Рентгенположительные (с высоким содержанием кальция) желчные камни; нефункционирующий желчный пузырь; острые воспалительные заболевания желчного пузыря, желчных протоков и кишечника; цирроз печени в стадии декомпенсации; выраженные нарушения функции почек; выраженные нарушения функции печени; выраженные нарушения функции поджелудочной железы; беременность; ...
Твердые, непрозрачные желатиновые капсулы №0; крышечка белого цвета, корпус белого цвета. Содержимое капсулы - порошок или гранулы белого цвета.
Фармакотерапевтическая группа
Гепатопротекторное средство
Фармакологические свойства
Гепатопротектор. Оказывает желчегонное действие. Уменьшает синтез холестерина в печени, всасывание его в кишечнике и концентрацию в желчи, повышает растворимость холестерина в желчевыводящей системе, стимулирует образование и выведение желчи. Снижает литогенность желчи, увеличивает в ней содержание желчных кислот. Вызывает усиление желудочной и панкреатической секреции, усиливает активность липазы. Оказывает гипогликемическое действие. Вызывает частичное или полное растворение холестериновых камней при приеме внутрь, уменьшает насыщенность желчи холестерином, что способствует мобилизации холестерина из желчных камней. Оказывает иммуномодулирующее действие, влияет на иммунологические реакции в печени: уменьшает экспрессию некоторых антигенов на мембране гепатоцитов, влияет на количество Т-лимфоцитов, образование интерлейкина-2, уменьшает количество эозинофилов.
Рентгенположительные (с высоким содержанием кальция) желчные камни; нефункционирующий желчный пузырь; острые воспалительные заболевания желчного пузыря, желчных протоков и кишечника; цирроз печени в стадии декомпенсации; выраженные нарушения функции почек; выраженные нарушения функции печени; выраженные нарушения функции поджелудочной железы; беременность; период лактации (грудного вскармливания); повышенная чувствительность к компонентам препарата.
Применение при беременности и в период грудного вскармливания
Препарат противопоказан в период беременности. Препарат может применяться во время беременности только в тех случаях когда потенциальная польза его применения для матери превышает возможный риск для плода.
Данные о выделение урсодезоксихолевой кислоты с грудным молоком отсутствуют. При необходимости применения урсодезоксихолевой кислоты в период лактации следует прекратить грудное вскармливание.
Способ применения и дозы
Растворение холестериновых желчных камней
Примерно 10 мг на 1 кг массы тела ежедневно, что соответствует:
2 капсулам (2 мерным ложкам) Урсофалька у больных с массой тела до 60 кг;
3 капсулам (3 мерным ложкам) Урсофалька у больных с массой тела до 80 кг;
4 капсулам (4 мерным ложкам) Урсофалька у больных с массой тела до 100 кг.
Капсулы необходимо принимать вечером, перед отходом ко сну, не разжевывая и запивая небольшим количеством жидкости. Длительность лечения 6-12 месяцев. Для профилактики повторного холелитиаза рекомендован приём препарата в течение нескольких месяцев после растворения камней.
Лечение билиарного рефлюкс-гастрита
1 капсула (1 мерная ложка) Урсофалька ежедневно. Курс лечения от 10-14 дней до 6 месяцев, при необходимости - до 2 лет.
Суточная доза зависит от массы тела и составляет от 2 до 6 капсул (мерных ложек) (примерно от 10 до 15 мг урсодеоксихолевой кислоты на 1 кг массы тела).
Рекомендуется следующий режим применения
Масса тела 34-50 кг: 2 капсулы (мерных ложки, суточная доза); утром - 1, днем - -, вечером - 1.
Масса тела 51-65 кг: 3 капсулы (мерных ложки, суточная доза); утром - 1, днем - 1, вечером - 1.
Масса тела 66-85 кг: 4 капсулы (мерных ложки, суточная доза); утром - 1, днем - 1, вечером - 2.
Масса тела 86-110 кг: 5 капсулы (мерных ложки, суточная доза); утром - 1, днем - 2, вечером - 2.
