Ezetimibe/Atorvastatine Sandoz 10 mg/10 mg, filmomhulde tabletten

Kraj: Holandia

Język: niderlandzki

Źródło: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Składnik aktywny:

ATORVASTATINE CALCIUM 3-WATER 10,8 mg/stuk SAMENSTELLING overeenkomend met ; ATORVASTATINE 10 mg/stuk ; EZETIMIB 10 mg/stuk

INN (International Nazwa):

ATORVASTATINE CALCIUM 3-WATER 10,8 mg/stuk SAMENSTELLING overeenkomend met ; ATORVASTATINE 10 mg/stuk ; EZETIMIB 10 mg/stuk

Forma farmaceutyczna:

Filmomhulde tablet

Skład:

CALCIUMCARBONAAT (E 170) ; CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CROSCARMELLOSE NATRIUM (E 468) ; HYPROLOSE (E 463) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE GEEL (E 172) ; LACTOSE 1-WATER ; MACROGOL 4000 ; MAGNESIUMSTEARAAT (E 470b) ; MANNITOL (D-) (E 421) ; NATRIUMLAURILSULFAAT ; POLYSORBAAT 80 (E 433) ; POVIDON K 30 (E 1201) ; TITAANDIOXIDE (E 171), CALCIUMCARBONAAT (E 170) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; HYPROLOSE (E 463) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE GEEL (E 172) ; LACTOSE 1-WATER ; MACROGOL 4000 ; MAGNESIUMSTEARAAT (E 470b) ; MANNITOL (D-) (E 421) ; NATRIUMLAURILSULFAAT (E 487) ; POLYSORBAAT 80 (E 433) ; POVIDON K 30 (E 1201) ; TITAANDIOXIDE (E 171)

Droga podania:

Oraal gebruik

Data autoryzacji:

1900-01-01

Ulotka dla pacjenta

Hexal
Ezetimibe/Atorvastatine Sandoz 10 mg/10,20,40,80 mg,
filmomhulde tabletten
RVG 126886-9
Page 1/6
1313-v3
1.3.1.3 Package Leaflet
November 2023
PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
EZETIMIBE/ATORVASTATINE SANDOZ 10 MG/10 MG, FILMOMHULDE TABLETTEN
EZETIMIBE/ATORVASTATINE SANDOZ 10 MG/20 MG, FILMOMHULDE TABLETTEN
EZETIMIBE/ATORVASTATINE SANDOZ 10 MG/40 MG, FILMOMHULDE TABLETTEN
EZETIMIBE/ATORVASTATINE SANDOZ 10 MG/80 MG, FILMOMHULDE TABLETTEN
ezetimibe and atorvastatin
_ _
_ _
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
1. What [Nationally completed name] is and what it is used for
2. What you need to know before you take [Nationally completed name]
3. How to take [Nationally completed name]
4. Possible side effects
5. How to store [Nationally completed name]
6. Contents of the pack and other information
1. WHAT [NATIONALLY COMPLETED NAME] IS AND WHAT IT IS USED FOR
_ _
[Nationally completed name] is a medicine to lower increased levels of
cholesterol. [Nationally
completed name] contains ezetimibe and atorvastatin.
[Nationally completed name] is used in adults to lower levels of total
cholesterol, “bad” cholesterol
(LDL cholesterol), and fatty substances called triglycerides in the
blood. In addition, [Nationally
completed name] raises levels of “good” cholesterol (HDL
cholesterol).
[Nationally completed name] works to reduce your cholesterol in two
ways. It reduces the cholesterol
absorbed in your digestive tract, as well as the cholesterol your body
makes by itself.
Cholesterol is one

Charakterystyka produktu

Sandoz
Page 1/28
Ezetimibe/Atorvastatine Sandoz 10 mg/10,20,40,80 mg,
filmomhulde tabletten
RVG 126886-89
1311-v2
1.3.1.1 Summary of Product Characteristics
maart 2023
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Ezetimibe/Atorvastatine Sandoz 10 mg/10 mg, filmomhulde tabletten
Ezetimibe/Atorvastatine Sandoz 10 mg/20 mg, filmomhulde tabletten
Ezetimibe/Atorvastatine Sandoz 10 mg/40 mg, filmomhulde tabletten
Ezetimibe/Atorvastatine Sandoz 10 mg/80 mg, filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
{[Nationally completed name]}
10 mg/ 10 mg film-coated tablets
Each film-coated tablet contains 10 mg of ezetimibe and 10 mg of
atorvastatin (as calcium trihydrate).
{[Nationally completed name]}
10 mg/ 20 mg film-coated tablets
Each film-coated tablet contains 10 mg of ezetimibe and 20 mg of
atorvastatin (as calcium trihydrate).
{[Nationally completed name]}
10 mg/ 40 mg film-coated tablets
Each film-coated tablet contains 10 mg of ezetimibe and 40 mg of
atorvastatin (as calcium trihydrate).
{[Nationally completed name]}
10 mg/ 80 mg film-coated tablets
Each film-coated tablet contains 10 mg of ezetimibe and 80 mg of
atorvastatin (as calcium trihydrate).
Excipients with known effect
Each [Nationally completed name] 10 mg/ 10 mg film-coated tablet
contains 2.74 mg of lactose.
Each [Nationally completed name] 10 mg/ 20 mg film-coated tablet
contains 3.76 mg of lactose.
Each [Nationally completed name] 10 mg/ 40 mg film-coated tablet
contains 5.81 mg of lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
{[Nationally completed name]}
10 mg/ 10 mg film-coated tablets
White, round, biconvex film-coated tablets, with diameter 8.1 mm
approximately
{[Nationally completed name]}
10 mg/ 20 mg film-coated tablets
Sandoz
Page 2/28
Ezetimibe/Atorvastatine Sandoz 10 mg/10,20,40,80 mg,
filmomhulde tabletten
RVG 126886-89
1311-v2
1.3.1.1 Summary of Product Characteristics
maart 2023
White, ovaloid, biconvex film-coated tablets, with dimensions 11