Rabevita tablets p / o 10mg, No. 14

Enteric-coated tablets, 10 mg

• Symptoms of dyspepsia associated with increased acidity of gastric juice, incl. symptoms of gastroesophageal reflux disease (GERD - eg heartburn, sour belching).

Enteric-coated tablets, 20 mg

• peptic ulcer in the acute stage and anastomotic ulcer;

• peptic ulcer of the duodenum in the acute stage;

• erosive and ulcerative GERD or reflux esophagitis;

• maintenance therapy for GERD;

• non-erosive gastroesophageal reflux disease (NERD);

• Zollinger-Ellison syndrome and other conditions characterized by pathological hypersecretion;

• in combination with appropriate antibiotic therapy for the eradication of Helicobacter pylori in patients with peptic ulcer disease.

Enteric-coated tablets, 10 mg

Inside, at a dose of 10 mg once a day. Do not chew or grind NofluxЃ tablets. The tablets should be swallowed whole. It is recommended to take the drug in the morning, before eating. It was found that neither time of day nor food intake affects the activity of rabeprazole sodium, but the recommended time for taking NofluxЃ tablets contributes to better patient compliance with the treatment regimen.

If there is no effect during the first 3 days of treatment, a specialist examination is required. The maximum course of treatment without consulting a doctor is 14 days.

Enteric-coated tablets, 20 mg

Inside. Do not chew or grind NofluxЃ tablets. The tablets should be swallowed whole. It was found that neither the time of day nor food intake affects the activity of rabeprazole sodium.

In case of gastric ulcer in the stage of exacerbation and anastomotic ulcer, it is recommended to take 20 mg orally 1 time per day. Usually, cure occurs after 6 weeks of therapy, but in some cases, the duration of treatment can be increased by another 6 weeks.

In case of duodenal ulcer disease in the acute stage, it is recommended to take 20 mg orally 1 time per day. The duration of treatment is 2 to 4 weeks. If necessary, the duration of treatment can be increased by another 4 weeks.

When treating erosive GERD or reflux esophagitis, it is recommended to take 20 mg orally once a day. The duration of treatment is 4 to 8 weeks. If necessary, the duration of treatment can be increased by another 8 weeks.

With maintenance therapy for GERD, it is recommended to take 20 mg orally once a day. The duration of treatment depends on the patient's condition.

For NERD without esophagitis, it is recommended to take 20 mg orally once a day. If symptoms persist after 4 weeks of treatment, additional examination of the patient should be performed. After relief of symptoms, to prevent their subsequent occurrence, the drug should be taken orally once a day on demand.

For the treatment of Zollinger-Ellison syndrome and other conditions characterized by pathological hypersecretion , the dose is selected individually. The initial dose is 60 mg / day, then the dose is increased and the drug is prescribed in a dose of up to 100 mg / day with a single dose or 60 mg 2 times a day. For some patients, fractional dosing is preferred. Treatment should be continued as clinically necessary. In some patients with Zollinger-Ellison syndrome, the duration of treatment with rabeprazole was up to one year.

For the eradication of Helicobacter pylori, it is recommended to take 20 mg orally 2 times a day according to a specific scheme with an appropriate combination of antibiotics. The duration of treatment is 7 days.

Special patient groups

Renal and hepatic impairment. No dose adjustment is required in patients with renal impairment. In patients with mild to moderate hepatic impairment, the concentration of rabeprazole in the blood is usually higher than in healthy patients. Caution should be exercised when prescribing NofluxЃ in patients with severe hepatic impairment.

Elderly patients. No dose adjustment is required.

Children. The safety and efficacy of rabeprazole sodium 20 mg for short-term (up to 8 weeks) treatment of GERD in children aged 12 years or more has been confirmed by extrapolating the results of adequate and well-controlled studies supporting the efficacy of rabeprazole sodium for adults, and safety and pharmacokinetic studies for pediatric patients. The recommended dose for children aged 12 years and over is 20 mg once a day for up to 8 weeks. The safety and effectiveness of rabeprazole sodium for the treatment of GERD in children under 12 years of age has not been established. The safety and efficacy of rabeprazole sodium for other indications has not been established in pediatric patients.

