Симптоматическое лечение боли, спазмов, дисфункции и дискомфорта в области кишечника, связанных с синдромом раздраженного кишечника.
Симптомы могут включать: боль в области живота, спазмы, ощущение вздутия и метеоризм, изменение частоты стула (диарея, запор или чередование диареи и запоров), изменение консистенции стула.
Противопоказания
Гиперчувствительность к любому компоненту препарата. Возраст до 18 лет. Врожденная непереносимость галактозы (лактозы) или фруктозы, недостаточность лактазы, дефицит сахаразы/изомальтазы, синдром глюкозо-галактозной мальабсорбции. Беременность и период грудного вскармливания.
Спазмолитик миотропного действия, оказывает прямое действие на гладкую мускулатуру желудочно-кишечного тракта без влияния на нормальную перистальтику кишечника.
Точный механизм действия неизвестен, но множественные механизмы, такие как снижение проницаемости ионных каналов, блокада обратного захвата норадреналина, местное анестезирующее действие, а также изменение абсорбции воды, могут вызвать местное действие мебеверина на желудочно-кишечный тракт. Посредством этих механизмов мебеверин обладает спазмолитическим действием, нормализуя перистальтику кишечника и не вызывая постоянной релаксации гладкомышечных клеток желудочнокишечного тракта («гипотонию»). Системные побочные эффекты, в том числе антихолинергические, отсутствуют.
Фармакокинетика
Всасывание
Мебеверин быстро и полностью всасывается после приема внутрь.
Распределение
При приеме повторных доз препарата значительной аккумуляции не происходит.
Метаболизм
Мебеверина гидрохлорид в основном метаболизируется эстеразами, которые на первом этапе расщепляют эфир на вератровую кислоту и спирт мебеверина. Основным метаболитом, циркулирующим в плазме, является деметилированная карбоновая кислота.
Период полувыведения в равновесном состоянии деметилированной карбоновой кислоты составляет приблизительно 2,45 ч. При приеме повторных доз максимальная концентрация деметилированной карбоновой кислоты в крови (Cmax) составляет 1670 нг/мл, время достижения максимальной концентрации деметилированной карбоновой кислоты в крови (Тmax) – 1 час.
Выведение
Мебеверин как таковой не выводится из организма, но полностью метаболизируется; его метаболиты практически полностью выводятся из организма. Вератровая кислота выводится почками. Спирт мебеверина также выводится почками, частично в виде карбоновой кислоты и частично в виде деметилированной карбоновой кислоты.
Показания к применению
Симптоматическое лечение боли, спазмов, дисфункции и дискомфорта в области кишечника, связанных с синдромом раздраженного кишечника.
Симптомы могут включать: боль в области живота, спазмы, ощущение вздутия и метеоризм, изменение частоты стула (диарея, запор или чередование диареи и запоров), изменение консистенции стула.
Противопоказания
Гиперчувствительность к любому компоненту препарата. Возраст до 18 лет. Врожденная непереносимость галактозы (лактозы) или фруктозы, недостаточность лактазы, дефицит сахаразы/изомальтазы, синдром глюкозо-галактозной мальабсорбции. Беременность и период грудного вскармливания.
Применение при беременности и в период грудного вскармливания
Беременность
Имеются только крайне ограниченные данные о применении мебеверина беременными женщинами. Данных исследований на животных недостаточно для оценки репродуктивной токсичности. Не рекомендуется применять Дюспаталин во время беременности.
Периодгрудноговскармливания
Информации об экскреции мебеверина или его метаболитов в грудное молоко недостаточно. Исследования экскреции мебеверина в молоко у животных не проводились.
Не следует принимать Дюспаталин во время кормления грудью.
Фертильность
Клинические данные по влиянию препарата на фертильность у мужчин или женщин отсутствуют, однако известные исследования на животных не продемонстрировали неблагоприятных эффектов препарата Дюспаталин.
Способ применения и дозы
Для приема внутрь.
Таблетки необходимо проглатывать, не разжевывая, запивая достаточным количеством воды (не менее 100 мл).
По одной таблетке 3 раза в день, приблизительно за 20 минут до еды.
Продолжительность приема препарата не ограничена.
Если пациент забыл принять одну или несколько доз, прием препарата следует продолжать со следующей дозы. Не следует принимать одну или несколько пропущенных доз в дополнение к обычной дозе.
