Rosuvastatine Denk 20 mg, filmomhulde tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

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

Beschikbaar vanaf:

Denk Pharma GmbH & Co. KG Prinzregentenstrasse 79 81675 MÜNCHEN (DUITSLAND)

ATC-code:

C10AA07

INN (Algemene Internationale Benaming):

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

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSPOVIDON (E 1202) ; GLYCEROLTRIACETAAT (E 1518) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; LACTOSE 1-WATER ; MACROGOL 3350 ; MAGNESIUMSTEARAAT (E 470b) ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171) ; TRINATRIUMCITRAAT 2-WATER (E 331),

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Rosuvastatin

Product samenvatting:

Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); CROSPOVIDON (E 1202); GLYCEROLTRIACETAAT (E 1518); HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464); LACTOSE 1-WATER; MACROGOL 3350; MAGNESIUMSTEARAAT (E 470b); SILICIUMDIOXIDE (E 551); TITAANDIOXIDE (E 171); TRINATRIUMCITRAAT 2-WATER (E 331);

Autorisatie datum:

2017-06-02

Bijsluiter

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ROSUVASTATINE DENK
5 MG, FILMOMHULDE TABLETTEN
ROSUVASTATINE DENK 10 MG, FILMOMHULDE TABLETTEN
ROSUVASTATINE DENK 20 MG, FILMOMHULDE TABLETTEN
ROSUVASTATINE DENK 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 [Invented name] is and what it is used for
2. What you need to know before you take [Invented name]
3. How to take [Invented name]
4. Possible side effects
5. How to store [Invented name]
6. Contents of the pack and other information
1.
WHAT [INVENTED NAME] IS AND WHAT IT IS USED FOR
[Invented name] belongs to a group of medicines called statins.
You have been prescribed [Invented name] because:
•
You have a
HIGH CHOLESTEROL LEVEL
. This means you are
AT RISK FROM A HEART ATTACK OR STROKE
.
[Invented 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 [Invented 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 due to build up of fatty deposits in your arteries.
WHY IT IS IMPORTANT TO KEEP TAKING [INVENTED NAME]
[Invented name] is used to correct

Productkenmerken

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Rosuvastatine Denk 5 mg, filmomhulde tabletten
Rosuvastatine Denk 10 mg, filmomhulde tabletten
Rosuvastatine Denk 20 mg, filmomhulde tabletten
Rosuvastatine Denk 40 mg, filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
[Invented name] 5 mg film-coated tablets: Each film-coated tablet
contains 5 mg rosuvastatin (as
rosuvastatin calcium).
[Invented name] 10 mg film-coated tablets: Each film-coated tablet
contains 10 mg rosuvastatin (as
rosuvastatin calcium).
[Invented name] 20 mg film-coated tablets: Each film-coated tablet
contains 20 mg rosuvastatin (as
rosuvastatin calcium).
[Invented name] 40 mg film-coated tablets: Each film-coated tablet
contains 40 mg rosuvastatin (as
rosuvastatin calcium).
Excipient with known effect: lactose monohydrate.
[Invented name] 5 mg film-coated tablets: Each film-coated tablet
contains 41.572 mg lactose
monohydrate.
[Invented name] 10 mg film-coated tablets: Each film-coated tablet
contains 83.145 mg lactose
monohydrate.
[Invented name] 20 mg film-coated tablets: Each film-coated tablet
contains 166.29 mg lactose
monohydrate.
[Invented name] 40 mg film-coated tablets: Each film-coated tablet
contains 332.58 mg lactose
monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
[Invented name] 5 mg film-coated tablets: White or almost white, round
and biconvex film-coated
tablets, engraving “5” on the one side, with a diameter of 4.9 mm
– 5.3 mm.
[Invented name] 10 mg film-coated tablets: White or almost white,
round and biconvex film-coated
tablets, engraving “10” on the one side, with a diameter of 6.9 mm
– 7.3 mm.
[Invented name] 20 mg film-coated tablets: White or almost white,
round and biconvex film-coated
tablets, engraving “20” on the one side, with a diameter of 8.9 mm
– 9.3 mm.
[Invented name] 40 mg film-coated tablets: White or almost white,
oblong and biconvex film-coated
tablets, with a width of 6.4 mm – 6.8 mm and a le