Esmya

Country: European Union

Language: Bulgarian

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
03-02-2021
Summary of Product characteristics Summary of Product characteristics (SPC)
03-02-2021
Public Assessment Report Public Assessment Report (PAR)
03-02-2021

Active ingredient:

улипристалов ацетат

Available from:

Gedeon Richter Ltd 

ATC code:

G03XB02

INN (International Name):

ulipristal

Therapeutic group:

Полови хормони и слиза на половата система,

Therapeutic area:

Лейомиома

Therapeutic indications:

Ulipristal ацетат е показан за предоперативно лечение на умерени до тежки симптоми на маточни фиброми при възрастни жени в репродуктивна възраст. Ulipristal acetate е показан при интермитентно лечение на умерени до тежки симптоми на миома на матката при жени в репродуктивна възраст.

Product summary:

Revision: 16

Authorization status:

упълномощен

Authorization date:

2012-02-22

Patient Information leaflet

                                28
Б. ЛИСТОВКА
29
ЛИСТОВКА: ИНФОРМАЦИЯ ЗА ПОТРЕБИТЕЛЯ
_ _
ESMYA 5 MG ТАБЛЕТКИ
Улипристалов ацетат (Ulipristal acetate)
ПРОЧЕТЕТЕ ВНИМАТЕЛНО ЦЯЛАТА ЛИСТОВКА,
ПРЕДИ ДА ЗАПОЧНЕТЕ ДА ПРИЕМАТЕ ТОВА
ЛЕКАРСТВО,
ТЪЙ КАТО ТЯ СЪДЪРЖА ВАЖНА ЗА ВАС
ИНФОРМАЦИЯ.
-
Запазете тази листовка. Може да се
наложи да я прочетете отново.
-
Ако имате някакви допълнителни
въпроси, попитайте Вашия лекар или
фармацевт.
-
Това лекарство е предписано
единствено и лично на Вас. Не го
преотстъпвайте на други
хора. То може да им навреди, независимо
че признаците на тяхното заболяване
са същите
като Вашите.
-
Ако получите някакви нежелани
реакции, уведомете Вашия лекар или
фармацевт. Това
включва и всички възможни нежелани
реакции, неописани в тази листовка.
Вижте точка
4.
КАКВО СЪДЪРЖА ТАЗИ ЛИСТОВКА
1.
Какво представлява Esmya и за какво се
използва
2.
Какво трябва да знаете, преди да
приемете Esmya
3.
Как да приемате Esmya
4.
Възможни нежелани реакции
5.
Как да съхранявате Esmya
6.
Съдържание на опаковката и
допълнителна информация
1.
КАКВО ПРЕДСТАВЛЯВА ESMYA И ЗА КАКВО СЕ
ИЗПОЛЗВА
Esmya съдържа активното вещество
улипристалов ацетат. Прилага се за
лечение на умерени до
тежки сим
                                
                                Read the complete document

Summary of Product characteristics

                                1
ПРИЛОЖЕНИЕ I
КРАТКА ХАРАКТЕРИСТИКА НА ПРОДУКТА
2
1.
ИМЕ НА ЛЕКАРСТВЕНИЯ ПРОДУКТ
Esmya 5 mg таблетки
2.
КАЧЕСТВЕН И КОЛИЧЕСТВЕН СЪСТАВ
Всяка таблетка съдържа 5 mg
улипристалов ацетат (ulipristal acetate).
За пълния списък на помощните
вещества вижте точка 6.1.
3.
ЛЕКАРСТВЕНА ФОРМА
Таблетка.
Бяла до почти бяла, кръгла,
двойноизпъкнала таблетка с диаметър 7
mm, гравирана с „ES5“ от
едната страна.
4.
КЛИНИЧНИ ДАННИ
4.1
ТЕРАПЕВТИЧНИ ПОКАЗАНИЯ
Улипристалов ацетат е показан за
интермитентно лечение на умерени до
тежки симптоми на
маточни фиброзни тумори при възрастни
жени, които не са достигнали
менопауза, когато
емболизацията на маточните артерии
и/или хирургичното лечение не са
подходящи или са били
неуспешни.
4.2
ДОЗИРОВКА И НАЧИН НА ПРИЛОЖЕНИЕ
Лечението с Esmya се започне и наблюдава
от лекари с опит в диагностицирането и
лечението
на маточни фиброзни тумори.
Дозировка
Лечението се състои от една таблетка
от 5 mg, която се приема веднъж дневно,
за курсове на
лечение, всеки от които с
продължителност до най-много 3 месеца.
Таблетките може да се
приемат със или без храна.
Курсовете на лечение трябва да
започват само при възникване на
менс
                                
                                Read the complete document

Similar products

Active ingredient улипристалов ацетат

улипристалов ацетат

ATC code G03XB02

G03XB02

Marketed by Gedeon Richter Ltd 

Gedeon Richter Ltd 

INN (International Name) ulipristal

ulipristal

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Esmya