Ezetimibe 10 mg tablets

Država: Irska

Jezik: angleščina

Source: HPRA (Health Products Regulatory Authority)

Aktivna sestavina:

Ezetimibe

Dostopno od:

Accord Healthcare Ireland Ltd.

Koda artikla:

C10AX; C10AX09

INN (mednarodno ime):

Ezetimibe

Odmerek:

10 milligram(s)

Farmacevtska oblika:

Tablet

Terapevtsko območje:

Other lipid modifying agents; ezetimibe

Status dovoljenje:

Marketed

Datum dovoljenje:

2016-04-15

Navodilo za uporabo

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
EZETIMIBE 10 MG TABLETS
EZETIMIBE
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 is and what it is used for
2.
What you need to know before you take Ezetimibe
3.
How to take Ezetimibe
4.
Possible side effects
5.
How to store Ezetimibe
6.
Contents of the pack and other information
1.
WHAT EZETIMIBE IS AND WHAT IT IS USED FOR
Ezetimibe is a medicine to lower increased levels of cholesterol.
Ezetimibe lowers levels of total cholesterol, "bad" cholesterol (LDL
cholesterol), and
fatty substances called triglycerides in the blood. In addition,
Ezetimibe raises levels
of "good" cholesterol (HDL cholesterol).
Ezetimibe, the active ingredient of Ezetimibe, works by reducing the
cholesterol
absorbed in your digestive tract.
Ezetimibe adds to the cholesterol-lowering effect of statins, a group
of medicines that
reduce 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” cholesterol because it
helps keep the bad
cholesterol

Lastnosti izdelka

Health Products Regulatory Authority
07 March 2023
CRN00DCSS
Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ezetimibe 10 mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg of ezetimibe .
Excipient(s) with known effect
Each tablet contains 83 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
White to off-white, capsule- shaped, flat faced with beveled edge,
uncoated tablets, debossed with “10” on one side and plain
on other side.
Length: 8.2 mm
Width: 4.1 mm
Thickness: 2.6 mm
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Primary Hypercholesterolaemia
Ezetimibe, co-administered with an HMG-CoA reductase inhibitor
(statin) is indicated as adjunctive therapy to diet for use in
patients with primary (heterozygous familial and non-familial)
hypercholesterolaemia who are not appropriately controlled with
a statin alone.
Ezetimibe monotherapy is indicated as adjunctive therapy to diet for
use in patients with primary (heterozygous familial and
non-familial) hypercholesterolaemia in whom a statin is considered
inappropriate or is not tolerated.
Prevention of Cardiovascular Events
Ezetimibe 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) when added to ongoing
statin therapy or initiated concomitantly with a statin.
Homozygous Familial Hypercholesterolaemia (HoFH)
Ezetimibe co-administered with a statin, is indicated as adjunctive
therapy to diet for use in patients with HoFH. Patients may
also receive adjunctive treatments (e.g. LDL apheresis).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The patient should be on an appropriate lipid-lowering diet and should
continue on this diet during treatment with Ezetimibe.
Route of administration is oral. The recommended dose is one Ezetimibe
daily. Ezetimibe can be administered at any time of
the day, with or without food.
When Ezeti