Повышенная чувствительность к действующему веществу или к вспомогательным веществам, входящим в состав препарата. Непереносимость фруктозы.
Не рекомендуется прием препарата кормящим женщинам.
Состав на 1 саше (10 мл):
Действующее вещество: Очищенная микронизированная флавоноидная фракция 1000 мг, содержащая диосмин 900,0 мг (90 %) и флавоноиды, в пересчете на гесперидин 100,0 мг (10 %).
Вспомогательные вещества:
Кислота лимонная 12,5 мг, ароматизатор апельсиновый 15,0 мг, мальтитол 1800,0 мг, натрия бензоат 15,0 мг, ксантановая камедь 50,0 мг, вода очищенная q.s. до 10 мл.
Описание
Однородная суспензия светло-желтого цвета с характерным запахом.
"Препарат имеет два показания к применению: хронические заболевания вен (ХЗВ) и геморрой. В частности, Детралекс® показан для лечения симптомов и проявлений хронических заболеваний вен, таких как: боль, судороги в ногах, ощущение тяжести и распирания в ногах, "усталость" ног, отеки, трофические изменения кожи и подкожной клетчатки венозные трофические язвы.
Способ применения при хроническом заболевании вен - 1000 мг (содержимое 1 саше) в сутки, предпочтительно утром, во время приема пищи. Продолжительность курса лечения может составлять несколько месяцев (вплость до 12). В случае повторного возникновения симптомов, по рекомендации врача, курс лечения может быть повторен. Также Детралекс® показан для симптоматической терапии острого и хронического геморроя. Рекомендуемая доза при остром геморрое - 3000 мг в сутки (по 1000 мг (содержимое 1 саше) утром, днем и вечером) в течение 4 дней, затем по 2000 мг в сутки ( по 1000 мг (содержимое 1 саше) утром и вечером) в течение последующих 3 дней; рекомендуемая доза при хроническом геморрое - 1000 мг (содержимое 1 саше) в сутки в любое удобное время дня вместе с приемом пищи. "
Фармакологические свойства
Венотонизирующее и венопротекторное средство.
Фармакодинамика
Детралекс® обладает венотонизирующим и ангиопротективным свойствами. Препарат уменьшает растяжимость вен и венозный застой, снижает проницаемость капилляров и повышает их резистентность.
Результатыклинических исследований подтверждают фармакологическую активность препарата в отношении показателей венозной гемодинамики.
Статистически достоверный дозозависимый эффект препарата Детралекс® был продемонстрирован для следующих венозных плетизмографических параметров: венозной емкости, венозной растяжимости, времени венозного опорожнения. Оптимальное соотношение "доза-эффект" наблюдается при приеме 1000 мг в день.
Детралекс® повышает венозный тонус: с помощью венозной окклюзионной плетизмографии было показано уменьшение времени венозного опорожнения. У пациентов с признаками выраженного нарушения микроциркуляции, после терапии препаратом. Детралекс® отмечается (статистически достоверное по сравнению с плацебо) повышение капиллярной резистентности, оцененной методом ангиостереометрии. Доказана терапевтическая эффективность препарата Детралекс® при лечении хронических заболеваний вен нижних конечностей, а также при лечении геморроя.
Детралекс® уменьшает нежелательные побочные эффекты инвазивных методов лечения ХЗВ (снижает частоту нежелательных побочных явлений при хирургическом и эндоваскулярном лечении варикозной болезни: достоверно снижает интенсивность послеоперационного болевого синдрома, отек и выраженность кровоизлияний после эндоваскулярного и хирургического лечения).
Фармакокинетика
Основное выделение препарата происходит с калом. С мочой, в среднем, выводится около 14 % принятого количества препарата.
Период полувыведения составляет 11 часов.
Препарат подвергается активному метаболизму, что подтверждается присутствием феноловых кислот в моче.
Показания к применению
Детралекс® показан для терапии симптомов хронических заболеваний вен (устранения и облегчения симптомов).
