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Описание
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Эскапел таб., 1.5 мг

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5.0
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Коротко о товаре

Артикул Маркета
3123235103
Тип препарата
Назначение
Действующее вещество
Возраст
от 16 лет
Инструкция
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Вспомогательные вещества: кремния диоксид коллоидный; крахмал картофельный; магния стеарат; тальк; крахмал кукурузный; лактозы моногидрат."},{"name":"Действующее вещество","value":"Левоноргестрел","transition":{"type":"catalog","params":{"categorySlug":"mochepolovaia-sistema-i-polovye-gormony","categoryId":"15756910","navnodeId":"72506","glfilters":["27144131:28710253"]}}},{"name":"Способ применения и дозы","value":"Внутрь.Препарат может применяться в любой период менструального цикла. В случае нерегулярного менструального цикла необходимо предварительно исключить беременность.Для достижения более надежного контрацептивного эффекта 1 таблетку препарата Эскапел® необходимо принять как можно скорее, предпочтительно в первые 12 часов (но не позднее 72 часов после незащищенного полового акта). Если в течение 3-х часов после приема таблетки произошла рвота, то следует принять еще 1 таблетку препарата Эскапел®. После приема препарата Эскапел® до наступления следующей менструации следует применять негормональные методы контрацепции (презерватив, спермицид + шеечный колпачок, диафрагма или контрацептивная губка). Применение левоноргестрела не является противопоказанием для продолжения плановой гормональной контрацепции. Применение препарата при повторном незащищенном половом акте в течение одного менструального цикла не рекомендуется из-за увеличения риска развития нарушений цикла.Особые группы пациентокДети и подростки до 16 летПрименение препарата Эскапел® в возрасте до 16 лет противопоказано (в связи с ограниченным количеством данных по безопасности и эффективности левоноргестрела в данной возрастной группе).Пациентки с почечной недостаточностьюДанные о применении левоноргестрела у пациенток с нарушением функции почек отсутствуют.Пациентки с печеночной недостаточностьюДанные о применении левоноргестрела у пациенток с печеночной недостаточностью отсутствуют. Применение препарата у пациенток с печеночной недостаточностью тяжелой степени противопоказано."},{"name":"Побочные действия","value":"При применении левоноргестрела наиболее частой нежелательной реакцией (HP) была тошнота.HP представлены по системно-органным классам в соответствии с классификацией MedDRA и с частотой возникновения: очень часто (≥1/10), часто (≥1/100, <1/10), нечасто (≥1/1000, <1/100), редко (≥1/10000, <1/1000), очень редко (<1/10000), включая отдельные сообщения. В пределах каждой группы HP распределены в порядке уменьшения их значимости.Нарушения со стороны нервной системыОчень часто: головная боль.Часто: головокружение.Нарушения со стороны желудочно-кишечного трактаОчень часто: тошнота, боль в нижних отделах живота.Часто: диарея, рвота.Нарушения со стороны половых органов и молочной железыОчень часто: кровотечение, не связанное с менструацией.Часто: задержка менструации более чем на 7 дней, нерегулярные менструальные кровотечения, нагрубание молочных желез.Общие расстройства и нарушения в месте введенияОчень часто: повышенная утомляемость.Характер менструального кровотечения может несколько измениться, однако у большинства женщин следующая менструация начинается в течение 5 дней от предполагаемого срока.Если наступление следующей менструации запаздывает больше чем на 5 дней, следует исключить беременность.Следующие нежелательные явления наблюдались в клинической практике в пострегистрационном периоде:Нарушения со стороны желудочно-кишечного тракта Очень редко: боль в животе.Нарушения со стороны кожи и подкожных тканейОчень редко: кожная сыпь, крапивница, зуд.Нарушения со стороны половых органов и молочной железыОчень редко: боль в области таза, дисменорея.Общие расстройства и нарушения в месте введенияОчень редко: отек лица."