Tovastibe 10 mg/80 mg, filmomhulde tabletten

Pays: Pays-Bas

Langue: néerlandais

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

Ingrédients actifs:

ATORVASTATINE CALCIUM 3-WATER SAMENSTELLING overeenkomend met ; ATORVASTATINE ; EZETIMIB

DCI (Dénomination commune internationale):

ATORVASTATIN CALCIUM 3-WATER COMPOSITION equivalent to ; ATORVASTATIN ; EZETIMIB

forme pharmaceutique:

Filmomhulde tablet

Composition:

CALCIUMCARBONAAT (E 170) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; HYPROLOSE (E 463) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE GEEL (E 172) ; MACROGOL 400 ; MAGNESIUMSTEARAAT (E 470b) ; MANNITOL (D-) (E 421) ; NATRIUMLAURILSULFAAT (E 487) ; POLYSORBAAT 80 (E 433) ; POVIDON K 30 (E 1201) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171)

Mode d'administration:

Oraal gebruik

Date de l'autorisation:

2021-11-19

Notice patient

PACKAGE LEAFLET
BIJSLUITER: INFORMATIE VOOR DE PATIËNT
TOVASTIBE 10 MG/ 10 MG, FILMOMHULDE TABLETTEN
TOVASTIBE 10 MG/ 20 MG, FILMOMHULDE TABLETTEN
TOVASTIBE 10 MG/ 40 MG, FILMOMHULDE TABLETTEN
TOVASTIBE 10 MG/ 80 MG, FILMOMHULDE TABLETTEN
ezetimibe and 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 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.
1. What Tovastibe is and what it is used for
2. What you need to know before you take Tovastibe
3. How to take Tovastibe
4. Possible side effects
5. How to store Tovastibe
6. Contents of the pack and other information
1. WHAT TOVASTIBE IS AND WHAT IT IS USED FOR
_ _
Tovastibe is a medicine to lower increased levels of cholesterol.
Tovastibe contains ezetimibe and
atorvastatin.
Tovastibe is used in adults to lower levels of total cholesterol,
“bad” cholesterol (LDL cholesterol),
and fatty substances called triglycerides in the blood. In addition,
Tovastibe raises levels of “good”
cholesterol (HDL cholesterol).
Tovastibe works to reduce your cholesterol in two ways. It reduces the
cholesterol absorbed in your
digestive tract, as well as the cholesterol your body makes by itself.
Cholesterol is one of several fatty substances found in the
bloodstream. Your total cholesterol is made
up mainly of LDL and HDL cholesterol.
LDL cholesterol is often called “bad” cholesterol because it can
build up in the walls of your arteries
forming plaque. Eventually this plaque build-up can lead to a
narrowing of the arteries. This
narrowing can slow or block blood flow to vital organs such as the
heart and brain. This

Résumé des caractéristiques du produit

SAMENVATTING VAN DE PRODUCTKENMERKEN
1.
NAAM VAN HET GENEESMIDDEL
Tovastibe
10 mg/ 10 mg, filmomhulde tabletten
Tovastibe
10 mg/ 20 mg, filmomhulde tabletten
Tovastibe
10 mg/ 40 mg, filmomhulde tabletten
Tovastibe
10 mg/ 80 mg, filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Tovastibe
10 mg/ 10 mg film-coated tablets
Each film-coated tablet contains 10 mg of ezetimibe and 10 mg of
atorvastatin (as calcium trihydrate).
Tovastibe
10 mg/ 20 mg film-coated tablets
Each film-coated tablet contains 10 mg of ezetimibe and 20 mg of
atorvastatin (as calcium trihydrate).
Tovastibe
10 mg/ 40 mg film-coated tablets
Each film-coated tablet contains 10 mg of ezetimibe and 40 mg of
atorvastatin (as calcium trihydrate).
Tovastibe
10 mg/ 80 mg film-coated tablets
Each film-coated tablet contains 10 mg of ezetimibe and 80 mg of
atorvastatin (as calcium trihydrate).
Excipients with known effect
Each Tovastibe 10 mg/ 10 mg film-coated tablet contains 2.74 mg of
lactose.
Each Tovastibe 10 mg/ 20 mg film-coated tablet contains 3.76 mg of
lactose.
Each Tovastibe 10 mg/ 40 mg film-coated tablet contains 5.81 mg of
lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
Tovastibe
10 mg/ 10 mg film-coated tablets
White, round, biconvex film-coated tablets, with diameter 8.1 mm
approximately
Tovastibe
10 mg/ 20 mg film-coated tablets
White, ovaloid, biconvex film-coated tablets, with dimensions 11.6 x
7.1 mm approximately
Tovastibe
10 mg/ 40 mg film-coated tablets
White, capsule shape, biconvex film-coated tablets, with dimensions
16.1 x 6.1 mm approximately
Tovastibe
10 mg/ 80 mg film-coated tablets
Yellow, oblong, biconvex film-coated tablets, with dimensions 19.1 x
7.6 mm approximately
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Hypercholesterolaemia
Tovastibe as an adjunct to diet is indicated as substitution therapy
for treatment of adults with primary
(heterozygous
and
homozygous
familial
and
non-familial)
hypercholesterolaemia
or
mixed
hyperlipidaemia already con