Ezetimibe Rowa 10 mg tablets

Šalis: Airija

kalba: anglų

Šaltinis: HPRA (Health Products Regulatory Authority)

Veiklioji medžiaga:

Ezetimibe

Prieinama:

Rowa Pharmaceuticals Limited

ATC kodas:

C10AX; C10AX09

INN (Tarptautinis Pavadinimas):

Ezetimibe

Dozė:

10 milligram(s)

Vaisto forma:

Tablet

Recepto tipas:

Product subject to prescription which may be renewed (B)

Gydymo sritis:

Other lipid modifying agents; ezetimibe

Autorizacija statusas:

Marketed

Leidimo data:

2017-07-28

Pakuotės lapelis

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

Prekės savybės

Health Products Regulatory Authority
19 November 2021
CRN00CJRX
Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ezetimibe Rowa 10 mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg of ezetimibe.
Excipient(s) with known effect
Each tablet contains 64 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
White to off-white round convex tablets of approximately 6 mm of
diameter.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Primary Hypercholesterolaemia
Ezetimibe Rowa 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 Rowa 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 Rowa 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 Rowa 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
Rowa.
Route of administration is oral. The recommended dose is one Ezetimibe
Rowa 10 mg tablet daily. Ezetimibe Rowa can be
administered at any time of the day, with or without food.
When Ezetimibe Rowa is added to a statin, either the indicated usual
in