Карсил Макс принадлежит к группе гепатопротекторных лекарств... Инструкция
Показания к применению
В качестве симптоматического средства в комплексной терапии токсических поражений печени вызванных алкоголем длительным применением лекарственных препаратов хронической интоксикацией (в том числе профессиональной) хронических воспалительных заболеваний печени (хронический гепатит невирусной этиологии) цирроза печени.
Противопоказания
Повышенная чувствительность к активному компоненту или любому из вспомогательных веществ детский возраст до 12 лет.
Корпус: краситель железа оксид красный (Е 172) - 0,5286 %, краситель железа оксид желтый (Е 172) - 0,3857 %, титана диоксид (Е 171) - 2,0 %, желатин - до 100%.
Крышечка: краситель железа оксид черный (Е 172) - 0,2857 %, краситель железа оксид красный (Е 172) - 1,619 %, титана диоксид (Е 171) - 0,6666%, желатин - до 100%.
Описание
Капсулы твердые цилиндрические желатиновые.
Корпус розово-коричневого цвета, крышечка коричневого цвета (размер капсул № 0).
Содержимое капсул: порошкообразная масса от светло-желтого до желто-коричневого цвета с агломератами, со слабым характерным запахом.
Фармакотерапевтическая группа
Гепатопротекторное средство растительного происхождения
Фармакологические свойства
Фармакодинамика:
Карсил Макс принадлежит к группе гепатопротекторных лекарственных средств. Содержит сухой экстракт плодов расторопши пятнистой (эквивалент силимарина) который является смесью 4 изомеров флавонолигнанов: силибинина изо-силибинина силидианина и силикристина.
Механизм действия препарата все еще недостаточно выяснен. Установлено что гепатопротекторное действие силимарина обуславливается конкурентным взаимодействием с токсинами на соответствующие рецепторы в мембране гепатоцитов проявляя таким образом мембраностабилизирующее действие.
Препарат оказывает метаболические и клеточно-регулирующие эффекты регулируя проницаемость клеточной мембраны подавляя 5- липооксигеназный путь в особенности лейкотриена В4 (LTB4) а также связываясь со свободными кислородными радикалами.
Стимулирует синтез белков (структурных и функциональных) и фосфолипидов в пораженных гепатоцитах ускоряя регенеративные процессы.
Действие флавоноидов к которым принадлежит силимарин также обуславливается их антиоксидантными и улучшающими микроциркуляцию эффектами.
Клинически эти эффекты выражаются в улучшении субъективной и объективной симптоматики и в нормализации показателей функционального состояния печени (трансаминазы гаммаглобулин билирубин). Это ведет к улучшению общего состояния уменьшению жалоб связанных с пищеварением а у пациентов с пониженным усвоением пищи вследствие заболевания печени ведет к повышению аппетита и увеличению массы тела.
Фармакокинетика:
Абсорбция низкая и медленная. Подвергается кишечно-печеночной рециркуляции. Не кумулирует. При исследовании силибинина меченного С14 самые высокие концентрации обнаруживаются в печени и совсем незначительные количества - в почках легких сердце и других органах. Метаболизируются в печени посредством конъюгации. В желчи в качестве метаболитов обнаружены глюкурониды и сульфаты. Период полувыведения составляет 6 часов. Выводится в основном с желчью (около 80%) в виде глюкуронидон и сульфатов и в незначительной степени (около 5%) с мочой.
Показания к применению
В качестве симптоматического средства в комплексной терапии токсических поражений печени вызванных алкоголем длительным применением лекарственных препаратов хронической интоксикацией (в том числе профессиональной) хронических воспалительных заболеваний печени (хронический гепатит невирусной этиологии) цирроза печени.
Противопоказания
Повышенная чувствительность к активному компоненту или любому из вспомогательных веществ детский возраст до 12 лет.
С осторожностью
Назначают пациентам с гормональными нарушениями (эндометриоз миома матки карцинома молочной железы яичников и матки карцинома предстательной железы) из-за возможного эстрогеноподобного эффекта силимарина; детям в возрасте с 12 лет.
Применение при беременности и в период грудного вскармливания
Не рекомендуется назначать препарат при беременности и в период грудного вскармливания в связи с отсутствием данных о безопасности применения препарата у данной категории пациентов.
Способ применения и дозы
Капсулы принимают внутрь запивая достаточным количеством жидкости.
