ИНСТРУКЦИЯ
По применению лекарственного препарата
Регистрационный номер:
Торговое (патентованное) название препарата: фезам ® / Phezam ®
Лекарственная форма:
Состав:
Описание: капсулы — твердые, цилиндрические желатиновые капсулы белого цвета, № 0 .
Содержимое капсул — порошкообразная смесь, от белого до почти белого цвета, допускается наличие конгломератов, которые при надавливании стеклянной палочкой легко превращаются в порошок.
Фармакотерапевтическая группа:
Код ATX: N06BX
Фармакологическое действие:
фармакодинамика:
Комбинированное лекарственное средство с выраженным антигипоксическим, ноотропным и сосудорасширяющим эффектом.
Пирацетам активирует метаболические процессы в головном мозге посредством усиления энергетического и белкового обмена, ускорения утилизации глюкозы клетками и повышения их устойчивости к гипоксии; улучшает межнейрональную передачу в центральной нервной системе, улучшает регионарный кровоток в ишемизированной зоне.
Циннаризин — селективный блокатор медленных кальциевых каналов, ингибирует поступление в клетки ионов кальция и уменьшает их содержание в депо плазмолеммы, снижает тонус гладкой мускулатуры артериол, уменьшает их реакцию на биогенные сосудосуживающие вещества (эпинефрин, норэпинефрин, дофамин, ангиотензин, вазопрессин). Обладает сосудорасширяющим эффектом (особенно в отношении сосудов головного мозга, усиливая антигипоксическое действие пирацетама), не оказывая существенного влияния на артериальное давление. Проявляет умеренную антигистаминную активность, уменьшает возбудимость вестибулярного аппарата, понижает тонус симпатической нервной системы. Повышает эластичность мембран эритроцитов, их способность к деформации, снижает вязкость крови.
Фармакокинетика:
Препарат быстро и полностью всасывается в желудочно-кишечном тракте. Максимальная концентрация пирацетама в плазме создается через 2-6 часов. Максимальная концентрация в ликворе — через 2-8 часов. Биодоступность составляет 100%. С белками плазмы не связывается. Проникает во все органы и ткани, проходит плацентарный барьер. Избирательно накапливается в коре головного мозга, в основном, в лобных, теменных и затылочных долях, мозжечке и базальных ганглиях. Не метаболизируется. Через 30 часов более 95% выводится почками.
Максимальная концентрация циннаризина в плазме создается через 1-4 часа. С белками плазмы связывается на 91%. Активно и полностью метаболизируется. Период полувыведения составляет 4 часа. 1/3 метаболитов выводится с мочой, 2/3 — с фекалиями.
Показания к применению:
Противопоказания:
С осторожностью:
болезнь Паркинсона.
Способ применения и дозы:
Побочное действие:
Взаимодействие с другими лекарственными средствами:
Особые указания:
Вождение машин и робота с механизмами.
Во время лечения следует соблюдать осторожность при управлении транспортными средствами и работе с машинами и оборудованием.
Форма выпуска:
Условия хранения:
Срок годности:
Условия отпуска из аптек:
Производитель:
Представительство в Москве:
127051, Москва, ул. Трубная, д. 17/4, стр. 2
Фезам относится к группе ноотропных препаратов, которые улучшают мозговое кровообращение, обладают сосудорасширяющим и антигипоксическим действием.
Основные действующие вещества – пирацетам 400 мг и циннаризин 25 мг.
Пирацетам – ноотропное средство. Активирует метаболические процессы в головном мозге посредством усиления энергетического и белкового обмена, ускорения утилизации глюкозы клетками и повышения их устойчивости к гипоксии. Улучшает межнейрональную передачу в ЦНС и регионарный кровоток в ишемизированной зоне.