1 tab.

core

active substance:

rabeprazole sodium - 10 mg

excipients: mannitol - 20 mg; magnesium oxide - 31 mg; hyprolosis - 9.8 mg; low-substituted hyprolosis - 1.5 mg; magnesium stearate - 0.8 mg

inner shell: ethyl cellulose - 0.6 mg; magnesium oxide - 0.6 mg

enteric shell: hypromellose phthalate - 8.8 mg; dibutylsebacate - 0.9 mg; iron dye red oxide - 0.02 mg; titanium dioxide - 0.4 mg; talc - 0.9 mg

• hypersensitivity to rabeprazole, substituted benzimidazoles or any of the excipients of the drug;

• pregnancy;

• lactation period;

• age up to 12 years (enteric-coated tablets, 20 mg for short-term treatment of GERD);

• age up to 18 years (enteric-coated tablets, 10 mg)

With care: children's age (enteric-coated tablets, 20 mg for all indications, except for GERD); severe renal failure.

pharmachologic effect

Antiulcer agent, inhibitor of H + -K + -ATPase (proton pump). The mechanism of action is associated with the inhibition of the enzyme H + -K + -ATPase in parietal cells of the stomach, which leads to blocking the final stage of the formation of hydrochloric acid. This action is dose-dependent and leads to inhibition of both basal and stimulated secretion of hydrochloric acid, regardless of the nature of the stimulus.

Indications

Enteric-coated tablets, 10 mg

• Symptoms of dyspepsia associated with increased acidity of gastric juice, incl. symptoms of gastroesophageal reflux disease (GERD - eg heartburn, sour belching).

Enteric-coated tablets, 20 mg

• peptic ulcer in the acute stage and anastomotic ulcer;

• peptic ulcer of the duodenum in the acute stage;

• erosive and ulcerative GERD or reflux esophagitis;

• maintenance therapy for GERD;

• non-erosive gastroesophageal reflux disease (NERD);

• Zollinger-Ellison syndrome and other conditions characterized by pathological hypersecretion;

• in combination with appropriate antibiotic therapy for the eradication of Helicobacter pylori in patients with peptic ulcer disease.

Contraindications

• hypersensitivity to rabeprazole, substituted benzimidazoles or any of the excipients of the drug;

• pregnancy;

• lactation period;

• age up to 12 years (enteric-coated tablets, 20 mg for short-term treatment of GERD);

• age up to 18 years (enteric-coated tablets, 10 mg)

With care: children's age (enteric-coated tablets, 20 mg for all indications, except for GERD); severe renal failure.

Application during pregnancy and lactation

There are no data on the safety of using rabeprazole during pregnancy.

Reproductive studies in rats and rabbits did not reveal signs of impaired fertility or fetal defects due to rabeprazole; however, in rats, in small amounts, the drug crosses the placental barrier. NofluxЃ should not be used during pregnancy unless the expected positive effect on the mother outweighs the potential harm to the fetus.

It is not known whether rabeprazole is excreted in breast milk. Appropriate studies have not been conducted in lactating women. At the same time, rabeprazole is found in the milk of lactating rats, and therefore NofluxЃ should not be prescribed to lactating women.

Side effects

Based on the experience of clinical trials, it can be concluded that NofluxЃ is usually well tolerated by patients. Side effects are generally mild to moderate and transient. When taking NofluxЃ during clinical trials, the following side effects were noted: headache, abdominal pain, diarrhea, flatulence, constipation, dry mouth, dizziness, rash, peripheral edema.

In the course of clinical studies and in the post-registration period, the following adverse reactions were reported.

From the immune system: rarely - acute systemic allergic reactions.

From the side of the blood and lymphatic system: rarely - thrombocytopenia, neutropenia, leukopenia.

From the side of metabolism and nutrition: rarely - hypomagnesemia.