},{"name":"Фармакологическое действие","value":"Левоноргестрел - это синтетический гестаген с контрацептивным действием, выраженными гестагенными и антиэстрогенными свойствами. Основным механизмом действия является ингибирование и/или задержка овуляции в результате подавления пика лютеинизирующего гормона. При рекомендуемом режиме дозирования левоноргестрел подавляет овуляцию и\nоплодотворение, если половой контакт произошел в предовуляторную фазу, когда возможность оплодотворения наибольшая. Левоноргестрел не эффективен, если имплантация оплодотворенной яйцеклетки уже произошла.Эффективность: согласно результатам ранее проведенного клинического исследования, прием двух доз левоноргестрела по 0,75 мг с интервалом в 12 часов предотвращает наступление беременности в 85% случаев. Эффективность препарата снижается с течением времени после полового контакта (95% - при применении в течение 24 часов, 85% - в интервале от 24 до 48 часов, 58% - от 48 до 72 часов).Результаты другого клинического исследования показали, что однократный прием левоноргестрела в дозе 1,5 мг (в течение 72 часов после незащищенного полового акта) предотвращает наступление беременности в 84% случаев.Имеются ограниченные данные, требующие дальнейшего подтверждения, о влиянии избыточной массы тела/высокого индекса массы тела (ИМТ) на контрацептивную эффективность. В 2-х клинических исследованиях (КИ) было выявлено снижение эффективности левоноргестрела и увеличение частоты беременности у женщин с ИМТ ≥30 кг/м2 в сравнении с женщинами с нормальным ИМТ (5,19% и 0,96% соответственно). Однако в других КИ снижение контрацептивной эффективности левоноргестрела не было подтверждено (частота наступления беременности составила 1,17% у женщин с ожирением и 0,99% у женщин с нормальным ИМТ).При рекомендуемом режиме дозирования левоноргестрел не оказывает существенного влияния на факторы свертываемости крови, липидный и углеводный обмен.Девочки-подростки до 18 летВ проспективном наблюдательном исследовании было показано, что из 305 случаев применения левоноргестрела в качестве средства экстренной контрацепции, в семи случаях наступила беременность. Таким образом, общий коэффициент неудачи составил 2,3%. Коэффициент неудачи у девочек-подростков моложе 18 лет (2,6% или 4/153) был сравним с коэффициентом неудачи у женщин 18 лет и старше (2,0% или 3/152)."},{"name":"Фармакологическая группа","value":"гестаген"},{"name":"Форма выпуска","value":"таблетки"},{"name":"Способ применения/введения","value":"пероральный","transition":{"type":"catalog","params":{"categorySlug":"mochepolovaia-sistema-i-polovye-gormony","categoryId":"15756910","navnodeId":"72506","glfilters":["35947170:36763744"]}}},{"name":"Пол","value":"для женщин","transition":{"type":"catalog","params":{"categorySlug":"mochepolovaia-sistema-i-polovye-gormony","categoryId":"15756910","navnodeId":"72506","glfilters":["14805991:14805993"]}}},{"name":"Минимальный возраст применения","value":"от 16 лет"},{"name":"Условия хранения","value":"При температуре не выше 30 °С. Хранить в недоступном для детей месте."},{"name":"Передозировка","value":"О серьезных нежелательных реакциях при острой передозировке большими дозами пероральных контрацептивов не сообщалось. Симптомы: тошнота и кровотечение «отмены». Лечение: симптоматическое. Специфического антидота нет."},{"name":"Применение при беременности и кормлении грудью","value":"БеременностьПрием препарата в период известной или предполагаемой беременности противопоказан. На основании имеющихся данных, неблагоприятного влияния на плод в случае продолжения беременности на фоне применения левоноргестрел-содержащих препаратов для экстренной контрацепции не выявлено.Период грудного вскармливанияЛевоноргестрел проникает в грудное молоко. Потенциальное воздействие левоноргестрела на ребенка можно уменьшить, если женщина будет принимать препарат непосредственно после кормления. После приема препарата грудное вскармливание следует прекратить не менее чем на 8 часов."},{"name":"Влияние на способность управлять транспортом и механизмами","value":"Воздействие препарата на способность к управлению транспортными средствами и работу с механизмами не исследовалось."