Порошок белого или почти белого цвета с запахом апельсина и грейпфрута, легко растворимый в воде, с образованием белого полупрозрачного раствора.
Фармакотерапевтическая группа
Слабительное средство
Фармакологические свойства
Фармакодинамика
Большая молекулярная масса макрогола 4000 обусловлена длинными линейными полимерами, которые удерживают молекулы воды посредством водородных связей.
Благодаря этому после перорального приема препарата увеличивается объем кишечного содержимого.
Объем неабсорбированной жидкости, находящейся в просвете кишечника, поддерживает слабительное действие раствора.
Фармакокинетика
Фармакокинетические данные подтверждают, что
макрогол 4000 не подвергается ни желудочно-кишечной резорбции, ни биотрасформации при пероральном приеме.
Показания к применению
Симптоматическое лечение запоров у взрослых и детей с 8 лет и старше.
Противопоказания
- серьезные воспалительные заболевания кишечника (язвенный колит, болезнь Крона) или токсическое расширение толстой кишки, сочетающееся с симптоматическим стенозом;
- прободение или угроза прободения желудочно-кишечного тракта;
- кишечная непроходимость или подозрение на кишечную непроходимость;
- боли в животе неясной этиологии;
- гиперчувствительность к макроголу (полиэтиленгликолю) или любому из компонентов препарата;
- детский возраст до 8 лет.
С осторожностью
Беременность
Результаты исследований на животных показали, что
Макрогол 4000 не обладает тератогенным эффектом.
Так как системное воздействие препарата Форлакс является незначительным, отрицательного воздействия на организм матери и плода не ожидается. Форлакс можно принимать во время беременности.
Лактация
Системное воздействие макрогола 4000 на организм кормящих женщин является незначительным, поэтому отрицательного воздействия на организм новорожденного/младенца не ожидается. Форлакс можно принимать во время лактации.
Применение при беременности и в период грудного вскармливания
Беременность
Экспериментальные исследования на животных не показали ни прямых, ни косвенных вредных эффектов токсического действия на репродуктивную функцию.
Существует ограниченное количество данных (менее 300 исходов беременности) по использованию препарата Форлакс у беременных женщин.
Т.к. системное воздействие препарата Форлакс является незначительным, никакого воздействия на течение беременности не ожидается. Препарат Форлакс можно принимать при беременности.
Период грудного вскармливания
Не существует данных об экскреции препарата Форлакс в грудное молоко.
Системное воздействие макрогола 4000 на организм кормящих женщин является незначительным, поэтому никакого воздействия на организм новорожденного/младенца не ожидается. Препарат Форлакс можно принимать в период грудного вскармливания.
Фертильность
Исследования влияния препарата Форлакс на фертильность не проводились, однако, поскольку макрогол 4000 всасывается незначительно, его влияние на фертильность не ожидается.
Способ применения и дозы
Внутрь, содержимое 1 - 2 пакетов (предпочтительно в виде однократного приема по утрам) или по 1 пакету (утром и вечером) в случае приема 2-х пакетов в день.
Ежедневная доза должна адаптироваться в соответствии с клиническим эффектом и может варьировать от 1 пакета каждый день (особенно у детей) до 2 пакетов в день.
Содержимое каждого пакета следует растворить в стакане воде непосредственно перед приемом.
Эффект от приема Форлакса® выражен в течение 24 - 48 часов после приема препарата.
Рекомендуемый курс лечения для детей и взрослых - 3 месяца.
У детей лечение не должно превышать 3 месяца в связи с недостаточностью клинических данных.
Поддержание эффекта после восстановления нормальной работы кишечника следует осуществлять с помощью активного образа жизни и диеты, богатой растительной клетчаткой.
Если симптомы запора сохраняются более 3-х месяцев, необходимо провести повторное расширенное диагностические обследование.
Побочное действие
У взрослых.
Побочные действия, наблюдаемые при проведении клинических исследований на 600 пациентах, имели транзиторный характер, наблюдались со следующей частотой и касались, в основном желудочно-кишечного тракта:
- частые побочные действия (более 1/100, менее 1/10): вздутие живота и/или боль, тошнота, диарея;
- редко встречающиеся побочные действия (более 1/1000, менее 1/100): рвота, неотложный позыв на дефекацию и недержание кала.
Дополнительная информация, полученная из постмаркетинговых наблюдений, включала: очень редко (менее 1/10000) случаи гиперчувствительности: кожный зуд, крапивница, преходящая (транзиторная) сыпь, отек лица, отек Квинке и отдельные случаи анафилактического шока.
Неизвестна частота возникновения диареи, приводящей к расстройству электролитного баланса (гипонатриемия, гипокалиемия) и/или обезвоживанию, особенно у взрослых пациентов.