From the nervous system: headache, dizziness.

From the gastrointestinal tract: abdominal pain, diarrhea, flatulence, constipation, dry mouth.

From the hepatobiliary system: increased activity of hepatic enzymes; rarely - hepatitis, jaundice, in patients with liver cirrhosis, the development of hepatic encephalopathy was rarely reported.

From the side of the kidneys and urinary tract: very rarely - interstitial nephritis.

On the part of the skin and subcutaneous tissues: rash; rarely - bullous rashes, urticaria; very rarely - erythema multiforme, toxic epidermal necrolysis, Stevens-Johnson syndrome.

From the musculoskeletal system: rarely - myalgia, arthralgia.

From the reproductive system and mammary glands: very rarely - gynecomastia.

General disorders and disorders at the injection site: peripheral edema.

There were no changes in other laboratory parameters while taking rabeprazole sodium.

According to post-marketing observations, taking PPIs may increase the risk of fractures (see 'Special instructions').

Interaction

Cytochrome P450 system

Rabeprazole sodium, like other PPIs, is metabolized with the participation of the cytochrome P450 (CYP450) system in the liver. In vitro studies on human liver microsomes have shown that sodium rabeprazole is metabolized by isoenzymes CYP2C19 and CYP3A4.

Studies in healthy volunteers have shown that rabeprazole sodium does not have pharmacokinetic or clinically significant interactions with drugs that are metabolized by the cytochrome P450 system - warfarin, phenytoin, theophylline and diazepam (regardless of whether patients metabolize diazepam intensively or weakly).

A study was conducted of combination therapy with antibacterial drugs. This four-way crossover study involved 16 healthy volunteers who received 20 mg of rabeprazole, 1000 mg of amoxicillin, 500 mg of clarithromycin, or a combination of these three drugs (CANCER - rabeprazole, amoxicillin, clarithromycin). AUC and Cmax values ??for clarithromycin and amoxicillin were similar when comparing combination therapy with monotherapy. AUC and Cmax for rabeprazole increased by 11 and 34%, respectively, and for 14-hydroxy-clarithromycin (an active metabolite of clarithromycin), AUC and Cmax increased by 42 and 46%, respectively, for combination therapy compared with monotherapy. This increase in exposure rates for rabeprazole and clarithromycin was not considered clinically significant.

Interactions due to inhibition of gastric acid secretion

Rabeprazole sodium provides stable and long-term suppression of gastric acid secretion. Thus, interactions can occur with substances for which the absorption depends on the pH. When taken simultaneously with rabeprazole sodium, the absorption of ketoconazole is reduced by 30%, and the absorption of digoxin is increased by 22%. Therefore, for some patients, observation should be carried out to resolve the issue of the need for dose adjustment while taking rabeprazole sodium with ketoconazole, digoxin, or other drugs for which absorption depends on pH.

Atazanavir

At the same time taking atazanavir 300 mg / ritonavir 100 mg with omeprazole (40 mg once a day) or atazanavir 400 mg with lansoprazole (60 mg once a day) in healthy volunteers, a significant decrease in the exposure to atazanavir was observed. The absorption of atazanavir is pH dependent. Although coadministration with rabeprazole has not been studied, similar results are expected for other proton pump inhibitors. Thus, concomitant use of atazanavir with proton pump inhibitors, including rabeprazole, is not recommended.

Antacids

In clinical studies, antacids have been used in conjunction with sodium rabeprazole. Clinically significant interactions of rabeprazole sodium with aluminum hydroxide gel or magnesium hydroxide were not observed.

Eating

In a clinical study, no clinically significant interactions were observed with rabeprazole sodium with a low-fat diet. Taking rabeprazole sodium simultaneously with food enriched with fats can slow down the absorption of rabeprazole up to 4 hours or more, however, Cmax and AUC do not change.

Cyclosporine

The experiments in vitro using human liver microsomes showed that cyclosporin inhibits metabolism rabeprazole IC50 with 62 micromol, i.e. at a concentration 50 times higher than the Cmax for healthy volunteers after 20 days of taking 20 mg of rabeprazole. The degree of inhibition is similar to that of omeprazole for equivalent concentrations.

