INEGY 10/10 TABLET

देश: दक्षिण अफ़्रीका

भाषा: अंग्रेज़ी

स्रोत: South African Health Products Regulatory Authority (SAHPRA)

थमां उपलब्ध:

Organon South Africa (Pty) Ltd

डोज़:

See ingredients

फार्मास्यूटिकल फॉर्म:

TABLET

रचना:

EACH TABLET CONTAINS EZETIMIBE 10,0 mg SIMVASTATIN 10,0 mg

प्राधिकरण का दर्जा:

Registered

प्राधिकरण की तारीख:

2006-11-08

सूचना पत्रक

Page 1 of 12
PATIENT INFORMATION LEAFLET
SCHEDULING STATUS
INEGY
®
10/10 Tablet
INEGY
®
10/20 Tablet
INEGY
®
10/40 Tablet
INEGY
®
10/80 Tablet
•
ezetimibe and simvastatin
INEGY contains sugar (lactose monohydrate):
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.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING INEGY
•
Keep this leaflet. You may need to read it again.
•
If you have further questions, please ask your doctor, pharmacist,
nurse or other
healthcare provider.
•
You should also read any information provided with other medicines you
are currently
taking.
•
INEGY has been prescribed for you personally and you should not share
your medicine
with other people. It may harm them even if their symptoms are the
same as yours.
WHAT IS IN THIS LEAFLET
1.
What INEGY is and what it is used for
S4
Page 2 of 12
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
WHAT INEGY IS USED FOR
INEGY is a medicine used to lower levels of total cholesterol, LDL
cholesterol, and fatty
substances called triglycerides in the blood. In addition, INEGY
raises levels of HDL
cholesterol. It is used for patients who cannot control their
cholesterol levels by diet alone.
You should stay on a cholesterol-lowering diet while taking INEGY.
If you have heart disease, INEGY reduces the risk of heart attack,
stroke, surgery to increase
heart blood flow or hospitalisation for chest pain.
HOW DOES INEGY WORK?
INEGY 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. INEGY does not
help you lose weight.
Your doctor has prescribed INEGY to reduce the amount of cholester

उत्पाद विशेषताएं

Page
1
of
30
SCHEDULING STATUS
1
NAME OF THE MEDICINE
INEGY
®
10/10 Tablet
INEGY
®
10/20 Tablet
INEGY
®
10/40 Tablet
INEGY
®
10/80 Tablet
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each INEGY 10/10 Tablet contains ezetimibe 10 mg and simvastatin 10
mg.
Each INEGY 10/20 Tablet contains ezetimibe 10 mg and simvastatin 20
mg.
Each INEGY 10/40 Tablet contains ezetimibe 10 mg and simvastatin 40
mg.
Each INEGY 10/80 Tablet contains ezetimibe 10 mg and simvastatin 80
mg.
INEGY contains sugar (lactose monohydrate):
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
INEGY 10/10: white to off-white, capsule shaped, biconvex compressed
tablets debossed
with 311 on one side and plain on the other side.
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Page
2
of
30
INEGY
10/20: white to off-white, capsule shaped, biconvex compressed tablets
debossed
with 312 on one side and plain on the other side.
INEGY 10/40: white to off-white, capsule shaped, biconvex compressed
tablets debossed
with 313 on one side and plain on the other side.
INEGY 10/80: white to off-white, capsule shaped, biconvex compressed
tablets debossed
with 315 on one side and plain on the other side.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
REDUCTION IN THE RISK OF CARDIOVASCULAR EVENTS
INEGY is indicated to reduce the risk of cardiovascular events in
patients with coronary
artery heart disease (CHD) and a history of acute coronary syndrome
(ACS), either
previously treated with a statin or not.
Benefits have been shown for this group of patients when their LDL-C
was above 1,2
mmol/L.
No statistically significant benefit was demonstrated for risk
reduction of stroke,
hospitalisation for unstable angina pectoris and for coronary artery
revascularisation
procedures.
_ _
PRIMARY HYPERCHOLESTEROLAEMIA
INEGY is indicated as adjuncti