Ezetimibe 10mg Tablets

Country: Միացյալ Թագավորություն

language: անգլերեն

source: myHealthbox

active_ingredient:

ezetimibe

MAH:

Glenmark Pharmaceuticals Europe Limited

ATC_code:

C10AX09

INN:

ezetimibe

dosage:

10mg

pharmaceutical_form:

Tablets

administration_route:

Oral use

units_in_package:

Pack sizes: 14, 28, 30, 50, 98 and 100 tablets

prescription_type:

POM - Prescription Only Medicine

manufactured_by:

Glenmark Pharmaceuticals Europe Limited

therapeutic_group:

Other lipid modifying agents

therapeutic_indication:

Primary Hypercholesterolaemia Homozygous Familial Hypercholesterolaemia (HoFH) Homozygous Sitosterolaemia (phytosterolaemia)

authorization_status:

Authorised

authorization_date:

2015-05-22

PIL

PACKAGE LEAFLET: INFORMATION FOR THE USER
EZETIMIBE 10 MG TABLETS
Ezetimibe
SAME SIZE ARTWORK
LEAFLET SIZE: 120 mm x 450 mm 
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.
-  T h i s   m e d i c i n e   h a s   b e e n  
  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 
" g o o d "   c h o l e s t e r o l   ( H D L
cholesterol). 
Ezetimibe,  the  active  ingredient  of 
Ezetimibe  tablets,  works  by 
reducing the cholesterol absorbed in 
your digestive tract. 
Ezetimibe  adds  to  the  cholesterol-
lowering effect of statins, a group of 
m e d i c i n e s   t h a t   r e d u c e   t h e  
cholesterol  your  

SPC

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 69.75 mg of lactose monohydrate. 

For the full list of excipients, see section 6.1 

3 PHARMACEUTICAL 
FORM 
Tablet 

White to off-white, capsule shaped, approximately 8.0 x 4.0 x 2.6
mm in size, 
flat, bevelled edged uncoated tablets engraved with ‘G’ on one
side and “44” 
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 nonfamilial) 
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. 

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