Methotrexate

According to reports of adverse events, published pharmacokinetic studies and retrospective analysis, it can be assumed that the simultaneous use of PPIs and methotrexate (primarily in high doses) may lead to an increase in the concentration of methotrexate and / or its metabolite hydroxymethotrexate and increase T1 / 2. However, there have been no specific studies of drug interactions between methotrexate and PPIs.

Method of administration and dosage

Enteric-coated tablets, 10 mg

Inside, at a dose of 10 mg once a day. Do not chew or grind NofluxЃ tablets. The tablets should be swallowed whole. It is recommended to take the drug in the morning, before eating. It was found that neither time of day nor food intake affects the activity of rabeprazole sodium, but the recommended time for taking NofluxЃ tablets contributes to better patient compliance with the treatment regimen.

If there is no effect during the first 3 days of treatment, a specialist examination is required. The maximum course of treatment without consulting a doctor is 14 days.

Enteric-coated tablets, 20 mg

Inside. Do not chew or grind NofluxЃ tablets. The tablets should be swallowed whole. It was found that neither the time of day nor food intake affects the activity of rabeprazole sodium.

In case of gastric ulcer in the stage of exacerbation and anastomotic ulcer, it is recommended to take 20 mg orally 1 time per day. Usually, cure occurs after 6 weeks of therapy, but in some cases, the duration of treatment can be increased by another 6 weeks.

In case of duodenal ulcer disease in the acute stage, it is recommended to take 20 mg orally 1 time per day. The duration of treatment is 2 to 4 weeks. If necessary, the duration of treatment can be increased by another 4 weeks.

When treating erosive GERD or reflux esophagitis, it is recommended to take 20 mg orally once a day. The duration of treatment is 4 to 8 weeks. If necessary, the duration of treatment can be increased by another 8 weeks.

With maintenance therapy for GERD, it is recommended to take 20 mg orally once a day. The duration of treatment depends on the patient's condition.

For NERD without esophagitis, it is recommended to take 20 mg orally once a day. If symptoms persist after 4 weeks of treatment, additional examination of the patient should be performed. After relief of symptoms, to prevent their subsequent occurrence, the drug should be taken orally once a day on demand.

For the treatment of Zollinger-Ellison syndrome and other conditions characterized by pathological hypersecretion , the dose is selected individually. The initial dose is 60 mg / day, then the dose is increased and the drug is prescribed in a dose of up to 100 mg / day with a single dose or 60 mg 2 times a day. For some patients, fractional dosing is preferred. Treatment should be continued as clinically necessary. In some patients with Zollinger-Ellison syndrome, the duration of treatment with rabeprazole was up to one year.

For the eradication of Helicobacter pylori, it is recommended to take 20 mg orally 2 times a day according to a specific scheme with an appropriate combination of antibiotics. The duration of treatment is 7 days.

Special patient groups

ѕочечна¤ и печеночна¤ недостаточность.  оррекци¤ дозы у пациентов с почечной недостаточностью не требуетс¤. ” пациентов с легкой и умеренной степенью печеночной недостаточности концентраци¤ рабепразола в крови обычно выше, чем у здоровых пациентов. ѕри назначении препарата ЌофлюксЃ пациентам с т¤желой степенью печеночной недостаточности следует соблюдать осторожность.

ѕожилые пациенты.  оррекци¤ дозы не требуетс¤.

?ети. Ѕезопасность и эффективность рабепразола натри¤ 20 мг дл¤ краткосрочного (до 8 нед) лечени¤ vЁ–Ѕ у детей в возрасте 12 лет и более подтверждена экстрапол¤цией результатов адекватных и хорошо контролируемых исследований, подкрепл¤ющих эффективность рабепразола натри¤ дл¤ взрослых, и исследовани¤ми безопасности и фармакокинетики дл¤ пациентов детского возраста. –екомендуема¤ доза дл¤ детей в возрасте 12 лет и более составл¤ет 20 мг 1 раз в день продолжительностью до 8 нед. Ѕезопасность и эффективность рабепразола натри¤ дл¤ лечени¤ vЁ–Ѕ у детей в возрасте младше 12 лет не установлена. Ѕезопасность и эффективность рабепразола натри¤ дл¤ применени¤ по другим показани¤м не установлена дл¤ пациентов детского возраста.