Исследования режима дозирования у пожилых пациентов, пациентов с почечной и/или печеночной недостаточностью не проводились. Доступные данные о постмаркетинговом применении препарата не выявили специфических факторов риска при его применении у пожилых пациентов и пациентов с почечной и/или печеночной недостаточностью.
Изменения режима дозирования у пожилых пациентов и пациентов с почечной и/или печеночной недостаточностью не требуется.
Побочное действие
Сообщения о перечисленных побочных эффектах носили спонтанный характер, и для точной оценки частоты случаев имеющихся данных недостаточно.
Аллергические реакции наблюдались преимущественно со стороны кожных покровов, но отмечались также и другие проявления аллергии.
Состороныкожныхпокровов:
Крапивница (аллергическая сыпь), ангионевротический отек (серьезная аллергическая реакция, которая может включать: затруднение дыхания, отечность лица, шеи, губ, языка, горла), отек лица, экзантема (кожная сыпь).
Состороныиммуннойсистемы:
Реакции гиперчувствительности (анафилактические реакции −серьезные аллергические реакции, которые могут включать: затруднение дыхания, учащенный пульс, резкое снижение артериального давления (слабость и головокружение), потоотделение).
Если у вас отмечаются какие-либо из побочных эффектов, в том числе не указанные в данной инструкции, прекратите прием препарата Дюспаталин и незамедлительно обратитесь к врачу.
Передозировка
В случае передозировки препаратом Дюспаталин® необходимо незамедлительно обратиться к врачу.
Симптомы
Теоретически, в случае передозировки возможно повышение возбудимости центральной нервной системы. В случаях передозировки мебеверина симптомы либо отсутствовали, либо были незначительными и, как правило, быстро обратимыми. Отмечавшиеся симптомы передозировки носили неврологический и сердечно-сосудистый характер.
Лечение
Специфический антидот неизвестен. Рекомендуется симптоматическое лечение.
Промывание желудка необходимо только в случае, если интоксикация выявлена в течение приблизительно одного часа после приема нескольких доз препарата. Мероприятия по снижению уровня всасывания не требуются.
Взаимодействие с другими лекарственными средствами
Исследования на животных продемонстрировали отсутствие какого-либо взаимодействия между препаратом Дюспаталин и этиловым спиртом.
Особые указания
Перед приемом препарата Дюспаталин® необходимо проконсультироваться с врачом, в случае:
− если симптомы заболевания возникли впервые;
− непреднамеренной и необъяснимой потери веса;
− анемии;
− ректального кровотечения или примеси крови в стуле;
− лихорадки;
− если у кого-то в вашей семье был диагностирован рак толстой кишки, целиакия или воспалительные заболевания кишечника;
− возраста старше 50 лет и если симптомы заболевания возникли впервые;
− недавнего применения антибиотиков.
Обратитесь к врачу, если на фоне приема препарата состояние ухудшилось или не наступило улучшение симптомов после 2 недель применения.
Влияние на способность управлять автомобилем и движущимися механизмами
Фармакологические свойства препарата, а также опыт его применения не свидетельствуют о каком-либо неблагоприятном влиянии мебеверина на способность к управлению автомобилем и другими механизмами.
Форма выпуска
Таблетки покрытые оболочкой 135 мг.
По 10 таблеток в блистер из ПВХ/алюминиевой фольги. По 1, 5 блистеров вместе с инструкцией по применению в картонную пачку.
По 15 таблеток в блистер из ПВХ/алюминиевой фольги. По 1, 2, 6 блистеров вместе с инструкцией по применению в картонную пачку.
По 20 таблеток в блистер из ПВХ/алюминиевой фольги. По 1, 2, 3, 5, 6 блистеров вместе с инструкцией по применению в картонную пачку.
Условия хранения
Хранить при температуре не выше 30 °С.
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Срок годности
5 лет.
Не применять по истечении срока годности, указанного на упаковке
Условия отпуска
Без рецепта.