},{"name":"Особые указания","value":"Эскапел следует применять исключительно для экстренной контрацепции! Повторное применение препарата Эскапел в течение одного менструального цикла не рекомендуется! Эскапел следует принять как можно скорее, но не позднее 72 ч после незащищенного полового акта. Эффективность экстренной контрацепции при отсроченном применении препарата существенно снижается.Препарат не заменяет применение постоянных методов контрацепции. В большинстве случаев Эскапел не оказывает влияния на характер менструального цикла. Однако возможно появление ациклических кровянистых выделений и задержка менструации на несколько дней. При задержке менструации более чем на 5-7 дней и изменение ее характера (скудные или обильные выделения) необходимо исключить беременность. Появление болей внизу живота, обморочных состояний может свидетельствовать о внематочной (эктопической) беременности.Подросткам до 16 лет в исключительных случаях (в том числе, при изнасиловании) необходима консультация гинеколога, для подтверждения беременности.После проведения экстренной контрацепции рекомендована консультация гинеколога для подбора наиболее приемлемого метода для постоянной контрацепции.Экстренная контрацепция не защищает от заболеваний, передающихся половым путем.При нарушениях функции желудочно-кишечного тракта (например, при болезни Крона) эффективность препарата может снижаться."},{"name":"Взаимодействие","value":"При одновременном применении с препаратами-индукторами микросомальных ферментов печени (главным образом, индукторов изофермента CYP3A4) происходит ускорение метаболизма левоноргестрела.Сопутствующее применение эфавиренза снижает концентрацию левоноргестрела в плазме крови примерно на 50%.Следующие препараты-индукторы ферментов печени могут снижать эффективность левоноргестрела: барбитураты (включая примидон), фенитоин и карбамазепин, препараты, содержащие Зверобой продырявленный (Hypericum perforatum), а также рифампицин, ритонавир, рифабутин и гризеофульвин.Препараты, содержащие левоноргестрел, могут повышать риск токсичности циклоспорина, вследствие подавления его метаболизма.Левоноргестрел может снижать эффективность улипристала ацетата путем конкурентного воздействия на рецептор прогестерона, в связи с чем их одновременное применение не рекомендуется."},{"name":"Регистрационный номер","value":"П N015924/01"},{"name":"Дата государственной регистрации","value":"19.05.2021"},{"name":"Владелец регистрационного удостоверения","value":"Гедеон Рихтер ОАО","transition":{"type":"catalog","params":{"categorySlug":"mochepolovaia-sistema-i-polovye-gormony","categoryId":"15756910","navnodeId":"72506","glfilters":["34324371:35649313","7893318:17672958"]}}},{"name":"Страна бренда","value":"Венгрия"},{"name":"Страна-производитель","value":"Венгрия"},{"name":"Название препарата","value":"Эскапел","transition":{"type":"catalog","params":{"categorySlug":"mochepolovaia-sistema-i-polovye-gormony","categoryId":"15756910","navnodeId":"72506","glfilters":["17796364:18038580"]}}},{"name":"Срок годности","value":"60 мес."}]}},"fullSpecsGrouped":{"7402292518932686549":{"groups":[{"name":"Общие характеристики","items":[{"name":"Бренд","value":"Гедеон Рихтер ОАО"},{"name":"Количество в упаковке","value":"1 шт."},{"name":"Тип препарата","value":"лекарственный препарат"},{"name":"Рецептурный препарат","value":"да"},{"name":"Органы и системы","value":"половая система"},{"name":"Назначение","value":"экстренная (посткоитальная) контрацепция"},{"name":"Показания к применению","value":"Экстренная (посткоитальная) контрацепция (после незащищенного полового контакта или ненадежности используемого метода контрацепции)."},{"name":"Противопоказания","value":"-гиперчувствительность к левоноргестрелу и/или к любому из вспомогательных веществ в составе препарата.-возраст до 16 лет (в связи с ограниченным количеством данных по безопасности и эффективности левоноргестрела в данной возрастной группе).-печеночная недостаточность тяжелой степени.-известная или предполагаемая беременность.-грудное вскармливание в течение не менее 8 часов после приема препарата.-непереносимость лактозы, дефицит лактазы, синдром глюкозо-галактозной мальабсорбции."