ѕередозировка

—имптомы: данные о намеренной или случайной передозировке минимальны. —лучаи сильной передозировки рабепразола не были отмечены.

Ћечение: специфический антидот препарата ЌофлюксЃ неизвестен. –абепразол хорошо св¤зываетс¤ с белками плазмы, и поэтому слабо выводитс¤ при диализе. Ќеобходимо проводить симптоматическую и поддерживающую терапию.

ќсобые указани¤

ќтвет пациента на терапию рабепразолом натри¤ не исключает наличие злокачественных новообразований в желудке.

“аблетки препарата ЌофлюксЃ нельз¤ разжевывать или измельчать. “аблетки следует глотать целиком. ”становлено, что ни врем¤ суток, ни прием пищи не вли¤ют на активность рабепразола натри¤.

¬ специальном исследовании у пациентов с легкими или умеренными нарушени¤ми функции печени не были обнаружены значимые отличи¤ частоты побочных эффектов препарата ЌофлюксЃ от таковой у подобранных по полу и возрасту здоровых лиц, но, несмотр¤ на это, рекомендуетс¤ соблюдать осторожность при первом назначении препарата ЌофлюксЃ пациентам с т¤желыми нарушени¤ми функции печени. AUC рабепразола натри¤ у пациентов с т¤желым нарушением функции печени примерно в 2 раза выше, чем у здоровых пациентов.

ѕациентам с нарушени¤ми функции почек или печени коррекци¤ дозы препарата ЌофлюксЃ не требуетс¤.

vипомагниеми¤

ѕри лечении »ѕѕ на прот¤жении по крайней мере 3 мес в редких случа¤х были отмечены случаи симптоматической или асимптоматической гипомагниемии. ¬ большинстве эти сообщени¤ поступали через год после проведени¤ терапии. —ерьезными побочными ¤влени¤ми были тетани¤, аритми¤ и судороги. Ѕольшинству пациентов требовалось лечение гипомагниемии, включающее замещение магни¤ и отмену терапии »ѕѕ. ” пациентов, которые будут получать длительное лечение или которые принимают »ѕѕ с препаратами, такими как дигоксин, или препаратами, которые могут вызвать гипомагниемию (например диуретики), медицинские работники должны контролировать уровень магни¤ до начала лечени¤ »ѕѕ и в период лечени¤. ѕациенты не должны принимать одновременно с препаратом ЌофлюксЃ другие средства, снижающие кислотность, например блокаторы Ќ2-рецепторов или другие ингибиторы протонного насоса.

ѕереломы

—огласно данным наблюдательных исследований, можно предположить, что терапи¤ »ѕѕ может привести к возрастанию риска св¤занных с остеопорозом переломов бедра, зап¤сть¤ или позвоночника. –иск переломов был увеличен у пациентов, получавших высокие дозы »ѕѕ длительно (год и более).

ќдновременное применение рабепразола с метотрексатом

—огласно литературным данным, одновременный прием »ѕѕ с метотрексатом (прежде всего в высоких дозах) может повысить концентрации метотрексата и/или его метаболита гидроксиметотрексата и увеличить T1/2, что может привести к про¤влению токсичности метотрексата. ѕри необходимости применени¤ высоких доз метотрексата может быть рассмотрена возможность временного прекращени¤ терапии »ѕѕ.

Clostridium difficile

“ерапи¤ »ѕѕ может приводить к возрастанию риска желудочно-кишечных инфекций, например вызванных Clostridium difficile.