Масса тела свыше 110 кг: 6 капсулы (мерных ложки, суточная доза); утром - 2, днем - 2, вечером - 2.
Больные с массой тела менее 34 кг должны применять Урсофальк в суспензии.
Побочное действие
Оценка нежелательных явлений основана на следующей классификации:
Очень частые (≥1/10)
Частые (≥1/100 - <1/10)
Нечастые (≥1/1000 - <1/100)
Редкие (≥1/10000 - <1/1000)
Очень редкие (<1/10000).
Нарушения со стороны желудочно-кишечного тракта:
В клинических исследованиях на фоне лечения урсодезоксихолевой кислотой часто наблюдались неоформленный стул или диарея.
При лечении первичного билиарного цирроза очень редко наблюдались острые боли в правой верхней части живота.
Нарушения со стороны печени и желчевыводящих путей:
В очень редких случаях на фоне лечения урсодезоксихолевой кислотой может произойти кальцинирование желчных камней.
При лечении развитых стадий первичного билиарного цирроза в очень редких случаях наблюдалась декомпенсация цирроза печени которая исчезает после отмены препарата.
Нарушения со стороны кожи и подкожных тканей:
В очень редких случаях может наблюдаться крапивница.
Если любое из указанных в инструкции побочных эффектов усугубляется или Вы заметили другие побочные эффекты не указанные в инструкции пожалуйста сообщите об этом врачу.
Передозировка
Случаев передозировки не выявлено. В случае передозировки проводят симптоматическое лечение.
Взаимодействие с другими лекарственными средствами
Колестирамин колестипол и антациды содержащие алюминия гидроксид или смектит (алюминия оксид) снижают абсорбцию урсодезоксихолевой кислоты в кишечнике и таким образом уменьшают ее поглощение и эффективность. Если же использование препаратов содержащих хотя бы одно из этих веществ все же является необходимым их нужно принимать минимум за 2 часа до приема Урсофалька.
Урсодезоксихолевая кислота может усилить поглощение циклоспорина из кишечника. Поэтому у больных принимающих циклоспорин врач должен проверить концентрацию циклоспорина в крови и скорректировать дозу циклоспорина в случае необходимости.
В отдельных случаях Урсофальк может снижать всасывание ципрофлоксацина.
Гиполипидемические лекарственные средства (особенно клофибрат) эстрогены неомицин или прогестины увеличивают насыщение желчи холестерином и могут снижать способность растворять холестериновые желчные конкременты.
Особые указания
Прием препарата Урсофальк должен осуществляться под наблюдением врача.
В течение первых трех месяцев лечения следует контролировать функциональные показатели печени: трансаминазы щелочную фосфатазу и гамма-глютамилтранспептидазу в сыворотке крови каждые 4 недели а затем каждые 3 месяца. Контроль указанных параметров позволяет выявить нарушения функции печени на ранних стадиях. Также это касается пациентов на поздних стадиях первичного билиарного цирроза. Кроме того так можно быстро определить реагирует ли пациент с первичным билиарным циррозом на проводимое лечение.
При применении для растворения холестериновых желчных камней:
Для того чтобы оценить прогресс в лечении и для своевременного выявления признаков кальциноза камней в зависимости от размера камней желчный пузырь следует визуализировать (пероральная холецистография) с осмотром затемнений в положении стоя и лежа на спине (ультразвуковое исследование) через 6-10 месяцев после начала лечения.
Если желчный пузырь невозможно визуализировать на рентгеновских снимках или в случаях кальциноза камней слабой сократимости желчного пузыря или частых приступов колик препарат Урсофальк применять не следует.
При лечении пациентов на поздних стадиях первичного билиарного цирроза:
Крайне редко отмечались случаи декомпенсации цирроза печени. После прекращения терапии отмечалось частичное обратное развитие проявлений декомпенсации.
При применении у пациентов с первичным склерозирующим холангитом:
Длительная терапия высокими дозами урсодезоксихолевой кислоты (28-30 мг / кг / день) у пациентов с данной патологией может вызвать серьезные побочные явления.
