Ezetimibe/Simvastatin Accord 10mg/40mg Tablets

Krajina: Írsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktívna zložka:

Ezetimibe; Simvastatin

Dostupné z:

Accord Healthcare Ireland Ltd.

ATC kód:

C10BA02

INN (Medzinárodný Name):

Ezetimibe; Simvastatin

Dávkovanie:

10 mg/40 milligram(s)

Forma lieku:

Tablet

Terapeutické oblasti:

simvastatin and ezetimibe

Stav Autorizácia:

Not marketed

Dátum Autorizácia:

2021-04-30

Príbalový leták

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
EZETIMIBE/SIMVASTATIN ACCORD 10 MG / 20 MG TABLETS
EZETIMIBE/SIMVASTATIN ACCORD 10 MG / 40 MG TABLETS
EZETIMIBE/SIMVASTATIN ACCORD 10 MG / 80 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 Ezetimibe/Simvastatin Accord is and what it is used for
2.
What you need to know before you take Ezetimibe/Simvastatin Accord
3.
How to take Ezetimibe/Simvastatin Accord
4.
Possible side effects
5.
How to store Ezetimibe/Simvastatin Accord
6.
Contents of the pack and other information
1.
WHAT EZETIMIBE/SIMVASTATIN ACCORD IS AND WHAT IT IS USED FOR
Ezetimibe/Simvastatin
Accord
contains
the
active
substances
ezetimibe
and
simvastatin.
Ezetimibe/Simvastatin Accord is
a medicine
used
to
lower
levels
of
total
cholesterol,
“bad”
cholesterol (LDL cholesterol), and fatty substances called
triglycerides in the blood. In addition,
Ezetimibe/Simvastatin Accord raises levels of “good” cholesterol
(HDL cholesterol).
Ezetimibe/Simvastatin Accord 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

Súhrn charakteristických

Health Products Regulatory Authority
09 May 2023
CRN00DJSF
Page 1 of 26
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ezetimibe/Simvastatin Accord 10mg/40mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg ezetimibe and 40 mg of simvastatin.
Excipient with known effect
Each 10/40 mg tablet contains 285 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
Light pink to pink colored with mosaic appearance, capsule shaped
biconvex uncoated tablets '337' on one side and plain on
other side. The size of the tablet is approximately 13.90 x 6.90 mm.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Prevention of Cardiovascular Events
Ezetimibe/Simvastatin Accord 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
Ezetimibe/Simvastatin Accord 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)
Ezetimibe/Simvastatin Accord 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
Ezetimibe/Simvastatin Accord.
Route of administration is oral. The dosage range of
Ezetimibe/Simvastatin Accord 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 i