Производитель
Майлан Лэбораториз САС
Рут де Бельвилль, Лье-ди Майар, 01400, Шатийон-сюр-Шаларон, Франция
Фасовщик, упаковщик
Майлан Лэбораториз САС
Рут де Бельвилль, Лье-ди Майар, 01400,
Шатийон-сюр-Шаларон, Франция
Выпускающий контроль качества
Майлан Лэбораториз САС
Рут де Бельвилль, Лье-ди Майар, 01400,
Шатийон-сюр-Шаларон, Франция
Организация, принимающая претензии потребителей
ООО «Эбботт Лэбораториз»
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Тел.: +7 (495) 258 42 80
Факс: +7 (495) 258 42 81
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номер","slug":"","body":[{"type":"paragraph","data":{"text":"ЛП-001454"}}]},{"id":1,"name":"Торговое название препарата","slug":"","body":[{"type":"paragraph","data":{"text":"Дюспаталин"}},{"type":"header","data":{"text":"Международное непатентованное наименование или группировочное наименование:","level":4}},{"type":"paragraph","data":{"text":"мебеверин\n"}}]},{"id":2,"name":"Лекарственная форма","slug":"","body":[{"type":"paragraph","data":{"text":"Таблетки покрытые оболочкой, круглые таблетки, покрытые оболочкой, белого цвета"}}]},{"id":4,"name":"Состав","slug":"ingredients","body":[{"type":"paragraph","data":{"text":"1 таблетка покрытая оболочкой содержит:"}},{"type":"paragraph","data":{"text":"\u003ci\u003eАктивное вещество:\u003c/i\u003e мебеверина гидрохлорид – 135,0 мг."}},{"type":"paragraph","data":{"text":"\u003ci\u003eВспомогательные вещества:\u003c/i\u003e лактозы моногидрат – 97,0 мг, крахмал картофельный – 45,0 мг, повидон-К25 – 5,5 мг, тальк – 12,0 мг, магния стеарат – 5,5 мг."}},{"type":"paragraph","data":{"text":"\u003ci\u003eОболочка:\u003c/i\u003e тальк – 40,0 мг, сахароза – 79,0 мг, желатин – 0,4 мг, акации камедь – 0,4 мг, карнаубский воск – 0,3 мг."}}]},{"id":5,"name":"Фармакотерапевтическая группа","slug":"","body":[{"type":"paragraph","data":{"text":"Спазмолитическое средство."}},{"type":"paragraph","data":{"text":"\u003cb\u003eКод АТХ:\u003c/b\u003e А03АА04 "}}]},{"id":6,"name":"Фармакологические свойства","slug":"","body":[{"type":"header","data":{"text":"Фармакодинамика","level":4}},{"type":"paragraph","data":{"text":"Спазмолитик миотропного действия, оказывает прямое действие на гладкую мускулатуру желудочно-кишечного тракта без влияния на нормальную перистальтику кишечника."}},{"type":"paragraph","data":{"text":"Точный механизм действия неизвестен, но множественные механизмы, такие как снижение проницаемости ионных каналов, блокада обратного захвата норадреналина, местное анестезирующее действие, а также изменение абсорбции воды, могут вызвать местное действие мебеверина на желудочно-кишечный тракт. Посредством этих механизмов мебеверин обладает спазмолитическим действием, нормализуя перистальтику кишечника и не вызывая постоянной релаксации гладкомышечных клеток желудочнокишечного тракта («гипотонию»). Системные побочные эффекты, в том числе антихолинергические, отсутствуют."}},{"type":"header","data":{"text":"Фармакокинетика","level":4}},{"type":"paragraph","data":{"text":"\u003ci\u003eВсасывание\u003c/i\u003e "}},{"type":"paragraph","data":{"text":"Мебеверин быстро и полностью всасывается после приема внутрь."}},{"type":"paragraph","data":{"text":"\u003ci\u003eРаспределение\u003c/i\u003e"}},{"type":"paragraph","data":{"text":"При приеме повторных доз препарата значительной аккумуляции не происходит."}},{"type":"paragraph","data":{"text":"\u003ci\u003eМетаболизм\u003c/i\u003e"}},{"type":"paragraph","data":{"text":"Мебеверина гидрохлорид в основном метаболизируется эстеразами, которые на первом этапе расщепляют эфир на вератровую кислоту и спирт мебеверина. Основным метаболитом, циркулирующим в плазме, является деметилированная карбоновая кислота."