Ezetimibe Krka 10 mg tablets

Nchi: Ayalandi

Lugha: Kiingereza

Chanzo: HPRA (Health Products Regulatory Authority)

Viambatanisho vya kazi:

Ezetimibe

Inapatikana kutoka:

KRKA, d.d., Novo mesto

ATC kanuni:

C10AX; C10AX09

INN (Jina la Kimataifa):

Ezetimibe

Kipimo:

10 milligram(s)

Dawa fomu:

Tablet

Dawa ya aina:

Product subject to prescription which may be renewed (B)

Eneo la matibabu:

Other lipid modifying agents; ezetimibe

Idhini hali ya:

Marketed

Idhini ya tarehe:

2016-12-02

Taarifa za kipeperushi

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

Tabia za bidhaa

Health Products Regulatory Authority
13 March 2024
CRN00F6CH
Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ezetimibe Krka 10 mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg ezetimibe.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
Tablets are presented as white to off white, capsule shaped tablets
with bevelled edges. Tablet dimensions: 8 x 4 mm.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
_Primary hypercholesterolaemia_
Ezetimibe Krka, 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 Krka 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 Krka 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 Krka 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).
Homozygous sitosterolaemia (phytosterolaemia)
Ezetimibe Krka is indicated as adjunctive therapy to diet for use in
patients with homozygous familial sitosterolaemia.
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
Krka.
The recommended dose is one Ezetimibe Krka 10 mg tablet daily.
Ezetimibe Krka can be administered at any time of the day,