Взрослым и детям старше 12-летнего возраста назначают:
при легких случаях и среднетяжелых случаях по 1 капсуле 2 раза в день;
лечение тяжелых поражений печени начинается с дозы 1 капсула 3 раза в день.
Курс лечения продолжается не менее 3 месяцев.
Если после лечения улучшения не наступает или симптомы усугубляются или появляются новые симптомы необходимо проконсультироваться с врачом.
Применяйте препарат только согласно тем показаниям тому способу применения и в тех дозах которые указаны в инструкции.
Побочное действие
Нежелательные побочные реакции классифицированы по частоте и по системно органному классу. Частота по MedDRA определяется следующим образом: очень частые (≥ 1/10) частые (≥ 1/100 до < 1/10) нечастые (≥ 1/1 000 до < 1/100) редкие (≥ 1/10 000 до < 1/1000) очень редкие (<1/10 000) с неизвестной частотой (на основании существующих данных нельзя сделать оценку).
Нарушения со стороны иммунной системы:
Очень редкие: кожные аллергические реакции - зуд сыпь алопеция.
С неизвестной частотой: анафилактический шок.
Нарушения со стороны органа слуха и лабиринтные нарушения:
Редкие: диарея в результате усиленной функции печени и желчного пузыря.
С неизвестной частотой: тошнота рвота диспепсия уменьшение аппетита метеоризм.
Если у Вас отмечаются побочные эффекты указанные в инструкции или они усугубляются или Вы заметили любые другие побочные эффекты не указанные в инструкции сообщите об этом врачу.
Передозировка
До настоящего времени случаев передозировки при применении препарата не зарегистрировано.
При случайном приеме высокой дозы возможно усиление дозозависимых побочных эффектов.
Лечение: вызвать рвоту промыть желудок принять активированный уголь и при необходимости провести симптоматическое лечение.
Взаимодействие с другими лекарственными средствами
Фармакодинамические лекарственные взаимодействия
Силимарин не оказывает существенного влияния на фармакодинамику других лекарственных препаратов.
При совместном применении силимарина и пероральных контрацептивных средств применяемых при заместительном лечении эстрогенами и тамоксифеном возможно уменьшение эффектов последних.
Фармакокинетические лекарственные взаимодействия
- Силимарин может усилить эффекты диазепама алпразолама кетоконазола ловастатина. аторвастатина винбластина из-за его подавляющего действия на изоферменты системы цитохрома Р450.
- Клинические исследования показывают незначительный риск возможных фармакокинетических взаимодействий силимарина как ингибитора изофермента CYP3A4 и UGT1A1 и цитостатиков которые являются субстратами этих ферментов.
Особые указания
Проконсультируйтесь с врачом прежде чем начать принимать препарат. Просим проинформировать Вашего врача если Вы принимаете или недавно принимали другие лекарственные препараты включительно и отпускаемые без рецепта. Лечение этим препаратом не может заменить соблюдения диеты или воздержания от употребления алкоголя.
Продолжительность курса лечения устанавливается Вашим врачом. Без консультации врача не рекомендуется принимать препарат более 1 месяца.
Если Вы пропустили одну дозу примите ее как можно скорее. Если почти наступило время для следующей дозы примите ее как обычно. Не принимайте двойную дозу для компенсаций пропущенной. Продолжайте принимать препарат по назначению.
Если Ваши жалобы сохраняются обратитесь за консультацией к Вашему врачу.
Влияние на способность управлять автомобилем и движущимися механизмами
Применение препарата в монотерапии не оказывает влияния на способность к выполнению потенциально опасных видов деятельности требующих повышенной концентрации внимания и быстроты психомоторных реакций (управление транспортными средствами работа с движущимися механизмами).
Форма выпуска
Капсулы 110 мг.
Условия хранения
Хранить при температуре не выше 25 °С.
Хранить в недоступном для детей месте.
Срок годности
3 года.
Не применять по истечении срока годности указанного на упаковке.
Условия отпуска
Без рецепта
Производитель
Софарма АО, 1220, Sofia, 16 Iliensko Shosse Str., Bulgaria, Болгария
Организация, принимающая претензии потребителей
Софарма АО
Для описания товара использована информация от партнера 36.6
Мобильное приложение «Все аптеки»
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Информация предоставляется в справочных целях. Не занимайтесь самолечением. При первых признаках заболевания обратитесь к врачу.
