Irbesartan 75mg Film-coated Tablets

国家: 马耳他

语言: 英文

来源: Medicines Authority

有效成分:

IRBESARTAN

可用日期:

Accord Healthcare Limited Sage House, 319, Pinner Road, North Harrow, Middlesex HA1 4HF, United Kingdom

ATC代码:

C09CA04

INN（国际名称）:

IRBESARTAN 75 mg

药物剂型:

FILM-COATED TABLET

组成:

IRBESARTAN 75 mg

处方类型:

POM

治疗领域:

AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM

授权状态:

Withdrawn

授权日期:

2011-08-29

资料单张

PACKAGE LEAFLET: INFORMATION FOR THE USER
IRBESARTAN 75 MG 
FILM-COATED TABLETS
IRBESARTAN 150 MG 
FILM-COATED TABLETS
IRBESARTAN 300 MG 
FILM-COATED TABLETS
irbesartan
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 further questions, please 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, call your doctor 
or pharmacist. This includes any possible 
side effects not listed in this leaflet.

WHAT IS IN THIS LEAFLET:
1. What Irbesartan Tablet is and what it is 
used for
2. What you need to know before you take 
Irbesartan Tablets 
3. How to take Irbesartan Tablets 
4. Possible side effects
5. How to store Irbesartan Tablets
6. Contents of the pack and other 
information
  1.  WHAT IRBESARTAN TABLET IS AND 
     WHAT IT IS USED FOR
Irbesartan Tablets belong to a group of 
medicines known as angiotensin –II receptor 
antagonists. 
Angiotensin –II is a substance produced in 
the body which binds to receptors in blood 
vessels causing them to tighten. This results 
in an increase in blood pressure. Irbesartan 
Tablets prevents the binding of angiotensin 
-II to these receptors, causing the blood 
vessels to relax and the blood pressure to 
lower. Irbesartan Tablets slows the decrease 
of kidney function in patients with high blood 
pressure and type 2 diabetes.
Irbesartan Tablets is used in adult patients
• to treat high blood pressure (essential 
hypertension)
• to protect the kidney in patients with high 
blood pressure, type 2 diabetes  and 
laboratory evidence of impaired kidney 
function. 
  2.  WHAT YOU NEED TO KNOW BEFORE 
     YOU TAKE IRBESARTAN TABLETS 
DO NOT TAKE IRBESARTAN TABLETS: 
• If you are allergi

产品特点

Page 1 of 13 
SUMMARY OF PRODUCT CHARACTERISTICS 

1.         NAME OF THE MEDICINAL PRODUCT 

            Irbesartan 75 mg Film-coated Tablets 
Irbesartan 150 mg Film-coated Tablets 
Irbesartan 300 mg Film-coated Tablets 

2. 
  QUALITATIVE AND QUANTITATIVE COMPOSITION 

Each film - coated tablet contains 75 mg Irbesartan. 

Excipient: 25.36 mg of lactose monohydrate per tablet. 

For thefull list of excipients, see section 6.1. 

Each film - coated tablet contains 150 mg Irbesartan. 

Excipient with known effect: 50.72 mg of lactose monohydrate per
tablet.   

For the full list of excipients, see section 6.1. 

Each film - coated tablet contains 300 mg Irbesartan. 

Excipient with known effect: 101.44 mg of lactose monohydrate per
tablet.   

For the full list of excipients, see section 6.1. 

3. 
   PHARMACEUTICAL FORM 

Film– coated tablet 

White to off white, oval, biconvex, film coated tablet debossed ‘I
75’ on one side and plain 
on other side.  

Film– coated tablet  
White to off white, oval, biconvex, film coated tablet debossed ‘I
150’ on one side and plain 
on other side. 

Film– coated tablet  
White to off white, oval, biconvex, film coated tablet debossed ‘I
300’ on one side and plain 
on other side. 

4.         CLINICAL PARTICULARS   

4.1     THERAPEUTIC INDICATIONS 

Irbesartan is indicated in adults for the treatment of essential
hypertension. 

It is also indicated for the treatment of renal disease in adult
patients with hypertension and 
type 2 diabetes mellitus as part of an antihypertensive medicinal
product regimen.  (See 
section 5.1) 

Page 2 of 13 
4.2       POSOLOGY AND METHOD OF ADMINISTRATION 

Posology 

The usual recommended initial and maintenance dose is 150 mg once
daily, with or without 
food. Irbesartan Tablets at a dose of 150 mg once daily generally
provides a better 24 hour 
blood pressure con