Сезонный или круглогодичный аллергический ринит (устранение или облегчение чихания, заложенности носа, выделения слизи из носа, зуда в носу, зуда неба, зуда и покраснения глаз, слезотечения);
крапивница (уменьшение или устранение кожного зуда, сыпи).
Противопоказания
повышенная чувствительность к дезлоратадину, лоратадину, а также любому из компонентов препарата;
беременность и период грудного вскармливания;
детский возраст до 12 лет.
Инструкция
Регистрационный номер
ЛП-005464
Торговое название препарата
Делорсин
Лекарственная форма
таблетки
Состав
Каждая таблетка содержит:
действующее вещество: дезлоратадин 5,00 мг;
вспомогательные вещества: целлюлоза микрокристаллическая (гранулированная), тип 102 – 89,45 мг, целлюлоза микрокристаллическая, тип 101 – 5,00 мг, карбоксиметилкрахмал натрия, тип А – 4,20 мг, магния стеарат – 1,20 мг, краситель железа оксид красный (Е 172) – 0,15 мг.
Описание
Круглые, двояковыпуклые таблетки розового цвета с риской на одной стороне таблетки. Фармакотерапевтическая группа:
Противоаллергическое средство – Н1-гистаминовых рецепторов блокатор.
Блокатор гистаминовых Н1-рецепторов (длительного действия). Является первичным активным метаболитом лоратадина. Ингибирует высвобождение гистамина и лейкотриена С4 из тучных клеток. Предупреждает развитие и облегчает течение аллергических реакций. Обладает противоаллергическим, противозудным и противоэкссудативным действием. Уменьшает проницаемость капилляров, предупреждает развитие отека тканей, снимает спазм гладкой мускулатуры. Практически не обладает седативным эффектом и при приеме в дозе 7.5 мг не влияет на скорость психомоторных реакций. В сравнительных исследованиях дезлоратадина и лоратадина качественных или количественных различий токсичности двух препаратов в сопоставимых дозах (с учетом концентрации дезлоратадина) не выявлено.
Показания к применению
Сезонный или круглогодичный аллергический ринит (устранение или облегчение чихания, заложенности носа, выделения слизи из носа, зуда в носу, зуда неба, зуда и покраснения глаз, слезотечения);
крапивница (уменьшение или устранение кожного зуда, сыпи).
Противопоказания
повышенная чувствительность к дезлоратадину, лоратадину, а также любому из компонентов препарата;
беременность и период грудного вскармливания;
детский возраст до 12 лет.
С осторожностью
тяжелая почечная недостаточность.
судороги в анамнезе
Применение при беременности и в период грудного вскармливания
Применение препарата при беременности противопоказано в связи с отсутствием клинических данных о безопасности применения дезлоратадина во время беременности. Дезлоратадин, активное вещество, выводится с грудным молоком, поэтому применение лекарственного препарата Делорсин во время кормления грудью противопоказано.
Способ применения и дозы
Для приема внутрь. Таблетку следует проглатывать целиком, не разжевывая, и запивать водой. Препарат желательно принимать регулярно в одно и тоже время суток, независимо от времени приема пищи.
Взрослым и подросткам от 12 лет – по 1 таблетке (5 мг) 1 раз в сутки.
При сезонном (интермиттирующем) аллергическом рините (при наличии симптомов продолжительностью менее 4 дней в неделю или менее 4 недель в году) необходимо оценивать течение заболевания. При исчезновении симптомов прием дезлоратадина следует прекратить, при повторном появлении симптомов прием препарата необходимо возобновить. При круглогодичном (персистирующем) аллергическом рините (при наличии симптомов продолжительностью более 4 дней в году) дезлоратадин следует принимать в течение всего периода экспозиции аллергена.
Если после лечения улучшения не наступает или симптомы усугубляются, или появляются новые симптомы, необходимо проконсультироваться с врачом.
Применяйте препарат только согласно тем показаниям, тому способу применения и в тех дозах, которые указаны в инструкции по применению.
Побочное действие
Наиболее часто встречающиеся побочные эффекты (≥1/100 до <1/10), частота которых была несколько выше, чем при приеме плацебо («пустышки»): повышенная утомляемость (1,2%), сухость во рту (0,8%) и головная боль (0,6%).
У детей в возрасте 12-17 лет по результатам клинических исследований наиболее часто встречающимся побочным эффектом являлась головная боль (5,9%), частота которой была не выше, чем при приеме плацебо (6,9%).