У пациентов с диареей следует уменьшить дозировку препарата. При персистирующей диарее следует прекратить лечение.
Влияние на способность управлять автомобилем и движущимися механизмами
Влияния на способность управлять транспортными средствами и движущимися механизмами выявлено не было.
Форма выпуска
Капсулы 250 мг.
Условия хранения
Хранить при температуре не выше 25 °С. Хранить в недоступном для детей месте.
Срок годности
5 лет. Не применять по истечении срока годности указанного на упаковке.
Условия отпуска
По рецепту
Производитель
Лозан Фарма ГмбХ, Otto-Hahn-Strasse 13, 79395 Neuenburg, Germany, Германия
Организация, принимающая претензии потребителей
Д-р Фальк Фарма ГмбХ
Для описания товара использована информация от партнера 36.6
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Содержимое капсулы - порошок или гранулы белого цвета."}}]},{"id":13,"name":"Фармакотерапевтическая группа","slug":"","body":[{"type":"paragraph","data":{"text":"Гепатопротекторное средство"}}]},{"id":2,"name":"Фармакологические свойства","slug":"pharmacologic_effects","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Гепатопротектор. Оказывает желчегонное действие. Уменьшает синтез холестерина в печени, всасывание его в кишечнике и концентрацию в желчи, повышает растворимость холестерина в желчевыводящей системе, стимулирует образование и выведение желчи. Снижает литогенность желчи, увеличивает в ней содержание желчных кислот. Вызывает усиление желудочной и панкреатической секреции, усиливает активность липазы. Оказывает гипогликемическое действие. Вызывает частичное или полное растворение холестериновых камней при приеме внутрь, уменьшает насыщенность желчи холестерином, что способствует мобилизации холестерина из желчных камней. Оказывает иммуномодулирующее действие, влияет на иммунологические реакции в печени: уменьшает экспрессию некоторых антигенов на мембране гепатоцитов, влияет на количество Т-лимфоцитов, образование интерлейкина-2, уменьшает количество эозинофилов."}}]},{"id":3,"name":"Показания к применению","slug":"indications","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Растворение холестериновых камней желчного пузыря; билиарный рефлюкс-гастрит; первичный билиарный цирроз печени при отсутствии признаков декомпенсации (симптоматическое лечение); хронические гепатиты различного генеза; первичный склерозирующий холангит, кистозный фиброз (муковисцидоз); неалкогольный стеатогепатит; алкогольная болезнь печени; дискинезия желчевыводящих путей."}}]},{"id":4,"name":"Противопоказания","slug":"contraindications","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Рентгенположительные (с высоким содержанием кальция) желчные камни; нефункционирующий желчный пузырь; острые воспалительные заболевания желчного пузыря, желчных протоков и кишечника; цирроз печени в стадии декомпенсации; выраженные нарушения функции почек; выраженные нарушения функции печени; выраженные нарушения функции поджелудочной железы; беременность; период лактации (грудного вскармливания); повышенная чувствительность к компонентам препарата."}}]},{"id":5,"name":"Применение при беременности и в период грудного вскармливания","slug":"pregnancy_warnings","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Препарат противопоказан в период беременности. Препарат может применяться во время беременности только в тех случаях когда потенциальная польза его применения для матери превышает возможный риск для плода."}},{"type":"paragraph","data":{"text":"Данные о выделение урсодезоксихолевой кислоты с грудным молоком отсутствуют. При необходимости применения урсодезоксихолевой кислоты в период лактации следует прекратить грудное вскармливание."