}},{"type":"paragraph","data":{"text":"Период полувыведения в равновесном состоянии деметилированной карбоновой кислоты составляет приблизительно 2,45 ч. При приеме повторных доз максимальная концентрация деметилированной карбоновой кислоты в крови (Cmax) составляет 1670 нг/мл, время достижения максимальной концентрации деметилированной карбоновой кислоты в крови (Тmax) – 1 час."}},{"type":"paragraph","data":{"text":"\u003ci\u003eВыведение\u003c/i\u003e"}},{"type":"paragraph","data":{"text":"Мебеверин как таковой не выводится из организма, но полностью метаболизируется; его метаболиты практически полностью выводятся из организма. Вератровая кислота выводится почками. Спирт мебеверина также выводится почками, частично в виде карбоновой кислоты и частично в виде деметилированной карбоновой кислоты."}}]},{"id":7,"name":"Показания к применению","slug":"indications","body":[{"type":"paragraph","data":{"text":"Симптоматическое лечение боли, спазмов, дисфункции и дискомфорта в области кишечника, связанных с синдромом раздраженного кишечника."}},{"type":"paragraph","data":{"text":"Симптомы могут включать: боль в области живота, спазмы, ощущение вздутия и метеоризм, изменение частоты стула (диарея, запор или чередование диареи и запоров), изменение консистенции стула."}}]},{"id":8,"name":"Противопоказания","slug":"contraindications","body":[{"type":"paragraph","data":{"text":"Гиперчувствительность к любому компоненту препарата. Возраст до 18 лет. Врожденная непереносимость галактозы (лактозы) или фруктозы, недостаточность лактазы, дефицит сахаразы/изомальтазы, синдром глюкозо-галактозной мальабсорбции. Беременность и период грудного вскармливания. "}}]},{"id":10,"name":"Применение при беременности и в период грудного вскармливания","slug":"pregnancy_warnings","body":[{"type":"paragraph","data":{"text":"\u003ci\u003eБеременность\u003c/i\u003e "}},{"type":"paragraph","data":{"text":"Имеются только крайне ограниченные данные о применении мебеверина беременными женщинами. Данных исследований на животных недостаточно для оценки репродуктивной токсичности. Не рекомендуется применять Дюспаталин во время беременности."}},{"type":"paragraph","data":{"text":"\u003ci\u003eПериод\u003c/i\u003e \u003ci\u003eгрудного\u003c/i\u003e \u003ci\u003eвскармливания\u003c/i\u003e"}},{"type":"paragraph","data":{"text":"Информации об экскреции мебеверина или его метаболитов в грудное молоко недостаточно. Исследования экскреции мебеверина в молоко у животных не проводились."}},{"type":"paragraph","data":{"text":"Не следует принимать Дюспаталин во время кормления грудью."}},{"type":"paragraph","data":{"text":"\u003ci\u003eФертильность\u003c/i\u003e"}},{"type":"paragraph","data":{"text":"Клинические данные по влиянию препарата на фертильность у мужчин или женщин отсутствуют, однако известные исследования на животных не продемонстрировали неблагоприятных эффектов препарата Дюспаталин."}}]},{"id":11,"name":"Способ применения и дозы","slug":"dosage","body":[{"type":"paragraph","data":{"text":"Для приема внутрь."}},{"type":"paragraph","data":{"text":"Таблетки необходимо проглатывать, не разжевывая, запивая достаточным количеством воды (не менее 100 мл)."}},{"type":"paragraph","data":{"text":"По одной таблетке 3 раза в день, приблизительно за 20 минут до еды."}},{"type":"paragraph","data":{"text":"Продолжительность приема препарата не ограничена."}},{"type":"paragraph","data":{"text":"Если пациент забыл принять одну или несколько доз, прием препарата следует продолжать со следующей дозы. Не следует принимать одну или несколько пропущенных доз в дополнение к обычной дозе."}},{"type":"paragraph","data":{"text":"Исследования режима дозирования у пожилых пациентов, пациентов с почечной и/или печеночной недостаточностью не проводились. Доступные данные о постмаркетинговом применении препарата не выявили специфических факторов риска при его применении у пожилых пациентов и пациентов с почечной и/или печеночной недостаточностью."