Информация о побочных эффектах представлена по результатам клинических исследований и наблюдений пострегистрационного периода.
По данным Всемирной организации здравоохранения (ВОЗ) побочные эффекты классифицированы в соответствии с их частотой развития следующим образом: 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), частота неизвестна (по имеющимся данным установить частоту возникновения не представляется возможным).
Нарушения со стороны психики:
очень редко – галлюцинации.
Нарушения со стороны нервной системы:
часто – головная боль;
очень редко – головокружение, сонливость, бессонница, психомоторная гиперактивность, судороги.
Нарушения со стороны печени и желчевыводящих путей:
очень редко – повышение активности ферментов печени, повышение концентрации билирубина, гепатит;
частота неизвестна – желтуха.
Нарушения со стороны пищеварительной системы:
часто – сухость во рту;
очень редко – боль в животе, тошнота, рвота, диспепсия, диарея.
Нарушения со стороны сердечно-сосудистой системы:
очень редко – тахикардия, сердцебиение;
частота неизвестна – удлинение интервала QT.
Нарушения со стороны опорно-двигательного аппарата:
очень редко – миалгия.
Нарушения со стороны кожи и подкожных тканей:
частота неизвестна – фотосенсибилизация.
Нарушения со стороны обмена веществ и питания:
частота неизвестна – повышение массы тела, повышение аппетита.
Общие расстройства:
часто – повышенная утомляемость;
очень редко – анафилаксия, ангионевротический отек, одышка, зуд, сыпь, в том числе крапивница;
Если любые из указанных в инструкции побочных эффектов усугубляются, или Вы заметили любые другие побочные эффекты, не указанные в инструкции, сообщите об этом врачу.
Передозировка
Симптомы. Прием дозы, превышающей рекомендованную в 5 раз, не приводил к появлению каких-либо симптомов. В ходе клинических испытаний ежедневное применение у взрослых и подростков дезлоратадина в дозе до 20 мг в течение 14 дней не сопровождалось статистически или клинически значимыми изменениями со стороны сердечно-сосудистой системы. В клинико-фармакологическом исследовании применение дезлоратадина в дозе 45 мг в сутки (в 9 раз выше рекомендуемой) в течение 10 дней не вызывало удлинения интервала QT и не сопровождалось появлением серьезных побочных эффектов.
Лечение. При случайном приеме внутрь большого количества препарата необходимо незамедлительно обратиться к врачу. Рекомендуется промывание желудка, прием активированного угля; при необходимости – симптоматическая терапия. Дезлоратадин не выводится при гемодиализе, эффективность перитонеального диализа не установлена.
Взаимодействие с другими лекарственными средствами
Не выявлено клинически-значимых взаимодействий в исследованиях при совместном применении с азитромицином, кетоконазолом, эритромицином, флуоксетином и циметидином. Одновременный прием пищи или употребление грейпфрутового сока не оказывает влияния на эффективность препарата.
Дезлоратадин не усиливает действие алкоголя на центральную нервную систему. Тем не менее, во время пострегистрационного применения были зарегистрированы случаи непереносимости алкоголя и алкогольного опьянения. Поэтому дезлоратадин одновременно с алкоголем следует применять с осторожностью.
Особые указания
Исследований эффективности лекарственного препарата при ринитах инфекционной этиологии не проводилось. Необходимо соблюдать осторожность при применении дезлоратадина у пациентов с судорогами в анамнезе, особенно у пациентов детского возраста. Следует прекратить применение дезлоратадина в случае развития судорог.
Влияние на способность управлять автомобилем и движущимися механизмами
Следует принимать во внимание потенциальную возможность развития таких побочных эффектов, как головокружение и сонливость. При появлении описанных нежелательных явлений следует воздержаться от вождения автотранспортных средств или управлению механизмами.
Форма выпуска
Таблетки 5 мг.
По 10 таблеток в оПА/Ал/ПВХ/Ал блистер. По 1, 2, 3, 5, 6, 9, 10 блистеров вместе с инструкцией по применению в картонной пачке.
Условия хранения
При температуре не выше 25 °С.
Хранить в недоступном для детей месте!
Срок годности
2 года.
Не применять по истечении срока годности.
Условия отпуска
Без рецепта.
Производитель
«Санека Фармасьютикалс а.с.»
Организация, принимающая претензии потребителей
ООО «Ксантис Фарма»
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Мобильное приложение «Все аптеки»
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Информация предоставляется в справочных целях. Не занимайтесь самолечением. При первых признаках заболевания обратитесь к врачу.
