Rosuvastatine Apotex 20 mg filmomhulde tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

ROSUVASTATINE CALCIUM 0-WATER SAMENSTELLING overeenkomend met ; ROSUVASTATINE

Beschikbaar vanaf:

Apotex Europe BV Archimedesweg 2 2333 CN LEIDEN

ATC-code:

C10AA07

INN (Algemene Internationale Benaming):

ROSUVASTATIN CALCIUM 0-WATER COMPOSITION corresponding to ; ROSUVASTATIN

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSPOVIDON (E 1202) ; HYPROLOSE (E 463) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE ROOD (E 172) ; LACTOSE 1-WATER ; MACROGOL 8000 ; MAGNESIUMSTEARAAT (E 470b) ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171),

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Rosuvastatin

Product samenvatting:

Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); CROSPOVIDON (E 1202); HYPROLOSE (E 463); HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464); IJZEROXIDE ROOD (E 172); LACTOSE 1-WATER; MACROGOL 8000; MAGNESIUMSTEARAAT (E 470b); SILICIUMDIOXIDE (E 551); TITAANDIOXIDE (E 171);

Autorisatie datum:

2016-08-22

Bijsluiter

MODULE 1.3
Product Information
Version: 2019-09
MODULE 1.3.1
Package Leaflet
Replaces: 2019-04
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
ROSUVASTATIN APOTEX 5 MG FILMOMHULDE TABLETTEN
ROSUVASTATIN APOTEX 10 MG FILMOMHULDE TABLETTEN ROSUVASTATIN APOTEX 20 MG FILMOMHULDE TABLETTEN
ROSUVASTATIN APOTEX 40 MG FILMOMHULDE TABLETTEN
Rosuvastatin
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 Rosuvastatin Apotex is and what it is used for
2. What you need to know before you take Rosuvastatin Apotex
3. How to take Rosuvastatin Apotex
4. Possible side effects
5. How to store Rosuvastatin Apotex
6. Contents of the pack and other information
1.
WHAT ROSUVASTATIN APOTEX IS AND WHAT IT IS USED FOR
Rosuvastatin Apotex belongs to a group of medicines called statins.
You have been prescribed Rosuvastatin because:
You have a high cholesterol level. This means you are at risk from a
heart attack or stroke. Rosuvastatin 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
taking more exercise were not
enough to correct your cholesterol levels. You should continue with
your cholesterol-lowering diet and
exercise while you are taking Rosuvastatin.
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 y

Productkenmerken

MODULE 1.3
Product Information
Version: 2019-09
MODULE 1.3.1
Summary of Product Characteristics
Replaces : 2019-4
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Rosuvastatine Apotex 5 mg
filmomhulde tabletten
Rosuvastatine Apotex 10 mg
filmomhulde tabletten
Rosuvastatine Apotex 20 mg
filmomhulde tabletten
Rosuvastatine Apotex 40 mg
filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Rosuvastatine Apotex 5 mg
filmomhulde tabletten
: Each film- coated tablet contains 5.20 mg
rosuvastatin calcium equivalent to 5 mg rosuvastatin.
Excipient(s) with known effect: Lactose monohydrate.
Each tablet contains 68.70 mg lactose
monohydrate.
Rosuvastatine Apotex 10 mg
filmomhulde tabletten
: Each film- coated tablet contains 10.40 mg
rosuvastatin calcium equivalent to 10 mg rosuvastatin.
Excipient(s) with known effect: Lactose monohydrate. Each tablet
contains 100.45 mg lactose
monohydrate.
Rosuvastatine Apotex 20 mg
filmomhulde tabletten
: Each film- coated tablet contains 20.79 mg
rosuvastatin calcium equivalent to 20 mg rosuvastatin.
Excipient(s) with known effect: Lactose monohydrate. Each tablet
contains 200.91 mg lactose
monohydrate.
Rosuvastatine Apotex 40 mg
filmomhulde tabletten
: Each film- coated tablet contains 41.60 mg
rosuvastatin calcium equivalent to 40 mg rosuvastatin.
Excipient(s) with known effect: Lactose monohydrate. Each tablet
contains 180.10 mg lactose
monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
filmcoated tablet
Rosuvastatine Apotex 5 mg
filmomhulde tabletten
are yellow, (6.35 mm)_ _ round, biconvex, film
coated tablets, engraved ‘APO’ on one side and ’ROS’ over
‘5’ on the other side.
Rosuvastatine Apotex 10 mg
filmomhulde tabletten
are pink, (7.14mm) round, biconvex, film-
coated tablets, engraved ‘APO’ on one side and ’ROS’ over
‘10’ on the other side.
Rosuvastatine Apotex 20 mg
filmomhulde tabletten
are pink, (9.52 mm) round, biconvex, film-
coated tablets, engraved ‘APO’ on one side and ’ROS