Valsartan 40mg capsules, hard

国家: 英国

语言: 英文

来源: myHealthbox

有效成分:

valsartan

可用日期:

Milpharm Limited

ATC代码:

C09AA03

INN（国际名称）:

valsartan

剂量:

40mg

药物剂型:

Capsule, hard

给药途径:

Oral use

每包单位数:

28, 30 and 500 capsules, hard

处方类型:

POM - Prescription Only Medicine

厂商:

APL Swift Services (Malta) Limited

治疗组:

Angiotensin II Antagonists, plain

疗效迹象:

Hypertension Treatment of hypertension in children and adolescents 6 to 18 years of age. Recent myocardial infarction Treatment of clinically stable adult patients with symptomatic heart failure or asymptomatic left ventricular systolic dysfunction after a recent (12 hours – 10 days) myocardial infarction Heart failure Treatment of symptomatic heart failure in adult patients when Angiotensin Converting Enzyme (ACE) inhibitors cannot be used, or as add-on therapy to ACE inhibitors when beta blockers cannot be used

授权状态:

Authorised

授权日期:

2015-09-14

资料单张

VALSARTAN 40 MG CAPSULES, HARD
VALSARTAN 80 MG CAPSULES, HARD
VALSARTAN 160 MG CAPSULES, HARD
Valsartan
PACKAGE LEAFLET: INFORMATION FOR THE USER
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 Valsartan is and what it is used for 
2.
What you need to know before you take Valsartan 
3.
How to take Valsartan 
4.
Possible side effects 
5.
How to store Valsartan 
6.
Contents of the pack and other information

Valsartan capsules belong to a class of medicines known as 
angiotensin II receptor antagonists, which help to control high
blood 
pressure. Angiotensin II is a substance in the body that causes 
vessels to tighten, thus causing your blood pressure to increase. 
Valsartan capsules work by blocking the effect of angiotensin
II. As 
a result, blood vessels relax and blood pressure is lowered.
Valsartan 40 mg capsules CAN BE USED FOR THREE DIFFERENT 
CONDITIONS:
•
TO TREAT HIGH BLOOD PRESSURE IN CHILDREN AND ADOLESCENTS 6 
TO 18 YEARS OF AGE. High blood pressure increases the 
workload on the heart and arteries. If not treated it can damage 
the blood vessels of the brain, heart, and kidneys, and may 
result in a stroke, heart failure, or kidney failure. High blood 
pressure increases the risk of heart attacks. Lowering your 
blood pressure to normal reduces the risk of developing these 
disorders.
•
TO TREAT ADULT PATIENTS AFTER A RECENT HEART ATTACK 
(myocardial infarction). “Recent” here means between 12 
hours and 10 days.
•
TO TREAT SYMPTOMATIC HEART FA

产品特点

SUMMARY OF PRODUCT CHARACTERISTICS 

1 
NAME OF THE MEDICINAL PRODUCT 
Valsartan 40 mg capsules, hard 

2 
QUALITATIVE AND QUANTITATIVE COMPOSITION 
Each hard capsule contains 40 mg of valsartan. 

For the full list of excipients, see section 6.1. 

3 PHARMACEUTICAL 
FORM 
Capsule, hard 

Opaque light grey cap/Opaque light grey body, size '4' hard
gelatin capsules 
imprinted in black ink with ‘I’ on cap and '70' on
body, filled with white to off white 
granular powder. 

4 CLINICAL 
PARTICULARS 

4.1

THERAPEUTIC INDICATIONS 
Hypertension

Treatment of hypertension in children and adolescents 6 to 18 years
of age. 

Recent myocardial infarction 
Treatment of clinically stable adult patients with symptomatic
heart failure or 
asymptomatic left ventricular systolic dysfunction after a recent
(12 hours – 10 days) 
myocardial infarction (see sections 4.4 and 5.1).  

Heart failure 
Treatment of symptomatic heart failure in adult patients when
Angiotensin 
Converting Enzyme (ACE) inhibitors cannot be used, or as add-on
therapy to ACE 
inhibitors when beta blockers cannot be used (see sections
4.4 and 5.1). 

4.2 
POSOLOGY AND METHOD OF ADMINISTRATION 
Posology 

Recent myocardial infarction 
In clinically stable patients, therapy may be initiated
as early as 12 hours after a 
myocardial infarction. After an initial dose of 20 mg twice
daily, valsartan should be 
titrated to 40 mg, 80 mg, and 160 mg twice daily over the
next few weeks. The 
starting dose is provided by the 40 mg divisible tablet.  

The target maximum dose is 160 mg twice daily. In general,
it is recommended that 
patients achieve a dose level of 80 mg twice daily by two weeks
after treatment 
initiation and that the target maximum dose, 160 mg twice
daily, be achieved by three 
months, based on the patient's tolerability.
If symptomatic hypotension or ren