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номер","slug":"","body":[{"type":"paragraph","data":{"text":"ЛП-005464"}}]},{"id":2,"name":"Торговое название препарата","slug":"","body":[{"type":"paragraph","data":{"text":"Делорсин"}}]},{"id":3,"name":"Лекарственная форма","slug":"","body":[{"type":"paragraph","data":{"text":"таблетки"}}]},{"id":4,"name":"Состав","slug":"ingredients","body":[{"type":"paragraph","data":{"text":"\n\nКаждая таблетка содержит:"}},{"type":"paragraph","data":{"text":"действующее вещество: дезлоратадин 5,00 мг;"}},{"type":"paragraph","data":{"text":"вспомогательные вещества: целлюлоза микрокристаллическая (гранулированная), тип 102 – 89,45 мг, целлюлоза микрокристаллическая, тип 101 – 5,00 мг, карбоксиметилкрахмал натрия, тип А – 4,20 мг, магния стеарат – 1,20 мг, краситель железа оксид красный (Е 172) – 0,15 мг.\n\n"}}]},{"id":5,"name":"Описание","slug":"common_description","body":[{"type":"paragraph","data":{"text":"Круглые, двояковыпуклые таблетки розового цвета с риской на одной стороне таблетки. Фармакотерапевтическая группа:"}},{"type":"paragraph","data":{"text":"Противоаллергическое средство – Н1-гистаминовых рецепторов блокатор."}}]},{"id":6,"name":"Фармакотерапевтическая группа","slug":"","body":[{"type":"paragraph","data":{"text":"\u003ca href=\"https://www.vidal.ru/drugs/pharm-group/813\"\u003eПротивоаллергическое средство - H\u003csub\u003e1\u003c/sub\u003e-гистаминовых рецепторов блокатор\u003c/a\u003e"}}]},{"id":7,"name":"Фармакологические свойства","slug":"pharmacologic_effects","body":[{"type":"paragraph","data":{"text":" Блокатор гистаминовых Н\u003csub\u003e1\u003c/sub\u003e-рецепторов (длительного действия). Является первичным активным метаболитом лоратадина. Ингибирует высвобождение гистамина и лейкотриена С\u003csub\u003e4\u003c/sub\u003e из тучных клеток. Предупреждает развитие и облегчает течение аллергических реакций. Обладает противоаллергическим, противозудным и противоэкссудативным действием. Уменьшает проницаемость капилляров, предупреждает развитие отека тканей, снимает спазм гладкой мускулатуры. Практически не обладает седативным эффектом и при приеме в дозе 7.5 мг не влияет на скорость психомоторных реакций. В сравнительных исследованиях дезлоратадина и лоратадина качественных или количественных различий токсичности двух препаратов в сопоставимых дозах (с учетом концентрации дезлоратадина) не выявлено. "}}]},{"id":8,"name":"Показания к применению","slug":"indications","body":[{"type":"list","data":{"style":"ordered","items":["Сезонный или круглогодичный аллергический ринит (устранение или облегчение чихания, заложенности носа, выделения слизи из носа, зуда в носу, зуда неба, зуда и покраснения глаз, слезотечения);","крапивница (уменьшение или устранение кожного зуда, сыпи)."]}}]},{"id":9,"name":"Противопоказания","slug":"contraindications","body":[{"type":"list","data":{"style":"ordered","items":["повышенная чувствительность к дезлоратадину, лоратадину, а также любому из компонентов препарата;","беременность и период грудного вскармливания;","детский возраст до 12 лет."]}}]},{"id":10,"name":"С осторожностью","slug":"cautions","body":[{"type":"list","data":{"style":"ordered","items":["тяжелая почечная недостаточность.","судороги в анамнезе"]}}]},{"id":11,"name":"Применение при беременности и в период грудного вскармливания","slug":"pregnancy_warnings","body":[{"type":"paragraph","data":{"text":"Применение препарата при беременности противопоказано в связи с отсутствием клинических данных о безопасности применения дезлоратадина во время беременности. Дезлоратадин, активное вещество, выводится с грудным молоком, поэтому применение лекарственного препарата Делорсин во время кормления грудью противопоказано."}}]},{"id":12,"name":"Способ применения и дозы","slug":"dosage","body":[{"type":"paragraph","data":{"text":"\n\nДля приема внутрь. Таблетку следует проглатывать целиком, не разжевывая, и запивать водой. Препарат желательно принимать регулярно в одно и тоже время суток, независимо от времени приема пищи."}},{"type":"paragraph","data":{"text":"Взрослым и подросткам от 12 лет – по 1 таблетке (5 мг) 1 раз в сутки."