}}]},{"id":6,"name":"Способ применения и дозы","slug":"dosage","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Растворение холестериновых желчных камней"}},{"type":"paragraph","data":{"text":"Примерно 10 мг на 1 кг массы тела ежедневно, что соответствует:"}},{"type":"list","data":{"style":"ordered","items":["2 капсулам (2 мерным ложкам) Урсофалька у больных с массой тела до 60 кг;","3 капсулам (3 мерным ложкам) Урсофалька у больных с массой тела до 80 кг;","4 капсулам (4 мерным ложкам) Урсофалька у больных с массой тела до 100 кг."]}},{"type":"paragraph","data":{"text":"Капсулы необходимо принимать вечером, перед отходом ко сну, не разжевывая и запивая небольшим количеством жидкости. Длительность лечения 6-12 месяцев. Для профилактики повторного холелитиаза рекомендован приём препарата в течение нескольких месяцев после растворения камней."}},{"type":"paragraph","data":{"text":"Лечение билиарного рефлюкс-гастрита"}},{"type":"paragraph","data":{"text":"1 капсула (1 мерная ложка) Урсофалька ежедневно. Курс лечения от 10-14 дней до 6 месяцев, при необходимости - до 2 лет."}},{"type":"paragraph","data":{"text":"Симптоматическое лечение первичного билиарного цирроза"}},{"type":"paragraph","data":{"text":"Суточная доза зависит от массы тела и составляет от 2 до 6 капсул (мерных ложек) (примерно от 10 до 15 мг урсодеоксихолевой кислоты на 1 кг массы тела)."}},{"type":"paragraph","data":{"text":"Рекомендуется следующий режим применения"}},{"type":"list","data":{"style":"ordered","items":["Масса тела 34-50 кг: 2 капсулы (мерных ложки, суточная доза); утром - 1, днем - -, вечером - 1.","Масса тела 51-65 кг: 3 капсулы (мерных ложки, суточная доза); утром - 1, днем - 1, вечером - 1.","Масса тела 66-85 кг: 4 капсулы (мерных ложки, суточная доза); утром - 1, днем - 1, вечером - 2.","Масса тела 86-110 кг: 5 капсулы (мерных ложки, суточная доза); утром - 1, днем - 2, вечером - 2.","Масса тела свыше 110 кг: 6 капсулы (мерных ложки, суточная доза); утром - 2, днем - 2, вечером - 2."]}},{"type":"paragraph","data":{"text":"Больные с массой тела менее 34 кг должны применять Урсофальк в суспензии."}}]},{"id":7,"name":"Побочное действие","slug":"side_effects","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Оценка нежелательных явлений основана на следующей классификации:"}},{"type":"paragraph","data":{"text":"Очень частые (≥1/10)"}},{"type":"paragraph","data":{"text":"Частые (≥1/100 - <1/10)"}},{"type":"paragraph","data":{"text":"Нечастые (≥1/1000 - <1/100)"}},{"type":"paragraph","data":{"text":"Редкие (≥1/10000 - <1/1000)"}},{"type":"paragraph","data":{"text":"Очень редкие (<1/10000)."}},{"type":"paragraph","data":{"text":"Нарушения со стороны желудочно-кишечного тракта:"}},{"type":"paragraph","data":{"text":"В клинических исследованиях на фоне лечения урсодезоксихолевой кислотой часто наблюдались неоформленный стул или диарея."}},{"type":"paragraph","data":{"text":"При лечении первичного билиарного цирроза очень редко наблюдались острые боли в правой верхней части живота."}},{"type":"paragraph","data":{"text":"Нарушения со стороны печени и желчевыводящих путей:"}},{"type":"paragraph","data":{"text":"В очень редких случаях на фоне лечения урсодезоксихолевой кислотой может произойти кальцинирование желчных камней."}},{"type":"paragraph","data":{"text":"При лечении развитых стадий первичного билиарного цирроза в очень редких случаях наблюдалась декомпенсация цирроза печени которая исчезает после отмены препарата."}},{"type":"paragraph","data":{"text":"Нарушения со стороны кожи и подкожных тканей:"}},{"type":"paragraph","data":{"text":"В очень редких случаях может наблюдаться крапивница."}},{"type":"paragraph","data":{"text":"Если любое из указанных в инструкции побочных эффектов усугубляется или Вы заметили другие побочные эффекты не указанные в инструкции пожалуйста сообщите об этом врачу."}}]},{"id":8,"name":"Передозировка","slug":"overdose","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Случаев передозировки не выявлено. В случае передозировки проводят симптоматическое лечение."