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номер","slug":"","body":[{"type":"paragraph","data":{"text":"ЛП-005250"}}]},{"id":2,"name":"Торговое название препарата","slug":"","body":[{"type":"paragraph","data":{"text":"Карсил Макс"}}]},{"id":3,"name":"Лекарственная форма","slug":"","body":[{"type":"paragraph","data":{"text":"капсулы"}}]},{"id":4,"name":"Состав","slug":"ingredients","body":[{"type":"paragraph","data":{"text":"На одну капсулу:"}},{"type":"paragraph","data":{"text":"Активный компонент:"}},{"type":"paragraph","data":{"text":"Расторопши пятнистой плодов экстракт сухой - 200,0-275,0 мг (эквивалентно 110,0 мг силимарина)"}},{"type":"paragraph","data":{"text":"Вспомогательные вещества:"}},{"type":"paragraph","data":{"text":"Содержимое капсулы: маннитол (от 125,0 до 50,0 мг), повидон К 25 (9,4 мг), полисорбат 80 (3,7 мг), натрия лаурилсульфат (3,7 мг), карбоксиметилкрахмал натрия (Тип А) (14,8 мг), магния стеарат(3,7 мг), кремния диоксид коллоидный безводный (3,7 мг), натрия гидрокарбонат (6,0 мг)."}},{"type":"paragraph","data":{"text":"Состав желатиновой капсулы:"}},{"type":"paragraph","data":{"text":"Корпус: краситель железа оксид красный (Е 172) - 0,5286 %, краситель железа оксид желтый (Е 172) - 0,3857 %, титана диоксид (Е 171) - 2,0 %, желатин - до 100%."}},{"type":"paragraph","data":{"text":"Крышечка: краситель железа оксид черный (Е 172) - 0,2857 %, краситель железа оксид красный (Е 172) - 1,619 %, титана диоксид (Е 171) - 0,6666%, желатин - до 100%."}}]},{"id":5,"name":"Описание","slug":"common_description","body":[{"type":"paragraph","data":{"text":"Капсулы твердые цилиндрические желатиновые."}},{"type":"paragraph","data":{"text":"Корпус розово-коричневого цвета, крышечка коричневого цвета (размер капсул № 0)."}},{"type":"paragraph","data":{"text":"Содержимое капсул: порошкообразная масса от светло-желтого до желто-коричневого цвета с агломератами, со слабым характерным запахом."}}]},{"id":6,"name":"Фармакотерапевтическая группа","slug":"","body":[{"type":"paragraph","data":{"text":"Гепатопротекторное средство растительного происхождения"}}]},{"id":7,"name":"Фармакологические свойства","slug":"pharmacologic_effects","body":[{"type":"header","data":{"text":"Фармакодинамика:","level":3}},{"type":"paragraph","data":{"text":"Карсил Макс принадлежит к группе гепатопротекторных лекарственных средств. Содержит сухой экстракт плодов расторопши пятнистой (эквивалент силимарина) который является смесью 4 изомеров флавонолигнанов: силибинина изо-силибинина силидианина и силикристина."}},{"type":"paragraph","data":{"text":"Механизм действия препарата все еще недостаточно выяснен. Установлено что гепатопротекторное действие силимарина обуславливается конкурентным взаимодействием с токсинами на соответствующие рецепторы в мембране гепатоцитов проявляя таким образом мембраностабилизирующее действие."}},{"type":"paragraph","data":{"text":"Препарат оказывает метаболические и клеточно-регулирующие эффекты регулируя проницаемость клеточной мембраны подавляя 5- липооксигеназный путь в особенности лейкотриена В4 (LTB4) а также связываясь со свободными кислородными радикалами."}},{"type":"paragraph","data":{"text":"Стимулирует синтез белков (структурных и функциональных) и фосфолипидов в пораженных гепатоцитах ускоряя регенеративные процессы."}},{"type":"paragraph","data":{"text":"Действие флавоноидов к которым принадлежит силимарин также обуславливается их антиоксидантными и улучшающими микроциркуляцию эффектами."}},{"type":"paragraph","data":{"text":"Клинически эти эффекты выражаются в улучшении субъективной и объективной симптоматики и в нормализации показателей функционального состояния печени (трансаминазы гаммаглобулин билирубин). Это ведет к улучшению общего состояния уменьшению жалоб связанных с пищеварением а у пациентов с пониженным усвоением пищи вследствие заболевания печени ведет к повышению аппетита и увеличению массы тела."