}},{"type":"paragraph","data":{"text":"Изменения режима дозирования у пожилых пациентов и пациентов с почечной и/или печеночной недостаточностью не требуется."}}]},{"id":12,"name":"Побочное действие","slug":"side_effects","body":[{"type":"paragraph","data":{"text":"Сообщения о перечисленных побочных эффектах носили спонтанный характер, и для точной оценки частоты случаев имеющихся данных недостаточно."}},{"type":"paragraph","data":{"text":"Аллергические реакции наблюдались преимущественно со стороны кожных покровов, но отмечались также и другие проявления аллергии."}},{"type":"paragraph","data":{"text":"\u003ci\u003eСо\u003c/i\u003e \u003ci\u003eстороны\u003c/i\u003e \u003ci\u003eкожных\u003c/i\u003e \u003ci\u003eпокровов:\u003c/i\u003e"}},{"type":"paragraph","data":{"text":"Крапивница (аллергическая сыпь), ангионевротический отек (серьезная аллергическая реакция, которая может включать: затруднение дыхания, отечность лица, шеи, губ, языка, горла), отек лица, экзантема (кожная сыпь)."}},{"type":"paragraph","data":{"text":"\u003ci\u003eСо\u003c/i\u003e \u003ci\u003eстороны\u003c/i\u003e \u003ci\u003eиммунной\u003c/i\u003e \u003ci\u003eсистемы\u003c/i\u003e:"}},{"type":"paragraph","data":{"text":"Реакции гиперчувствительности (анафилактические реакции −серьезные аллергические реакции, которые могут включать: затруднение дыхания, учащенный пульс, резкое снижение артериального давления (слабость и головокружение), потоотделение)."}},{"type":"paragraph","data":{"text":"Если у вас отмечаются какие-либо из побочных эффектов, в том числе не указанные в данной инструкции, прекратите прием препарата Дюспаталин и незамедлительно обратитесь к врачу.\n"}}]},{"id":13,"name":"Передозировка","slug":"overdose","body":[{"type":"paragraph","data":{"text":"В случае передозировки препаратом Дюспаталин® необходимо незамедлительно обратиться к врачу."}},{"type":"paragraph","data":{"text":"\u003ci\u003eСимптомы\u003c/i\u003e "}},{"type":"paragraph","data":{"text":"Теоретически, в случае передозировки возможно повышение возбудимости центральной нервной системы. В случаях передозировки мебеверина симптомы либо отсутствовали, либо были незначительными и, как правило, быстро обратимыми. Отмечавшиеся симптомы передозировки носили неврологический и сердечно-сосудистый характер."}},{"type":"paragraph","data":{"text":"\u003ci\u003eЛечение\u003c/i\u003e"}},{"type":"paragraph","data":{"text":"Специфический антидот неизвестен. Рекомендуется симптоматическое лечение."}},{"type":"paragraph","data":{"text":"Промывание желудка необходимо только в случае, если интоксикация выявлена в течение приблизительно одного часа после приема нескольких доз препарата. Мероприятия по снижению уровня всасывания не требуются."}}]},{"id":14,"name":"Взаимодействие с другими лекарственными средствами","slug":"drugs_interaction","body":[{"type":"paragraph","data":{"text":"Исследования на животных продемонстрировали отсутствие какого-либо взаимодействия между препаратом Дюспаталин и этиловым спиртом."}}]},{"id":15,"name":"Особые указания","slug":"","body":[{"type":"paragraph","data":{"text":"Перед приемом препарата Дюспаталин® необходимо проконсультироваться с врачом, в случае:"}},{"type":"paragraph","data":{"text":"− если симптомы заболевания возникли впервые;"}},{"type":"paragraph","data":{"text":"− непреднамеренной и необъяснимой потери веса;"}},{"type":"paragraph","data":{"text":"− анемии;"}},{"type":"paragraph","data":{"text":"− ректального кровотечения или примеси крови в стуле;"}},{"type":"paragraph","data":{"text":"− лихорадки;"}},{"type":"paragraph","data":{"text":"− если у кого-то в вашей семье был диагностирован рак толстой кишки, целиакия или воспалительные заболевания кишечника;"}},{"type":"paragraph","data":{"text":"− возраста старше 50 лет и если симптомы заболевания возникли впервые;"}},{"type":"paragraph","data":{"text":"− недавнего применения антибиотиков."