Ezetimibe/Simvastatin Rowex 10 mg/40 mg tablets

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

Ezetimibe; Simvastatin

Tilgjengelig fra:

Rowex Ltd

ATC-kode:

C10BA; C10BA02

INN (International Name):

Ezetimibe; Simvastatin

Dosering :

10 mg/40 milligram(s)

Legemiddelform:

Tablet

Resept typen:

Product subject to prescription which may be renewed (B)

Terapeutisk område:

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

Autorisasjon status:

Marketed

Autorisasjon dato:

2017-04-07

Informasjon til brukeren

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

Preparatomtale

Health Products Regulatory Authority
16 June 2023
CRN00DJVD
Page 1 of 26
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ezetimibe/Simvastatin Rowex 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 tablet contains 224.7 mg of lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
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 Rowex 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 Rowex 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 Rowex 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 Rowex.
Route of administration is oral. The dose range of
Ezetimibe/Simvastatin Rowex 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 1