Циннаризин эффективно блокирует кальций в клетках и увеличивает стойкость стенок сосудов головного мозга к гипоксии. Проявляет умеренную антигистаминную активность, уменьшает возбудимость вестибулярного аппарата, повышает тонус симпатической нервной системы. Повышает эластичность мембран эритроцитов, их способность к деформации, снижает вязкость крови.
Быстро и полностью абсорбируется из ЖКТ. Сmах циннаризина в плазме достигается через 1-4 ч, Сmах пирацетама – через 2-6 ч. Биодоступность составляет 100%.
Связывание циннаризина с белками плазмы составляет 91%. Пирацетам не связывается с белками плазмы. Проникает во все органы и ткани, проникает через плацентарный барьер. Избирательно накапливается в коре головного мозга, в основном, в лобных, теменных и затылочных долях, мозжечке и базальных ганглиях.
После перорального приема абсорбция циннаризина медленная. Максимальная концентрация циннаризина в плазме создается через 1-4 часа. С белками плазмы связывается на 91%. Активно и полностью метаболизируется изоферментами печени CYP2D6 посредством дезалкилирования. Т1/2 составляет 4 часа. 1/3 метаболитов выводится почками, 2/3 — через кишечник.
Показания к применению
От чего помогает Фезам? Назначают препарат в случае диагностики следующих болезней или состояний:
- Недостаточность мозгового кровообращения (атеросклероз сосудов мозга, восстановительный период ишемического и геморрагического инсультов, черепно-мозговых травм, энцефалопатии различного генеза).
- Интоксикации.
- Другие заболевания ЦНС, сопровождающиеся снижением интеллектуально-мнестических функций (нарушения памяти, внимания, настроения).
- Психоорганический синдром с преобладанием признаков астении и адинамии, астенический синдром.
- Лабиринтопатии, синдром Меньера.
- Отставание интеллектуального развития у детей.
- Профилактика мигрени и кинетозов.
У детей от 8 лет Фезам применяют для терапии дизлексии в составе комплексного лечения (включая логопедию).
Инструкция по применению Фезам и дозировки
Принимают капсулы внутрь (перорально) после еды, не измельчая предварительно и запивая водой. Стандартные дозировки, согласно инструкции по применению Фезам:
- взрослым при нарушениях равновесия – по 1 капсуле 3 раза в сутки. Взрослым при болезни движения – по 1йкапсуле за 30 минут до прогулки, а затем каждые 6 часов при необходимости;
- взрослым при нарушениях мозгового кровообращения – по 1капсуле 3 раза в сутки;
- детям при дизлексии – по 1-2 капсулы 1 или 2 раза в день (зависит от степени тяжести нарушений) в течение 1-3 месяцев, но не более 3 месяцев подряд, при необходимости проводят 2-3 курса терапии в год.
- При одновременном применении с Фезам возможно усиление седативного действия средств, угнетающих деятельность ЦНС, а также этанола, ноотропных и гипотензивных средств.
- Во время применения недопустимо принимать алкогольные напитки.
- При проведении специальных тестов, препарат может давать ложные результаты на радиоактивный йод и допинг.
- При одновременном применении вазодилататоры усиливают действие препарата.
- Препарат улучшает переносимость антипсихотических лекарственных средств и трициклических антидепрессантов.
Побочные действия
Применение препарата вызывать следующие побочные действия:
- головная боль и головокружение;
- рвота, тошнота, диарея, диспепсия;
- нарушения координации, заторможенность и снижение психомоторных реакций;
- аллергические реакции – крапивница, зуд, отек Квинке, бронхоспазм, экзема, кожная сыпь.
При возникновении побочных эффектов прием рекомендуется прекратить и обратиться за консультацией к врачу.
Противопоказания
Гиперчувствительность к пирацетаму, циннаризину или к какому-либо из вспомогательных веществ, включенных в состав препарата. Другие противопоказания к назначению Фезам:
-
Тяжелая почечная (клиренс креатинина
4 отзывов к “Фезам”
Почему-то врачи рекомендуют (а должны выписывать на рецептурном бланке) именно Фезам .В ведь есть более дешевые аналоги – мемозам, ноозам…. К тому же это препарат с недоказанной терапевтической эффективностью
Из побочных эффектов могу четко заявить только один – Фезам у меня вызывал сонливость. Особенно тяжело было на работе, хотелось подремать хоть несколько минут.
