Bristaflam таблетки инструкция по применению на русском - Инструкции, руководства, мануалы

Торговое название:

Бристафлам
Bristaflam

Состав:

Каждая таблетка содержит:

Ацеклофенак – 100 мг

Вспомогательные компоненты:

Целлюлоза микрокристаллическая, кроскармеллоза натрия, повидон К30, натрия стеарила фумарат.

Свойства:

НПВС, производное фенилуксусной кислоты. Оказывает противовоспалительное, анальгезирующее и жаропонижающее действие, что обусловлено ингибированием ЦОГ-1 и ЦОГ-2 и угнетением синтеза простагландинов.

При ревматических заболеваниях противовоспалительное и анальгезирующее действие ацеклофенака способствует значительному уменьшению выраженности боли, утренней скованности, припухлости суставов, что улучшает двигательную активность пациента.

Показания:

Cимптоматическое лечение заболеваний опорно-двигательного аппарата, в т.ч.: ревматоидный артрит; остеоартроз; анкилозирующий спондилит.

Для купирования воспаления и болевого синдрома: люмбаго; плечелопаточный периартрит; ревматическое поражение мягких тканей; зубная боль.

Способ применения и дозы:

Оптимальный режим дозирования определяет врач. Следует строго соблюдать соответствие используемой лекарственной формы конкретного препарата показаниям к применению и режиму дозирования.
Ацеклофенак предназначен для симптоматической терапии, уменьшения боли и воспаления на момент использования, на регрессирование заболевания не влияет.
Для снижения риска развития нежелательных явлений ацеклофенак следует использовать в минимальной эффективной дозе минимально возможным коротким курсом.
Для приема внутрь – по 100 мг 2 раза/сут утром и вечером.
Продолжительность терапии без назначения врача составляет не более 7 дней.

Противопоказания:

Повышенная чувствительность к ацеклофенаку и другим НПВС; “аспириновая триада” (сочетание бронхиальной астмы, рецидивирующего полипоза носа и околоносовых пазух и непереносимости ацетилсалициловой кислоты и препаратов пиразолонового ряда);
эрозивно-язвенные поражения ЖКТ (в фазе обострения);
желудочно-кишечное кровотечение или подозрение на него;
воспалительные заболевания кишечника;
тяжелая почечная недостаточность (КК <30 мл/мин);
прогрессирующие заболевания почек; активное заболевание печени;
заболевания щитовидной железы;
подтвержденная гиперкалиемия;
острый инфаркт миокарда;
период после проведения аортокоронарного шунтирования;
артериальная гипотензия;
артериальная гипертензия;
острые нарушения мозгового кровообращения (ишемический, геморрагический инсульт);
нарушения кроветворения и заболевания крови (лейкопения, в т.ч. в анамнезе, тромбоцитопения, гемофилия);
выраженная миопатия, тяжелая миастения;
беременность;
период лактации (грудного вскармливания);
детский и подростковый возраст до 18 лет.

Меры предосторожности:

С осторожностью применять при заболеваниях печени, почек и ЖКТ в анамнезе, бронхиальной астме, артериальной гипертензии, ИБС, указаниях в анамнезе на развитие язвенного поражения ЖКТ, при наличии инфекции Helicobacter pylori, при цереброваскулярных заболеваниях, дислипидемии/гиперлипидемии, сахарном диабете, заболеваниях периферических артерий, у курящих, у пациентов пожилого возраста, при длительном приеме НПВС, при частом употреблении алкоголя, при тяжелых соматических заболеваниях.

Побочные эффекты:

Со стороны нервной системы: часто – головокружение; очень редко – парестезия, тремор, сонливость, головная боль, дисгевзия (извращение вкуса).
Со стороны пищеварительной системы: часто – диспепсия, боль в животе, тошнота, диарея; нечасто – метеоризм, гастрит, запор, рвота, язвенный стоматит; редко – мелена, образование язв желудка и кишечника, геморрагическая диарея, желудочно-кишечное кровотечение; очень редко – стоматит, рвота кровью, прободение кишечника, обострение болезни Крона и язвенного колита, панкреатит.
Со стороны печени и желчевыводящих путей: часто – повышение активности ферментов печени; очень редко – заболевание печени (включая гепатит), увеличение активности ЩФ.

Способ хранения:

При температуре не выше 30°С в сухом месте.

Упаковка:

Картонная коробка вмещает 1 или 2 блистера по 10 таблеток, бумажную инструкцию.

Источник

Торговое название:

Бристафлам

Bristaflam

Состав:

Каждая таблетка содержит:

Ацеклофенак 100 мг

Вспомогательные компоненты:

целлюлоза микрокристаллическая , кроскармеллоза натрия , повидон К30 , натрия стеарила фумарат .

Свойства:

Показания:

Способ применения и дозы:

Оптимальный режим дозирования определяет врач. Следует строго соблюдать соответствие используемой лекарственной формы конкретного препарата показаниям к применению и режиму дозирования.

Ацеклофенак предназначен для симптоматической терапии, уменьшения боли и воспаления на момент использования, на регрессирование заболевания не влияет.

Для снижения риска развития нежелательных явлений ацеклофенак следует использовать в минимальной эффективной дозе минимально возможным коротким курсом.

Для приема внутрь — по 100 мг 2 раза/сут утром и вечером.

Продолжительность терапии без назначения врача составляет не более 7 дней.

Противопоказания:

Повышенная чувствительность к ацеклофенаку и другим НПВС; «аспириновая триада» (сочетание бронхиальной астмы, рецидивирующего полипоза носа и околоносовых пазух и непереносимости ацетилсалициловой кислоты и препаратов пиразолонового ряда); эрозивно-язвенные поражения ЖКТ (в фазе обострения); желудочно-кишечное кровотечение или подозрение на него; воспалительные заболевания кишечника; тяжелая почечная недостаточность (КК <30 мл/мин); прогрессирующие заболевания почек; активное заболевание печени; заболевания щитовидной железы; подтвержденная гиперкалиемия; острый инфаркт миокарда; период после проведения аортокоронарного шунтирования; артериальная гипотензия; артериальная гипертензия; острые нарушения мозгового кровообращения (ишемический, геморрагический инсульт); нарушения кроветворения и заболевания крови (лейкопения, в т.ч. в анамнезе, тромбоцитопения, гемофилия); выраженная миопатия, тяжелая миастения; беременность; период лактации (грудного вскармливания); детский и подростковый возраст до 18 лет.

Меры предосторожности:

Побочные эффекты:

Со стороны нервной системы: часто — головокружение; очень редко — парестезия, тремор, сонливость, головная боль, дисгевзия (извращение вкуса).

Со стороны пищеварительной системы: часто — диспепсия, боль в животе, тошнота, диарея; нечасто — метеоризм, гастрит, запор, рвота, язвенный стоматит; редко — мелена, образование язв желудка и кишечника, геморрагическая диарея, желудочно-кишечное кровотечение; очень редко — стоматит, рвота кровью, прободение кишечника, обострение болезни Крона и язвенного колита, панкреатит.

Со стороны печени и желчевыводящих путей: часто — повышение активности ферментов печени; очень редко — заболевание печени (включая гепатит), увеличение активности ЩФ.

Способ хранения:

При температуре не выше 30 градусов. В сухом месте.

Упаковка:

Картонная коробка вмещает 1 или 2 блистера по 10 таблеток, бумажную инструкцию.

