Фармакологическое действие — адаптогенное. Инструкция
Показания к применению
При расстройствах сна, в т.ч. обусловленных нарушением ритма «сон-бодрствование», таких как десинхроноз (резкая смена часовых поясов).
Противопоказания
Гиперчувствительность к компонентам препарата, аутоиммунные заболевания, печеночная недостаточность, тяжелая почечная недостаточность, детский возраст до 18 лет.
оболочка пленочная: Opadry 85F48105 II белый (в т.ч. поливиниловый спирт — 2,345 мг, макрогол (полиэтиленгликоль 4000) — 1,18 мг, тальк — 0,87 мг, титана диоксид — 0,605 мг) — 5 мг
Фармакотерапевтическая группа
Адаптогенное средство
Фармакологические свойства
Фармакологическое действие — адаптогенное.
Показания к применению
При расстройствах сна, в т.ч. обусловленных нарушением ритма «сон-бодрствование», таких как десинхроноз (резкая смена часовых поясов).
Противопоказания
Гиперчувствительность к компонентам препарата, аутоиммунные заболевания, печеночная недостаточность, тяжелая почечная недостаточность, детский возраст до 18 лет.
Способ применения и дозы
Внутрь.
При нарушении сна, десинхронозе — по 1 табл. 1 раз в сутки за 30–40 мин до сна.
При применении в качестве адаптогена при смене часовых поясов — за 1 день до перелета и в последующие 2–5 дней — по 1 табл. за 30–40 мин до сна. Максимальная суточная доза — 6 мг.
Пожилые пациенты. С возрастом происходит снижение метаболизма мелатонина, что необходимо учитывать при выборе режима дозирования для пожилых пациентов. С учетом этого у пациентов пожилого возраста, возможен прием препарата за 60–90 мин до сна.
Почечная недостаточность. Влияние различной степени почечной недостаточности на фармакокинетику мелатонина не изучено, поэтому таким пациентам мелатонин нужно применять с осторожностью. Пациентам с тяжелой почечной недостаточностью применение препарата не рекомендуется.
Побочное действие
Классификация частоты развития побочных эффектов согласно рекомендациям Всемирной Организации Здравоохранения:
очень часто (≥1/10), часто (от ≥1/100 до <1/10), нечасто (от ≥1/1000 до <1/100), редко (от ≥1/10000 до <1/1000), очень редко (<1/10000), включая отдельные сообщения; частота неизвестна (по имеющимся данным установить частоту возникновения не представляется возможным).
Инфекционные и паразитарные заболевания:
редко: опоясывающий герпес.
Нарушения со стороны крови и лимфатической системы:
редко: лейкопения, тромбоцитопения.
Нарушения со стороны иммунной системы:
частота неизвестна: реакции гиперчувствительности.
Нарушения со стороны скелетно-мышечной и соединительной ткани:
нечасто: боль в конечностях;
редко: артрит, мышечный спазм, боль в шее, ночные судороги.
Нарушения со стороны почек и мочевыводящих путей:
нечасто: глюкозурия, протеинурия;
редко: полиурия, гематурия, никтурия.
Нарушения со стороны половых органов и грудной железы:
нечасто: менопаузальные симптомы;
редко: приапизм, простатит;
частота неизвестна: галакторея.
Общие расстройства и нарушения в месте введения:
нечасто: астения, боль в груди;
редко: утомляемость, боль, жажда.
Лабораторные и инструментальные данные:
нечасто: отклонение от нормы лабораторных показателей функции печени, увеличение массы тела;
редко: повышение активности «печеночных» трансаминаз, отклонение от нормы содержания электролитов в крови, отклонение от нормы результатов лабораторных тестов.
Передозировка
По имеющимся литературным данным, применение мелатонина в суточной дозе до 300 мг не вызывало клинически значимых нежелательных реакций.
Наблюдались гиперемия, спазмы в брюшной полости, диарея, головная боль и скотома при применении мелатонина в дозах 3000 - 6600 мг в течение нескольких недель.
При применении очень высоких доз мелатонина (до 1 г) наблюдалась непроизвольная потеря сознания. При передозировке возможно развитие сонливости.
Лечение - промывание желудка и применение активированного угля, симптоматическая терапия. Клиренс активного вещества предполагается в пределах 12 часов после приема внутрь.
Особые указания
В период применения препарата Соннован® рекомендуется избегать пребывания на ярком свету.
Необходимо проинформировать женщин, желающих забеременеть, о наличии у препарата слабого контрацептивного действия.
Отсутствуют клинические данные о применении мелатонина у больных с аутоиммунными заболеваниями, в связи с чем, применение у данной категории пациентов не рекомендуется.
Влияние на способность управления транспортными средствами и механизмами
Препарат Соннован® вызывает сонливость, в связи с этим в период лечения следует воздержаться от вождения автотранспорта и занятий потенциально опасными видами деятельности, требующими повышенной концентрации внимания и быстроты психомоторных реакций.
Форма выпуска
Таблетки, покрытые пленочной оболочкой, 3 мг. По 2, 7, 10 или 30 табл. в контурной ячейковой упаковке из пленки ПВХ и фольги алюминиевой печатной лакированной. По 1, 2, 3 контурных ячейковых упаковки по 2, 7 или 10 табл. или по 1 контурной ячейковой упаковке по 30 табл. помещают в пачку из картона.
Срок годности
2 года
Условия отпуска
Без рецепта
Производитель
Канонфарма Продакшн, Российская Федерация
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Мобильное приложение «Все аптеки»
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