Memantine Accord

Country: European Union

Language: Bulgarian

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
13-01-2022
Summary of Product characteristics Summary of Product characteristics (SPC)
13-01-2022
Public Assessment Report Public Assessment Report (PAR)
16-12-2013

Active ingredient:

мемантин хидрохлорид

Available from:

Accord Healthcare S.L.U.

ATC code:

N06DX01

INN (International Name):

memantine

Therapeutic group:

Други лекарства против деменция

Therapeutic area:

Болест на Алцхаймер

Therapeutic indications:

Лечение на пациенти с умерена до тежка болест на Алцхаймер.

Product summary:

Revision: 7

Authorization status:

упълномощен

Authorization date:

2013-12-03

Patient Information leaflet

                                56
Б. ЛИСТОВКА
57
ЛИСТОВКА: ИНФОРМАЦИЯ ЗА ПОТРЕБИТЕЛЯ
МЕМАНТИН ACCORD 10 MG ФИЛМИРАНИ ТАБЛЕТКИ
мемантинов хидрохлорид (memantine hydrochloride)
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, моля, консултирайте се с
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
лекарствени 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 Мемантин Accord и за
какво се използва
2.
Какво трябва да знаете, преди да
приемете Мемантин Accord
3.
Как да приемате Мемантин Accord
4.
Възможни нежелани реакции
5.
Как да съхранявате Мемантин Accord
6.
Съдържание на опаковката и
допълнителна информация
1.
КАКВО ПРЕДСТАВЛЯВА МЕМАНТИН ACCORD И ЗА
КАКВО СЕ ИЗПОЛЗВА
КАК ДЕЙСТВ
                                
                                Read the complete document

Summary of Product characteristics

                                1
ПРИЛОЖЕНИЕ I
КРАТКА ХАРАКТЕРИСТИКА НА ПРОДУКТА
2
1.
ИМЕ НА ЛЕКАРСТВЕНИЯ ПРОДУКТ
Мемантин Accord 10 mg филмирани таблетки
2.
КАЧЕСТВЕН И КОЛИЧЕСТВЕН СЪСТАВ
Всяка филмирана таблетка съдържа 10 mg
мемантинoв хидрохлорид (memantine hydrochloride),
еквивалентно на 8,31 mg мемантин.
Помощно вещество с известно действие:
всяка филмирана таблетка съдържа 183,13
mg
лактоза
(като монохидрат).
За пълния списък на помощните
вещества вижте точка 6.1.
3.
ЛЕКАРСТВЕНА ФОРМА
Филмирана таблетка.
Бяла, продълговата, обвита таблетка с
делителна черта, с вдлъбнато релефно
означение „MT” на
едната, разделено от делителната
черта и „10“ на другата страна,
разделено от делителната черта.
Таблетката може да бъде разделена на
две равни дози.
4.
КЛИНИЧНИ ДАННИ
4.1
ТЕРАПЕВТИЧНИ ПОКАЗАНИЯ
Лечение на пациенти с умерена до тежка
степен на болестта на Алцхаймер.
4.2
ДОЗИРОВКА И НАЧИН НА ПРИЛОЖЕНИЕ
Дозировка
Лечението трябва да бъде започнато и
наблюдавано от лекар, с опит в
диагностицирането и
лечението на деменцията на Алцхаймер.
Лечението трябва да започне само ако
има лице, което
да се грижи за болния и редовно да
следи приема на лекарствения продукт
от пациента.
Д
                                
                                Read the complete document

Similar products

Active ingredient мемантин хидрохлорид

мемантин хидрохлорид

ATC code N06DX01

N06DX01

Marketed by Accord Healthcare S.L.U.

Accord Healthcare S.L.U.

INN (International Name) memantine

memantine

Documents in other languages

Patient Information leaflet Patient Information leaflet Spanish 13-01-2022
Summary of Product characteristics Summary of Product characteristics Spanish 13-01-2022
Public Assessment Report Public Assessment Report Spanish 16-12-2013
Patient Information leaflet Patient Information leaflet Czech 13-01-2022
Summary of Product characteristics Summary of Product characteristics Czech 13-01-2022
Public Assessment Report Public Assessment Report Czech 16-12-2013
Patient Information leaflet Patient Information leaflet Danish 13-01-2022
Summary of Product characteristics Summary of Product characteristics Danish 13-01-2022
Public Assessment Report Public Assessment Report Danish 16-12-2013
Patient Information leaflet Patient Information leaflet German 13-01-2022
Summary of Product characteristics Summary of Product characteristics German 13-01-2022
Public Assessment Report Public Assessment Report German 16-12-2013
Patient Information leaflet Patient Information leaflet Estonian 13-01-2022
Summary of Product characteristics Summary of Product characteristics Estonian 13-01-2022
Public Assessment Report Public Assessment Report Estonian 16-12-2013
Patient Information leaflet Patient Information leaflet Greek 13-01-2022
Summary of Product characteristics Summary of Product characteristics Greek 13-01-2022
Public Assessment Report Public Assessment Report Greek 16-12-2013
Patient Information leaflet Patient Information leaflet English 13-01-2022
Summary of Product characteristics Summary of Product characteristics English 13-01-2022
Public Assessment Report Public Assessment Report English 16-12-2013
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Summary of Product characteristics Summary of Product characteristics French 13-01-2022
Public Assessment Report Public Assessment Report French 16-12-2013
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Public Assessment Report Public Assessment Report Italian 16-12-2013
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Public Assessment Report Public Assessment Report Polish 16-12-2013
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Summary of Product characteristics Summary of Product characteristics Romanian 13-01-2022
Public Assessment Report Public Assessment Report Romanian 16-12-2013
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Summary of Product characteristics Summary of Product characteristics Slovak 13-01-2022
Public Assessment Report Public Assessment Report Slovak 16-12-2013
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Summary of Product characteristics Summary of Product characteristics Slovenian 13-01-2022
Public Assessment Report Public Assessment Report Slovenian 16-12-2013
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Public Assessment Report Public Assessment Report Finnish 16-12-2013
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Public Assessment Report Public Assessment Report Croatian 16-12-2013

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