INEGY 10/20 Milligram Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

EZETIMIBE, SIMVASTATIN

Available from:

Merck Sharp and Dohme Limited

ATC code:

C10BA02

INN (International Name):

EZETIMIBE, SIMVASTATIN

Dosage:

10/20 Milligram

Pharmaceutical form:

Tablets

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

HMG CoA reductase inhibitors in combination with other lipid modifying agents

Authorization status:

Transfer Pending

Authorization date:

2012-12-18

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
INEGY
® 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 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 stroke.
HDL cholesterol is oft

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Inegy 10 mg / 20 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg ezetimibe and 20 mg of simvastatin.
Excipient(s) with known effect
Each 10/20 mg tablet contains 126.5 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 “312” 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).
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 single
dose in the evening. The 10/80-mg dose is only recommended in patients
with severe hypercholesterolaemia and at
high risk for cardiovascular complications who have not achieved their
treatment goals on lower doses and when the
benefits are expected to outweigh the potential