Ezetimibe/Simvastatin Clonmel 10 mg/40 mg tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Ezetimibe; Simvastatin

Available from:

Clonmel Healthcare Ltd

ATC code:

C10BA; C10BA02

INN (International Name):

Ezetimibe; Simvastatin

Dosage:

10 mg/40 milligram(s)

Pharmaceutical form:

Tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

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

Authorization status:

Marketed

Authorization date:

2017-04-07

Patient Information leaflet

Page 1 of 8
PACKAGE LEAFLET: INFORMATION FOR THE USER
EZETIMIBE/SIMVASTATIN CLONMEL 10 MG/10 MG TABLETS
EZETIMIBE/SIMVASTATIN CLONMEL 10 MG/20 MG TABLETS
EZETIMIBE/SIMVASTATIN CLONMEL 10 MG/40 MG TABLETS
EZETIMIBE/SIMVASTATIN CLONMEL 10 MG/80 MG TABLETS
ezetimibe/simvastatin
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 Clonmel
is and what it is used for
2.
What you need to know before you take Ezetimibe/Simvastatin Clonmel
3.
How to take Ezetimibe/Simvastatin Clonmel
4.
Possible side effects
5.
How to store Ezetimibe/Simvastatin Clonmel
6.
Contents of the pack and other information
1.
WHAT EZETIMIBE/SIMVASTATIN CLONMEL IS AND WHAT IT IS USED FOR
Ezetimibe/Simvastatin Clonmel
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 Clonmel
raises levels of “good” cholesterol (HDL cholesterol).
Ezetimibe/Simvastatin Clonmel contains the active substances ezetimibe
and simvastatin.
Ezetimibe/Simvastatin Clonmel 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

Summary of Product characteristics

Health Products Regulatory Authority
24 July 2023
CRN00DHYL
Page 1 of 26
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ezetimibe/Simvastatin Clonmel 10 mg/40 mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg ezetimibe and 80 mg simvastatin.
Excipient with known effect:
Each 10 mg/80 mg tablet contains 483.0 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
Ezetimibe/Simvastatin Clonmel 10 mg/40 mg tablets: Light tan, mottled,
round, 10 mm in diameter, biconvex tablets, plain on
one side and “513” on the other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Prevention of Cardiovascular Events
Ezetimibe/Simvastatin Clonmel 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 Clonmel 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 Clonmel 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 Clonmel.
Route of administration is oral. The dosage range of
Ezetimibe/Simvastatin Clonmel is 10 mg/10 mg/day through
10 mg/80 mg/day in the evening. In clinical cases where the optimum
dosage of ezetimibe/simvastatin is not possible