У детей.
Побочные действия, касающиеся желудочно-кишечного тракта, были минимальны и носили преходящий характер в клинических исследованиях при участии 147 детей в возрасте от 6 месяцев до 15 лет, выявлялись со следующей частотой:
Расстройства желудочно-кишечного тракта:
- частые побочные действия (более 1/100, менее 1/10): диарея и абдоминальные боли,
- редко встречающиеся побочные действия (более 1/1000, менее 1/100): метеоризм, тошнота и рвота.
- побочные действия, которые не могут быть оценены на основе имеющихся данных: реакции гиперчувствительности.
Диарея может быть причиной болезненных ощущений в перианальной области.
Передозировка
Передозировка препарата приводит к диарее с последующим исчезновением после уменьшения дозы или прекращения лечения.
Избыточная потеря жидкости при диарее или рвоте может требовать коррекции электролитных нарушений.
Взаимодействие с другими лекарственными средствами
Не описаны. Возможно замедление абсорбции лекарственных средств, принимаемых одновременно с Форлаксом. Поэтому рекомендуется назначать Форлакс спустя, по меньшей мере, 2 ч после назначения других препаратов.
Особые указания
Органические расстройства желудочно-кишечного тракта должны быть исключены до начала терапии.
Предупреждение.
Лечение запоров с помощью лекарственных препаратов рекомендовано только как вспомогательное средство к здоровому образу жизни и диете, например:
- увеличение потребления жидкостей и клетчатки,
- адекватная физическая активность, которая способствует восстановлению моторики пищеварительного тракта.
В случае развития диареи с особой осторожностью следует относиться к пациентам, предрасположенным к нарушению водно-электролитного баланса (например, у пожилых пациентов, у пациентов с нарушением функции печени или почек, или пациентов, принимающих диуретики) и необходимо проводить электролитный контроль.
Форлакс не содержит значительных количеств углеводов и/или полиолов (сахарных спиртов) и может применяться у больных сахарным диабетом или у пациентов, из рациона которых исключена
галактоза.
Особые предупреждения.
Были зарегистрированы очень редкие случаи гиперчувствительности (включающие сыпь, крапивницу, отек) при приеме препаратов, содержащих
макрогол (полиэтиленгликоль). В исключительных случаях наблюдался анафилактический шок.
Из-за присутствия сорбитола, пациентам с врожденной непереносимостью фруктозы не следует принимать этот препарат.
Из-за присутствия серы диоксида в редких случаях возможно возникновение серьезных аллергических реакций и бронхоспазма.
Сообщалось о случаях аспирации, когда большой объем макрогола и электролитов вводился с помощью назогастрального зонда.
Дети с неврологическими нарушениями, у которых есть нарушение глотания, подвержены риску аспирации.
Влияние на способность управлять автомобилем и движущимися механизмами
Не влияет на способность управлять автотранспортом и механизмами.
Форма выпуска
Порошок для приготовления раствора для приема внутрь 10 г.
Условия хранения
При температуре не выше 30 °С, в недоступном для детей месте.
Срок годности
3 года.
Не использовать по истечении срока годности, указанного на упаковке.
Условия отпуска
Без рецепта
Производитель
ИПСЕН ФАРМА
Организация, принимающая претензии потребителей
ИПСЕН ФАРМА
Для описания товара использована информация от партнера 36.6
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(Е320)."}}]},{"id":5,"name":"Описание","slug":"common_description","body":[{"type":"paragraph","data":{"text":"Порошок белого или почти белого цвета с запахом апельсина и грейпфрута, легко растворимый в воде, с образованием белого полупрозрачного раствора."}}]},{"id":6,"name":"Фармакотерапевтическая группа","slug":"","body":[{"type":"paragraph","data":{"text":"Слабительное средство"}}]},{"id":7,"name":"Фармакологические свойства","slug":"pharmacologic_effects","body":[{"type":"header","data":{"text":"Фармакодинамика","level":3}},{"type":"paragraph","data":{"text":"Большая молекулярная масса макрогола 4000 обусловлена длинными линейными полимерами, которые удерживают молекулы воды посредством водородных связей."}},{"type":"paragraph","data":{"text":"Благодаря этому после перорального приема препарата увеличивается объем кишечного содержимого."}},{"type":"paragraph","data":{"text":"Объем неабсорбированной жидкости, находящейся в просвете кишечника, поддерживает слабительное действие раствора."}},{"type":"header","data":{"text":"Фармакокинетика","level":3}},{"type":"paragraph","data":{"text":"Фармакокинетические данные подтверждают, что"}},{"type":"paragraph","data":{"text":"макрогол 4000 не подвергается ни желудочно-кишечной резорбции, ни биотрасформации при пероральном приеме."