Источник

Торговое название:

Бристафлам

Bristaflam

Состав:

Каждая таблетка содержит:

Ацеклофенак 100 мг

Вспомогательные компоненты:

микрокристаллическая целлюлоза, кроскармеллоза натрия, повидон К30, стеарилфумарат натрия.

Свойства:

НПВП, производное фенилуксусной кислоты. Он обладает противовоспалительным, обезболивающим и жаропонижающим действием, что обусловлено ингибированием ЦОГ-1 и ЦОГ-2 и ингибированием синтеза простагландинов.

При ревматических заболеваниях противовоспалительное и обезболивающее действие ацеклофенака способствует значительному уменьшению выраженности болей, утренней скованности, припухлости суставов, что улучшает двигательную активность пациента.

Показания:

Cимптоматическое лечение заболеваний опорно-двигательного аппарата, в т. ч. : ревматоидный артрит; остеоартроз; анкилозирующий спондилит.

Способ применения и дозы:

Для приема внутрь — по 100 мг 2 раза/сут утром и вечером.

Продолжительность терапии без назначения врача составляет не более 7 дней.

Противопоказания:

Повышенная чувствительность к ацеклофенаку и другим НПВС; «аспириновая триада» (сочетание бронхиальной астмы, рецидивирующего полипоза носа и околоносовых пазух и непереносимости ацетилсалициловой кислоты и препаратов пиразолонового ряда); эрозивно-язвенные поражения ЖКТ (в фазе обострения); желудочно-кишечное кровотечение или подозрение на него; воспалительные заболевания кишечника; тяжелая почечная недостаточность (КК <30 мл/мин); прогрессирующие заболевания почек; активное заболевание печени; заболевания щитовидной железы; подтвержденная гиперкалиемия; острый инфаркт миокарда; период после проведения аортокоронарного шунтирования; артериальная гипотензия; артериальная гипертензия; острые нарушения мозгового кровообращения (ишемический, геморрагический инсульт); нарушения кроветворения и заболевания крови (лейкопения, в т. ч. в анамнезе, тромбоцитопения, гемофилия); выраженная миопатия, тяжелая миастения; беременность; период лактации (грудного вскармливания); детский и подростковый возраст до 18 лет.

Меры предосторожности:

Побочные эффекты:

Со стороны пищеварительной системы: часто — диспепсия, боли в животе, тошнота, диарея; нечасто — метеоризм, гастрит, запор, рвота, язвенный стоматит; редко — мелена, образование язв желудка и кишечника, геморрагическая диарея, желудочно-кишечные кровотечения; очень редко — стоматит, рвота кровью, перфорация кишечника, обострение болезни Крона и язвенного колита, панкреатит.

Со стороны печени и желчевыводящих путей: часто — повышение активности печеночных ферментов; очень редко — заболевания печени (в том числе гепатит), повышение активности щелочной фосфатазы.

Способ хранения:

Хранить при температуре не выше 30 градусов. В сухом месте.

Упаковка:

Картонная коробка содержит 2 блистера по 10 таблеток, бумажную инструкцию.

Источник

Bristaflam - изображение 0

Состав:

Применение:

Применяется при лечении:

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Топ 20 лекарств с такими-же компонентами:

Топ 20 лекарств с таким-же применением:

Предоставленная в разделе Bristaflamинформация составлена на основе данных о другом лекарстве с точно таким же составом как лекарство Bristaflam. Будьте
внимательны и обязательно уточняйте информацию по разделу в инструкции к лекарству Bristaflam непосредственно из упаковки или у фармацевта в аптеке.

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Bristaflam

Состав

Предоставленная в разделе Состав Bristaflamинформация составлена на основе данных о другом лекарстве с точно таким же составом как лекарство Bristaflam. Будьте
внимательны и обязательно уточняйте информацию по разделу Состав
в инструкции к лекарству Bristaflam непосредственно из упаковки или у фармацевта в аптеке.

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Aceclofenac

Терапевтические показания

Предоставленная в разделе Терапевтические показания Bristaflamинформация составлена на основе данных о другом лекарстве с точно таким же составом как лекарство Bristaflam. Будьте
внимательны и обязательно уточняйте информацию по разделу Терапевтические показания
в инструкции к лекарству Bristaflam непосредственно из упаковки или у фармацевта в аптеке.

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Крем для наружного применения; Таблетки, покрытые пленочной оболочкой; Порошок для пероральной суспензии; Порошок для приготовления суспензии для приема внутрь

Порошок для суспензии; Таблетка

лечение местной боли вследствие травматических повреждений и воспалительных заболеваний опорно-двигательного аппарата, в т.ч. спортивных травм;

уменьшение воспаления сухожилий, связок, мышц и суставов в случаях растяжения, перенапряжения или ушибов, а также лечение люмбаго, кривошеи и периартрита.

Способ применения и дозы

Предоставленная в разделе Способ применения и дозы Bristaflamинформация составлена на основе данных о другом лекарстве с точно таким же составом как лекарство Bristaflam. Будьте
внимательны и обязательно уточняйте информацию по разделу Способ применения и дозы
в инструкции к лекарству Bristaflam непосредственно из упаковки или у фармацевта в аптеке.

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Порошок для суспензии; Таблетка

Местно.

Крем Аэртал^® предназначен только для наружного применения и не должен наноситься под окклюзионные повязки.

Крем Аэртал^® следует наносить легкими массирующими движениями на пораженный участок 3 раза в день. Применяемая доза зависит от размера пораженного участка: 1,5–2 г крема Аэртал^® (приблизительно соответствует полоске крема длиной 5–7 см).

Особые группы пациентов

Дети. Опыт применения крема Аэртал^® у детей отсутствует, поэтому крем Аэртал^® противопоказан к применению у детей.

Пожилой возраст. Коррекция режима дозирования у лиц пожилого возраста не требуется.

Местно.

Крем Bristaflam^® предназначен только для наружного применения и не должен наноситься под окклюзионные повязки.

Крем Bristaflam^® следует наносить легкими массирующими движениями на пораженный участок 3 раза в день. Применяемая доза зависит от размера пораженного участка: 1,5–2 г крема Bristaflam^® (приблизительно соответствует полоске крема длиной 5–7 см).

Особые группы пациентов

Дети. Опыт применения крема Bristaflam^® у детей отсутствует, поэтому крем Bristaflam^® противопоказан к применению у детей.

Пожилой возраст. Коррекция режима дозирования у лиц пожилого возраста не требуется.

Противопоказания

Предоставленная в разделе Противопоказания Bristaflamинформация составлена на основе данных о другом лекарстве с точно таким же составом как лекарство Bristaflam. Будьте
внимательны и обязательно уточняйте информацию по разделу Противопоказания
в инструкции к лекарству Bristaflam непосредственно из упаковки или у фармацевта в аптеке.

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повышенная чувствительность к ацеклофенаку или каким-либо из вспомогательных веществ;

наличие в прошлом непереносимости НПВП, в т.ч. диклофенака;

наличие в прошлом приступов бронхиальной астмы, уртикарной сыпи или острого ринита на фоне приема ацетилсалициловой кислоты или других НПВП;

наличие инфекции, вызванной вирусом варицелла-зостер;

нарушение целостности кожных покровов в предполагаемом месте нанесения;

беременность;

детский возраст до 18 лет.