},{"name":"Состав","value":"Действующее вещество: левоноргестрел 1,5 мг. Вспомогательные вещества: кремния диоксид коллоидный; крахмал картофельный; магния стеарат; тальк; крахмал кукурузный; лактозы моногидрат."},{"name":"Действующее вещество","value":"Левоноргестрел"},{"name":"Способ применения и дозы","value":"Внутрь.Препарат может применяться в любой период менструального цикла. В случае нерегулярного менструального цикла необходимо предварительно исключить беременность.Для достижения более надежного контрацептивного эффекта 1 таблетку препарата Эскапел® необходимо принять как можно скорее, предпочтительно в первые 12 часов (но не позднее 72 часов после незащищенного полового акта). Если в течение 3-х часов после приема таблетки произошла рвота, то следует принять еще 1 таблетку препарата Эскапел®. После приема препарата Эскапел® до наступления следующей менструации следует применять негормональные методы контрацепции (презерватив, спермицид + шеечный колпачок, диафрагма или контрацептивная губка). Применение левоноргестрела не является противопоказанием для продолжения плановой гормональной контрацепции. Применение препарата при повторном незащищенном половом акте в течение одного менструального цикла не рекомендуется из-за увеличения риска развития нарушений цикла.Особые группы пациентокДети и подростки до 16 летПрименение препарата Эскапел® в возрасте до 16 лет противопоказано (в связи с ограниченным количеством данных по безопасности и эффективности левоноргестрела в данной возрастной группе).Пациентки с почечной недостаточностьюДанные о применении левоноргестрела у пациенток с нарушением функции почек отсутствуют.Пациентки с печеночной недостаточностьюДанные о применении левоноргестрела у пациенток с печеночной недостаточностью отсутствуют. Применение препарата у пациенток с печеночной недостаточностью тяжелой степени противопоказано."},{"name":"Побочные действия","value":"При применении левоноргестрела наиболее частой нежелательной реакцией (HP) была тошнота.HP представлены по системно-органным классам в соответствии с классификацией MedDRA и с частотой возникновения: очень часто (≥1/10), часто (≥1/100, <1/10), нечасто (≥1/1000, <1/100), редко (≥1/10000, <1/1000), очень редко (<1/10000), включая отдельные сообщения. В пределах каждой группы HP распределены в порядке уменьшения их значимости.Нарушения со стороны нервной системыОчень часто: головная боль.Часто: головокружение.Нарушения со стороны желудочно-кишечного трактаОчень часто: тошнота, боль в нижних отделах живота.Часто: диарея, рвота.Нарушения со стороны половых органов и молочной железыОчень часто: кровотечение, не связанное с менструацией.Часто: задержка менструации более чем на 7 дней, нерегулярные менструальные кровотечения, нагрубание молочных желез.Общие расстройства и нарушения в месте введенияОчень часто: повышенная утомляемость.Характер менструального кровотечения может несколько измениться, однако у большинства женщин следующая менструация начинается в течение 5 дней от предполагаемого срока.Если наступление следующей менструации запаздывает больше чем на 5 дней, следует исключить беременность.Следующие нежелательные явления наблюдались в клинической практике в пострегистрационном периоде:Нарушения со стороны желудочно-кишечного тракта Очень редко: боль в животе.Нарушения со стороны кожи и подкожных тканейОчень редко: кожная сыпь, крапивница, зуд.Нарушения со стороны половых органов и молочной железыОчень редко: боль в области таза, дисменорея.Общие расстройства и нарушения в месте введенияОчень редко: отек лица."},{"name":"Фармакологическое действие","value":"Левоноргестрел - это синтетический гестаген с контрацептивным действием, выраженными гестагенными и антиэстрогенными свойствами. Основным механизмом действия является ингибирование и/или задержка овуляции в результате подавления пика лютеинизирующего гормона. При рекомендуемом режиме дозирования левоноргестрел подавляет овуляцию и\nоплодотворение, если половой контакт произошел в предовуляторную фазу, когда возможность оплодотворения наибольшая. Левоноргестрел не эффективен, если имплантация оплодотворенной яйцеклетки уже произошла.