Но через 2 месяца мне стало гораздо лучше, стала более стрессоустойчивой, перестали мучить тревожность и раздражительность, пропала постоянная зевота.
10 дней я принимаю Фезам, и вот голова стала светлее, память лучше, а главное, головокружение ушло!
Отличный препарат, у меня остеохондроз, частое головокружение. препарат мне помог уже через несколько дней, мне стало лучше, головокружение прошло, головные боли ушли, память даже улучшилась.
Фезам – двухкомпонентный препарат, относящийся к группе ноотропов. Обладает сосудорасширяющим и антигипоксическим действием. Основное назначение – улучшение кровообращения в головном мозге, улучшение метаболизма.
Доказана эффективность Фезама при лечения заболеваний головного мозга, мигрени и астенических состояний. В настоящее время выпускается болгарским производителем в единственной лекарственной форме – капсулы Фезам для приема внутрь.
Основные терапевтические свойства препарата:
– Активизирует метаболические процессы в головном мозге;
– Увеличивает устойчивость нейронов к гипоксии (кислородное голодание);
– Ускоряет скорость проведения электрического импульса нервных клеток;
– Улучшает способность к обучению и усвоению новой информации в больших объемах;
– Поддерживает работу мозга у пожилых людей, улучшает когнитивные способности;
– Стимулирует процессы кровообращения в организме;
– Способствует формированию новых нейронных цепей и связей, задействуя новые участки головного мозга.
Фезам, фото капсул
Фезам является комбинированным препаратом, каждая капсула содержит следующие активные компоненты:
Пирацетам – 400 мг;
Циннаризин – 25 мг.
Пирацетам относится к ноотропным средствам, которые направлены на активацию процессов метаболизма головного мозга, усиление обмена веществ, снижение риска возникновения гипоксии, улучшение работы центральной нервной системы.
Циннаризин – блокирует поступление ионов кальция в плазму, понижает тонус гладкой мускулатуры, не снижая артериального давления пациента. Циннаризин обладает легким антигистаминным эффектом, это вещество способно понижать возбудимость вестибулярного аппарата, а также повышать тонус симпатической нервной системы.
Активные действующие вещества Фезама направлены на повышение мозгового кровообращение и следовательно – улучшение памяти. Оба компонента взаимно потенцируют действие, направленное на снижение сопротивления сосудов, повышение стойкости нейроцитов в условиях ишемии.
Показания по применению Фезам
- атеросклероз сосудов головного мозга;
- инсульт;
- слабоумие;
- нарушения кровообращения;
- афазия вследствие патологии сосудов;
- мигрень различной этиологии;
- энцефалопатия различных типов;
- синдром Меньера;
- артериальная гипертония;
- нарушения зрения;
- астения.
Также показанием к Фезаму может быть интоксикация, заболевания ЦНС, которые сопровождаются снижением уровня памяти и внимания, а также колебаниями эмоционального фона. Часто инструкция к Фезаму предполагает его употребление при адинамии, лабиринтопатии (ощущение шума, звона, писка в ушах, головокружение, тошнота и рвота).
Имеются положительные отзывы о Фезаме как средстве борьбы с отставанием в интеллектуальном развитии детей, а также при профилактике морской болезни, кинетозов и мигреней.
Сочетание вазоактивного (циннаризин) и метаболического (пирацетам) компонентов препарата Фезам позволило в ряде клинических исследований применить препарат для повышения эффективности существующих методов лечения функциональных и органических поражений зрительно-нервного аппарата глаз у детей и с целью стабилизации достигнутых зрительных функций.