С осторожностью: печеночная порфирия (обострение); эрозивно-язвенные поражения ЖКТ (в фазе обострения); тяжелые нарушения функции печени и почек; хроническая сердечная недостаточность; бронхиальная астма; крапивница или острый ринит, спровоцированные приемом АСК или других НПВП; нарушения свертываемости крови (в т.ч. гемофилия, удлинение времени кровотечения, склонность к кровотечениям); пожилой возраст; период лактации.

Побочные эффекты

Предоставленная в разделе Побочные эффекты Bristaflamинформация составлена на основе данных о другом лекарстве с точно таким же составом как лекарство Bristaflam. Будьте
внимательны и обязательно уточняйте информацию по разделу Побочные эффекты
в инструкции к лекарству Bristaflam непосредственно из упаковки или у фармацевта в аптеке.

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Ниже представлены нежелательные явления, информация о которых была получена в клинических исследованиях и в ходе постмаркетингового наблюдения; нежелательные явления сгруппированы в соответствии с классами систем органов согласно MedDRA и частотой возникновения: 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).

Общие расстройства и нарушения в месте введения: нечасто — реакция фоточувствительности, эритема, кожный зуд; редко — раздражение кожи; очень редко — буллезные реакции (в т.ч. синдром Стивенса-Джонсона и токсический эпидермальный некролиз).

Известны очень редкие сообщения о тяжелых кожных реакциях, иногда приводящих к смерти, включающие эксфолиативный дерматит, синдром Стивенса-Джонсона и токсический эпидермальный некролиз, связанные с применением НПВП.

Передозировка

Предоставленная в разделе Передозировка Bristaflamинформация составлена на основе данных о другом лекарстве с точно таким же составом как лекарство Bristaflam. Будьте
внимательны и обязательно уточняйте информацию по разделу Передозировка
в инструкции к лекарству Bristaflam непосредственно из упаковки или у фармацевта в аптеке.

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Случаи передозировки ацеклофенака неизвестны. Точные симптомы передозировки ацеклофенака неизвестны.

Симптомы: в случае неправильного применения или случайного проглатывания могут развиваться артериальная гипотензия, почечная недостаточность, судороги, раздражение слизистой оболочки ЖКТ, а также угнетение дыхания.

Лечение: симптоматическая и поддерживающая терапия. Следует как можно скорее предотвратить всасывание препарата путем промывания желудка и назначения активированного угля. Форсированный диурез или гемоперфузия неэффективны вследствие высокой степени связывания ацеклофенака с белками плазмы крови и его интенсивным метаболизмом.

Фармакодинамика

Предоставленная в разделе Фармакодинамика Bristaflamинформация составлена на основе данных о другом лекарстве с точно таким же составом как лекарство Bristaflam. Будьте
внимательны и обязательно уточняйте информацию по разделу Фармакодинамика
в инструкции к лекарству Bristaflam непосредственно из упаковки или у фармацевта в аптеке.

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Порошок для суспензии; Таблетка

Ацеклофенак представляет собой НПВП, обладающее противовоспалительным и анальгезирующим действием. Препарат подавляет развитие отека и эритемы независимо от этиологии воспаления. Ацеклофенак подавляет образование ПГ и ЛТ за счет обратимого подавления ЦОГ-1 и ЦОГ-2.

Установленная клиническая эффективность препарата дополняется хорошей переносимостью.

Применение крема Аэртал^® целесообразно у пациентов с травматическими повреждениями или воспалительными заболеваниями опорно-двигательного аппарата.

Установленная клиническая эффективность препарата дополняется хорошей переносимостью.

Применение крема Bristaflam^® целесообразно у пациентов с травматическими повреждениями или воспалительными заболеваниями опорно-двигательного аппарата.

Фармакокинетика

Предоставленная в разделе Фармакокинетика Bristaflamинформация составлена на основе данных о другом лекарстве с точно таким же составом как лекарство Bristaflam. Будьте
внимательны и обязательно уточняйте информацию по разделу Фармакокинетика
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Всасывание. После нанесения ацеклофенак всасывается из зоны нанесения, быстро достигая насыщения. Он накапливается в зоне всасывания, что способствует увеличению противовоспалительной активности, и постепенно поступает в системный кровоток в небольших количествах, в связи с чем риск побочного действия, в т.ч. на ЖКТ, минимизируется.

Распределение. Ацеклофенак распределяется по всему организму.

Выведение. Ацеклофенак метаболизируется в печени и выводится медленно почками и через кишечник, частично в неизмененном виде.

Взаимодействие

Предоставленная в разделе Взаимодействие Bristaflamинформация составлена на основе данных о другом лекарстве с точно таким же составом как лекарство Bristaflam. Будьте
внимательны и обязательно уточняйте информацию по разделу Взаимодействие
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Несмотря на отсутствие данных о возможных взаимодействиях ацеклофенака с другими препаратами, необходимо соблюдать осторожность при назначении его пациентам, принимающим другие лекарственные препараты, в особенности те, в состав которых входят литий, дигоксин.

Также следует соблюдать осторожность при сопутствующей терапии антикоагулянтами, диуретиками или другими обезболивающими препаратами.

Фармокологическая группа

Предоставленная в разделе Фармокологическая группа Bristaflamинформация составлена на основе данных о другом лекарстве с точно таким же составом как лекарство Bristaflam. Будьте
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Нестероидный противовоспалительный препарат (НПВП) [НПВС — Производные уксусной кислоты и родственные соединения]

Bristaflam цена

У нас нет точных данных по стоимости лекарства.
Однако мы предоставим данные по каждому действующему веществу

Средняя стоимость Aceclofenac 100 mg за единицу в онлайн аптеках от 0.3$ до 0.55$, за упаковку от 23$ до 39$.

Источники:

https://www.drugs.com/search.php?searchterm=bristaflam
https://pubmed.ncbi.nlm.nih.gov/?term=bristaflam

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The information provided in of Bristaflam
is based on data of another medicine with exactly the same composition as the Bristaflam.
. Be careful and be sure to specify the information on the section in the instructions to the drug Bristaflam directly from the package or from the pharmacist at the pharmacy.

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Bristaflam

Qualitative and quantitative composition

The information provided in Qualitative and quantitative composition of Bristaflam
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. Be careful and be sure to specify the information on the section Qualitative and quantitative composition in the instructions to the drug Bristaflam directly from the package or from the pharmacist at the pharmacy.

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Aceclofenac

Therapeutic indications

The information provided in Therapeutic indications of Bristaflam
is based on data of another medicine with exactly the same composition as the Bristaflam.
. Be careful and be sure to specify the information on the section Therapeutic indications in the instructions to the drug Bristaflam directly from the package or from the pharmacist at the pharmacy.

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Bristaflam film-coated tablets are indicated for the relief of pain and inflammation in osteoarthritis, rheumatoid arthritis and ankylosing spondylitis.

Dosage (Posology) and method of administration

The information provided in Dosage (Posology) and method of administration of Bristaflam
is based on data of another medicine with exactly the same composition as the Bristaflam.
. Be careful and be sure to specify the information on the section Dosage (Posology) and method of administration in the instructions to the drug Bristaflam directly from the package or from the pharmacist at the pharmacy.

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Bristaflam film-coated tablets are supplied for oral administration and should be swallowed whole with a sufficient quantity of liquid.

To be taken preferably with or after food. When Bristaflam was administered to fasting and fed healthy volunteers only the rate and not the extent of Bristaflam absorption was affected.

Undesirable effects may be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms.

Adults

The recommended dose is 200 mg daily, taken as two separate 100 mg doses, one tablet in the morning and one in the evening.

