Ezetimibe 10mg tablets

Nchi: Uingereza

Lugha: Kiingereza

Chanzo: MHRA (Medicines & Healthcare Products Regulatory Agency)

Viambatanisho vya kazi:

Ezetimibe

Inapatikana kutoka:

Teva UK Ltd

ATC kanuni:

C10AX09

INN (Jina la Kimataifa):

Ezetimibe

Kipimo:

10mg

Dawa fomu:

Oral tablet

Njia ya uendeshaji:

Oral

Darasa:

No Controlled Drug Status

Dawa ya aina:

Valid as a prescribable product

Bidhaa muhtasari:

BNF: 02120000; GTIN: 5017007027638

Taarifa za kipeperushi

EZETIMIBE 10 MG TABLETS
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.
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
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 10 mg Tablets 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 from building up in the
arteries and protects against heart
disease.
Tr

Tabia za bidhaa

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Ezetimibe 10 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg ezetimibe.
Excipient with known effect:
Each tablet contains 35 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet.
8.2 mm x 4.1 mm white, biconvex, capsule shaped tablets, with debossed
“10”
on one side.
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 recommended dose is one Ezetimibe 10 mg tablet daily. Ezetimibe
can be
administered at any time of the day, with or without food.
When Ezetimibe is added to a statin, either the indicated usual
initial dose of that
particular statin or the already established higher statin dose should
be continued. In
this setting, the dosage instructions for that particular statin
should be consulted.
_USE IN PATIENTS WITH CORONARY HEART DISEASE AND ACS EVENT HISTORY _
For incre