}}]},{"id":8,"name":"Показания к применению","slug":"indications","body":[{"type":"paragraph","data":{"text":"Симптоматическое лечение запоров у взрослых и детей с 8 лет и старше."}}]},{"id":9,"name":"Противопоказания","slug":"contraindications","body":[{"type":"paragraph","data":{"text":"- серьезные воспалительные заболевания кишечника (язвенный колит, болезнь Крона) или токсическое расширение толстой кишки, сочетающееся с симптоматическим стенозом;"}},{"type":"paragraph","data":{"text":"- прободение или угроза прободения желудочно-кишечного тракта;"}},{"type":"paragraph","data":{"text":"- кишечная непроходимость или подозрение на кишечную непроходимость;"}},{"type":"paragraph","data":{"text":"- боли в животе неясной этиологии;"}},{"type":"paragraph","data":{"text":"- гиперчувствительность к макроголу (полиэтиленгликолю) или любому из компонентов препарата;"}},{"type":"paragraph","data":{"text":"- детский возраст до 8 лет."}}]},{"id":10,"name":"С осторожностью","slug":"cautions","body":[{"type":"paragraph","data":{"text":"Беременность"}},{"type":"paragraph","data":{"text":"Результаты исследований на животных показали, что"}},{"type":"paragraph","data":{"text":"Макрогол 4000 не обладает тератогенным эффектом."}},{"type":"paragraph","data":{"text":"Так как системное воздействие препарата Форлакс является незначительным, отрицательного воздействия на организм матери и плода не ожидается. Форлакс можно принимать во время беременности."}},{"type":"paragraph","data":{"text":"Лактация"}},{"type":"paragraph","data":{"text":"Системное воздействие макрогола 4000 на организм кормящих женщин является незначительным, поэтому отрицательного воздействия на организм новорожденного/младенца не ожидается. Форлакс можно принимать во время лактации."}}]},{"id":11,"name":"Применение при беременности и в период грудного вскармливания","slug":"pregnancy_warnings","body":[{"type":"paragraph","data":{"text":"Беременность"}},{"type":"paragraph","data":{"text":"Экспериментальные исследования на животных не показали ни прямых, ни косвенных вредных эффектов токсического действия на репродуктивную функцию."}},{"type":"paragraph","data":{"text":"Существует ограниченное количество данных (менее 300 исходов беременности) по использованию препарата Форлакс у беременных женщин."}},{"type":"paragraph","data":{"text":"Т.к. системное воздействие препарата Форлакс является незначительным, никакого воздействия на течение беременности не ожидается. Препарат Форлакс можно принимать при беременности."}},{"type":"paragraph","data":{"text":"Период грудного вскармливания"}},{"type":"paragraph","data":{"text":"Не существует данных об экскреции препарата Форлакс в грудное молоко."}},{"type":"paragraph","data":{"text":"Системное воздействие макрогола 4000 на организм кормящих женщин является незначительным, поэтому никакого воздействия на организм новорожденного/младенца не ожидается. Препарат Форлакс можно принимать в период грудного вскармливания."}},{"type":"paragraph","data":{"text":"Фертильность"}},{"type":"paragraph","data":{"text":"Исследования влияния препарата Форлакс на фертильность не проводились, однако, поскольку макрогол 4000 всасывается незначительно, его влияние на фертильность не ожидается."}}]},{"id":12,"name":"Способ применения и дозы","slug":"dosage","body":[{"type":"paragraph","data":{"text":"Внутрь, содержимое 1 - 2 пакетов (предпочтительно в виде однократного приема по утрам) или по 1 пакету (утром и вечером) в случае приема 2-х пакетов в день."}},{"type":"paragraph","data":{"text":"Ежедневная доза должна адаптироваться в соответствии с клиническим эффектом и может варьировать от 1 пакета каждый день (особенно у детей) до 2 пакетов в день."}},{"type":"paragraph","data":{"text":"Содержимое каждого пакета следует растворить в стакане воде непосредственно перед приемом."}},{"type":"paragraph","data":{"text":"Эффект от приема Форлакса® выражен в течение 24 - 48 часов после приема препарата."}},{"type":"paragraph","data":{"text":"Рекомендуемый курс лечения для детей и взрослых - 3 месяца."}},{"type":"paragraph","data":{"text":"У детей лечение не должно превышать 3 месяца в связи с недостаточностью клинических данных."}},{"type":"paragraph","data":{"text":"Поддержание эффекта после восстановления нормальной работы кишечника следует осуществлять с помощью активного образа жизни и диеты, богатой растительной клетчаткой."