Paediatric population

There are no clinical data on the use of Bristaflam in children and therefore it is not recommended for use in children under 18 years of age.

Elderly

The elderly, who are more likely to be suffering from impaired renal, cardiovascular or hepatic function and receiving concomitant medication, are at increased risk of serious consequences of adverse reactions. If an NSAID is considered necessary, the lowest effective dose should be used and for the shortest possible duration. The patient should be monitored regularly for GI bleeding during NSAID therapy.

The pharmacokinetics of Bristaflam are not altered in elderly patients, therefore it is not considered necessary to modify the dose or dose frequency.

Renal insufficiency

There is no evidence that the dosage of Bristaflam needs to be modified in patients with mild renal impairment, but as with other NSAIDs caution should be exercised.

Hepatic insufficiency

There is some evidence that the dose of Bristaflam should be reduced in patients with hepatic impairment and it is suggested that an initial daily dose of 100 mg be used.

Method of administration

Swallow the tablet whole with a glass of water. Do not crush or chew the tablets. Never change the dose of your medicine without talking to your doctor first. Continue to take your tablets for as long as your doctor recommends.

Contraindications

The information provided in Contraindications of Bristaflam
is based on data of another medicine with exactly the same composition as the Bristaflam.
. Be careful and be sure to specify the information on the section Contraindications in the instructions to the drug Bristaflam directly from the package or from the pharmacist at the pharmacy.

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Hypersensitivity to Bristaflam or to any of the excipients.

Active, or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding).

History of active bleedings or bleeding disorders

NSAIDS are contraindicated in patients who have previously shown hypersensitivity reactions (e.g. Asthma, rhinitis, angioedema or urticaria) in response to ibuprofen, aspirin, or other non-steroidal anti-inflammatory drugs.

Patients with established congestive heart failure (NYHA class II-IV), ischaemic heart disease, peripheral arterial disease and/or cerebrovascular disease.

Severe heart failure, hepatic failure and renal failure.

History of gastrointestinal bleeding or perforation, related to previous NSAIDS therapy.

Bristaflam should not be prescribed during pregnancy, especially during the last trimester of pregnancy, unless there are compelling reasons for doing so. The lowest effective dosage should be used.

Special warnings and precautions for use

The information provided in Special warnings and precautions for use of Bristaflam
is based on data of another medicine with exactly the same composition as the Bristaflam.
. Be careful and be sure to specify the information on the section Special warnings and precautions for use in the instructions to the drug Bristaflam directly from the package or from the pharmacist at the pharmacy.

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The use of Bristaflam with concomitant NSAIDs including cyclooxygenase- 2 selective inhibitors should be avoided.

Elderly:

The elderly have an increased frequency of adverse reactions to NSAIDs especially gastrointestinal bleeding and perforation which may be fatal.

Respiratory disorders:

Caution is required if administered to patients suffering from, or with a previous history of, bronchial asthma since NSAIDs have been reported to precipitate bronchospasm in such patients.

Cardiovascular, Renal and Hepatic Impairment:

The administration of an NSAID may cause a dose dependent reduction in prostaglandin formation and precipitate renal failure.).

Renal:

The administration of an NSAID may cause a dose dependent reduction in prostaglandin formation and precipitate renal failure. The importance of prostaglandins in maintaining renal blood flow should be taken into account in patients with impaired cardiac or renal function, liver dysfunction, those being treated with diuretics or recovering from major surgery. Effects on renal function are usually reversible on withdrawal of Bristaflam Tablets.

Patients with mild to moderate renal impairment should be kept under surveillance, since the use of NSAIDs may result in deterioration of renal function. The lowest effective dose should be used and renal function monitored regularly. Effects on renal function are usually reversible on withdrawal of Bristaflam.

Hepatic:

If abnormal liver function tests persist or worsen, clinical signs or symptoms consistent with liver disease develop or if other manifestations occur (eosinophilia, rash), Bristaflam Tablets should be discontinued. Close medical surveillance is necessary in patients suffering from mild to moderate impairment of hepatic function. Hepatitis may occur without prodromal symptoms.

Use of NSAIDs in patients with hepatic porphyria may trigger an attack.

Cardiovascular and cerebrovascular effects:

Appropriate monitoring and advice are required for patients with a history of hypertension and/or mild to moderate congestive heart failure as fluid retention and oedema have been reported in association with NSAID therapy. As the cardiovascular risks of Bristaflam may increase with dose and duration of exposure, the shortest duration possible and the lowest effective daily dose should be used. The patient’s need for symptomatic relief and response to therapy should be re- evaluated periodically.

Bristaflam should also be administered with caution and under close medical surveillance to patients with congestive heart failure, significant risk factors for cardiovascular events and history of cerebrovascular bleeding.

Clinical trial and epidemiological data suggest that use of some NSAIDs (particularly at high doses and in long term treatment) may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke). There are insufficient data to exclude such a risk for Bristaflam.

Patients with uncontrolled hypertension, congestive heart failure, established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease should only be treated with Bristaflam after careful consideration. Similar consideration should be made before initiating longer-term treatment of patients with risk factors for cardiovascular disease (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking).

Gastrointestinal bleeding, ulceration and perforation:

GI bleeding, ulceration or perforation, which can be fatal, has been reported with all NSAIDs at any time during treatment, with or without warning symptoms or a previous history of serious GI events.

Close medical surveillance is imperative in patients with:

— symptoms indicative of gastro-intestinal disorders involving either the upper or lower gastrointestinal tract

— with a history suggestive of gastro-intestinal ulceration, bleeding or perforation

— with ulcerative colitis or with Crohn’s disease

— bleeding diathesis or haematological abnormalities.

The risk of GI bleeding, ulceration or perforation is higher with increasing NSAID doses, in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation , and in the elderly.).

Patients with a history of GI toxicity, particularly when elderly, should report any unusual abdominal symptoms (especially GI bleeding) particularly in the initial stages of treatment.

Caution should be advised in patients receiving concomitant medications which could increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin-reuptake inhibitors or antiplatelet agents such as aspirin.

When GI bleeding or ulceration occurs in patients receiving Bristaflam, the treatment should be withdrawn.

NSAIDs should be given with care to patients with a history of gastrointestinal disease (ulcerative colitis, Crohn’s disease) as these conditions may be exacerbated.

SLE and mixed connective tissue disease:

In patients with systemic lupus erythematosus (SLE) and mixed connective tissue disorders there may be an increased risk of aseptic meningitis.

Dermatological:

Impaired female fertility:

The use of Bristaflam Tablets may impair female fertility and is not recommended in women attempting to conceive. In women who have difficulties conceiving or who are undergoing investigation of infertility, withdrawal of Bristaflam Tablets should be considered.

Hypersensitivity/Dermatological reactions:

As with other NSAIDs, allergic reactions, including anaphylactic/anaphylactoid reactions, can also occur without earlier exposure to the drug. Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Jonson syndrome, and toxic epidermal necrolysis, have been reporting very rarely in association with the use of NSAIDs. Patients appear to be at highest risk of these reactions early in the course of therapy, the onset of the reaction occurring in the majority of cases within the first month of treatment. Bristaflam should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.

Exceptionally, varicella can trigger serious cutaneous and soft tissues infections complications. To date, the contributing role of NSAIDs in the worsening of these infections cannot be ruled out. Thus, it is advisable to avoid use of Bristaflam in case of varicella.

Haematological:

Bristaflam Tablets may reversibly inhibit platelet aggregation (see anticoagulants under ‘Interactions’).

