Zerene

Country: European Union

Language: Bulgarian

Source: EMA (European Medicines Agency)

Buy It Now

Patient Information leaflet Patient Information leaflet (PIL)
15-10-2012
Summary of Product characteristics Summary of Product characteristics (SPC)
15-10-2012
Public Assessment Report Public Assessment Report (PAR)
16-10-2012

Active ingredient:

залеплон

Available from:

Meda AB

ATC code:

N05CF03

INN (International Name):

zaleplon

Therapeutic group:

психолептици

Therapeutic area:

Смущения при започване и поддържане на съня

Therapeutic indications:

Zerene е показан за лечение на пациенти с безсъние, които имат затруднения при заспиване. Показва се само когато разстройството е тежко, деактивира или подлага индивида на екстремен стрес.

Product summary:

Revision: 13

Authorization status:

Отменено

Authorization date:

1999-03-12

Patient Information leaflet

                                33
Б. ЛИСТОВКА
Лекарствен продукт, който вече не е
разрешен за употреба
34
ЛИСТОВКА: ИНФОРМАЦИЯ ЗА ПОТРЕБИТЕЛЯ
Zerene 5 mg капсули, твърди
Zaleplon (Залеплон)
ПРОЧЕТЕТЕ ВНИМАТЕЛНО ЦЯЛАТА ЛИСТОВКА
ПРЕДИ ДА ЗАПОЧНЕТЕ ДА ПРИЕМАТЕ ТОВА
ЛЕКАРСТВО.
-
Запазете тази листовка. Може да имате
нужда 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 от това, че
техните симптоми са същите както
Вашите.
-
Ако някоя от нежеланите лекарствени
реакции стане сериозна, или
забележите други,
неописани в тази листовка нежелани
реакции, моля уведомете Вашия лекар
или фармацевт.
В ТАЗИ ЛИСТОВКА:
1.
Какво представлява Zerene и за какво се
използва
2.
Преди да приемете Zerene
3.
Как да приемате Zerene
4.
Възможни нежелани реакции
5.
Съхранение на Zerene
6.
Допълнителна информация
1.
КАКВО ПРЕДСТАВЛЯВА ZERENE И ЗА КАКВО СЕ
ИЗПОЛЗВА
Zerene принадлежи към клас вещества,
наречени бензодиазепин-подобни
лекарствени продукти,
който включва продукти с хипнотично
действие.
Zerene ще Ви помогне да заспите.
Проблемите съ
                                
                                Read the complete document

Summary of Product characteristics

                                1
ПРИЛОЖЕНИЕ I
КРАТКА ХАРАКТЕРИСТИКА НА ПРОДУКТА
Лекарствен продукт, който вече не е
разрешен за употреба
2
1.
ИМЕ НА ЛЕКАРСТВЕНИЯ ПРОДУКТ
Zerene 5 mg капсули, твърди
2.
КАЧЕСТВЕН И КОЛИЧЕСТВЕН СЪСТАВ
Всяка капсула съдържа по 5 mg залеплон
(_zaleplon_).
Помощни вещества: Лактоза монохидрат
54 mg
За пълния списък на помощните
вещества, вж. точка 6.1.
3.
ЛЕКАРСТВЕНА ФОРМА
Капсули, твърди.
Капсулите имат непрозрачна бяла и
непрозрачна светлокафява твърда
обвивка със златистa лента,
знак “W” и означение на
концентрацията “5 mg”.
4.
КЛИНИЧНИ ДАННИ
4.1
ТЕРАПЕВТИЧНИ ПОКАЗАНИЯ
Zerene е показан за лечение на пациенти с
безсъние, които имат трудности със
заспиването. Той е
показан само когато нарушението е
тежко, водещо до недееспособност, или
поставя лицето в краен
дистрес.
4.2
ДОЗИРОВКА И НАЧИН НА ПРИЛОЖЕНИЕ
При възрастни, препоръчваната доза е 10
mg
Лечението трябва да бъде възможно
най-кратко с максимална
продължителност от две седмици.
Zerene може да се приема непосредствено
преди лягане или след като пациентът е
легнал и има
затруднения със заспиването. Приемът
след хранене забавя достигането на
максималните стойности
на плазмена концентр
                                