Эффективность: согласно результатам ранее проведенного клинического исследования, прием двух доз левоноргестрела по 0,75 мг с интервалом в 12 часов предотвращает наступление беременности в 85% случаев. Эффективность препарата снижается с течением времени после полового контакта (95% - при применении в течение 24 часов, 85% - в интервале от 24 до 48 часов, 58% - от 48 до 72 часов).Результаты другого клинического исследования показали, что однократный прием левоноргестрела в дозе 1,5 мг (в течение 72 часов после незащищенного полового акта) предотвращает наступление беременности в 84% случаев.Имеются ограниченные данные, требующие дальнейшего подтверждения, о влиянии избыточной массы тела/высокого индекса массы тела (ИМТ) на контрацептивную эффективность. В 2-х клинических исследованиях (КИ) было выявлено снижение эффективности левоноргестрела и увеличение частоты беременности у женщин с ИМТ ≥30 кг/м2 в сравнении с женщинами с нормальным ИМТ (5,19% и 0,96% соответственно). Однако в других КИ снижение контрацептивной эффективности левоноргестрела не было подтверждено (частота наступления беременности составила 1,17% у женщин с ожирением и 0,99% у женщин с нормальным ИМТ).При рекомендуемом режиме дозирования левоноргестрел не оказывает существенного влияния на факторы свертываемости крови, липидный и углеводный обмен.Девочки-подростки до 18 летВ проспективном наблюдательном исследовании было показано, что из 305 случаев применения левоноргестрела в качестве средства экстренной контрацепции, в семи случаях наступила беременность. Таким образом, общий коэффициент неудачи составил 2,3%. Коэффициент неудачи у девочек-подростков моложе 18 лет (2,6% или 4/153) был сравним с коэффициентом неудачи у женщин 18 лет и старше (2,0% или 3/152)."},{"name":"Фармакологическая группа","value":"гестаген"},{"name":"Форма выпуска","value":"таблетки"},{"name":"Способ применения/введения","value":"пероральный"},{"name":"Пол","value":"для женщин"},{"name":"Минимальный возраст применения","value":"от 16 лет"}]},{"name":"Дополнительно","items":[{"name":"Условия хранения","value":"При температуре не выше 30 °С. Хранить в недоступном для детей месте."},{"name":"Передозировка","value":"О серьезных нежелательных реакциях при острой передозировке большими дозами пероральных контрацептивов не сообщалось. Симптомы: тошнота и кровотечение «отмены». Лечение: симптоматическое. Специфического антидота нет."},{"name":"Применение при беременности и кормлении грудью","value":"БеременностьПрием препарата в период известной или предполагаемой беременности противопоказан. На основании имеющихся данных, неблагоприятного влияния на плод в случае продолжения беременности на фоне применения левоноргестрел-содержащих препаратов для экстренной контрацепции не выявлено.Период грудного вскармливанияЛевоноргестрел проникает в грудное молоко. Потенциальное воздействие левоноргестрела на ребенка можно уменьшить, если женщина будет принимать препарат непосредственно после кормления. После приема препарата грудное вскармливание следует прекратить не менее чем на 8 часов."},{"name":"Влияние на способность управлять транспортом и механизмами","value":"Воздействие препарата на способность к управлению транспортными средствами и работу с механизмами не исследовалось."},{"name":"Особые указания","value":"Эскапел следует применять исключительно для экстренной контрацепции! Повторное применение препарата Эскапел в течение одного менструального цикла не рекомендуется! Эскапел следует принять как можно скорее, но не позднее 72 ч после незащищенного полового акта. Эффективность экстренной контрацепции при отсроченном применении препарата существенно снижается.Препарат не заменяет применение постоянных методов контрацепции. В большинстве случаев Эскапел не оказывает влияния на характер менструального цикла. Однако возможно появление ациклических кровянистых выделений и задержка менструации на несколько дней. При задержке менструации более чем на 5-7 дней и изменение ее характера (скудные или обильные выделения) необходимо исключить беременность. Появление болей внизу живота, обморочных состояний может свидетельствовать о внематочной (эктопической) беременности.