Long-term treatment:

All patients who are receiving NSAIDs should be monitored as a precautionary measure e.g. renal failure, hepatic function (elevation of liver enzymes may occur) and blood counts.

Effects on ability to drive and use machines

The information provided in Effects on ability to drive and use machines of Bristaflam
is based on data of another medicine with exactly the same composition as the Bristaflam.
. Be careful and be sure to specify the information on the section Effects on ability to drive and use machines in the instructions to the drug Bristaflam directly from the package or from the pharmacist at the pharmacy.

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Undesirable effects such as dizziness, vertigo, drowsiness, fatigue and visual disturbances are possible after taking NSAIDs. If affected, patients should not drive or operate machinery.

Undesirable effects

The information provided in Undesirable effects of Bristaflam
is based on data of another medicine with exactly the same composition as the Bristaflam.
. Be careful and be sure to specify the information on the section Undesirable effects in the instructions to the drug Bristaflam directly from the package or from the pharmacist at the pharmacy.

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Exceptionally, occurrence of serious cutaneous and soft tissues infections complications during varicella has been reported in association with NSAID treatment.

Bristaflam is both structurally related and metabolised to diclofenac for which a greater amount of clinical and epidemiological data consistently point towards an increased risk of general arterial thrombotic events (myocardial infarction or stroke, particularly at high doses and in long treatment).4 for contraindication and Special warnings and special precautions for use).

Gastrointestinal:

The most commonly-observed adverse events are gastrointestinal in nature. Peptic ulcers, perforation or GI bleeding, sometimes fatal, particularly in the elderly, may occur. Nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn’s disease have been reported following administration. Less frequently, gastritis has been observed. Pancreatitis has been reported very rarely.

Hypersensitivity:

Hypersensitivity reactions have been reported following treatment with NSAIDs. These may consist of (a) non-specific allergic reactions and anaphylaxis (b) respiratory tract reactivity comprising asthma, aggravated asthma, bronchospasm or dyspnoea, or (c) assorted skin disorders, including rashes of various types, pruritus, urticaria, purpura, angiodema and, more rarely exfoliative and bullous dermatoses (including epidermal necrolysis and erythema multiforme).

Cardiovascular:

Oedema, hypertension and cardiac failure have been reported in association with NSAID treatment.

Clinical trial and epidemiological data suggest that use of some NSAIDs (particularly at high doses and in long term treatment) may be associated with an increased risk of arterial thrombotic events (for example myocardial infarction or stroke).

Other adverse reactions reported less commonly include:

Renal:

Nephrotoxicity in various forms, including interstitial nephritis, nephritic syndrome and renal failure.

Hepatic:

abnormal liver function, hepatitis and jaundice.

Neurological and special senses:

Visual disturbances, optic neuritis, headaches, paraesthesia, reports of aseptic meningitis (especially in patients with existing auto-immune disorders, such as systemic lupus erythematosus, mixed connective tissue disease), with symptoms such as stiff neck, headache, nausea, vomiting, fever or disorientation , depression, confusion, hallucinations, tinnitus, vertigo, dizziness, malaise, fatigue and drowsiness.

Haematological:

Thrombocytopenia, neutropenia, agranulocytosis, aplastic anaemia and haemolytic anaemia.

Dermatological:

Bullous reactions including Stevens Johnson Syndrome and Toxic Epidermal Necrolysis (very rare). Photosensitivity.

Within the system organ classes, undesirable effects are listed under headings of frequency, using the following categories: very common (>1/10); common (>1/100 to <1/10); uncommon (>1/1,000 to <1/100); rare (>1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

System organ class	Common (>1/100 to <1/10)	Uncommon (>1/1,000 to <1/100)	Rare (>1/10,000 to <1/1,000)	Very rare/ isolated reports (<1/10,000)
Blood and lymphatic system disorders			Anaemia	Bone Marrow depression, Granulocytopenia Thrombocytopenia Neutropenia Haemolytic anaemia
Immune system disorders			Anaphylactic reaction (including shock) Hypersensitivity
Metabolism and nutrition disorders				Hyperkalemia
Psychiatric disorders				Depression Abnormal dreams Insomnia
Nervous system disorders	Dizziness			Paraesthesia Tremor Somnolence Headache Dysgeusia (abnormal taste)
Eye disorders			Visual disturbance
Ear and labyrinth disorders				Vertigo Tinnitus
Cardiac disorders			Cardiac failure	Palpitations
Vascular disorders			Hypertension	Flushing Hot flush vasculitis
Respiratory, thoracic and mediastinal disorders			Dyspnoea	Bronchospasm Stridor
Gastrointestinal disorders	Dyspepsia Abdominal pain Nausea Diarrhoea	Flatulence Gastritis Constipation Vomiting Mouth ulceration	Melaena Gastrointestinal haemorrhage Gastrointestinal ulceration	Stomatitis Intestinal perforation Exacerbation of Crohn’s disease and colitis Ulcerative Haematemesis Gastrointestinal haemorrhage Gastric ulcer Pancreatitis
Skin and subcutaneous tissue disorders		Pruritus Rash Dermatitis Urticaria	Face oedema Angioedema	Purpura Severe mucocutaneous skin reaction (including Stevens Johnson Syndrome and Toxic Epidermal Necrolysis) Dermatitis bullous
Musculoskeletal and connective tissue disorders				Cramps in the leg
Renal and urinary disorders		Blood urea increased Blood creatinine increased		Renal insufficiency Nephrotic syndrome Renal failure
Hepatobiliar disorders	Hepatic enzyme increased			Hepatitis Jaundice Hepatic injury (including hepatitis) Blood alkaline phosphatase increased
General disorders and administration site conditions				Oedema Fatigue Cramps in legs
Investigations				Weight increase

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

Overdose

The information provided in Overdose of Bristaflam
is based on data of another medicine with exactly the same composition as the Bristaflam.
. Be careful and be sure to specify the information on the section Overdose in the instructions to the drug Bristaflam directly from the package or from the pharmacist at the pharmacy.

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There is insufficient data available on the consequences of Bristaflam in humans.

a) Symptoms

Symptoms include headache, nausea, vomiting, epigastric pain, gastrointestinal irritation, gastrointestinal bleeding, rarely diarrhoea, disorientation, excitation, coma, drowsiness, dizziness, tinnitus, hypotension, respiratory depression, fainting, occasionally convulsions. In cases of significant poisoning acute renal failure and liver damage are possible.

b) Therapeutic measure:

Patients should be treated symptomatically as required. Within one hour of ingestion of a potentially toxic amount, activated charcoal should be considered. Alternatively, in adults, gastric lavage should be considered within one hour of ingestion of a potentially life-threatening overdose.

Given the route of administration and the pharmaceutical form, an overdose with injectable Bristaflam is unlikely.

Specific therapies such as forced diuresis, dialysis or haemoperfusion are probably of no help in eliminating NSAIDs due to their high rate of protein binding and extensive metabolism. Good urine output should be ensured.

Renal and liver function should be closely monitored. Patients should be observed for at least four hours after ingestion of potentially toxic amounts. In case of frequent or prolonged convulsions, patients should be treated with intravenous diazepam. Other measures may be indicated by the patient’s clinical condition.

Management of acute poisoning with NSAIDs essentially consists of supportive and symptomatic measures.

Pharmacodynamic properties

The information provided in Pharmacodynamic properties of Bristaflam
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Bristaflam is a non-steroidal agent with marked anti-inflammatory and analgesic properties.