Терапия симптомов венозно-лимфатической недостаточности:
боль;
судороги нижних конечностей;
ощущение тяжести и распирания в ногах;
«усталость» ног.
Терапия проявлений венозно-лимфатической недостаточности:
отеки нижних конечностей;
трофические изменения кожи и подкожной клетчатки; венозные трофические язвы.
Симптоматическая терапия острого и хронического геморроя.
Противопоказания
Повышенная чувствительность к действующему веществу или к вспомогательным веществам, входящим в состав препарата. Непереносимость фруктозы.
Не рекомендуется прием препарата кормящим женщинам.
Применение при беременности и в период грудного вскармливания
Беременность
Эксперименты на животных не выявили тератогенных эффектов.
До настоящего времени не было сообщений о нежелательных эффектах при применении препарата беременными женщинами.
Период грудного вскармливания
Из-за отсутствия данных относительно выведения препарата с грудным молоком, кормящим женщинам не рекомендуется прием препарата.
Влияние на репродуктивную функцию
Исследования репродуктивной токсичности не показали влияния на репродуктивную функцию у крыс обоего пола.
Способ применения и дозы
Внутрь.
Рекомендуемая доза при венозно-лимфатической недостаточности - 1000 мг (содержимое 1 саше) в сутки, предпочтительно утром, во время приема пищи.
Продолжительность курса лечения может составлять несколько месяцев (вплоть до 12 месяцев). В случае повторного возникновения симптомов, по рекомендации врача, курс лечения может быть повторен.
Рекомендуемая доза при остром геморрое - 3000 мг в сутки (по 1000 мг (содержимое 1 саше) утром, днем и вечером) в течение 4 дней, затем по 2000 мг в сутки (по 1000 мг (содержимое 1 саше) утром и вечером) в течение последующих 3 дней.
Рекомендуемая доза при хроническом геморрое - 1000 мг (содержимое 1 саше) в сутки в любое удобное время дня вместе с приемом пищи.
Побочное действие
Побочные эффекты препарата Детралекс®, наблюдаемые в ходе клинических исследований, были легкой степени выраженности. Преимущественно отмечались нарушения со стороны желудочно-кишечного тракта (диарея, диспепсия, тошнота, рвота).
Во время приёма препарата Детралекс® сообщалось о следующих побочных эффектах, в виде следующей градации: очень часто (>1/10); часто (>1/100, <1/10); нечасто (>1/1 000, <1/100); редко (>1/10 000, <1/1 000); крайне редко (<1/10 000), неуточненной частоты (частота не может быть подсчитана по доступным данным).
Со стороны центральной нервной системы:
Редко: головокружение, головная боль, общее недомогание. Со стороны желудочно-кишечного тракта:
Часто: диарея, диспепсия, тошнота, рвота. Нечасто: колит.
Неуточненной частоты: боль в животе.
Со стороны кожных покровов:
Редко: кожная сыпь, кожный зуд, крапивница.
Неуточненной частоты: изолированныйотек
исключительных случаях ангионевротический отек.
ИНФОРМИРУЙТЕ ВРАЧА О ПОЯВЛЕНИИ У ВАС ЛЮБЫХ, В ТОМ ЧИСЛЕ НЕ УПОМЯНУТЫХ В ДАННОЙ ИНСТРУКЦИИ, НЕЖЕЛАТЕЛЬНЫХ РЕАКЦИЙ И ОЩУЩЕНИЙ. А ТАКЖЕ, ОБ ИЗМЕНЕНИИ ЛАБОРАТОРНЫХ ПОКАЗАТЕЛЕЙ НА ФОНЕ ТЕРАПИИ.
Передозировка
Случаев передозировки не описано.
При передозировке препарата немедленно обратитесь за медицинской помощью.
Особые указания
Перед тем как начать принимать препарат Детралекс®, рекомендуется проконсультироваться с врачом.
При обострении геморроя назначение препарата Детралекс® не заменяет специфического лечения других анальных нарушений. Продолжительность лечения не должна превышать сроки, указанные в разделе «Способ применения и дозы». В том случае, если симптомы не исчезают после рекомендуемого курса терапии, следует пройти осмотр у проктолога, который подберет дальнейшую терапию.
