Atozet 10mg/80mg film-coated Tablets

Pays: Malte

Langue: anglais

Source: Medicines Authority

Ingrédients actifs:

ATORVASTATIN, EZETIMIBE

Disponible depuis:

Merck Sharp & Dohme B.V. Waarderweg 39, Haarlem Noord-Holland, 2031 BN, Netherlands

Code ATC:

C10BA05

DCI (Dénomination commune internationale):

ATORVASTATIN, EZETIMIBE

forme pharmaceutique:

FILM-COATED TABLET

Composition:

ATORVASTATIN 80 milligram(s) ; EZETIMIBE 10 milligram(s)

Type d'ordonnance:

POM

Domaine thérapeutique:

LIPID MODIFYING AGENTS

Statut de autorisation:

Authorised

Date de l'autorisation:

2014-10-17

Notice patient

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PACKAGE LEAFLET: INFORMATION FOR THE USER
ATOZET 10 MG/10 MG FILM-COATED TABLETS
ATOZET 10 MG/20 MG FILM-COATED TABLETS
ATOZET 10 MG/40 MG FILM-COATED TABLETS
ATOZET 10 MG/80 MG FILM-COATED TABLETS
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.
WHAT IS IN THIS LEAFLET
1.
What ATOZET is and what it is used for
2.
What you need to know before you take ATOZET
3.
How to take ATOZET
4.
Possible side effects
5.
How to store ATOZET
6.
Contents of the pack and other information
1.
WHAT ATOZETATOZET IS AND WHAT IT IS USED FOR
ATOZET is a medicine to lower increased levels of cholesterol. ATOZET
contains ezetimibe and
atorvastatin.
ATOZET is used in adults to lower levels of total cholesterol,
“bad” cholesterol (LDL cholesterol),
and fatty substances called triglycerides in the blood. In addition,
ATOZET raises levels of “good”
cholesterol (HDL cholesterol).
ATOZET 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 blocking of
blood flow can result in a hea

Résumé des caractéristiques du produit

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
ATOZET 10 mg/10 mg film-coated tablets
ATOZET 10 mg/20 mg film-coated tablets
ATOZET 10 mg/40 mg film-coated tablets
ATOZET 10 mg/80 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 10 mg of ezetimibe and 10, 20, 40 or
80 mg of atorvastatin (as
atorvastatin calcium trihydrate).
Excipient(s) with known effect
Each 10 mg/10 mg film-coated tablet contains 153 mg of lactose.
Each 10 mg/20 mg film-coated tablet contains 179 mg of lactose.
Each 10 mg/40 mg film-coated tablet contains 230 mg of lactose.
Each 10 mg/80 mg film-coated tablet contains 334 mg of lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
10 mg/10 mg tablet: Capsule-shaped, biconvex, white to off-white,
film-coated, size 12.74 mm x
5.10 mm, “257” debossed on one side
10 mg/20 mg tablet: Capsule-shaped, biconvex, white to off-white,
film-coated, size 14.48 mm x
5.79 mm, “333” debossed on one side
10 mg/40 mg tablet: Capsule-shaped, biconvex, white to off-white,
film-coated size 16.38 mm x
6.27 mm, “337” debossed on one side
10 mg/80 mg tablet: Capsule-shaped, biconvex, white to off-white,
film-coated, size 19.05 mm x
7.94 mm, “357” debossed on one side
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_Prevention of Cardiovascular Events _
ATOZET is indicated to reduce the risk of cardiovascular events (see
section 5.1) in patients with
coronary heart disease (CHD) and a history of acute coronary syndrome
(ACS), either previously
treated with a statin or not.
_Hypercholesterolaemia _
ATOZET is indicated as adjunctive therapy to diet for use in adults
with primary (heterozygous
familial and non-familial) hypercholesterolaemia or mixed
hyperlipidaemia where use of a
combination product is appropriate.
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•
patients not appropriately controlled with a statin alone
•
patients already treated with a statin and ezetimibe
_Homozygous Familial Hyperc