ATC code: M01A B16

The mode of action of Bristaflam is largely based on the inhibition to prostaglandin synthesis. Bristaflam is a potent inhibitor of the enzyme cyclo-oxygenase, which is involved in the production of prostaglandins.

Pharmacokinetic properties

The information provided in Pharmacokinetic properties of Bristaflam
is based on data of another medicine with exactly the same composition as the Bristaflam.
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After oral administration, Bristaflam is rapidly and completely absorbed as unchanged drug. Peak plasma concentrations are reached approximately 1.25 to 3.00 hours following ingestion. Bristaflam penetrates into the synovial fluid, where the concentrations reach approximately 57% of those in plasma. The volume of distribution is approximately 25 L.

The mean plasma elimination half-life is around 4 hours. Bristaflam is highly protein- bound (>99%). Bristaflam circulates mainly as unchanged drug. 4′- hydroxyBristaflam is the main metabolite detected in plasma. Approximately two- thirds of the administered dose is excreted via the urine, mainly as hydroxymetabolites.

No changes in the pharmacokinetics of Bristaflam have been detected in the elderly.

Preclinical safety data

The information provided in Preclinical safety data of Bristaflam
is based on data of another medicine with exactly the same composition as the Bristaflam.
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The results from preclinical studies conducted with Bristaflam are consistent with those expected for NSAIDs. The principal target organ was the gastro-intestinal tract.

No unexpected findings were recorded.

Bristaflam was not considered to have any mutagenic activity in three in vitro studies and an in vivo study in the mouse.

Bristaflam was not found to be carcinogenic in either the mouse or rat.

Incompatibilities

The information provided in Incompatibilities of Bristaflam
is based on data of another medicine with exactly the same composition as the Bristaflam.
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Not applicable

Special precautions for disposal and other handling

The information provided in Special precautions for disposal and other handling of Bristaflam
is based on data of another medicine with exactly the same composition as the Bristaflam.
. Be careful and be sure to specify the information on the section Special precautions for disposal and other handling in the instructions to the drug Bristaflam directly from the package or from the pharmacist at the pharmacy.

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Any unused product or waste material should be disposed of in accordance with local requirements.

Bristaflam price

We have no data on the cost of the drug.
However, we will provide data for each active ingredient

The approximate cost of Aceclofenac 100 mg per unit in online pharmacies is from 0.3$ to 0.55$, per package is from 23$ to 39$.

References:

https://www.drugs.com/search.php?searchterm=bristaflam
https://pubmed.ncbi.nlm.nih.gov/?term=bristaflam

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Use
How to use
Dosage
Precautions
Side-effects
Warnings
Interactions
Contraindications

Why it’s used

Bristaflam Tablet is used to relieve pain from long-lasting damage to the joints caused by osteoarthritis. It is a prescription medicine. This medicine works by preventing the release of an organic substance in the body that causes swelling and pain. Bristaflam is also used to relieve pain associated with swelling and stiffness of the joints caused by rheumatoid arthritis. It is also used to relieve swelling of the backbone caused by spondylitis.

Nonsteroidal Anti-inflammatory Drugs

Bristaflam belongs to a class of medicines called Nonsteroidal Anti-inflammatory Drugs. Nonsteroidal anti-inflammatory drugs, also called as NSAIDs, help reduce fever, decrease pain, and prevent clotting of blood. NSAIDs also reduce inflammation in the body when used in higher doses.

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How to use

Follow directions on the product label, information guide, and provided by your doctor before using Bristaflam. Eat this medicine as per your doctor’s instructions.

Bristaflam Tablet is used to relieve pain. Pain medicines usually work the best if used at the first sign of pain and may not work well if delayed until the symptoms have worsened.

Bristaflam is eaten with or after food. Bristaflam is eaten usually in the morning and evening.

Typical Dosage

The typical adult dose of Bristaflam is 200 mg daily (100 mg twice a day). There are no known habit-forming tendencies with this medicine.

This medicine should be used on an as-needed basis. Careful monitoring is required while starting long-term treatment in patients with known conditions that may have increased their risk of heart disease including high blood pressure, high count of lipids in the blood, high blood sugar level or diabetes, and smoking.

Talk to Your Doctor

Tell your doctor if your condition persists or worsens or if you develop new symptoms. If you have any kidney disease, a smaller dose may be prescribed to decrease the risk of kidney problems. If you have issues with the health of your liver, a lower dose may be prescribed to lower the risk of liver problems.

Taking a high dose of this medicine is known to increase the chances of side-effects. A lower dose of Bristaflam Tablet may be recommended to reduce the risk of side-effects. Older patients may see an increase in the risk of side-effects. Hence, a lower dose may be recommended.

Use in Children

The safety and effectiveness of using this medicine in children has not been established. Hence, this medicine should not be used in children under 18 years.

Medicines may be given for uses other than those listed in the medicine guide. Do not use Bristaflam Tablet for symptoms for which it was not prescribed. Do not give Bristaflam Tablet to others who may have similar symptoms as you. Self-medication can cause harm.

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How to take Bristaflam

The dose and frequency of using Bristaflam will depend on the following factors:

age of the patient
patient’s health
the health of the patient’s liver
the health of the patient’s kidneys
medicines recommended by the doctor
any other medicines being used
response to the medicine

Bristaflam Dosage

Dosage for osteoarthritis

Adult

Recommended: 200 mg/day

Dosage for rheumatoid arthritis

Adult

Recommended: 200 mg/day

Dosage for ankylosing spondylitis

Adult

Recommended: 200 mg/day

Minimum Age

18 years

Forms

Film-coated Tablet

Strength: 100 mg

Missed Dose

Take your dose as soon as you remember it. Do not double your dose to make up a forgotten dose.

Overdose

What to do if you overdose on Bristaflam?

If you have taken more than the recommended dose of Bristaflam, get medical advice immediately. If the overdose has happened within the last 1 hour, the toxic effect can be reduced by taking activated charcoal. Activated Charcoal is a form of carbon that has small, low-volume pores. These pores help trap chemicals as in the case of poisoning. In adults, removal of the contents of the stomach (gastric lavage) should be done up within one hour of ingestion of Bristaflam. There should be adequate urine output. Patients should be under medical observation for at least four hours after toxic ingestion of Bristaflam. Careful monitoring of kidney and liver function is required. In case of occurrence of convulsions, patients should be treated with intravenous diazepam.

Symptoms of an overdose of Bristaflam

If you use too much of this medicine, it could lead to dangerous levels of the medicine in your body. In such cases, symptoms of an overdose may include:

coma
diarrhea
dizziness
drowsiness
gastric pain
gastrointestinal bleeding
gastrointestinal irritation
headache
kidney failure
liver damage
low blood pressure
nausea
perception of ringing in the ears
respiratory problems
vomiting

If you think you have overdosed on Bristaflam Tablet, call a poison control center immediately. You can look up the poison control center information from the Poison Center Finder at TabletWise.com.

Precautions while using Bristaflam

Before you use Bristaflam, tell your doctor of your medical and health history including the following:

abnormal pumping of blood by heart
an overactive immune system
bleeding disorder
bleeding from ruptured blood vessels associated with brain
bleeding in the stomach or intestines
diabetes
difficulty in breathing due to bronchial asthma
diminished blood supply to the brain
high blood pressure
high cholesterol levels
if you are pregnant women
inflammation in the digestive tract (ulcerative colitis)
kidney failure
liver failure
other problems of the stomach or intestines
recurrent ulcers in stomach
recurring chickenpox or shingles
reduced blood supply to limbs due to narrowing of blood vessels
reduced blood supply to the heart

Using NSAIDs in these patients can worsen the existing conditions.