Инструкция по применению Фезам, дозировки
Согласно официальной аннотации к медикаменту, Фезам следует принимать взрослым по 2 капсулы 2-3 раза в сутки, а детям – по 1 капсуле 2 раза в сутки. Курс лечения – 1.5-3 мес.
Точная дозировка препарата и длительность терапии должны определяться только лечащим врачом по показаниям пациента.
При необходимости курсы лечения Фезамом повторяют 2-3 раза в год.
Особенности применения
Следует стараться всегда принимать капсулы Фезам в одно и то же время, например, каждый день в 9-00 утра, или ежедневно в 8-00 и 18-00, в зависимости от того, сколько раз в день рекомендовано пить препарат. Причем если человек пропустил прием в установленное время, то следует выпить капсулу немедленно, если не подошел следующий срок приема Фезама.
Специалисты категорически не советуют употреблять спиртные напитки любой крепости во время проведения терапии лекарственным средством.
Этанол, трициклические антидепрессанты, гипотензивные (снижающие давление) препараты, средства, угнетающие ЦНС, усиливают седативный эффект препарата.
Фезам не рекомендуется принимать на ночь – это грозит нарушением сна и бессонницей, а также совмещать с вождением автомобиля и выполнением работ повышенной внимательности из-за возможных побочных реакций со стороны ЦНС.
Побочные эффекты и противопоказания
Побочные эффекты могут проявляться в форме:
- различные нарушения пищеварения (диспесия): тошнота, тяжесть в животе, изжога, отрыжка, вздутие живота;
- нарушения координации, заторможенность, тремор конечностей и снижение психомоторных реакций;
- головная боль и головокружение;
- сбои в режиме сна и бодрствования;
- аллергическая реакция на препарат или его компоненты: кожная сыпь, зуд, чес, дерматит, крапивница др.
При длительном курсе лечения в единичных случаях может наблюдаться увеличение массы тела.
Передозировка
Случаи передозировки известны, однако здесь речь скорее идет о детском организме, поскольку юные пациенты становились крайне раздражительными. В таких ситуациях следует как можно быстрее вывести активные компоненты медикамента из организма.
Симптомы передозировки медикаментом у взрослых пациентов: возможна боль в животе.
Лечение: следует провести промывание желудка и вызвать рвоту, в дальнейшем показано проведение симптоматической терапии, при необходимости – гемодиализа. Специфического антидота нет.
Противопоказания
Лекарство Фезам не следует принимать в следующих случаях:
- почечная и печеночная недостаточность в тяжелой форме;
- психомоторное возбуждение в период назначения лекарственного средства;
- при хорее Гентингтона;
- в период беременности и лактации;
- в возрасте пациента до 5 лет;
- при высокой чувствительности к составляющим средства.
При заболевании Паркинсона, нарушении гемостаза, тяжелом кровотечении, нарушении работы почек или печени, лекарство назначается с осторожностью и только после тщательного обследования.
Аналоги Фезам, список препаратов
Аналоги препарата по сфере применения и медицинским показателям:
- Комбитропил;
- НооКам;
- Омарон;
- Кавинтон;
- Ноозам;
- Мемозам;
- Эвризам;
- Пирацезин;
- Аминалон;
- Биотропил;
- Бравинтон;
- Вазавитал;
- Луцетам;
- Когнифен.
Важно – инструкция по применению Фезам, цена и отзывы к аналогам не относятся и не могут применяться как руководство по применению препаратов схожего состава или действия. Все терапевтические назначения должен делать врач. При замене Фезам на аналог важно получить консультацию специалиста, возможно потребуется изменение курса терапии, дозировок и др. Не занимайтесь самолечением!
Следует отметить, что Фезам всасывается в организме значительно быстрее, чем аналоги лекарственного средства. Несмотря на относительную безопасность данных лекарственных препаратов, предварительная консультация с врачом является обязательным критерием для проведения успешного лечения.
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