Ezetimibe 10mg tablets

Nchi: Uingereza

Lugha: Kiingereza

Chanzo: MHRA (Medicines & Healthcare Products Regulatory Agency)

Viambatanisho vya kazi:

Ezetimibe

Inapatikana kutoka:

Accord-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: 5055565742334

Taarifa za kipeperushi

Artwork No.
Customer
Description
Market
Language
Size
Min. Font Size
Version No.
Date
-
Accord
Ezetimibe 10 mg
UK
English
170 x 550 mm (PIL)
9
2 (Page 1 of 2)
18.03.21 (Ezetimibe 10 mg (ACC-UK) PIL)
Colours Used
Pantone Black
Prepared By
Regulatory Affairs
Checked By
Regulatory Affairs
Approved By
Quality Assurance
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 c

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 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 Ezetimibe is added to a statin, either the indicated usual
initial dose of that