При наличии нарушений венозного кровообращения максимальный эффект лечения обеспечивается сочетанием терапии со здоровым (сбалансированным) образом жизни; желательно избегать долгого пребывания на солнце, длительного пребывания на ногах, а также, рекомендуется снижение избыточной массы тела. Пешие прогулки и, в некоторых случаях, ношение специальных чулок (компрессионного трикотажа) способствуют улучшению циркуляции крови.
Незамедлительно обратитесь к врачу, если в процессе лечения ваше состояние ухудшилось или улучшения не наступило.
Влияние на способность управлять автомобилем и выполнять работы, требующие высокой скорости психических и физических реакций
Не влияет.
Условия хранения
Хранить при температуре не выше 30 °С. Хранить в недоступных для детей местах.
Срок годности
3 года.
Не применять после истечения срока годности, указанного на упаковке.
Условия отпуска
Отпускают без рецепта.
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на 1 саше (10 мл):\u003cbr /\u003e\nДействующее вещество: Очищенная микронизированная флавоноидная фракция 1000 мг, содержащая диосмин 900,0 мг (90 %) и флавоноиды, в пересчете на гесперидин 100,0 мг (10 %).\u003cbr /\u003e\nВспомогательные вещества:\u003cbr /\u003e\nКислота лимонная 12,5 мг, ароматизатор апельсиновый 15,0 мг, мальтитол 1800,0 мг, натрия бензоат 15,0 мг, ксантановая камедь 50,0 мг, вода очищенная q.s. до 10 мл."}}]},{"id":2,"name":"Описание","slug":"common_description","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Однородная суспензия светло-желтого цвета с характерным запахом. \u003cbr /\u003e\n\"Препарат имеет два показания к применению: хронические заболевания вен (ХЗВ) и геморрой. В частности, Детралекс® показан для лечения симптомов и проявлений хронических заболеваний вен, таких как: боль, судороги в ногах, ощущение тяжести и распирания в ногах, \"усталость\" ног, отеки, трофические изменения кожи и подкожной клетчатки венозные трофические язвы.\u003cbr /\u003e\nСпособ применения при хроническом заболевании вен - 1000 мг (содержимое 1 саше) в сутки, предпочтительно утром, во время приема пищи. Продолжительность курса лечения может составлять несколько месяцев (вплость до 12). В случае повторного возникновения симптомов, по рекомендации врача, курс лечения может быть повторен. Также Детралекс® показан для симптоматической терапии острого и хронического геморроя. Рекомендуемая доза при остром геморрое - 3000 мг в сутки (по 1000 мг (содержимое 1 саше) утром, днем и вечером) в течение 4 дней, затем по 2000 мг в сутки ( по 1000 мг (содержимое 1 саше) утром и вечером) в течение последующих 3 дней; рекомендуемая доза при хроническом геморрое - 1000 мг (содержимое 1 саше) в сутки в любое удобное время дня вместе с приемом пищи. \""}}]},{"id":3,"name":"Фармакологические свойства","slug":"pharmacologic_effects","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Венотонизирующее и венопротекторное средство.\nФармакодинамика\u003cbr /\u003e\nДетралекс® обладает венотонизирующим и ангиопротективным свойствами. Препарат уменьшает растяжимость вен и венозный застой, снижает проницаемость капилляров и повышает их резистентность. \u003cbr /\u003e\nРезультатыклинических исследований подтверждают фармакологическую активность препарата в отношении показателей венозной гемодинамики.\u003cbr /\u003e\nСтатистически достоверный дозозависимый эффект препарата Детралекс® был продемонстрирован для следующих венозных плетизмографических параметров: венозной емкости, венозной растяжимости, времени венозного опорожнения. Оптимальное соотношение \"доза-эффект\" наблюдается при приеме 1000 мг в день.