Before you use Bristaflam Tablet, discuss with your doctor if you are allergic to it or its ingredients. Your doctor may prescribe an alternative medicine and update your medical records to record this information. Tell your doctor if you are allergic any of the following substances: aspirin, ibuprofen, or other NSAIDs (non-steroidal anti-inflammatory drugs).

Before having surgery during the use of Bristaflam, discuss with your doctor and dentist about the medicinal products you use including prescription/non-prescription/herbal medicines.

The use of Bristaflam Tablet may change the functioning of liver. Bristaflam can increase the levels of liver enzymes which can result in a liver failure.

The use of this medicine may change gastrointestinal secretion. If you are giving this medicine to elderly patients, this may result in an increased risk of gastrointestinal bleeding.

Dizziness

Bristaflam Tablet can make you feel sleepy. Be careful when using any machinery, driving a vehicle, or doing any other activity that needs you to be fully alert. The consumption of alcohol with Bristaflam Tablet can worsen the sleepiness.

Use in Pregnancy

The use of Bristaflam during pregnancy should only be when required. This medicine increases the risk of abnormal fetal development, congenital heart abnormalities and sudden loss of pregnancy if used in the early stages of pregnancy. Bristaflam should not be used in the third trimester of pregnancy, because it may lead to kidney failure in the fetus, prolongation of bleeding time and delayed or prolonged labor in mother. Bristaflam belongs to the NSAID class of medicines. NSAIDs should not be taken after 29 weeks of pregnancy as these medicines may cause serious harm to the unborn baby.

Use while Breastfeeding

The use of Bristaflam Tablet Bristaflam Tablet while breastfeeding should only be when required. The use of Bristaflam should therefore be avoided in lactation unless the potential benefits to the other outweigh the possible risks to the foetus.

Use while Conceiving

Bristaflam may impact fertility in women. If you are trying to conceive, discuss with your doctor on the use of this medicine. This medicine may impact female fertility. The temporary discontinuation of Bristaflam should be considered in women having difficulties to conceive or undergoing investigations for infertility.

Increased Risks

This medicine may cause bleeding in the stomach. Regular use of tobacco or alcohol while using this medicine can increase your risk. Discuss with your doctor if you smoke and drink alcohol regularly. This medicine may increase your sensitivity to sunlight. If this happens, use a sunscreen and cover your skin when you are outdoors. Limit your time in the sun.

Side-effects in Older Patients

Bristaflam Tablet may cause increased incidence of side-effects in older patients. Elderly patients may see an increased risk of stomach bleeding, bleeding in the intestines, and gastrointestinal perforation.

Long-term Use

Use of Bristaflam for a long time at high doses increase the risk of stroke and heart attack.

What precautions should be taken during Pregnancy and Nursing, and administering Bristaflam to Children or the Older Adults?

Pregnant Women

Only When Necessary

Warning: Using this medicine during the first and second trimester of pregnancy may cause abnormal fetal development, increased risk of heart abnormalities and sudden loss of pregnancy. Bristaflam should not be used in the third trimester of pregnancy, because it may lead to kidney failure in the fetus, prolongation of bleeding time and delayed or prolonged labor in mother.

Breastfeeding

Only When Necessary

Warning: This medicine can only be used if the potential benefits outweigh the possible risks to the fetus.

Younger Adults Population

Contraindicated or Not Recommended

Warning: This medicine should not be given to children under 18 years.

Older Adults Population

Precaution

Warning: The lowest effective dose should be taken for the shortest possible duration.

Bristaflam Side-effects

The following side-effects may commonly occur in older patients on the use of Bristaflam Tablet. Discuss with your doctor if any of these side-effects last for a long time or are severe:

gastrointestinal bleeding
gastrointestinal perforation
ruptured bowel
stomach ulcer

Rarely, the use of Bristaflam Tablet may cause the following side-effects:

abnormal accumulation of fluid within the body
abnormal dreams
abnormal skin sensation such as tingling, chilling, prickling, burning, or numbness
black tarry stools
constipation
cramps in legs
decrease in granulocytes (a type of white blood cells)
decrease in production of immunity cells
decrease in white blood cells
decreased taste sensitivity
fatigue
fluid collection in the tissues of the face
gas
gastritis
headache
hives
increased blood alkaline phosphatase
increased blood creatinine levels
increased blood urea
increased weight
inflammation in the lining of the digestive tract (Crohn’s disease)
itchy inflammation of the skin
itchy skin
jaundice
liver injury
low levels of platelets
mouth ulceration
palpitation
purple or red discolored spots on the skin
rapid reddening of upper chest, neck, or face
rash
ringing in the ears
sensation of spinning dizziness (vertigo)
shortness of breath
sleeplessness
sudden feeling of feverish heat
swelling of the lower layer of skin
tremor
visual disturbance
vomiting
vomiting of blood

The following severe side-effects may also occur when using Bristaflam Tablet:

Severe skin reactions such as loss of outer skin layer and mucosal layer (Stevens Johnson syndrome) and redness or peeling of the skin (possible death)

Symptoms: skin rash injury on the inner lining of the mouth

If this happens, stop using this medicine.
The treatment should be done with the lowest dose available.
Gastrointestinal ulceration

The lowest dose should be selected for treatment in this disease.
Bronchospasm (tightening of the respiratory muscles)

This medicine should be used with caution in the patients who are suffering from or having a history of bronchial asthma.
Worsening of ulcerative colitis (inflammation in the digestive tract)

The treatment should be done with the lowest dose available.

Your doctor has prescribed this medicine because they judge that the benefit is greater than the risk posed by side-effects. Many people using this medicine do not have serious cases of side-effects. This page does not contain a complete list of all possible side-effects.

If you experience side-effects or notice other side-effects not listed above, contact your doctor for medical advice. You may also report side-effects to your local food and drug administration authority. You can look up the drug authority contact information from the Drug Authority Finder at TabletWise.com.

Side-effects and Allergic Reactions of Bristaflam by Severity and Frequency

Side-effects in Older Adults

Following are the side-effects of this medicine in elderly patients:

gastrointestinal bleeding
gastrointestinal perforation

Serious Allergic Reactions

Following are the symptoms of serious allergic reactions to this medicine:

mucosal lesions
skin rash

Discontinue this medicine after the appearance of allergic symptoms.

Warnings

Known Allergic Reactions to NSAIDs

Patients with known allergic reaction to NSAIDs are at increased risk when using this medicine. These patients may have an increased risk of severe skin reactions. Discontinue this medicine at the first appearance of the symptoms like oral lesions, skin rashes or any other sign of skin reactions.

Female Infertility

Women who are trying to conceive are at increased risk when using this medicine. The women using this medicine may have difficulty in conceiving. This medicine should be discontinued in women who are trying to be pregnant, who have difficulty in conceiving or who are undergoing evaluation for infertility.

Blood Disorders

Patients with blood disorder may be at an increased risk while using this medicine. Bristaflam reduces blood clot formation which can result in abnormal bleeding. Bristaflam should not be used in such patients.

Long-Term Treatment with Bristaflam

Patients using Bristaflam for long-term treatment are at increased risk. The long-term use of this medicine may cause heart problems. Careful monitoring of the functioning of the kidneys, the functioning of the liver, and blood count is required when using this medicine for the long term.

