Sitagliptin / Metformin hydrochloride Accord

Country: European Union

Language: Bulgarian

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
01-09-2022
Summary of Product characteristics Summary of Product characteristics (SPC)
01-09-2022
Public Assessment Report Public Assessment Report (PAR)
03-08-2022

Active ingredient:

metformin hydrochloride, sitagliptin hydrochloride monohydrate

Available from:

Accord Healthcare S.L.U.

ATC code:

A10BD07

INN (International Name):

sitagliptin, metformin hydrochloride

Therapeutic group:

Лекарства, използвани при диабет

Therapeutic area:

Захарен диабет тип 2

Therapeutic indications:

For adult patients with type 2 diabetes mellitus:It is indicated as an adjunct to diet and exercise to improve glycaemic control in patients inadequately controlled on their maximal tolerated dose of metformin alone or those already being treated with the combination of sitagliptin and metformin. It is indicated in combination with a sulphonylurea (i. тройно комбинирано лечение) като допълнение към диета и упражнения при пациенти, недостатъчно контролирани за тяхното максимално переносимой дозата на метформина и сульфонилмочевины. It is indicated as triple combination therapy with a peroxisome proliferator-activated receptor gamma (PPARγ) agonist (i. , a thiazolidinedione) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a PPARγ agonist. It is also indicated as add-on to insulin (i. , triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in patients when stable dose of insulin and metformin alone do not provide adequate glycaemic control.

Product summary:

Revision: 1

Authorization status:

упълномощен

Authorization date:

2022-07-22

Patient Information leaflet

                                36
Б. ЛИСТОВКА
37
ЛИСТОВКА: ИНФОРМАЦИЯ ЗА ПАЦИЕНТА
СИТАГЛИПТИН/МЕТФОРМИНОВ ХИДРОХЛОРИД
ACCORD 50 MG/850 MG ФИЛМИРАНИ ТАБЛЕТКИ
СИТАГЛИПТИН/МЕТФОРМИНОВ ХИДРОХЛОРИД
ACCORD 50 MG/1 000 MG ФИЛМИРАНИ ТАБЛЕТКИ
ситаглиптин/метформинов хидрохлорид
(sitagliptin/metformin 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, попитайте Вашия лекар,
фармацевт или
медицинска сестра.
-
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, фармацевт или
медицинска сестра. Това включва и
всички възможни нежелани реакции,
неописани в тази
листовка. Вижте точка 4.
КАКВО СЪДЪРЖА ТАЗИ ЛИСТОВКА
1.
Какво представлява
Ситаглиптин/Метформинов хидрохлорид
Accord и за какво се
използва
2.
Какво трябва да знаете, преди да
приемете Ситаглиптин/Метформинов
хидрохлорид
Accord
3.
Как да прием
                                
                                Read the complete document

Summary of Product characteristics

                                1
ПРИЛОЖЕНИЕ I
КРАТКА ХАРАКТЕРИСТИКА НА ПРОДУКТА
2
1.
ИМЕ НА ЛЕКАРСТВЕНИЯ ПРОДУКТ
Ситаглиптин/Метформинов хидрохлорид
Accord 50 mg/850 mg филмирани таблетки
Ситаглиптин/Метформинов хидрохлорид
Accord 50 mg/1 000 mg филмирани таблетки
2.
КАЧЕСТВЕН И КОЛИЧЕСТВЕН СЪСТАВ
Ситаглиптин/Метформинов хидрохлорид
Accord 50 mg/850 mg филмирани таблетки
Всяка таблетка съдържа ситаглиптинов
хидрохлорид монохидрат, еквивалентен
на 50 mg
ситаглиптин (sitagliptin),
и 850 mg метформинов хидрохлорид (metformin
hydrochloride).
Ситаглиптин/Метформинов хидрохлорид
Accord 50 mg/1 000 mg филмирани таблетки
Всяка таблетка съдържа ситаглиптинов
хидрохлорид монохидрат, еквивалентен
на 50 mg
ситаглиптин (sitagliptin), и 1 000 mg
метформинов хидрохлорид (metformin
hydrochloride).
За пълния списък на помощните
вещества вижте точка 6.1.
3.
ЛЕКАРСТВЕНА ФОРМА
Филмирана таблетка (таблетка)
Ситаглиптин/Метформинов хидрохлорид
Accord 50 mg/850 mg филмирани таблетки
Розова филмирана таблетка с форма на
капсула с вдлъбнато релефно означение
„SM2“ от
едната страна и гладка от другата
страна. Размери: 20х10 mm.
Ситаглиптин/Метформинов хидрохлорид
Accord 50 mg/1 000 mg филмирани таблетки
Червена филмирана таблетка с форма на
капсула с в
                                
                                Read the complete document

Similar products

Active ingredient metformin hydrochloride, sitagliptin hydrochloride monohydrate

metformin hydrochloride, sitagliptin hydrochloride monohydrate

ATC code A10BD07

A10BD07

Marketed by Accord Healthcare S.L.U.

Accord Healthcare S.L.U.

INN (International Name) sitagliptin, metformin hydrochloride

sitagliptin, metformin hydrochloride

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Patient Information leaflet Patient Information leaflet Spanish 01-09-2022
Summary of Product characteristics Summary of Product characteristics Spanish 01-09-2022
Public Assessment Report Public Assessment Report Spanish 03-08-2022
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Public Assessment Report Public Assessment Report Czech 03-08-2022
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Public Assessment Report Public Assessment Report Danish 03-08-2022
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Public Assessment Report Public Assessment Report Estonian 03-08-2022
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Sitagliptin / Metformin hydrochloride Accord