Ezetimibe 10mg Tablets

Quốc gia: Malta

Ngôn ngữ: Tiếng Anh

Nguồn: Medicines Authority

Thành phần hoạt chất:

ezetimibe 10 mg

Sẵn có từ:

Sandoz Limited

Mã ATC:

C10AX09

INN (Tên quốc tế):

ezetimibe

Dạng dược phẩm:

tablet

Tình trạng ủy quyền:

Authorised

Ngày ủy quyền:

2014-01-23

Tờ rơi thông tin

Page 1 of 7 

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.  

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 contains the active substance ezetimibe. 
Ezetimibe is a medicine used to lower levels of total cholesterol,
"bad" cholesterol (LDL 
cholesterol), and fatty substances called triglycerides in the blood.
In addition, this medicine raises 
levels of "good" cholesterol (HDL cholesterol). It is used for
patients who cannot control their 
cholesterol levels by diet alone. You should stay on a
cholesterol-lowering diet while taking this 
medicine. 
This medicine works by reducing the cholesterol absorbed in your
digestive tract. It does not help 
you lose weight. 

Ezetimibe adds to the cholesterol-lowering effect of statins, a group
of medicines that reduce the 
cholesterol your body makes by itself. 

Ezetimibe is used in addition to diet if you have: 

  a raised cholesterol level in your blood (primary
hypercholesterolaemia [heterozygous familial 
and non-familial]) 
This medicine can be taken 
- 
together with a statin, when your cholesterol level is not well
controlled with a stati

Đặc tính sản phẩm

Page 1 of 14 

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: 68 mg lactose monohydrate  

For the full list of excipients, see section 6.1. 

3. PHARMACEUTICAL 
FORM 

Tablet 

White to almost white, oval tablets (7.4 mm x 4.1 mm) with
debossing “10” on one side and “EZT” 
on the other 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. 

_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). 

_Homozygous sitosterolaemia (phytosterolaemia) _
_ _
Ezetimibe is indicated as adjunctive therapy to diet for use in
patients with homozygous familial 
sitosterolaemia. 

A beneficial effect of Ezetimibe on cardiovascular morbidity and
mortality has not yet been 
demonstrated. 

Page 2 of 14 

4.2  POSOLOGY AND METHOD OF ADMINISTRATION 

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
10 mg tablet daily. 
Ezetimibe can be administered at any time of