}},{"type":"paragraph","data":{"text":"При сезонном (интермиттирующем) аллергическом рините (при наличии симптомов продолжительностью менее 4 дней в неделю или менее 4 недель в году) необходимо оценивать течение заболевания. При исчезновении симптомов прием дезлоратадина следует прекратить, при повторном появлении симптомов прием препарата необходимо возобновить. При круглогодичном (персистирующем) аллергическом рините (при наличии симптомов продолжительностью более 4 дней в году) дезлоратадин следует принимать в течение всего периода экспозиции аллергена."}},{"type":"paragraph","data":{"text":"Если после лечения улучшения не наступает или симптомы усугубляются, или появляются новые симптомы, необходимо проконсультироваться с врачом."}},{"type":"paragraph","data":{"text":"Применяйте препарат только согласно тем показаниям, тому способу применения и в тех дозах, которые указаны в инструкции по применению.\n\n"}}]},{"id":13,"name":"Побочное действие","slug":"side_effects","body":[{"type":"paragraph","data":{"text":"Наиболее часто встречающиеся побочные эффекты (≥1/100 до <1/10), частота которых была несколько выше, чем при приеме плацебо («пустышки»): повышенная утомляемость (1,2%), сухость во рту (0,8%) и головная боль (0,6%)."}},{"type":"paragraph","data":{"text":"У детей в возрасте 12-17 лет по результатам клинических исследований наиболее часто встречающимся побочным эффектом являлась головная боль (5,9%), частота которой была не выше, чем при приеме плацебо (6,9%)."}},{"type":"paragraph","data":{"text":"Информация о побочных эффектах представлена по результатам клинических исследований и наблюдений пострегистрационного периода."}},{"type":"paragraph","data":{"text":"По данным Всемирной организации здравоохранения (ВОЗ) побочные эффекты классифицированы в соответствии с их частотой развития следующим образом: 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), частота неизвестна (по имеющимся данным установить частоту возникновения не представляется возможным)."}},{"type":"paragraph","data":{"text":"Нарушения со стороны психики:"}},{"type":"paragraph","data":{"text":"очень редко – галлюцинации."}},{"type":"paragraph","data":{"text":"Нарушения со стороны нервной системы:"}},{"type":"paragraph","data":{"text":"часто – головная боль;"}},{"type":"paragraph","data":{"text":"очень редко – головокружение, сонливость, бессонница, психомоторная гиперактивность, судороги."}},{"type":"paragraph","data":{"text":"Нарушения со стороны печени и желчевыводящих путей:"}},{"type":"paragraph","data":{"text":"очень редко – повышение активности ферментов печени, повышение концентрации билирубина, гепатит;"}},{"type":"paragraph","data":{"text":"частота неизвестна – желтуха."}},{"type":"paragraph","data":{"text":"Нарушения со стороны пищеварительной системы:"}},{"type":"paragraph","data":{"text":"часто – сухость во рту;"}},{"type":"paragraph","data":{"text":"очень редко – боль в животе, тошнота, рвота, диспепсия, диарея."}},{"type":"paragraph","data":{"text":"Нарушения со стороны сердечно-сосудистой системы:"}},{"type":"paragraph","data":{"text":"очень редко – тахикардия, сердцебиение;"}},{"type":"paragraph","data":{"text":"частота неизвестна – удлинение интервала QT."}},{"type":"paragraph","data":{"text":"Нарушения со стороны опорно-двигательного аппарата:"}},{"type":"paragraph","data":{"text":"очень редко – миалгия."}},{"type":"paragraph","data":{"text":"Нарушения со стороны кожи и подкожных тканей:"}},{"type":"paragraph","data":{"text":"частота неизвестна – фотосенсибилизация."}},{"type":"paragraph","data":{"text":"Нарушения со стороны обмена веществ и питания:"}},{"type":"paragraph","data":{"text":"частота неизвестна – повышение массы тела, повышение аппетита."}},{"type":"paragraph","data":{"text":"Общие расстройства:"}},{"type":"paragraph","data":{"text":"часто – повышенная утомляемость;"}},{"type":"paragraph","data":{"text":"очень редко – анафилаксия, ангионевротический отек, одышка, зуд, сыпь, в том числе крапивница;"}},{"type":"paragraph","data":{"text":"Пострегистрационный период."}},{"type":"paragraph","data":{"text":"Дети:"}},{"type":"paragraph","data":{"text":"частота неизвестна – удлинение интервала QT, аритмия, брадикардия."