Gastrointestinal Problems in Elderly Patients

Elderly patients with gastrointestinal problems, particularly those who are sensitive to NSAIDs are at increased risk when using this medicine. Patients using Bristaflam may have gastrointestinal bleeding and ulceration. This medicine should be used carefully in such patients.

Gastrointestinal Disorders

Patients with gastrointestinal disorder like ulcerative colitis and Crohn’s disease are at an increased risk when using this medicine. Patients using Bristaflam may have gastrointestinal bleeding and ulceration. This medicine should be used carefully in such patients.

Systemic Autoimmune Disease

Patients with lupus are at increased risk when using this medicine. These patients may have an increased risk of inflammation of the brain and spinal cord membranes (aseptic meningitis).

Bronchial Asthma

Patients suffering from, or with a previous history of bronchial asthma are at increased risk of difficulty in breathing when using this medicine. These patients may have an increased risk of narrowing of the airway passage of the lungs a condition also known as bronchospasm. Caution is required while using Bristaflam in such patients.

Mild to Moderate Kidney Problems

Patients with mild to moderate kidney problems are at increased risk when using this medicine. These patients may have an increased risk of kidney failure. While using Bristaflam in such patients, the functioning of the kidneys should be monitored carefully.

High Blood Pressure and Heart Disease

Patients with a history of high blood pressure and mild to moderate congestive heart failure are at increased risk when using this medicine. These patients may have an increased risk of heart attack, stroke, and accumulation of excessive water in the body. Bristaflam should be taken with caution and under close medical supervision.

Interactions with Bristaflam

When two or more medicines are taken together, it can change how the medicines work and increase the risk of side-effects. In medical terms, this is called as a Drug Interaction.

This page does not contain all the possible interactions of Bristaflam Tablet. Share a list of all medicines that you use with your doctor and pharmacist. Do not start, stop, or change the dose of any medicines without the approval of your doctor.

Diuretics

Bristaflam Tablet may interact with potassium-sparing diuretics, which are used to increase urine output. The combined usage of these medicines may increase the risk of kidney damage. Monitor potassium levels in the body while using diuretics with Bristaflam.

Cardiac Glycosides

There may be an interaction of Bristaflam with cardiac glycosides, which are used to treat heart failure and palpitation. The combined usage of these medicines may increase the risk of heart failure.

Antimanic Agents

Bristaflam Tablet interacts with lithium, which is used to treat mental disorders. Bristaflam reduces the removal of lithium from the kidney which results in increased levels of the medicine lithium in the body. Avoid this combination to prevent the drug interactions.

Antimetabolites

Special instructions need to be followed while taking this medicine along with methotrexate, which is used to treat cancer. The interaction of these medicine reduces the elimination of methotrexate from the body. Use with caution, when both the drugs are taken within 24 hours of each other.

Immunosupressants

Your doctor’s guidelines may need to be followed while taking this medicine along with tacrolimus, which is used to suppress the immune system during organ transplantation. Combined use of these medicines increases the risk of kidney damage. Functioning of the kidneys should be carefully monitored while using this combination.

Antihypertensive Drugs

Bristaflam Tablet may interact with antihypertensive drugs, which are used to lower the high blood pressure. NSAIDs decrease the effect of these medicines. Patients taking these medicines should drink sufficient water and a doctor should monitor the functioning of their kidneys on a regular basis.

Antiprogestins

There may be an interaction of Bristaflam with mifepristone, which is used for medical termination of pregnancy. NSAIDs reduce the effect of these medicines. Do not use NSAIDs for 8-12 days after taking mifepristone.

Corticosteroids

Bristaflam Tablet interacts with corticosteroids, which are used to relieve inflammation. These medicines increase the risk of gastrointestinal bleeding or ulceration. The combination of Bristaflam with corticosteroids should be used with caution.

Anticoagulants

Special instructions need to be followed while taking this medicine along with warfarin, which is used to prevent blood clot formation. NSAIDs increase the effect of such medicines. Patients taking this combination should be carefully monitored.

Antidiabetic Agents

Your doctor’s guidelines may need to be followed while taking this medicine along with antidiabetic agents, which are medicines used to treat diabetes. This combined use of these medicines affects blood sugar levels in the body. As a result, dosage adjustment is required while giving antidiabetic drugs along with Bristaflam.

Interactions of Bristaflam by Severity

When should Bristaflam be not used?

Allergic to Bristaflam

This medicine should not be given in patients with known allergic reactions to the Bristaflam and its excipients. These patients may have the following symptoms if they use this medicine:

skin rash
mucosal lesion

Stomach Ulcer

This medicine is not recommended for patients who have a history of stomach ulcers. Such patients may see an increased risk of gastrointestinal bleeding. These patients may have the following symptoms if they use this medicine:

nausea
vomiting
diarrhea
gas
abdominal pain
passage of black, tarry stools containing blood (melaena)
vomiting of blood (haematemesis)
constipation
indigestion
painful swelling and sores inside the mouth
worsening of colitis
inflammation of the lining of the digestive system (Crohn’s disease)

History of Bleeding Disorder

This medicine should not be given in patients with prior history of bleeding disorders.

Pregnancy

This medicine should not be given during the last trimester of pregnancy. Use of this medicine during pregnancy may increase the risk of high blood pressure within the arteries of the lungs after birth, damage to the heart and lungs by ingestion of harmful chemicals, and kidney dysfunction in newborn. These patients may have the following symptoms if they use this medicine:

longer bleeding time
prolonged labor

Heart Diseases

This medicine should be avoided in patients with known heart diseases (congestive heart failure and ischaemic heart disease). These patients may have the following symptoms if they use this medicine:

fluid retention

Kidney Failure

This medicine is not recommended in patients with kidney failure.

Liver Failure

This medicine is not recommended in patients with kidney failure.

Traveling With Medication

Ensure that you carry enough doses of each of your prescription medicines to last the entire trip. The best place to store your medicines is in the carry on baggage. However, while flying, if carrying liquid medicines, make sure you do not go over the limits imposed for carry-on liquids.
While traveling overseas, make sure that you can carry each of your prescription medicines legally to your destination country. One way to ensure this is by checking with your destination country’s embassy or website.
Make sure that you carry each of your medicines in their original packaging, which should typically include your name and address, and the details of the prescribing doctor.
If your travel involves crossing time zones, and you are required to take your medicine as per a fixed schedule, make sure that you adjust for the change in time.

Expired Medication

Taking a single dose of expired Bristaflam is unlikely to cause a side-effect. However, please discuss with your doctor or pharmacist, if you feel unwell or sick. An expired medicine may become ineffective in treating your prescribed conditions. To be on the safe side, it is important not to use an expired drug. You are much safer by always keeping a fresh supply of unexpired medicines.

Safe Disposal of Medication

If there are disposal instructions on the package, please follow the instructions.
If there are medicine take-back programs in your country, you should contact the respective authority to arrange for the disposal of the medicine. For example, in the USA, the Drug Enforcement Administration regularly hosts National Prescription Drug Take-Back events.
If there are no take-back programs, mix the medicine with dirt and place them in a sealed plastic bag. Throw the plastic bag in your household trash. Separately, remove all personal information including the prescription label from the medicine packaging and then dispose off the container.
If specifically indicated on the medicine package that it needs to be flushed down the toilet when no longer needed, perform the required step.

This page provides information for Bristaflam Tablet .

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