}},{"type":"header","data":{"text":"Фармакокинетика:","level":3}},{"type":"paragraph","data":{"text":"Абсорбция низкая и медленная. Подвергается кишечно-печеночной рециркуляции. Не кумулирует. При исследовании силибинина меченного С\u003csup\u003e14\u003c/sup\u003e самые высокие концентрации обнаруживаются в печени и совсем незначительные количества - в почках легких сердце и других органах. Метаболизируются в печени посредством конъюгации. В желчи в качестве метаболитов обнаружены глюкурониды и сульфаты. Период полувыведения составляет 6 часов. Выводится в основном с желчью (около 80%) в виде глюкуронидон и сульфатов и в незначительной степени (около 5%) с мочой.\n\n"}}]},{"id":8,"name":"Показания к применению","slug":"indications","body":[{"type":"paragraph","data":{"text":"В качестве симптоматического средства в комплексной терапии токсических поражений печени вызванных алкоголем длительным применением лекарственных препаратов хронической интоксикацией (в том числе профессиональной) хронических воспалительных заболеваний печени (хронический гепатит невирусной этиологии) цирроза печени."}}]},{"id":9,"name":"Противопоказания","slug":"contraindications","body":[{"type":"paragraph","data":{"text":"Повышенная чувствительность к активному компоненту или любому из вспомогательных веществ детский возраст до 12 лет."}}]},{"id":10,"name":"С осторожностью","slug":"cautions","body":[{"type":"paragraph","data":{"text":"Назначают пациентам с гормональными нарушениями (эндометриоз миома матки карцинома молочной железы яичников и матки карцинома предстательной железы) из-за возможного эстрогеноподобного эффекта силимарина; детям в возрасте с 12 лет."}}]},{"id":11,"name":"Применение при беременности и в период грудного вскармливания","slug":"pregnancy_warnings","body":[{"type":"paragraph","data":{"text":"Не рекомендуется назначать препарат при беременности и в период грудного вскармливания в связи с отсутствием данных о безопасности применения препарата у данной категории пациентов."}}]},{"id":12,"name":"Способ применения и дозы","slug":"dosage","body":[{"type":"paragraph","data":{"text":"Капсулы принимают внутрь запивая достаточным количеством жидкости."}},{"type":"paragraph","data":{"text":"Взрослым и детям старше 12-летнего возраста назначают:"}},{"type":"list","data":{"style":"ordered","items":["при легких случаях и среднетяжелых случаях по 1 капсуле 2 раза в день;","лечение тяжелых поражений печени начинается с дозы 1 капсула 3 раза в день."]}},{"type":"paragraph","data":{"text":"Курс лечения продолжается не менее 3 месяцев."}},{"type":"paragraph","data":{"text":"Если после лечения улучшения не наступает или симптомы усугубляются или появляются новые симптомы необходимо проконсультироваться с врачом."}},{"type":"paragraph","data":{"text":"Применяйте препарат только согласно тем показаниям тому способу применения и в тех дозах которые указаны в инструкции."}}]},{"id":13,"name":"Побочное действие","slug":"side_effects","body":[{"type":"paragraph","data":{"text":"Нежелательные побочные реакции классифицированы по частоте и по системно органному классу. Частота по MedDRA определяется следующим образом: очень частые (≥ 1/10) частые (≥ 1/100 до < 1/10) нечастые (≥ 1/1 000 до < 1/100) редкие (≥ 1/10 000 до < 1/1000) очень редкие (<1/10 000) с неизвестной частотой (на основании существующих данных нельзя сделать оценку)."}},{"type":"paragraph","data":{"text":"Нарушения со стороны иммунной системы:"}},{"type":"paragraph","data":{"text":"Очень редкие: кожные аллергические реакции - зуд сыпь алопеция."}},{"type":"paragraph","data":{"text":"С неизвестной частотой: анафилактический шок."}},{"type":"paragraph","data":{"text":"Нарушения со стороны органа слуха и лабиринтные нарушения:"}},{"type":"paragraph","data":{"text":"Редкие: усиление существующих вестибулярных нарушений."}},{"type":"paragraph","data":{"text":"Нарушения со стороны желудочно-кишечного тракта:"}},{"type":"paragraph","data":{"text":"Редкие: диарея в результате усиленной функции печени и желчного пузыря."}},{"type":"paragraph","data":{"text":"С неизвестной частотой: тошнота рвота диспепсия уменьшение аппетита метеоризм."}},{"type":"paragraph","data":{"text":"Если у Вас отмечаются побочные эффекты указанные в инструкции или они усугубляются или Вы заметили любые другие побочные эффекты не указанные в инструкции сообщите об этом врачу."