}},{"type":"paragraph","data":{"text":"Если любые из указанных в инструкции побочных эффектов усугубляются, или Вы заметили любые другие побочные эффекты, не указанные в инструкции, сообщите об этом врачу."}}]},{"id":14,"name":"Передозировка","slug":"overdose","body":[{"type":"paragraph","data":{"text":"\n\nСимптомы. Прием дозы, превышающей рекомендованную в 5 раз, не приводил к появлению каких-либо симптомов. В ходе клинических испытаний ежедневное применение у взрослых и подростков дезлоратадина в дозе до 20 мг в течение 14 дней не сопровождалось статистически или клинически значимыми изменениями со стороны сердечно-сосудистой системы. В клинико-фармакологическом исследовании применение дезлоратадина в дозе 45 мг в сутки (в 9 раз выше рекомендуемой) в течение 10 дней не вызывало удлинения интервала QT и не сопровождалось появлением серьезных побочных эффектов."}},{"type":"paragraph","data":{"text":"Лечение. При случайном приеме внутрь большого количества препарата необходимо незамедлительно обратиться к врачу. Рекомендуется промывание желудка, прием активированного угля; при необходимости – симптоматическая терапия. Дезлоратадин не выводится при гемодиализе, эффективность перитонеального диализа не установлена.\n\n"}}]},{"id":15,"name":"Взаимодействие с другими лекарственными средствами","slug":"drugs_interaction","body":[{"type":"paragraph","data":{"text":"\n\nНе выявлено клинически-значимых взаимодействий в исследованиях при совместном применении с азитромицином, кетоконазолом, эритромицином, флуоксетином и циметидином. Одновременный прием пищи или употребление грейпфрутового сока не оказывает влияния на эффективность препарата."}},{"type":"paragraph","data":{"text":"Дезлоратадин не усиливает действие алкоголя на центральную нервную систему. Тем не менее, во время пострегистрационного применения были зарегистрированы случаи непереносимости алкоголя и алкогольного опьянения. Поэтому дезлоратадин одновременно с алкоголем следует применять с осторожностью.\n\n"}}]},{"id":16,"name":"Особые указания","slug":"","body":[{"type":"paragraph","data":{"text":"Исследований эффективности лекарственного препарата при ринитах инфекционной этиологии не проводилось. Необходимо соблюдать осторожность при применении дезлоратадина у пациентов с судорогами в анамнезе, особенно у пациентов детского возраста. Следует прекратить применение дезлоратадина в случае развития судорог."}}]},{"id":17,"name":"Влияние на способность управлять автомобилем и движущимися механизмами","slug":"","body":[{"type":"paragraph","data":{"text":"Следует принимать во внимание потенциальную возможность развития таких побочных эффектов, как головокружение и сонливость. При появлении описанных нежелательных явлений следует воздержаться от вождения автотранспортных средств или управлению механизмами."}}]},{"id":18,"name":"Форма выпуска","slug":"","body":[{"type":"paragraph","data":{"text":"\n\nТаблетки 5 мг."}},{"type":"paragraph","data":{"text":"По 10 таблеток в оПА/Ал/ПВХ/Ал блистер. По 1, 2, 3, 5, 6, 9, 10 блистеров вместе с инструкцией по применению в картонной пачке.\n\n"}}]},{"id":19,"name":"Условия хранения","slug":"storage","body":[{"type":"paragraph","data":{"text":"\n\nПри температуре не выше 25 °С."}},{"type":"paragraph","data":{"text":"Хранить в недоступном для детей месте!\n\n"}}]},{"id":20,"name":"Срок годности","slug":"expiry_date","body":[{"type":"paragraph","data":{"text":"\n\n2 года."}},{"type":"paragraph","data":{"text":"Не применять по истечении срока годности.\n\n"}}]},{"id":21,"name":"Условия отпуска","slug":"release_condition","body":[{"type":"paragraph","data":{"text":"Без рецепта."}}]},{"id":22,"name":"Производитель","slug":"","body":[{"type":"paragraph","data":{"text":"«Санека Фармасьютикалс а.с.»"}}]},{"id":23,"name":"Организация, принимающая претензии потребителей","body":[{"type":"paragraph","data":{"text":"ООО «Ксантис Фарма»"}}]}],"source":null},"description_toggle":false,"short_description":"Блокатор гистаминовых Н1-рецепторов (длительного действия). 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