Sitagliptin / Metformin hydrochloride Sun

Country: European Union

Language: Bulgarian

Source: EMA (European Medicines Agency)

Buy It Now

Patient Information leaflet Patient Information leaflet (PIL)
17-07-2023
Summary of Product characteristics Summary of Product characteristics (SPC)
17-07-2023
Public Assessment Report Public Assessment Report (PAR)
17-07-2023

Active ingredient:

sitagliptin fumarate, metformin hydrochloride

Available from:

Sun Pharmaceutical Industries Europe B.V.

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:Sitagliptin/Metformin hydrochloride SUN 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. Sitagliptin/Metformin hydrochloride SUN 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. Sitagliptin/Metformin hydrochloride SUN 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. Sitagliptin/Metformin hydrochloride SUN 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.

Authorization status:

упълномощен

Authorization date:

2023-03-31

Patient Information leaflet

                                37
Б. ЛИСТОВКА
38
ЛИСТОВКА: ИНФОРМАЦИЯ ЗА ПАЦИЕНТА
СИТАГЛИПТИН/МЕТФОРМИНОВ ХИДРОХЛОРИД
SUN 50 MG/850
MG ФИЛМИРАНИ ТАБЛЕТКИ
СИТАГЛИПТИН/МЕТФОРМИНОВ ХИДРОХЛОРИД
SUN 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
SUN и за какво се използва
2.
Какво трябва да знаете, преди да
приемете Ситаглиптин/Метформинов
хидрохлорид SUN
3.
Как да приемате
Сит
                                
                                Read the complete document

Summary of Product characteristics

                                1
ПРИЛОЖЕНИЕ I
КРАТКА ХАРАКТЕРИСТИКА НА ПРОДУКТА
2
1.
ИМЕ НА ЛЕКАРСТВЕНИЯ ПРОДУКТ
Ситаглиптин/Метформинов хидрохлорид
SUN 50 mg/850 mg филмирани таблетки
Ситаглиптин/Метформинов хидрохлорид
SUN 50 mg/1 000 mg филмирани таблетки
2.
КАЧЕСТВЕН И КОЛИЧЕСТВЕН СЪСТАВ
Ситаглиптин/Метформинов хидрохлорид
SUN 50 mg/850 mg филмирани таблетки
Всяка таблетка съдържа ситаглиптинов
фумарат, еквивалентен на 50 mg
ситаглиптин
(sitagliptin), и 850 mg метформинов хидрохлорид
(metformin hydrochloride).
_Помощни вещества с известно действие_
Всяка филмирана таблетка съдържа 6,9 mg
хидрогенирано рициново масло.
Ситаглиптин/Метформинов хидрохлорид
SUN 50 mg/1 000 mg филмирани таблетки
Всяка таблетка съдържа ситаглиптинов
фумарат, еквивалентен на 50 mg
ситаглиптин
(sitagliptin), и 1 000 mg метформинов
хидрохлорид (metformin hydrochloride).
_Помощни вещества с известен ефект_
Всяка филмирана таблетка съдържа 8,0 mg
хидрогенирано рициново масло.
За пълния списък на помощните
вещества вижте точка 6.1.
3.
ЛЕКАРСТВЕНА ФОРМА
Филмирана таблетка (таблетка)
Ситаглиптин/Метформинов хидрохлорид
SUN 50 mg/850 mg филмирани таблетки
Розова филмирана таблетка с форма на
капсула, приблизителни размери 20 mm x 10
mm x
6 mm,с вдлъбн
                                
                                Read the complete document

Similar products

Active ingredient sitagliptin fumarate, metformin hydrochloride

sitagliptin fumarate, metformin hydrochloride

ATC code A10BD07

A10BD07

Marketed by Sun Pharmaceutical Industries Europe B.V.

Sun Pharmaceutical Industries Europe B.V.

