Atorvastatine STADA 80 mg, filmomhulde tabletten

País: Països Baixos

Idioma: neerlandès

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

ingredients actius:

ATORVASTATINE CALCIUM 3-WATER 86,6 mg/stuk SAMENSTELLING overeenkomend met ; ATORVASTATINE 80 mg/stuk

Disponible des:

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

Codi ATC:

C10AA05

Designació comuna internacional (DCI):

ATORVASTATINE CALCIUM 3-WATER 86,6 mg/stuk SAMENSTELLING overeenkomend met ; ATORVASTATINE 80 mg/stuk

formulario farmacéutico:

Filmomhulde tablet

Composición:

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),

Vía de administración:

Oraal gebruik

Área terapéutica:

Atorvastatin

Resumen del producto:

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);

Data d'autorització:

2016-04-14

Informació per a l'usuari

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
•

Fitxa tècnica

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