ѕациентам, принимающим препарат ЌофлюксЃ дл¤ кратковременного симптоматического лечени¤ про¤влений vЁ–Ѕ и ЌЁ–Ѕ (например изжога) без рецепта, следует обратитьс¤ к врачу в следующих случа¤х:

- применение средств дл¤ сн¤ти¤ симптомов изжоги и нарушени¤ пищеварени¤ в течение 4 нед и более;

- по¤вление новых симптомов или изменение ранее наблюдавшихс¤ симптомов у пациентов в возрасте более 55 лет;

- случаи ненамеренного уменьшени¤ массы тела, анемии, кровотечений в ? “, дисфагии, боли при глотании, посто¤нной рвоты или рвоты с кровью и содержимым эпигастри¤, случаи ¤звы желудка или операций на желудке в анамнезе, желтухи и т.д. (в т.ч. нарушение функции печени и почек).

ѕациенты, длительное врем¤ страдающие от повтор¤ющихс¤ симптомов нарушени¤ пищеварени¤ или изжоги, должны регул¤рно наблюдатьс¤ у врача.

ѕациенты в возрасте более 55 лет, ежедневно принимающие безрецептурные препараты дл¤ сн¤ти¤ симптомов изжоги и нарушени¤ пищеварени¤, должны проинформировать об этом своего лечащего врача.

ѕациенты не должны принимать одновременно с препаратом ЌофлюксЃ другие средства, снижающие кислотность, например блокаторы Ќ2-рецепторов или другие »ѕѕ.

ѕри применении других препаратов пациентам следует проконсультироватьс¤ с фармацевтом или врачом перед началом терапии препаратом ЌофлюксЃ, отпускаемым без рецепта.

ѕациенты должны сообщить врачу перед началом применени¤ препарата ЌофлюксЃ без рецепта, если им назначено эндоскопическое исследование.

—ледует избегать приема препарата ЌофлюксЃ перед проведением мочевинного дыхательного теста.

ѕациенты с т¤желыми нарушени¤ми функции печени должны обратитьс¤ к врачу перед началом терапии препаратом ЌофлюксЃ, отпускаемым без рецепта, дл¤ кратковременного симптоматического лечени¤ про¤влений vЁ–Ѕ и ЌЁ–Ѕ (например изжога).

¬ли¤ние на способность управл¤ть транспортными средствами и работать с механизмами. »сход¤ из особенностей фармакодинамики рабепразола и его профил¤ нежелательных эффектов, маловеро¤тно, что ЌофлюксЃ оказывает вли¤ние на способность водить автомобиль и работать с техникой. ќднако в случае по¤влени¤ сонливости следует избегать этих видов де¤тельности.

‘орма выпуска

“аблетки, покрытые кишечнорастворимой оболочкой, 10 мг, 20 мг. ѕо 7 табл. в блистере (алюминий/алюминий). 2 или 4 блистера в картонной пачке.

ѕроизводитель

Ћабораториос Ћиконса —.ј., »спани¤. јвенида ћиралькампо, 7, ѕолигоно »ндустриаль ћиралькампо, 19200, јсукека-де-Ёнарес (vвадалахара), »спани¤.

?ержатель регистрационного удостоверени¤: «јќ Ђ‘армацевтический завод Ёv»—ї. 1106, Ѕудапешт, ул.  ерестури, 30Ц38, ¬енгри¤.

“ел.: (36 1) 803-55-55; факс: (36 1) 803-55-29.

ѕретензии потребителей направл¤ть в представительство «јќ Ђ‘армацевтический завод Ёv»—ї (¬енгри¤) в ћоскве. 121108, ћосква, ул. »вана ‘ранко, 8.

“ел.: (495) 363-39-66.

”слови¤ отпуска из аптек

“аблетки, покрытые кишечнорастворимой оболочкой, 10 мг. Ѕез рецепта.

“аблетки, покрытые кишечнорастворимой оболочкой, 20 мг. ѕо рецепту.

Storage conditions

At a temperature not exceeding 25 ? C.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use after the expiration date printed on the package.