}},{"type":"paragraph","data":{"text":"Если симптомы запора сохраняются более 3-х месяцев, необходимо провести повторное расширенное диагностические обследование."}}]},{"id":13,"name":"Побочное действие","slug":"side_effects","body":[{"type":"paragraph","data":{"text":"У взрослых."}},{"type":"paragraph","data":{"text":"Побочные действия, наблюдаемые при проведении клинических исследований на 600 пациентах, имели транзиторный характер, наблюдались со следующей частотой и касались, в основном желудочно-кишечного тракта:"}},{"type":"paragraph","data":{"text":"- частые побочные действия (более 1/100, менее 1/10): вздутие живота и/или боль, тошнота, диарея;"}},{"type":"paragraph","data":{"text":"- редко встречающиеся побочные действия (более 1/1000, менее 1/100): рвота, неотложный позыв на дефекацию и недержание кала."}},{"type":"paragraph","data":{"text":"Дополнительная информация, полученная из постмаркетинговых наблюдений, включала: очень редко (менее 1/10000) случаи гиперчувствительности: кожный зуд, крапивница, преходящая (транзиторная) сыпь, отек лица, отек Квинке и отдельные случаи анафилактического шока."}},{"type":"paragraph","data":{"text":"Неизвестна частота возникновения диареи, приводящей к расстройству электролитного баланса (гипонатриемия, гипокалиемия) и/или обезвоживанию, особенно у взрослых пациентов."}},{"type":"paragraph","data":{"text":"У детей."}},{"type":"paragraph","data":{"text":"Побочные действия, касающиеся желудочно-кишечного тракта, были минимальны и носили преходящий характер в клинических исследованиях при участии 147 детей в возрасте от 6 месяцев до 15 лет, выявлялись со следующей частотой:"}},{"type":"paragraph","data":{"text":"Расстройства желудочно-кишечного тракта:"}},{"type":"paragraph","data":{"text":"- частые побочные действия (более 1/100, менее 1/10): диарея и абдоминальные боли,"}},{"type":"paragraph","data":{"text":"- редко встречающиеся побочные действия (более 1/1000, менее 1/100): метеоризм, тошнота и рвота."}},{"type":"paragraph","data":{"text":"- побочные действия, которые не могут быть оценены на основе имеющихся данных: реакции гиперчувствительности."}},{"type":"paragraph","data":{"text":"Диарея может быть причиной болезненных ощущений в перианальной области."}}]},{"id":14,"name":"Передозировка","slug":"overdose","body":[{"type":"paragraph","data":{"text":"Передозировка препарата приводит к диарее с последующим исчезновением после уменьшения дозы или прекращения лечения."}},{"type":"paragraph","data":{"text":"Избыточная потеря жидкости при диарее или рвоте может требовать коррекции электролитных нарушений."}}]},{"id":15,"name":"Взаимодействие с другими лекарственными средствами","slug":"drugs_interaction","body":[{"type":"paragraph","data":{"text":"Не описаны. Возможно замедление абсорбции лекарственных средств, принимаемых одновременно с Форлаксом. Поэтому рекомендуется назначать Форлакс спустя, по меньшей мере, 2 ч после назначения других препаратов."}}]},{"id":16,"name":"Особые указания","slug":"","body":[{"type":"paragraph","data":{"text":"Органические расстройства желудочно-кишечного тракта должны быть исключены до начала терапии."}},{"type":"paragraph","data":{"text":"Предупреждение."}},{"type":"paragraph","data":{"text":"Лечение запоров с помощью лекарственных препаратов рекомендовано только как вспомогательное средство к здоровому образу жизни и диете, например:"}},{"type":"paragraph","data":{"text":"- увеличение потребления жидкостей и клетчатки,"}},{"type":"paragraph","data":{"text":"- адекватная физическая активность, которая способствует восстановлению моторики пищеварительного тракта."}},{"type":"paragraph","data":{"text":"В случае развития диареи с особой осторожностью следует относиться к пациентам, предрасположенным к нарушению водно-электролитного баланса (например, у пожилых пациентов, у пациентов с нарушением функции печени или почек, или пациентов, принимающих диуретики) и необходимо проводить электролитный контроль."}},{"type":"paragraph","data":{"text":"Форлакс не содержит значительных количеств углеводов и/или полиолов (сахарных спиртов) и может применяться у больных сахарным диабетом или у пациентов, из рациона которых исключена"}},{"type":"paragraph","data":{"text":"галактоза."}},{"type":"paragraph","data":{"text":"Особые предупреждения."}},{"type":"paragraph","data":{"text":"Были зарегистрированы очень редкие случаи гиперчувствительности (включающие сыпь, крапивницу, отек) при приеме препаратов, содержащих"}},{"type":"paragraph","data":{"text":"макрогол (полиэтиленгликоль). 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