Rozemib 20 mg/10 mg, filmomhulde tabletten

Country: Netherlands

Language: Dutch

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

Active ingredient:

EZETIMIB 10 mg/stuk ; ROSUVASTATINE CALCIUM 0-WATER 20,8 mg/stuk SAMENSTELLING overeenkomend met ; ROSUVASTATINE 20 mg/stuk

Available from:

Aurora Biofarma S.R.L. Via Nicola Antonio Porpora 127 20131 MILAAN (ITALIË)

INN (International Name):

EZETIMIB 10 mg/stuk ; ROSUVASTATINE CALCIUM 0-WATER 20,8 mg/stuk SAMENSTELLING overeenkomend met ; ROSUVASTATINE 20 mg/stuk

Pharmaceutical form:

Filmomhulde tablet

Composition:

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

Administration route:

Oraal gebruik

Authorization date:

2020-12-24

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
ROZEMIB 5 MG/10 MG, FILMOMHULDE TABLETTEN
ROZEMIB 10 MG/10 MG, FILMOMHULDE TABLETTEN
ROZEMIB 20 MG/10 MG, FILMOMHULDE TABLETTEN
ROZEMIB 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 Rozemib is and what it is used for
2.
What you need to know before you use Rozemib
3.
How to use Rozemib
4.
Possible side effects
5.
How to store Rozemib
6.
Contents of the pack and other information
1.
WHAT ROZEMIB IS AND WHAT IT IS USED FOR
Rozemib 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.
Rozemib 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 causing them to narrow.
Sometimes, these narrowed blood vessels can get blocked which can cut
off the blood supply to the
heart or brain lea

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Rozemib 5 mg/10 mg, filmomhulde tabletten
Rozemib 10 mg/10 mg, filmomhulde tabletten
Rozemib 20 mg/10 mg, filmomhulde tabletten
Rozemib 40 mg/10 mg, filmomhulde tabletten
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Rozemib 5 mg/10 mg
Each film-coated tablet contains 5.20 mg rosuvastatin calcium
(equivalent to 5 mg
rosuvastatin) and 10 mg of ezetimibe.
Rozemib 10 mg/10 mg
Each film-coated tablet contains 10.40 mg rosuvastatin calcium
(equivalent to 10 mg
rosuvastatin) and 10 mg of ezetimibe.
Rozemib 20 mg/10 mg
Each film-coated tablet contains 20.80 mg rosuvastatin calcium
(equivalent to 20 mg
rosuvastatin) and 10 mg of ezetimibe.
Rozemib 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:
Rozemib 5 mg/10 mg: Each film-coated tablet contains 200.50 mg of
lactose monohydrate.
Rozemib 10 mg/10 mg: Each film-coated tablet contains 200.50 mg of
lactose monohydrate.
Rozemib 20 mg/10 mg: Each film-coated tablet contains 200.50 mg of
lactose monohydrate.
Rozemib 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
Rozemib is indicated as adjunct to diet for treatment of primary
hypercholesterolemiaas
substitution therapy in adult patients adequately controlled with t