex [Vertex, JSC (Russia)]
Enteric-coated capsules 20 mg: 14, 15, 28, or 30 pcs.

Marketing Authorization Holder

Vertex, JSC (Russia)

Dosage Form

Rabeprazole-Vertex

Enteric-coated capsules 20 mg: 14, 15, 28, or 30 pcs.

Dosage Form, Packaging, and Composition

Enteric-coated capsules hard gelatin, size #2, green in color; capsule contents – spherical pellets from almost white to white with a brownish or yellowish tint.

	1 caps.
Rabeprazole sodium (in the form of rabeprazole pellet substance)*	20 mg

* Rabeprazole pellet substance (Rabeprazole sodium 8.5%) – 235.3 mg.

Excipients: sugar pellets (sucrose – 85.91%, starch – 13.64%, povidone K30 – 0.45%) – 142.48 mg, sodium carbonate – 3.3 mg, talc – 3.52 mg, titanium dioxide – 1.64 mg, hypromellose – 29.42 mg.

Pellet coating composition hypromellose phthalate (hydroxypropyl methylcellulose phthalate) – 31.76 mg, cetyl alcohol – 3.18 mg.
Hard gelatin capsule composition titanium dioxide – 1%, iron oxide yellow dye – 0.27%, patent blue dye – 0.015%, gelatin – up to 100%.

Medixlife (Author)

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