}}]},{"id":14,"name":"Передозировка","slug":"overdose","body":[{"type":"paragraph","data":{"text":"До настоящего времени случаев передозировки при применении препарата не зарегистрировано."}},{"type":"paragraph","data":{"text":"При случайном приеме высокой дозы возможно усиление дозозависимых побочных эффектов."}},{"type":"paragraph","data":{"text":"Лечение: вызвать рвоту промыть желудок принять активированный уголь и при необходимости провести симптоматическое лечение."}}]},{"id":15,"name":"Взаимодействие с другими лекарственными средствами","slug":"drugs_interaction","body":[{"type":"paragraph","data":{"text":"Фармакодинамические лекарственные взаимодействия"}},{"type":"paragraph","data":{"text":"Силимарин не оказывает существенного влияния на фармакодинамику других лекарственных препаратов."}},{"type":"paragraph","data":{"text":"При совместном применении силимарина и пероральных контрацептивных средств применяемых при заместительном лечении эстрогенами и тамоксифеном возможно уменьшение эффектов последних."}},{"type":"paragraph","data":{"text":"Фармакокинетические лекарственные взаимодействия"}},{"type":"paragraph","data":{"text":"- Силимарин может усилить эффекты диазепама алпразолама кетоконазола ловастатина. аторвастатина винбластина из-за его подавляющего действия на изоферменты системы цитохрома Р450."}},{"type":"paragraph","data":{"text":"- Клинические исследования показывают незначительный риск возможных фармакокинетических взаимодействий силимарина как ингибитора изофермента CYP3A4 и UGT1A1 и цитостатиков которые являются субстратами этих ферментов."}}]},{"id":16,"name":"Особые указания","slug":"","body":[{"type":"paragraph","data":{"text":"Проконсультируйтесь с врачом прежде чем начать принимать препарат. Просим проинформировать Вашего врача если Вы принимаете или недавно принимали другие лекарственные препараты включительно и отпускаемые без рецепта. Лечение этим препаратом не может заменить соблюдения диеты или воздержания от употребления алкоголя."}},{"type":"paragraph","data":{"text":"Продолжительность курса лечения устанавливается Вашим врачом. Без консультации врача не рекомендуется принимать препарат более 1 месяца."}},{"type":"paragraph","data":{"text":"Если Вы пропустили одну дозу примите ее как можно скорее. Если почти наступило время для следующей дозы примите ее как обычно. Не принимайте двойную дозу для компенсаций пропущенной. Продолжайте принимать препарат по назначению."}},{"type":"paragraph","data":{"text":"Если Ваши жалобы сохраняются обратитесь за консультацией к Вашему врачу."}}]},{"id":17,"name":"Влияние на способность управлять автомобилем и движущимися механизмами","slug":"","body":[{"type":"paragraph","data":{"text":"Применение препарата в монотерапии не оказывает влияния на способность к выполнению потенциально опасных видов деятельности требующих повышенной концентрации внимания и быстроты психомоторных реакций (управление транспортными средствами работа с движущимися механизмами)."}}]},{"id":18,"name":"Форма выпуска","slug":"","body":[{"type":"paragraph","data":{"text":"Капсулы 110 мг."}}]},{"id":19,"name":"Условия хранения","slug":"storage","body":[{"type":"paragraph","data":{"text":"Хранить при температуре не выше 25 °С."}},{"type":"paragraph","data":{"text":"Хранить в недоступном для детей месте."}}]},{"id":20,"name":"Срок годности","slug":"expiry_date","body":[{"type":"paragraph","data":{"text":"3 года."}},{"type":"paragraph","data":{"text":"Не применять по истечении срока годности указанного на упаковке."}}]},{"id":21,"name":"Условия отпуска","slug":"release_condition","body":[{"type":"paragraph","data":{"text":"Без рецепта"}}]},{"id":22,"name":"Производитель","slug":"","body":[{"type":"paragraph","data":{"text":"Софарма АО, 1220, Sofia, 16 Iliensko Shosse Str., Bulgaria, Болгария"}}]},{"id":23,"name":"Организация, принимающая претензии потребителей","body":[{"type":"paragraph","data":{"text":"Софарма АО"}}]}],"source":null},"description_toggle":false,"short_description":"Карсил Макс принадлежит к группе гепатопротекторных лекарственных средств. 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