                                Read the complete document

Similar products

Active ingredient залеплон

залеплон

ATC code N05CF03

N05CF03

Marketed by Meda AB

Meda AB

INN (International Name) zaleplon

zaleplon

Documents in other languages

Patient Information leaflet Patient Information leaflet Spanish 15-10-2012
Summary of Product characteristics Summary of Product characteristics Spanish 15-10-2012
Public Assessment Report Public Assessment Report Spanish 16-10-2012
Patient Information leaflet Patient Information leaflet Czech 15-10-2012
Summary of Product characteristics Summary of Product characteristics Czech 15-10-2012
Public Assessment Report Public Assessment Report Czech 16-10-2012
Patient Information leaflet Patient Information leaflet Danish 15-10-2012
Summary of Product characteristics Summary of Product characteristics Danish 15-10-2012
Public Assessment Report Public Assessment Report Danish 16-10-2012
Patient Information leaflet Patient Information leaflet German 15-10-2012
Summary of Product characteristics Summary of Product characteristics German 15-10-2012
Public Assessment Report Public Assessment Report German 16-10-2012
Patient Information leaflet Patient Information leaflet Estonian 15-10-2012
Summary of Product characteristics Summary of Product characteristics Estonian 15-10-2012
Public Assessment Report Public Assessment Report Estonian 16-10-2012
Patient Information leaflet Patient Information leaflet Greek 15-10-2012
Summary of Product characteristics Summary of Product characteristics Greek 15-10-2012
Public Assessment Report Public Assessment Report Greek 16-10-2012
Patient Information leaflet Patient Information leaflet English 15-10-2012
Summary of Product characteristics Summary of Product characteristics English 15-10-2012
Public Assessment Report Public Assessment Report English 16-10-2012
Patient Information leaflet Patient Information leaflet French 15-10-2012
Summary of Product characteristics Summary of Product characteristics French 15-10-2012
Public Assessment Report Public Assessment Report French 16-10-2012
Patient Information leaflet Patient Information leaflet Italian 15-10-2012
Summary of Product characteristics Summary of Product characteristics Italian 15-10-2012
Public Assessment Report Public Assessment Report Italian 16-10-2012
Patient Information leaflet Patient Information leaflet Latvian 15-10-2012
Summary of Product characteristics Summary of Product characteristics Latvian 15-10-2012
Public Assessment Report Public Assessment Report Latvian 16-10-2012
Patient Information leaflet Patient Information leaflet Lithuanian 15-10-2012
Summary of Product characteristics Summary of Product characteristics Lithuanian 15-10-2012
Public Assessment Report Public Assessment Report Lithuanian 16-10-2012
Patient Information leaflet Patient Information leaflet Hungarian 15-10-2012
Summary of Product characteristics Summary of Product characteristics Hungarian 15-10-2012
Public Assessment Report Public Assessment Report Hungarian 16-10-2012
Patient Information leaflet Patient Information leaflet Maltese 15-10-2012
Summary of Product characteristics Summary of Product characteristics Maltese 15-10-2012
Public Assessment Report Public Assessment Report Maltese 16-10-2012
Patient Information leaflet Patient Information leaflet Dutch 15-10-2012
Summary of Product characteristics Summary of Product characteristics Dutch 15-10-2012
Public Assessment Report Public Assessment Report Dutch 16-10-2012
Patient Information leaflet Patient Information leaflet Polish 15-10-2012
Summary of Product characteristics Summary of Product characteristics Polish 15-10-2012
Public Assessment Report Public Assessment Report Polish 16-10-2012
Patient Information leaflet Patient Information leaflet Portuguese 15-10-2012
Summary of Product characteristics Summary of Product characteristics Portuguese 15-10-2012
Public Assessment Report Public Assessment Report Portuguese 16-10-2012
Patient Information leaflet Patient Information leaflet Romanian 15-10-2012
Summary of Product characteristics Summary of Product characteristics Romanian 15-10-2012
Public Assessment Report Public Assessment Report Romanian 16-10-2012
Patient Information leaflet Patient Information leaflet Slovak 15-10-2012
Summary of Product characteristics Summary of Product characteristics Slovak 15-10-2012
Public Assessment Report Public Assessment Report Slovak 16-10-2012
Patient Information leaflet Patient Information leaflet Slovenian 15-10-2012
Summary of Product characteristics Summary of Product characteristics Slovenian 15-10-2012
Public Assessment Report Public Assessment Report Slovenian 16-10-2012
Patient Information leaflet Patient Information leaflet Finnish 15-10-2012
Summary of Product characteristics Summary of Product characteristics Finnish 15-10-2012
Public Assessment Report Public Assessment Report Finnish 16-10-2012
Patient Information leaflet Patient Information leaflet Swedish 15-10-2012
Summary of Product characteristics Summary of Product characteristics Swedish 15-10-2012
Public Assessment Report Public Assessment Report Swedish 16-10-2012

Search alerts related to this product

Alerts Zerene залеплон zaleplon

Zerene залеплон zaleplon

View documents history

Documents history Documents history

Zerene