\u003cbr /\u003e\nДетралекс® повышает венозный тонус: с помощью венозной окклюзионной плетизмографии было показано уменьшение времени венозного опорожнения. У пациентов с признаками выраженного нарушения микроциркуляции, после терапии препаратом. Детралекс® отмечается (статистически достоверное по сравнению с плацебо) повышение капиллярной резистентности, оцененной методом ангиостереометрии. Доказана терапевтическая эффективность препарата Детралекс® при лечении хронических заболеваний вен нижних конечностей, а также при лечении геморроя.\u003cbr /\u003e\nДетралекс® уменьшает нежелательные побочные эффекты инвазивных методов лечения ХЗВ (снижает частоту нежелательных побочных явлений при хирургическом и эндоваскулярном лечении варикозной болезни: достоверно снижает интенсивность послеоперационного болевого синдрома, отек и выраженность кровоизлияний после эндоваскулярного и хирургического лечения).\u003cbr /\u003e\nФармакокинетика\u003cbr /\u003e\nОсновное выделение препарата происходит с калом. С мочой, в среднем, выводится около 14 % принятого количества препарата.\nПериод полувыведения составляет 11 часов.\u003cbr /\u003e\nПрепарат подвергается активному метаболизму, что подтверждается присутствием феноловых кислот в моче."}}]},{"id":4,"name":"Показания к применению","slug":"indications","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Детралекс® показан для терапии симптомов хронических заболеваний вен (устранения и облегчения симптомов).\u003cbr /\u003e\nТерапия симптомов венозно-лимфатической недостаточности:\u003cbr /\u003e"}},{"type":"list","data":{"style":"unordered","items":["боль;\u003cbr /\u003e","судороги нижних конечностей;\u003cbr /\u003e","ощущение тяжести и распирания в ногах;\u003cbr /\u003e","«усталость» ног.\u003cbr /\u003e"]}},{"type":"paragraph","data":{"text":"Терапия проявлений венозно-лимфатической недостаточности:\u003cbr /\u003e\nотеки нижних конечностей;\u003cbr /\u003e\nтрофические изменения кожи и подкожной клетчатки; венозные трофические язвы.\u003cbr /\u003e\nСимптоматическая терапия острого и хронического геморроя.\u003cbr /\u003e"}}]},{"id":5,"name":"Противопоказания","slug":"contraindications","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Повышенная чувствительность к действующему веществу или к вспомогательным веществам, входящим в состав препарата. Непереносимость фруктозы.\u003cbr /\u003e\nНе рекомендуется прием препарата кормящим женщинам."}}]},{"id":6,"name":"Применение при беременности и в период грудного вскармливания","slug":"pregnancy_warnings","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Беременность\u003cbr /\u003e\nЭксперименты на животных не выявили тератогенных эффектов.\nДо настоящего времени не было сообщений о нежелательных эффектах при применении препарата беременными женщинами.\u003cbr /\u003e\nПериод грудного вскармливания\u003cbr /\u003e\nИз-за отсутствия данных относительно выведения препарата с грудным молоком, кормящим женщинам не рекомендуется прием препарата.\u003cbr /\u003e\nВлияние на репродуктивную функцию\u003cbr /\u003e\nИсследования репродуктивной токсичности не показали влияния на репродуктивную функцию у крыс обоего пола."}}]},{"id":7,"name":"Способ применения и дозы","slug":"dosage","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Внутрь.\u003cbr /\u003e\nРекомендуемая доза при венозно-лимфатической недостаточности - 1000 мг (содержимое 1 саше) в сутки, предпочтительно утром, во время приема пищи.\u003cbr /\u003e\nПродолжительность курса лечения может составлять несколько месяцев (вплоть до 12 месяцев). В случае повторного возникновения симптомов, по рекомендации врача, курс лечения может быть повторен.