Рацекадотрил является кишечным антисекреторным веществом. Он... Инструкция
Показания к применению
Симптоматическое лечение острой диареи у взрослых. В случае, если этиотропное лечение возможно, Гидрасек может применяться в качестве вспомогательной терапии.
Противопоказания
Повышенная чувствительность к рацекадотрилу или к какому-либо другому компоненту препарата; ангионевротический отек в анамнезе, в том числе ангионевротический отек при применении ингибиторов АПФ; врожденная непереносимость галактозы, в том числе галактоземия; дефицит лактазы Лаппа, глюкозо-галактозная мальабсорбция; беременность; период грудного вскармливания; ...
Твердая желатиновая капсула: краситель железа оксид желтый (E 172) - 0,10 %, титана диоксид (E 171) - 2,0 %, желатин - до 100 %.
Описание
твердые желатиновые капсулы № 2 светло-желтого цвета. Содержимое капсул - белый порошок с характерным запахом.
Фармакотерапевтические свойства
противодиарейное средство
Фармакологические свойства
Рацекадотрил является кишечным антисекреторным веществом. Он уменьшает кишечную гиперсекрецию воды и электролитов, вызываемую энтеротоксином холеры или воспалением, и не влияет на базальную секрецию кишечника; оказывает быстрое противодиарейное действие, не изменяя время прохождения кишечного содержимого через кишечник; не вызывает вздутия живота. В клинических исследованиях частота возникновения вторичных запоров при приеме рацекадотрила была сравнима с плацебо.
Показания к применению
Симптоматическое лечение острой диареи у взрослых. В случае, если этиотропное лечение возможно, Гидрасек может применяться в качестве вспомогательной терапии.
Противопоказания
Повышенная чувствительность к рацекадотрилу или к какому-либо другому компоненту препарата; ангионевротический отек в анамнезе, в том числе ангионевротический отек при применении ингибиторов АПФ; врожденная непереносимость галактозы, в том числе галактоземия; дефицит лактазы Лаппа, глюкозо-галактозная мальабсорбция; беременность; период грудного вскармливания; детский возраст до 18 лет; антибиотик-ассоциированная диарея; хроническая диарея.
С осторожностью
Пациенты с печеночной и почечной недостаточностью; одновременное применение с ингибиторами АПФ.
Применение при беременности и в период грудного вскармливания
В связи с отсутствием специальных клинических исследований применение препарата во время беременности противопоказано. В связи с отсутствием информации об экскреции рацекадотрила в грудное молоко применение препарата в период грудного вскармливания противопоказано.
Способ применения и дозы
Для приема внутрь.
Первую капсулу в начале лечения принимают независимо от времени суток. Далее − одну капсулу три раза в день перед едой.
Лечение необходимо продолжать до нормализации стула (появления нормального кала до двух раз), но не более 7 дней. Не рекомендуется применять рацекадотрил длительное время. Коррекция дозы препарата для пациентов пожилого возраста не требуется.
Побочное действие
Головная боль. Перечень всех побочных действий представлен в инструкции по медицинскому применению.
Передозировка
В настоящее время известны единичные случаи передозировки без побочных эффектов. У взрослых прием однократной дозы препарата более 2 г, эквивалентной 20-кратной терапевтической дозе, неблагоприятных эффектов не вызывал.
Взаимодействие с другими лекарственными средствами
Применение ингибиторов АПФ при совместном применении с рацекадотрилом может повысить риск развития ангионевротического синдрома. Лоперамид и нифуроксазид не влияют на кинетику рацекадотрила при совместном применении этих препаратов.
Особые указания
Применение препарата Гидрасек не освобождает от необходимости проведения регидратации, в том числе пероральной, в тех случаях, когда она необходима. В случае серьезной или продолжительной диареи, сопровождающейся рвотой, или отсутствием/снижением аппетита следует рассмотреть вопрос о проведении внутривенной регидратации.
Наличие кровянистых или гнойных выделений в стуле и высокая температура могут служить симптомами инвазивной бактериальной инфекции, ставшей причиной диареи, или другого серьезного заболевания. Монотерапия рацекадотрилом при данных состояниях противопоказана.
В качестве дополнительной терапии острой бактериальной диареи рацекадотрил может применяться совместно с антибиотиками. В связи с недостаточностью данных применение рацекадотрила при антибиотик-ассоциированной диарее и хронической диарее противопоказано. В связи с недостаточностью данных рацекадотрил следует применять с осторожностью пациентам с почечной и печеночной недостаточностью. Возможно снижение биодоступности рацекадотрила у пациентов с длительной рвотой.
При применении рацекадотрила сообщалось о случаях развития кожных реакций. В большинстве случаев кожные симптомы имеют легкую степень тяжести и не требуют лечения, однако в некоторых случаях могут быть тяжелыми и представлять угрозу для жизни. При развитии тяжелых кожных реакций применение препарата следует немедленно прекратить. Сообщалось о случаях развития гиперчувствительности/ ангионевротического отека у пациентов на фоне применения рацекадотрила, которые могут возникнуть в любой момент в течение терапии. У пациентов с ангионевротическим отеком в анамнезе, не связанным с применением рацекадотрила, может быть повышен риск развития ангионевротического отека.
Влияние на способность управлять автомобилем и движущимися механизмами
Применение препарата Гидрасек не влияет или оказывает незначительное влияние на способность к управлению транспортными средствами и механизмами.
Форма выпуска
Капсулы, 100 мг.
Условия хранения
Хранить при температуре не выше 25 °С. Хранить в недоступном для детей месте!
Срок годности
З года.
Не применять по истечении срока годности, указанного на упаковке.
Условия отпуска
без рецепта
Производитель
СОФАРТЕКС
Рю дю Прессуар 21,
28500 Вернуйе, Франция
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