Rozesta 40 mg/10 mg filmomhulde tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

EZETIMIB 10 mg/stuk ; ROSUVASTATINE CALCIUM 0-WATER 41,6 mg/stuk SAMENSTELLING overeenkomend met ; ROSUVASTATINE 40 mg/stuk

Beschikbaar vanaf:

Zentiva k.s. U kabelovny 130 102 37 PRAGUE 10 (TSJECHIË)

INN (Algemene Internationale Benaming):

EZETIMIB 10 mg/stuk ; ROSUVASTATINE CALCIUM 0-WATER 41,6 mg/stuk SAMENSTELLING overeenkomend met ; ROSUVASTATINE 40 mg/stuk

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

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

Toedieningsweg:

Oraal gebruik

Autorisatie datum:

1900-01-01

Bijsluiter

EN/NL PI_NL/H/4758/001-004_CMC 07.2023_addition of primary and
secondary packaging site
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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ROZESTA 5 MG/10 MG FILMOMHULDE TABLETTEN
ROZESTA 10 MG/10 MG FILMOMHULDE TABLETTEN
ROZESTA 20 MG/10 MG FILMOMHULDE TABLETTEN
ROZESTA 40 MG/10 MG FILMOMHULDE TABLETTEN
rosuvastatin/ezetimibe
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 Rozesta is and what it is used for
2. What you need to know before you take Rozesta
3. How to take Rozesta
4. Possible side effects
5. How to store Rozesta
6. Contents of the pack and other information
1.
WHAT ROZESTA IS AND WHAT IT IS USED FOR
Rozesta contains 2 different active substances in 1 tablet. One of the
active substances is
rosuvastatin, belonging to the group of so called statins, the other
active substance is ezetimibe.
Rozesta is a medicine used to lower levels of total cholesterol,
“bad” cholesterol (LDL
cholesterol), and fatty substances called triglycerides in the blood.
In addition, Rozesta raises
levels of “good” cholesterol (HDL cholesterol).
Rozesta works to reduce your cholesterol in 2 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” cholesterol because it can
build up in the walls of your
arteries forming plaque. Eventually this p

Productkenmerken

EN/NL PI_NL/H/4758/001-004 – Ezetimibe+rosuvastatin FCT_PRAC recom.
02.2023
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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Rozesta 5 mg/10 mg filmomhulde tabletten
Rozesta 10 mg/10 mg filmomhulde tabletten
Rozesta 20 mg/10 mg filmomhulde tabletten
Rozesta 40 mg/10 mg filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Rozesta
5 mg / 10 mg:
Each
film-coated
tablet
contains
5.20 mg
rosuvastatin
calcium
(equivalent to 5 mg rosuvastatin) and 10 mg ezetimibe.
Rozesta 10 mg / 10 mg: Each film-coated tablet contains 10.40 mg
rosuvastatin calcium
(equivalent to 10 mg rosuvastatin) and 10 mg ezetimibe.
Rozesta 20 mg / 10 mg: Each film-coated tablet contains 20.80 mg
rosuvastatin calcium
(equivalent to 20 mg rosuvastatin) and 10 mg ezetimibe.
Rozesta 40 mg / 10 mg: Each film-coated tablet contains 41.60 mg
rosuvastatin calcium
(equivalent to 40 mg rosuvastatin) and 10 mg ezetimibe.
Excipients with known effect
Rozesta 5 mg / 10 mg: Each film-coated tablet contains
200.50 mg lactose monohydrate
(equivalent to 190.47 mg lactose anhydrous).
Rozesta 10 mg / 10 mg: Each film-coated tablet contains 200.50 mg
lactose monohydrate
(equivalent to 190.47 mg lactose anhydrous).
Rozesta 20 mg / 10 mg: Each film-coated tablet contains 200.50 mg
lactose monohydrate
(equivalent to 190.47 mg lactose anhydrous).
Rozesta 40 mg / 10 mg: Each film-coated tablet contains 205.54 mg
lactose monohydrate.
(equivalent to 195.26 mg lactose anhydrous).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Rozesta 5 mg / 10 mg: Light yellow, round, biconvex film-coated
tablets with a diameter of 10
mm approximately and “EL5” embossed on one side.
Rozesta 10 mg / 10 mg: Beige, round, biconvex film-coated tablets with
a diameter of 10 mm
approximately and “EL4” embossed on one side.
EN/NL PI_NL/H/4758/001-004 – Ezetimibe+rosuvastatin FCT_PRAC recom.
02.2023
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Rozesta 20 mg / 10 mg: Yellow, round, biconvex film-coated tablets
with a diameter of 10 m