\u003cbr /\u003e\nРекомендуемая доза при остром геморрое - 3000 мг в сутки (по 1000 мг (содержимое 1 саше) утром, днем и вечером) в течение 4 дней, затем по 2000 мг в сутки (по 1000 мг (содержимое 1 саше) утром и вечером) в течение последующих 3 дней.\u003cbr /\u003e\nРекомендуемая доза при хроническом геморрое - 1000 мг (содержимое 1 саше) в сутки в любое удобное время дня вместе с приемом пищи."}}]},{"id":8,"name":"Побочное действие","slug":"side_effects","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Побочные эффекты препарата Детралекс®, наблюдаемые в ходе клинических исследований, были легкой степени выраженности. \u003cbr /\u003eПреимущественно отмечались нарушения со стороны желудочно-кишечного тракта (диарея, диспепсия, тошнота, рвота).\u003cbr /\u003e\nВо время приёма препарата Детралекс® сообщалось о следующих побочных эффектах, в виде следующей градации: очень часто (\u003e1/10); часто (\u003e1/100, \u003c1/10); нечасто (\u003e1/1 000, \u003c1/100); редко (\u003e1/10 000, \u003c1/1 000); крайне редко (\u003c1/10 000), неуточненной частоты (частота не может быть подсчитана по доступным данным).\u003cbr /\u003e\nСо стороны центральной нервной системы:\u003cbr /\u003e\nРедко: головокружение, головная боль, общее недомогание. Со стороны желудочно-кишечного тракта:\u003cbr /\u003e\nЧасто: диарея, диспепсия, тошнота, рвота. Нечасто: колит.\u003cbr /\u003e\nНеуточненной частоты: боль в животе.\u003cbr /\u003e\nСо стороны кожных покровов:\u003cbr /\u003e\nРедко: кожная сыпь, кожный зуд, крапивница.\u003cbr /\u003e\nНеуточненной частоты: изолированныйотек\u003cbr /\u003e\nисключительных случаях ангионевротический отек.\u003cbr /\u003e\nИНФОРМИРУЙТЕ ВРАЧА О ПОЯВЛЕНИИ У ВАС ЛЮБЫХ, В ТОМ ЧИСЛЕ НЕ УПОМЯНУТЫХ В ДАННОЙ ИНСТРУКЦИИ, НЕЖЕЛАТЕЛЬНЫХ РЕАКЦИЙ И ОЩУЩЕНИЙ. А ТАКЖЕ, ОБ ИЗМЕНЕНИИ ЛАБОРАТОРНЫХ ПОКАЗАТЕЛЕЙ НА ФОНЕ ТЕРАПИИ."}}]},{"id":9,"name":"Передозировка","slug":"overdose","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Случаев передозировки не описано.\u003cbr /\u003e\nПри передозировке препарата немедленно обратитесь за медицинской помощью."}}]},{"id":10,"name":"Особые указания","slug":"cautions","displayInMenu":true,"body":[{"type":"list","data":{"style":"unordered","items":["Перед тем как начать принимать препарат Детралекс®, рекомендуется проконсультироваться с врачом.\u003cbr /\u003e","При обострении геморроя назначение препарата Детралекс® не заменяет специфического лечения других анальных нарушений. \u003cbr /\u003eПродолжительность лечения не должна превышать сроки, указанные в разделе «Способ применения и дозы». В том случае, если симптомы не исчезают после рекомендуемого курса терапии, следует пройти осмотр у проктолога, который подберет дальнейшую терапию.\u003cbr /\u003e","При наличии нарушений венозного кровообращения максимальный эффект лечения обеспечивается сочетанием терапии со здоровым (сбалансированным) образом жизни; желательно избегать долгого пребывания на солнце, длительного пребывания на ногах, а также, рекомендуется снижение избыточной массы тела. Пешие прогулки и, в некоторых случаях, ношение специальных чулок (компрессионного трикотажа) способствуют улучшению циркуляции крови.\u003cbr /\u003e"]}},{"type":"paragraph","data":{"text":"Незамедлительно обратитесь к врачу, если в процессе лечения ваше состояние ухудшилось или улучшения не наступило.\nВлияние на способность управлять автомобилем и выполнять работы, требующие высокой скорости психических и физических реакций\nНе влияет."}}]},{"id":11,"name":"Условия хранения","slug":"storage","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Хранить при температуре не выше 30 °С. 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