INEGY 10/80 Milligram Tablets

Nazione: Irlanda

Lingua: inglese

Fonte: HPRA (Health Products Regulatory Authority)

Principio attivo:

EZETIMIBE, SIMVASTATIN

Commercializzato da:

PCO Manufacturing

Codice ATC:

C10BA02

INN (Nome Internazionale):

EZETIMIBE, SIMVASTATIN

Dosaggio:

10/80 Milligram

Forma farmaceutica:

Tablets

Tipo di ricetta:

Product subject to prescription which may be renewed (B)

Area terapeutica:

HMG CoA reductase inhibitors in combination with other lipid modifying agents

Stato dell'autorizzazione:

Authorised

Data dell'autorizzazione:

2009-06-19

Foglio illustrativo

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT 
INEGY
®
 10 MG/20 MG, 10MG/40MG, OR 10MG/80MG 
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 c
holesterol, “bad” cholesterol (LDL cholesterol), and fatty 
substances called triglycerides in the blood. 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�

Scheda tecnica

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Inegy 10mg/80mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10mg ezetimibe and 80mg of simvastatin.
Excipient(s) with known effect:
Each 10/80 mg tablet contains lactose monohydrate.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
_Product imported from the UK:_
White to off-white capsule-shaped tablets with code “315” on one side.
4 CLINICAL PARTICULARS
As per PA0035/095/004
5 PHARMACOLOGICAL PROPERTIES
As per PA0035/095/004
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Butylated hydroxyanisole
Citric acid monohydrate
Croscarmellose sodium
Hypromellose
Lactose monohydrate
Magnesium stearate
Microcrystalline cellulose
Propyl gallate
6.2 INCOMPATIBILITIES
Not applicable
6.3 SHELF LIFE
The shelf-life expiry date of this product is the date shown on the container and outer package of the product on the
market in the country of origin.
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 26/04/2016_
_CRN 2175053_
_page number: 1_
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 30
°
C.
Store in the original package in order to protect from moisture and light.
6.5 NATURE AND CONTENTS OF CONTAINER
Push through blisters of opaque polychlorotrifluoroethylene/PVC sealed to vinyl coated aluminium in packs of 28
tablets in an over-labelled outer carton.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
PCO Manufacturing
Unit 10, Ashbourne Business Park
Rath
Ashbourne
Co. Meath
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA0465/223/003
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 19th June 2009
10 D