Rosuvastatine/Ezetimibe Ferrer 5 mg/10 mg filmomhulde tabletten

Țară: Țările de Jos

Limbă: olandeză

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

Ingredient activ:

EZETIMIB ; ROSUVASTATINE CALCIUM 0-WATER SAMENSTELLING overeenkomend met ; ROSUVASTATINE

Disponibil de la:

Ferrer International S.A. Gran Via Carlos III, 94 08028 BARCELONA (SPANJE)

Codul ATC:

C10BA06

INN (nume internaţional):

EZETIMIB ; ROSUVASTATIN CALCIUM 0-WATER COMPOSITION corresponding to ; ROSUVASTATIN

Forma farmaceutică:

Filmomhulde tablet

Compoziție:

CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; LACTOSE 1-WATER ; MACROGOL 4000 ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMLAURILSULFAAT (E 487) ; POVIDON K 30 (E 1201) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171)

Calea de administrare:

Oraal gebruik

Zonă Terapeutică:

Rosuvastatin and ezetimibe

Data de autorizare:

2020-01-16

Prospect

PACKAGE LEAFLET: INFORMATION FOR THE USER
ROSUVASTATINE/EZETIMIBE FERRER 5 MG/10 MG FILMOMHULDE TABLETTEN
ROSUVASTATINE/EZETIMIBE FERRER 10 MG/10 MG FILMOMHULDE TABLETTEN
ROSUVASTATINE/EZETIMIBE FERRER 20 MG/10 MG FILMOMHULDE TABLETTEN
ROSUVASTATINE/EZETIMIBE FERRER 40 MG/10 MG FILMOMHULDE TABLETTEN
ROSUVASTATIN & EZETIMIBE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 is and what it is used for
2.
What you need to know before you use
3.
How to use
4.
Possible side effects
5.
How to store
6.
Contents of the pack and other information
1.
WHAT IS AND WHAT IT IS USED FOR
contains two different active substances in one film
coated tablet. One of the active
substances is rosuvastatin calcium, belonging to the group of so
called statins, the other active
substance is ezetimibe.
is a medicine used to lower levels of total
cholesterol, “bad” cholesterol (LDL
cholesterol) and fatty substances called triglycerides in your blood.
In addition, it also raises levels of
“good” cholesterol (HDL cholesterol). This medicine 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.
For most people, high cholesterol does not affect the way they feel
because it does not produce any
symptoms. However, if it is left untreated, fatty deposits can build
up in the walls of your blood
vessels cau

Caracteristicilor produsului

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Rosuvastatine/Ezetimibe Ferrer 5 mg/10 mg filmomhulde tabletten
Rosuvastatine/Ezetimibe Ferrer 10 mg/10 mg filmomhulde tabletten
Rosuvastatine/Ezetimibe Ferrer 20 mg/10 mg filmomhulde tabletten
Rosuvastatine/Ezetimibe Ferrer 40 mg/10 mg filmomhulde tabletten
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
5 mg/10 mg
Each film-coated tablet contains 5.20 mg rosuvastatin calcium
(equivalent to 5 mg
rosuvastatin) and 10 mg of ezetimibe.
10 mg/10 mg
Each film-coated tablet contains 10.40 mg rosuvastatin calcium
(equivalent to 10 mg
rosuvastatin) and 10 mg of ezetimibe.
20 mg/10 mg
Each film-coated tablet contains 20.80 mg rosuvastatin calcium
(equivalent to 20 mg
rosuvastatin) and 10 mg of ezetimibe.
40 mg/10 mg
Each film-coated tablet contains 41.60 mg rosuvastatin calcium
(equivalent to 40 mg
rosuvastatin) and 10 mg of ezetimibe.
Excipients with known effect:
5 mg/10 mg: Each film-coated tablet contains 200.50 mg
of lactose
monohydrate.
10 mg/10 mg: Each film-coated tablet contains 200.50 mg
of lactose
monohydrate.
20 mg/10 mg: Each film-coated tablet contains 200.50 mg
of lactose
monohydrate.
40 mg/10 mg: Each film-coated tablet contains 200.50 mg
of lactose
monohydrate.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film coated tablets
5 mg / 10 mg: Light yellow, round, biconvex film coated tablets
with a diameter of 10mm
approximately and "EL 5" embossed on one side
10 mg / 10 mg: Beige, round, biconvex film coated tablets
with a diameter of 10mm
approximately and "EL 4" embossed on one side
20 mg / 10 mg: Yellow, round, biconvex film coated tablets
with a diameter of 10mm
approximately and "EL 3" embossed on one side
40 mg / 10 mg: White, round, biconvex film coated tablets with a
diameter of 10mm
approximately and "EL 2" embossed on one side
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS

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