Rosuvastatine Torrent 40 mg, filmomhulde tabletten

Land: Nederland

Språk: nederlandsk

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

Aktiv ingrediens:

ROSUVASTATINE CALCIUM 0-WATER 41,7 mg/stuk SAMENSTELLING overeenkomend met ; ROSUVASTATINE 40 mg/stuk

Tilgjengelig fra:

Torrent Pharma GmbH Sudwestpark 50 90449 NURNBERG (DUITSLAND)

ATC-kode:

C10AA07

INN (International Name):

ROSUVASTATINE CALCIUM 0-WATER 41,7 mg/stuk SAMENSTELLING overeenkomend met ; ROSUVASTATINE 40 mg/stuk

Legemiddelform:

Filmomhulde tablet

Sammensetning:

CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CROSPOVIDON (E 1202) ; GLYCEROLTRIACETAAT (E 1518) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE ROOD (E 172) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; TITAANDIOXIDE (E 171), CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSPOVIDON (E 1202) ; GLYCEROLTRIACETAAT (E 1518) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE ROOD (E 172) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; TITAANDIOXIDE (E 171),

Administreringsrute:

Oraal gebruik

Terapeutisk område:

Rosuvastatin

Produkt oppsummering:

Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); CROSPOVIDON (E 1202); GLYCEROLTRIACETAAT (E 1518); HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464); IJZEROXIDE ROOD (E 172); LACTOSE 1-WATER; MAGNESIUMSTEARAAT (E 470b); TITAANDIOXIDE (E 171);

Autorisasjon dato:

1900-01-01

Informasjon til brukeren

Rosuvastatin Torrent 5/10/20/40 mg, filmomhulde tabletten, 5/10/20/40
mg, film-coated tablet – NL/H/2854/001-004/DC
NL pl
NL/p/003/17/12
PACKAGE LEAFLET: INFORMATION FOR THE USER
ROSUVASTATINE TORRENT 5 MG, FILMOMHULDE TABLETTEN
ROSUVASTATINE TORRENT 10 MG, FILMOMHULDE TABLETTEN
ROSUVASTATINE TORRENT 20 MG, FILMOMHULDE TABLETTEN
ROSUVASTATINE TORRENT 40 MG, FILMOMHULDE TABLETTEN
Rosuvastatin
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 [Product name] is and what it is used for
2.
What you need to know before you take [Product name]
3.
How to take [Product name]
4.
Possible side effects
5.
How to store [Product name]
6.
Contents of the pack and other information
1.
WHAT [PRODUCT NAME] IS AND WHAT IT IS USED FOR
[Product name] belongs to a group of medicines called statins.
YOU HAVE BEEN PRESCRIBED [PRODUCT NAME] BECAUSE:
•
You have a high cholesterol level. This means you are at risk from a
heart attack or stroke. [Product
name] is used in adults, adolescents and children 6 years or older to
treat high cholesterol.
You have been advised to take a statin, because changing your diet and
doing more exercise were not
enough to correct your cholesterol levels. You should continue with
your cholesterol-lowering diet and
exercise while you are taking [Product name].
Or
•
You have other factors that increase your risk of having a heart
attack, stroke or related health
problems.
Heart
attack,
stroke
and
other
problems
can
be
caused
by
a
disease
called
atherosclerosis.
Atherosclerosis is du

Preparatomtale

Rosuvastatin, 5/10/20/40 mg, film-coated tablet - NL/H/2854/001-004/DC
NL SmPC
NL/s/001/17/10
1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Rosuvastatine Torrent 5 mg, filmomhulde tabletten
Rosuvastatine Torrent 10 mg, filmomhulde tabletten
Rosuvastatine Torrent 20 mg, filmomhulde tabletten
Rosuvastatine Torrent 40 mg, filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Rosuvastatine Torrent 5 mg, filmomhulde tabletten
One film-coated tablet contains 5 mg rosuvastatin (as rosuvastatin
calcium).
Excipient with known effect
One film-coated tablet contains 50.7 mg lactose monohydrate.
Rosuvastatine Torrent 10 mg, filmomhulde tabletten
One film-coated tablet contains 10 mg rosuvastatin (as rosuvastatin
calcium).
Excipient with known effect
One film-coated tablet contains 101.3 mg lactose monohydrate.
Rosuvastatine Torrent 20 mg, filmomhulde tabletten
One film-coated tablet contains 20 mg rosuvastatin (as rosuvastatin
calcium).
Excipient with known effect
One film-coated tablet contains 202.6 mg lactose monohydrate.
Rosuvastatine Torrent 40 mg, filmomhulde tabletten
One film-coated tablet contains 40 mg rosuvastatin (as rosuvastatin
calcium).
Excipient with known effect
One film-coated tablet contains 194.6 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
Rosuvastatine Torrent 5 mg, filmomhulde tabletten
Yellow coloured, round, biconvex, film-coated tablets with a diameter
of approx. 5.7 mm, debossed
with “135” on one side and “5” on the other side.
Rosuvastatine Torrent 10 mg, filmomhulde tabletten
Light pink coloured, round, biconvex, film-coated tablets with a
diameter of approx. 7.5 mm, debossed
with break line on both sides, separating “11” and “36” on one
side and “10” on the other side.
Rosuvastatin, 5/10/20/40 mg, film-coated tablet - NL/H/2854/001-004/DC
NL SmPC
NL/s/001/17/10
2
The tablet can be divided into equal doses.
Rosuvastatine Torrent 20 mg, filmomhulde tabletten
Light pink col