Ezetimibe/Simvastatin 10 mg/40 mg tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Ezetimibe; Simvastatin

Available from:

McDermott Laboratories Ltd., T/A Gerard Laboratories

ATC code:

C10BA; C10BA02

INN (International Name):

Ezetimibe; Simvastatin

Dosage:

10 mg/40 milligram(s)

Pharmaceutical form:

Tablet

Administration route:

Oral use

Units in package:

Blister of 14, 28, 3, 980 and 100 tablets, perforated blister of 14 x 1 and 28 x 1 30 x 1 and 90 x 1 tablets

Prescription type:

Product subject to prescription which may be renewed (B)

Manufactured by:

McDermott Laboratories Ltd t/a Gerard Laboratories, Mylan Hungary, Generics

Therapeutic group:

Reductase inhibitors in combination with other lipid modifying agents

Therapeutic area:

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

Therapeutic indications:

It is indicated as adjunctive therapy to diet for use in patients with primary (heterozygous familiar and non-familiar) hypercholesterolaemia or mixed hyperlipidaemia, and in patient with HoFH

Product summary:

Also avalaible in bottle, containing: 30, 100, 250 and 500 tablets

Authorization status:

Not marketed

Authorization date:

2015-05-22

Patient Information leaflet

41
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
EZETIMIBE/SIMVASTATIN 10 MG/20 MG TABLETS
EZETIMIBE/SIMVASTATIN 10 MG/40 MG TABLETS
EZETIMIBE/SIMVASTATIN 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 Ezetimibe/Simvastatin is and what it is used for
2.
What you need to know before you take Ezetimibe/Simvastatin
3.
How to take Ezetimibe/Simvastatin
4.
Possible side effects
5.
How to store Ezetimibe/Simvastatin
6.
Contents of the pack and other information
1.
WHAT EZETIMIBE/SIMVASTATIN IS AND WHAT IT IS USED FOR
Ezetimibe/Simvastatin contains two active substances ezetimibe and
simvastatin.
Ezetimibe/Simvastatin 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
raises levels of “good” cholesterol (HDL cholesterol).
Ezetimibe/Simvastatin 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-

Summary of Product characteristics

Health Products Regulatory Authority
21 August 2023
CRN00DL0Q
Page 1 of 26
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ezetimibe/Simvastatin 10 mg/40 mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg of ezetimibe and 40 mg of simvastatin.
Excipient with known effect
Each 10 mg/40 mg tablet contains 305.42 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
White to off-white, oval, biconvex tablet approximately 14 mm long and
8 mm in width, debossed with M on one side of the
tablet and ES3 on the other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Prevention of Cardiovascular Events
Ezetimibe/Simvastatin 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 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 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.
The dosage range of Ezetimibe/Simvastatin is 10 mg/10 mg/day through
10 mg/80 mg/day in the evening. All dosages may
not be available in all member states. The typical dose is 10 mg/20
mg/day or 10 mg/40 mg/day given as a single dose in the
evening. The 10 mg/80 mg dose i