Atorvastatine STADA 10 mg, filmomhulde tabletten

מדינה: הולנד

שפה: הולנדית

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

מרכיב פעיל:

ATORVASTATINE CALCIUM 3-WATER 10,8 mg/stuk SAMENSTELLING overeenkomend met ; ATORVASTATINE 10 mg/stuk

זמין מ:

Stada Arzneimittel AG Stadastrasse 2-18 61118 BAD VILBEL (DUITSLAND)

קוד ATC:

C10AA05

INN (שם בינלאומי):

ATORVASTATINE CALCIUM 3-WATER 10,8 mg/stuk SAMENSTELLING overeenkomend met ; ATORVASTATINE 10 mg/stuk

טופס פרצבטיות:

Filmomhulde tablet

הרכב:

CALCIUMCARBONAAT (E 170) ; CELLULOSE, GEPOEDERD (E 460(ii)) ; CROSCARMELLOSE NATRIUM (E 468) ; HYPROMELLOSE (E 464) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; LACTOSE 1-WATER ; MACROGOL 8000 ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL, GEPREGELATINEERD ; TALK (E 553 B) ; TITAANDIOXIDE (E 171), CALCIUMCARBONAAT (E 170) ; CELLULOSE, GEPOEDERD (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; HYPROMELLOSE (E 464) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; LACTOSE 1-WATER ; MACROGOL 8000 ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL, GEPREGELATINEERD ; TALK (E 553 B) ; TITAANDIOXIDE (E 171),

מסלול נתינה (של תרופות):

Oraal gebruik

איזור תרפויטי:

Atorvastatin

leaflet_short:

Hulpstoffen: CALCIUMCARBONAAT (E 170); CELLULOSE, GEPOEDERD (E 460); CROSCARMELLOSE NATRIUM (E 468); HYPROMELLOSE (E 464); HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464); LACTOSE 1-WATER; MACROGOL 8000; MAGNESIUMSTEARAAT (E 470b); MAÏSZETMEEL, GEPREGELATINEERD; TALK (E 553 B); TITAANDIOXIDE (E 171);

תאריך אישור:

2016-04-14

עלון מידע

PACKAGE LEAFLET: INFORMATION FOR THE USER
ATORVASTATINE STADA 10 MG, FILMOMHULDE TABLETTEN
ATORVASTATINE STADA 20 MG, FILMOMHULDE TABLETTEN
ATORVASTATINE STADA 30 MG, FILMOMHULDE TABLETTEN
ATORVASTATINE STADA 40 MG, FILMOMHULDE TABLETTEN
ATORVASTATINE STADA 60 MG, FILMOMHULDE TABLETTEN
ATORVASTATINE STADA 80 MG, FILMOMHULDE TABLETTEN
atorvastatin
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, pharmacist or
nurse.
-
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, pharmacist or nurse.
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 known as statins, which
are lipid (fat)
regulating medicines.
[product name] is used to lower lipids known as cholesterol and
triglycerides in the blood when
a low fat diet and life style changes on their own have failed. If you
are at an increased risk of
heart disease, [product name] can also be used to reduce such risk
even if your cholesterol
levels are normal. You should maintain a standard cholesterol lowering
diet during treatment.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE [PRODUCT NAME]
DO NOT TAKE [PRODUCT NAME]
•
if you are allergic to atorvastatin or any of the other ingredients of
this medicine (listed in
section 6)
•
if you have or have ever had a disease which affects the liver
•
if you have had any unexplained abnormal blood tests for liver
function
•

מאפייני מוצר

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Atorvastatine STADA 10 mg, filmomhulde tabletten
Atorvastatine STADA 20 mg, filmomhulde tabletten
Atorvastatine STADA 30 mg, filmomhulde tabletten
Atorvastatine STADA 40 mg, filmomhulde tabletten
Atorvastatine STADA 60 mg, filmomhulde tabletten
Atorvastatine STADA 80 mg, filmomhulde tabletten
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
_[PRODUCT NAME] 10 MG FILM-COATED TABLETS _
Each film-coated tablet contains 10 mg of atorvastatin (as
atorvastatin calcium trihydrate).
Excipients with known effect
Each film-coated tablet contains 39 mg lactose monohydrate.
_[PRODUCT NAME] 20 MG FILM-COATED TABLETS _
Each film-coated tablet contains 20 mg of atorvastatin (as
atorvastatin calcium trihydrate).
Excipients with known effect
Each film-coated tablet contains 78 mg lactose monohydrate.
_[PRODUCT NAME] 30 MG FILM-COATED TABLETS _
Each film-coated tablet contains 30 mg of atorvastatin (as
atorvastatin calcium trihydrate).
Excipients with known effect
Each film-coated tablet contains 117 mg lactose monohydrate.
_[PRODUCT NAME] 40 MG FILM-COATED TABLETS _
Each film-coated tablet contains 40 mg of atorvastatin (as
atorvastatin calcium trihydrate).
Excipients with known effect
Each film-coated tablet contains 156 mg lactose monohydrate.
_[PRODUCT NAME] 60 MG FILM-COATED TABLETS _
Each film-coated tablet contains 60 mg of atorvastatin (as
atorvastatin calcium trihydrate).
Excipients with known effect
Each film-coated tablet contains 234 mg lactose monohydrate.
_[PRODUCT NAME] 80 MG FILM-COATED TABLETS _
Each film-coated tablet contains 80 mg of atorvastatin (as
atorvastatin calcium trihydrate).
Excipients with known effect
Each film-coated tablet contains 312 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablet.
_[PRODUCT NAME] 10 MG FILM-COATED TABLETS _
White to off-white, round, biconvex film-coated tablets, diameter: 6
mm.
_[PRODUCT NAME] 20 MG FILM-COATED TABLETS _
White to off-white, round, b