}}]},{"id":15,"name":"Взаимодействие с другими лекарственными средствами","slug":"drugs_interaction","body":[{"type":"paragraph","data":{"text":"Колестирамин колестипол и антациды содержащие алюминия гидроксид или смектит (алюминия оксид) снижают абсорбцию урсодезоксихолевой кислоты в кишечнике и таким образом уменьшают ее поглощение и эффективность. Если же использование препаратов содержащих хотя бы одно из этих веществ все же является необходимым их нужно принимать минимум за 2 часа до приема Урсофалька."}},{"type":"paragraph","data":{"text":"Урсодезоксихолевая кислота может усилить поглощение циклоспорина из кишечника. Поэтому у больных принимающих циклоспорин врач должен проверить концентрацию циклоспорина в крови и скорректировать дозу циклоспорина в случае необходимости."}},{"type":"paragraph","data":{"text":"В отдельных случаях Урсофальк может снижать всасывание ципрофлоксацина."}},{"type":"paragraph","data":{"text":"Гиполипидемические лекарственные средства (особенно клофибрат) эстрогены неомицин или прогестины увеличивают насыщение желчи холестерином и могут снижать способность растворять холестериновые желчные конкременты."}}]},{"id":9,"name":"Особые указания","slug":"","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Прием препарата Урсофальк должен осуществляться под наблюдением врача."}},{"type":"paragraph","data":{"text":"В течение первых трех месяцев лечения следует контролировать функциональные показатели печени: трансаминазы щелочную фосфатазу и гамма-глютамилтранспептидазу в сыворотке крови каждые 4 недели а затем каждые 3 месяца. Контроль указанных параметров позволяет выявить нарушения функции печени на ранних стадиях. Также это касается пациентов на поздних стадиях первичного билиарного цирроза. Кроме того так можно быстро определить реагирует ли пациент с первичным билиарным циррозом на проводимое лечение."}},{"type":"paragraph","data":{"text":"При применении для растворения холестериновых желчных камней:"}},{"type":"paragraph","data":{"text":"Для того чтобы оценить прогресс в лечении и для своевременного выявления признаков кальциноза камней в зависимости от размера камней желчный пузырь следует визуализировать (пероральная холецистография) с осмотром затемнений в положении стоя и лежа на спине (ультразвуковое исследование) через 6-10 месяцев после начала лечения."}},{"type":"paragraph","data":{"text":"Если желчный пузырь невозможно визуализировать на рентгеновских снимках или в случаях кальциноза камней слабой сократимости желчного пузыря или частых приступов колик препарат Урсофальк применять не следует."}},{"type":"paragraph","data":{"text":"При лечении пациентов на поздних стадиях первичного билиарного цирроза:"}},{"type":"paragraph","data":{"text":"Крайне редко отмечались случаи декомпенсации цирроза печени. После прекращения терапии отмечалось частичное обратное развитие проявлений декомпенсации."}},{"type":"paragraph","data":{"text":"При применении у пациентов с первичным склерозирующим холангитом:"}},{"type":"paragraph","data":{"text":"Длительная терапия высокими дозами урсодезоксихолевой кислоты (28-30 мг / кг / день) у пациентов с данной патологией может вызвать серьезные побочные явления."}},{"type":"paragraph","data":{"text":"У пациентов с диареей следует уменьшить дозировку препарата. При персистирующей диарее следует прекратить лечение."}}]},{"id":16,"name":"Влияние на способность управлять автомобилем и движущимися механизмами","slug":"","body":[{"type":"paragraph","data":{"text":"Влияния на способность управлять транспортными средствами и движущимися механизмами выявлено не было."}}]},{"id":17,"name":"Форма выпуска","slug":"","body":[{"type":"paragraph","data":{"text":"Капсулы 250 мг."}}]},{"id":18,"name":"Условия хранения","slug":"storage","body":[{"type":"paragraph","data":{"text":"Хранить при температуре не выше 25 °С. Хранить в недоступном для детей месте."}}]},{"id":19,"name":"Срок годности","slug":"expiry_date","body":[{"type":"paragraph","data":{"text":"5 лет. 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