Inegy 10mg/10mg Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

EZETIMIBE, SIMVASTATIN

Available from:

Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

ATC code:

C10BA02

INN (International Name):

EZETIMIBE 10 mg SIMVASTATIN 10 mg

Pharmaceutical form:

TABLET

Composition:

EZETIMIBE 10 mg SIMVASTATIN 10 mg

Prescription type:

POM

Therapeutic area:

LIPID MODIFYING AGENTS

Authorization status:

Withdrawn

Authorization date:

2006-10-25

Patient Information leaflet

Page 1 of 9
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
INEGY 10 MG/10 MG, 10 MG/20 MG, 10 MG/40 MG, OR 10 MG/80 MG TABLETS
EZETIMIBE AND SIMVASTATIN
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 INEGY is and what it is used for
2.
What you need to know before you take INEGY
3.
How to take INEGY
4.
Possible side effects
5.
How to store INEGY
6.
Contents of the pack and other andother information
1.
WHAT INEGY IS AND WHAT IT IS USED FOR
INEGY contains the active substances ezetimibe and simvastatin.INEGY
is a medicine used
to lower levels of total cholesterol, “bad” cholesterol (LDL
cholesterol), and fatty substances
called triglycerides in the blood. In addition, INEGY raises levels of
“good” cholesterol (HDL
cholesterol).
INEGY works to reduce your cholesterol in two ways. The active
ingredient ezetimibe
reduces the cholesterol absorbed in your digestive tract. The active
ingredient simvastatin
belonging to the class of “statins” inhibits the production of 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 heart attack or

Summary of Product characteristics

Page 1 of 34
1.
NAME OF THE MEDICINAL PRODUCT
INEGY 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg, or 10 mg/80 mg Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg ezetimibe and 10, 20, 40 or 80 mg of
simvastatin.
Excipient(s) with known effect
Each 10/10 mg tablet contains 58.2 mg of lactose monohydrate.
Each 10/20 mg tablet contains 126.5 mg of lactose monohydrate.
Each 10/40 mg tablet contains 262.9 mg of lactose monohydrate.
Each 10/80 mg tablet contains 535.8 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
White to off-white capsule-shaped tablets with code “311”,
“312”, “313”, or “315” on one side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Prevention of Cardiovascular Events
INEGY 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_ _
INEGY is indicated as adjunctive therapy to diet for use in patients
with primary (heterozygous
familial and non-familial) hypercholesterolaemia or mixed
hyperlipidaemia where use of a
combination product is appropriate:

patients not appropriately controlled with a statin alone

patients already treated with a statin and ezetimibe
Homozygous Familial Hypercholesterolaemia (HoFH)
INEGY is indicated as adjunctive therapy to diet for use in patients
with HoFH. Patients may also
receive adjunctive treatments (e.g., low-density lipoprotein [LDL]
apheresis).
Page 2 of 34
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Hypercholesterolaemia _
The patient should be on an appropriate lipid-lowering diet and should
continue on this diet during
treatment with INEGY.
Route of administration is oral. The dosage range of INEGY is 10/10
mg/day through 10/80 mg/day
in the evening. All dosages may not be available in all member states.
The typical dose is
10/20 mg/day or 10/40 mg/day given as a