Ezetimibe/Atorvastatine Elpen 10 mg/20 mg, filmomhulde tabletten

Pajjiż: Olanda

Lingwa: Olandiż

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

Ingredjent attiv:

ATORVASTATINE CALCIUM 3-WATER 21,69 mg/stuk SAMENSTELLING overeenkomend met ; ATORVASTATINE 20 mg/stuk ; EZETIMIB 10 mg/stuk

INN (Isem Internazzjonali):

ATORVASTATINE CALCIUM 3-WATER 21,69 mg/stuk SAMENSTELLING overeenkomend met ; ATORVASTATINE 20 mg/stuk ; EZETIMIB 10 mg/stuk

Għamla farmaċewtika:

Filmomhulde tablet

Kompożizzjoni:

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)

Rotta amministrattiva:

Oraal gebruik

Data ta 'l-awtorizzazzjoni:

1900-01-01

Fuljett ta 'informazzjoni

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
EZETIMIBE/ATORVASTATINE ELPEN 10 MG/10 MG, FILMOMHULDE TABLETTEN
EZETIMIBE/ATORVASTATINE ELPEN 10 MG/20 MG, FILMOMHULDE TABLETTEN
EZETIMIBE/ATORVASTATINE ELPEN 10 MG/40 MG, FILMOMHULDE TABLETTEN
EZETIMIBE/ATORVASTATINE ELPEN 10 MG/80 MG, FILMOMHULDE TABLETTEN
ezetimibe/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.
WHAT IS IN THIS LEAFLET
1.
What Ezetimib/Atorvastatin Elpen is and what it is used for
2.
What you need to know before you take Ezetimib/Atorvastatin Elpen
3.
How to take Ezetimib/Atorvastatin Elpen
4.
Possible side effects
5.
How to store Ezetimib/Atorvastatin Elpen
6.
Contents of the pack and other information
1.
WHAT EZETIMIB/ATORVASTATIN ELPEN IS AND WHAT IT IS USED FOR
Ezetimib/Atorvastatin Elpen is a medicine to lower increased levels of
cholesterol.
Ezetimib/Atorvastatin Elpen contains ezetimibe and atorvastatin.
Ezetimib/Atorvastatin Elpen is used in adults to lower levels of total
cholesterol, “bad” cholesterol
(LDL cholesterol), and fatty substances called triglycerides in the
blood. In addition,
Ezetimib/Atorvastatin Elpen raises levels of “good” cholesterol
(HDL cholesterol).
Ezetimib/Atorvastatin Elpen 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 of several fatty substances found in the
bloodstream. Your total cholesterol is made
up mainly of LDL and HDL cholesterol.
LDL cholesterol is often called “bad�

Karatteristiċi tal-prodott

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Ezetimibe/Atorvastatine Elpen 10 mg/10 mg, filmomhulde tabletten
Ezetimibe/Atorvastatine Elpen 10 mg/20 mg, filmomhulde tabletten
Ezetimibe/Atorvastatine Elpen 10 mg/40 mg, filmomhulde tabletten
Ezetimibe/Atorvastatine Elpen 10 mg/80 mg, filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ezetimib/Atorvastatin Elpen 10 mg/10 mg film-coated tablets
Each film-coated tablet contains 10 mg of ezetimibe and 10 mg of
atorvastatin (as atorvastatin
calcium trihydrate).
Ezetimib/Atorvastatin Elpen 10 mg/20 mg film-coated tablets
Each film-coated tablet contains 10 mg of ezetimibe and 20 mg of
atorvastatin (as atorvastatin
calcium trihydrate).
Ezetimib/Atorvastatin Elpen 10 mg/40 mg film-coated tablets
Each film-coated tablet contains 10 mg of ezetimibe and 40 mg of
atorvastatin (as atorvastatin
calcium trihydrate).
Ezetimib/Atorvastatin Elpen 10 mg/80 mg film-coated tablets
Each film-coated tablet contains 10 mg of ezetimibe and 80 mg of
atorvastatin (as atorvastatin
calcium trihydrate).
Excipients with known effect
Each Ezetimib/Atorvastatin Elpen 10 mg/ 10 mg film-coated tablet
contains 2.74 mg of lactose.
Each Ezetimib/Atorvastatin Elpen 10 mg/ 20 mg film-coated tablet
contains 3.76 mg of lactose.
Each Ezetimib/Atorvastatin Elpen 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
Ezetimib/Atorvastatin Elpen10 mg/ 10 mg film-coated tablet
White, round, biconvex film-coated tablets, with diameter 8.1 mm
approximately
Ezetimib/Atorvastatin Elpen 10 mg/ 20 mg film-coated tablet
White, ovaloid, biconvex film-coated tablets, with dimensions 11.6 x
7.1 mm approximately
Ezetimib/Atorvastatin Elpen 10 mg/ 40 mg film-coated tablet
White, capsule shape, biconvex film-coated tablets, with dimensions
16.1 x 6.1 mm approximately
Ezetimib/Atorvastatin Elpen10 mg/ 80 mg film-coated tablet
Yellow, oblong, biconvex film-coated tablets, with dimensions 19