Inegy 10 mg/40 mg tablets

Kraj: Irlandia

Język: angielski

Źródło: HPRA (Health Products Regulatory Authority)

Składnik aktywny:

Simvastatin; Ezetimibe

Dostępny od:

PCO Manufacturing Ltd.

Kod ATC:

C10BA; C10BA02

INN (International Nazwa):

Simvastatin; Ezetimibe

Dawkowanie:

10 mg / 40 milligram(s)

Forma farmaceutyczna:

Tablet

Typ recepty:

Product subject to prescription which may be renewed (B)

Dziedzina terapeutyczna:

HMG CoA reductase inhibitors in combination with other lipid modifying agents; simvastatin and ezetimibe

Data autoryzacji:

2018-12-14

Ulotka dla pacjenta

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
INEGY
® 10 MG/40 MG TABLETS
ezetimibe/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 often called “good” chol

Charakterystyka produktu

Health Products Regulatory Authority
04 February 2021
CRN00C4TR
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Inegy 10 mg/40 mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg ezetimibe and 40 mg of simvastatin.
Excipient(s) with known effect
Each 10 mg/40 mg tablet contains lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
_Product imported from Italy_
White to off-white capsule-shaped tablets with code '313' on one side.
4 CLINICAL PARTICULARS
As per PA1286/062/003
5 PHARMACOLOGICAL PROPERTIES
As per PA1286/062/003
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
blister and outer package of the product on the market in the
country of origin.
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.
Health Products Regulatory Authority
04 February 2021
CRN00C4TR
Page 2 of 2
6.5 NATURE AND CONTENTS OF CONTAINER
Blisters of 30 tablets in an outer carton.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
PCO Manufacturing Ltd.
Unit 10, Ashbourne Business Park
Rath
Ashbourne
Co. Meath
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA0465/223/004
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 14
th
December 2018
10 DATE OF REVISION OF THE TEXT
February 2021