Champix

Country: European Union

Language: Bulgarian

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
31-10-2023
Summary of Product characteristics Summary of Product characteristics (SPC)
31-10-2023
Public Assessment Report Public Assessment Report (PAR)
03-04-2014

Active ingredient:

варениклин

Available from:

Pfizer Europe MA EEIG

ATC code:

N07BA03

INN (International Name):

varenicline

Therapeutic group:

Други лекарства в нервната система

Therapeutic area:

Прекратяване употребата на тютюн

Therapeutic indications:

Champix е показан за спиране на тютюнопушенето при възрастни.

Product summary:

Revision: 38

Authorization status:

упълномощен

Authorization date:

2006-09-25

Patient Information leaflet

                                126
Б. ЛИСТОВКА
127
ЛИСТОВКА: ИНФОРМАЦИЯ ЗА ПОТРЕБИТЕЛЯ
CHAMPIX 0,5 MG ФИЛМИРАНИ ТАБЛЕТКИ
CHAMPIX 1 MG ФИЛМИРАНИ ТАБЛЕТКИ
варениклин (varenicline)
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 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 CHAMPIX и за какво се
използва
2.
Какво трябва да знаете, преди да
приемете CHAMPIX
3.
Как да приемате CHAMPIX
4.
Възможни нежелани реакции
5.
Как да съхранявате CHAMPIX
6.
Съдържание на опаковката и
допълнителна информация
1.
КАКВО ПРЕДСТАВЛЯВА CHAMPIX И ЗА КАКВО СЕ
ИЗПОЛЗВА
CHAMPIX съдържа активното вещество
варениклин. CHAMPIX е лекарство, което се
употребяв
                                
                                Read the complete document

Summary of Product characteristics

                                1
ПРИЛОЖЕНИЕ I
КРАТКА ХАРАКТЕРИСТИКА НА ПРОДУКТА
2
1.
ИМЕ НА ЛЕКАРСТВЕНИЯ ПРОДУКТ
CHAMPIX 0,5 mg филмирани таблетки
2.
КАЧЕСТВЕН И КОЛИЧЕСТВЕН СЪСТАВ
Всяка филмирана таблетка съдържа 0,5 mg
варениклин (varenicline) (като тартарат).
За пълния списък на помощните
вещества вижте точка 6.1.
3.
ЛЕКАРСТВЕНА ФОРМА
Филмирана таблетка с размери 4 mm x 8 mm
Бели, с формата на капсула,
двойноизпъкнали таблетки, с вдлъбнато
релефно означение
“_Pfizer_” от едната страна и “CHX 0.5” от
другата страна.
4.
КЛИНИЧНИ ДАННИ
4.1
ТЕРАПЕВТИЧНИ ПОКАЗАНИЯ
CHAMPIX е показан за спиране на
тютюнопушенето при възрастни.
4.2
ДОЗИРОВКА И НАЧИН НА ПРИЛОЖЕНИЕ
Дозировка
Препоръчителната доза е 1 mg варениклин
два пъти дневно, предшествана от
1-седмичен курс
на титриране, както следва:
Ден 1 – 3:
0,5 mg веднъж дневно
Ден 4 – 7:
0,5 mg два пъти дневно
Ден 8 – край на лечението:
1 mg два пъти дневно
Пациентът трябва да определи дата за
спиране на тютюнопушенето. Приемът на
CHAMPIX
трябва обичайно да започне 1-2 седмици
преди тази дата (вж. точка 5.1).
Пациентите трябва да
бъдат лекувани с CHAMPIX 12 седмици.
При пациенти, които са спрели успешно
тютюнопушенето в края на 12-те седмици,
може да се
има предвид 
                                
                                Read the complete document

Similar products

Active ingredient варениклин

варениклин

ATC code N07BA03

N07BA03

Marketed by Pfizer Europe MA EEIG

Pfizer Europe MA EEIG

INN (International Name) varenicline

varenicline

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Patient Information leaflet Patient Information leaflet Spanish 31-10-2023
Summary of Product characteristics Summary of Product characteristics Spanish 31-10-2023
Public Assessment Report Public Assessment Report Spanish 03-04-2014
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Summary of Product characteristics Summary of Product characteristics Czech 31-10-2023
Public Assessment Report Public Assessment Report Czech 03-04-2014
Patient Information leaflet Patient Information leaflet Danish 31-10-2023
Summary of Product characteristics Summary of Product characteristics Danish 31-10-2023
Public Assessment Report Public Assessment Report Danish 03-04-2014
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Public Assessment Report Public Assessment Report German 03-04-2014
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Public Assessment Report Public Assessment Report Estonian 03-04-2014
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Public Assessment Report Public Assessment Report Greek 03-04-2014
Patient Information leaflet Patient Information leaflet English 31-10-2023
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Public Assessment Report Public Assessment Report English 03-04-2014
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Public Assessment Report Public Assessment Report French 03-04-2014
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