INN (International Name) sitagliptin, metformin hydrochloride

sitagliptin, metformin hydrochloride

Documents in other languages

Patient Information leaflet Patient Information leaflet Spanish 17-07-2023
Summary of Product characteristics Summary of Product characteristics Spanish 17-07-2023
Public Assessment Report Public Assessment Report Spanish 17-07-2023
Patient Information leaflet Patient Information leaflet Czech 17-07-2023
Summary of Product characteristics Summary of Product characteristics Czech 17-07-2023
Public Assessment Report Public Assessment Report Czech 17-07-2023
Patient Information leaflet Patient Information leaflet Danish 17-07-2023
Summary of Product characteristics Summary of Product characteristics Danish 17-07-2023
Public Assessment Report Public Assessment Report Danish 17-07-2023
Patient Information leaflet Patient Information leaflet German 17-07-2023
Summary of Product characteristics Summary of Product characteristics German 17-07-2023
Public Assessment Report Public Assessment Report German 17-07-2023
Patient Information leaflet Patient Information leaflet Estonian 17-07-2023
Summary of Product characteristics Summary of Product characteristics Estonian 17-07-2023
Public Assessment Report Public Assessment Report Estonian 17-07-2023
Patient Information leaflet Patient Information leaflet Greek 17-07-2023
Summary of Product characteristics Summary of Product characteristics Greek 17-07-2023
Public Assessment Report Public Assessment Report Greek 17-07-2023
Patient Information leaflet Patient Information leaflet English 17-07-2023
Summary of Product characteristics Summary of Product characteristics English 17-07-2023
Public Assessment Report Public Assessment Report English 17-07-2023
Patient Information leaflet Patient Information leaflet French 17-07-2023
Summary of Product characteristics Summary of Product characteristics French 17-07-2023
Public Assessment Report Public Assessment Report French 17-07-2023
Patient Information leaflet Patient Information leaflet Italian 17-07-2023
Summary of Product characteristics Summary of Product characteristics Italian 17-07-2023
Public Assessment Report Public Assessment Report Italian 17-07-2023
Patient Information leaflet Patient Information leaflet Latvian 17-07-2023
Summary of Product characteristics Summary of Product characteristics Latvian 17-07-2023
Public Assessment Report Public Assessment Report Latvian 17-07-2023
Patient Information leaflet Patient Information leaflet Lithuanian 17-07-2023
Summary of Product characteristics Summary of Product characteristics Lithuanian 17-07-2023
Public Assessment Report Public Assessment Report Lithuanian 17-07-2023
Patient Information leaflet Patient Information leaflet Hungarian 17-07-2023
Summary of Product characteristics Summary of Product characteristics Hungarian 17-07-2023
Public Assessment Report Public Assessment Report Hungarian 17-07-2023
Patient Information leaflet Patient Information leaflet Maltese 17-07-2023
Summary of Product characteristics Summary of Product characteristics Maltese 17-07-2023
Public Assessment Report Public Assessment Report Maltese 17-07-2023
Patient Information leaflet Patient Information leaflet Dutch 17-07-2023
Summary of Product characteristics Summary of Product characteristics Dutch 17-07-2023
Public Assessment Report Public Assessment Report Dutch 17-07-2023
Patient Information leaflet Patient Information leaflet Polish 17-07-2023
Summary of Product characteristics Summary of Product characteristics Polish 17-07-2023
Public Assessment Report Public Assessment Report Polish 17-07-2023
Patient Information leaflet Patient Information leaflet Portuguese 17-07-2023
Summary of Product characteristics Summary of Product characteristics Portuguese 17-07-2023
Public Assessment Report Public Assessment Report Portuguese 17-07-2023
Patient Information leaflet Patient Information leaflet Romanian 17-07-2023
Summary of Product characteristics Summary of Product characteristics Romanian 17-07-2023
Public Assessment Report Public Assessment Report Romanian 17-07-2023
Patient Information leaflet Patient Information leaflet Slovak 17-07-2023
Summary of Product characteristics Summary of Product characteristics Slovak 17-07-2023
Public Assessment Report Public Assessment Report Slovak 17-07-2023
Patient Information leaflet Patient Information leaflet Slovenian 17-07-2023
Summary of Product characteristics Summary of Product characteristics Slovenian 17-07-2023
Public Assessment Report Public Assessment Report Slovenian 17-07-2023
Patient Information leaflet Patient Information leaflet Finnish 17-07-2023
Summary of Product characteristics Summary of Product characteristics Finnish 17-07-2023
Public Assessment Report Public Assessment Report Finnish 17-07-2023
Patient Information leaflet Patient Information leaflet Swedish 17-07-2023
Summary of Product characteristics Summary of Product characteristics Swedish 17-07-2023
Public Assessment Report Public Assessment Report Swedish 17-07-2023
Patient Information leaflet Patient Information leaflet Norwegian 17-07-2023
Summary of Product characteristics Summary of Product characteristics Norwegian 17-07-2023
Patient Information leaflet Patient Information leaflet Icelandic 17-07-2023
Summary of Product characteristics Summary of Product characteristics Icelandic 17-07-2023
Patient Information leaflet Patient Information leaflet Croatian 17-07-2023
Summary of Product characteristics Summary of Product characteristics Croatian 17-07-2023
Public Assessment Report Public Assessment Report Croatian 17-07-2023

Search alerts related to this product

Alerts Sitagliptin Metformin hydrochloride Sun fumarate, sitagliptin,

Sitagliptin Metformin hydrochloride Sun fumarate, sitagliptin,

View documents history

Documents history Documents history

Sitagliptin / Metformin hydrochloride Sun