Подросткам до 16 лет в исключительных случаях (в том числе, при изнасиловании) необходима консультация гинеколога, для подтверждения беременности.После проведения экстренной контрацепции рекомендована консультация гинеколога для подбора наиболее приемлемого метода для постоянной контрацепции.Экстренная контрацепция не защищает от заболеваний, передающихся половым путем.При нарушениях функции желудочно-кишечного тракта (например, при болезни Крона) эффективность препарата может снижаться."},{"name":"Взаимодействие","value":"При одновременном применении с препаратами-индукторами микросомальных ферментов печени (главным образом, индукторов изофермента CYP3A4) происходит ускорение метаболизма левоноргестрела.Сопутствующее применение эфавиренза снижает концентрацию левоноргестрела в плазме крови примерно на 50%.Следующие препараты-индукторы ферментов печени могут снижать эффективность левоноргестрела: барбитураты (включая примидон), фенитоин и карбамазепин, препараты, содержащие Зверобой продырявленный (Hypericum perforatum), а также рифампицин, ритонавир, рифабутин и гризеофульвин.Препараты, содержащие левоноргестрел, могут повышать риск токсичности циклоспорина, вследствие подавления его метаболизма.Левоноргестрел может снижать эффективность улипристала ацетата путем конкурентного воздействия на рецептор прогестерона, в связи с чем их одновременное применение не рекомендуется."},{"name":"Регистрационный номер","value":"П N015924/01"},{"name":"Дата государственной регистрации","value":"19.05.2021"},{"name":"Владелец регистрационного удостоверения","value":"Гедеон Рихтер ОАО"},{"name":"Страна бренда","value":"Венгрия"},{"name":"Страна-производитель","value":"Венгрия"},{"name":"Название препарата","value":"Эскапел"},{"name":"Срок годности","value":"60 мес."}]}],"transitionId":"tr_17625166292629854347"}}}}
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Инструкция

Показания к применению

Экстренная (посткоитальная) контрацепция (после незащищенного полового контакта или ненадежности используемого метода контрацепции).

Противопоказания

-гиперчувствительность к левоноргестрелу и/или к любому из вспомогательных веществ в составе препарата.
-возраст до 16 лет (в связи с ограниченным количеством данных по безопасности и эффективности левоноргестрела в данной возрастной группе).
-печеночная недостаточность тяжелой степени.
-известная или предполагаемая беременность.
-грудное вскармливание в течение не менее 8 часов после приема препарата.
-непереносимость лактозы, дефицит лактазы, синдром глюкозо-галактозной мальабсорбции.

Способ применения и дозы

Внутрь.
Препарат может применяться в любой период менструального цикла. В случае нерегулярного менструального цикла необходимо предварительно исключить беременность.
Для достижения более надежного контрацептивного эффекта 1 таблетку препарата Эскапел® необходимо принять как можно скорее, предпочтительно в первые 12 часов (но не позднее 72 часов после незащищенного полового акта). Если в течение 3-х часов после приема таблетки произошла рвота, то следует принять еще 1 таблетку препарата Эскапел®. После приема препарата Эскапел® до наступления следующей менструации следует применять негормональные методы контрацепции (презерватив, спермицид + шеечный колпачок, диафрагма или контрацептивная губка). Применение левоноргестрела не является противопоказанием для продолжения плановой гормональной контрацепции. Применение препарата при повторном незащищенном половом акте в течение одного менструального цикла не рекомендуется из-за увеличения риска развития нарушений цикла.
Особые группы пациенток
Дети и подростки до 16 лет
Применение препарата Эскапел® в возрасте до 16 лет противопоказано (в связи с ограниченным количеством данных по безопасности и эффективности левоноргестрела в данной возрастной группе).
Пациентки с почечной недостаточностью
Данные о применении левоноргестрела у пациенток с нарушением функции почек отсутствуют.
Пациентки с печеночной недостаточностью
Данные о применении левоноргестрела у пациенток с печеночной недостаточностью отсутствуют. Применение препарата у пациенток с печеночной недостаточностью тяжелой степени противопоказано.
Полная инструкция
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