}},{"type":"paragraph","data":{"text":"Обратитесь к врачу, если на фоне приема препарата состояние ухудшилось или не наступило улучшение симптомов после 2 недель применения."}}]},{"id":16,"name":"Влияние на способность управлять автомобилем и движущимися механизмами","slug":"","body":[{"type":"paragraph","data":{"text":"Фармакологические свойства препарата, а также опыт его применения не свидетельствуют о каком-либо неблагоприятном влиянии мебеверина на способность к управлению автомобилем и другими механизмами. "}}]},{"id":17,"name":"Форма выпуска","slug":"","body":[{"type":"paragraph","data":{"text":"Таблетки покрытые оболочкой 135 мг."}},{"type":"paragraph","data":{"text":"По 10 таблеток в блистер из ПВХ/алюминиевой фольги. По 1, 5 блистеров вместе с инструкцией по применению в картонную пачку."}},{"type":"paragraph","data":{"text":"По 15 таблеток в блистер из ПВХ/алюминиевой фольги. По 1, 2, 6 блистеров вместе с инструкцией по применению в картонную пачку."}},{"type":"paragraph","data":{"text":"По 20 таблеток в блистер из ПВХ/алюминиевой фольги. По 1, 2, 3, 5, 6 блистеров вместе с инструкцией по применению в картонную пачку."}}]},{"id":18,"name":"Условия хранения","slug":"storage","body":[{"type":"paragraph","data":{"text":"Хранить при температуре не выше 30 °С."}},{"type":"paragraph","data":{"text":"Хранить в недоступном для детей месте!"}}]},{"id":19,"name":"Срок годности","slug":"expiry_date","body":[{"type":"paragraph","data":{"text":"5 лет."}},{"type":"paragraph","data":{"text":"Не применять по истечении срока годности, указанного на упаковке"}}]},{"id":20,"name":"Условия отпуска","slug":"release_condition","body":[{"type":"paragraph","data":{"text":"Без рецепта."}}]},{"id":21,"name":"Производитель","slug":"","body":[{"type":"paragraph","data":{"text":"Майлан Лэбораториз САС"}},{"type":"paragraph","data":{"text":"Рут де Бельвилль, Лье-ди Майар, 01400, Шатийон-сюр-Шаларон, Франция"}},{"type":"header","data":{"text":"Фасовщик, упаковщик","level":4}},{"type":"paragraph","data":{"text":"Майлан Лэбораториз САС"}},{"type":"paragraph","data":{"text":"Рут де Бельвилль, Лье-ди Майар, 01400,"}},{"type":"paragraph","data":{"text":"Шатийон-сюр-Шаларон, Франция"}},{"type":"header","data":{"text":"Выпускающий контроль качества","level":4}},{"type":"paragraph","data":{"text":"Майлан Лэбораториз САС"}},{"type":"paragraph","data":{"text":"Рут де Бельвилль, Лье-ди Майар, 01400,"}},{"type":"paragraph","data":{"text":"Шатийон-сюр-Шаларон, Франция"}}]},{"id":22,"name":"Организация, принимающая претензии потребителей","body":[{"type":"paragraph","data":{"text":"ООО «Эбботт Лэбораториз»"}},{"type":"paragraph","data":{"text":"125171, г. Москва, Ленинградское шоссе, дом 16 А, стр. 1"}},{"type":"paragraph","data":{"text":"Тел.: +7 (495) 258 42 80"}},{"type":"paragraph","data":{"text":"Факс: +7 (495) 258 42 81"}},{"type":"paragraph","data":{"text":"abbott-russia@abbott.com"}}]}],"source":null},"description_toggle":false,"short_description":"","substance":[{"id":651,"title":"Мебеверин","title_latin":"Mebeverinum","slug":"mebeverin_651"}],"branding":null,"valid_for_quick_buy":true,"is_available_to_delivery":true,"comments":null,"image_alt":"Дюспаталин - фото упаковки","image_share":{"isTouch":{"default":"https://vseapteki.ru/cropping/thumbnails/101/70161/share_default/"},"isFromTablet":{"default":"https://vseapteki.ru/cropping/thumbnails/101/70161/share_default/"}},"diseases":[{"id":"878","title":"Синдром раздраженного кишечника","slug":"878-sindrom_razdrazhennogo_kishechnika"},{"id":"1249","title":"Боли, локализованные в верхней части 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