Diovan 160 mg film-coated tablets

国家: 爱尔兰

语言: 英文

来源: HPRA (Health Products Regulatory Authority)

有效成分:

Valsartan

可用日期:

IMED Healthcare Ltd.

ATC代码:

C09CA; C09CA03

INN（国际名称）:

Valsartan

剂量:

160 milligram(s)

药物剂型:

Film-coated tablet

处方类型:

Product subject to prescription which may be renewed (B)

治疗领域:

Angiotensin II antagonists, plain; valsartan

授权状态:

Authorised

授权日期:

2013-03-15

资料单张

PACKAGE LEAFLET: INFORMATION FOR THE USER
DIOVAN 80 MG FILM-COATED TABLETS
DIOVAN 160 MG FILM-COATED TABLETS
VALSARTAN
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 Diovan is and what it is used for
2. What you need to know before you take Diovan
3. How to take Diovan
4. Possible side effects
5. How to store Diovan
6. Contents of the pack and other information
1. WHAT DIOVAN IS AND WHAT IT IS USED FOR
Diovan contains the active substance: valsartan and belongs 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. Diovan works by
blocking
the effect of angiotensin II. As a result, blood vessels relax and
blood pressure is
lowered.
Diovan 80 mg film-coated tablets CAN BE USED FOR THREE DIFFERENT
CONDITIONS:

TO TREAT HIGH BLOOD PRESSURE IN ADULT AND 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 HE

产品特点

Health Products Regulatory Authority
22 February 2021
CRN00C4RN
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Diovan 160 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One film-coated tablet contains 160 mg valsartan.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablets.
_Product imported from Italy:_
Grey-orange, ovaloid film-coated tablet, slightly convex, scored on
one side with debossing “DX” on one side of the score and
“DX” on the other side of the score and “NVR” on the reverse
side of the tablet.
The score line is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
4 CLINICAL PARTICULARS
As per PA0896/009/002
5 PHARMACOLOGICAL PROPERTIES
As per PA0896/009/002
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Tablet Core
Microcrystalline cellulose
Crospovidone
Colloidal anhydrous silica
Magnesium stearate
Film coat
Hypromellose
Titanium dioxide (E171)
Macrogol 8000
Iron oxide red (E172)
Iron oxide yellow (E172)
Iron oxide black (E172)
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf-life expiry date of this product is the date shown on the
container and outer package of the product on the market in
the country of origin.
Health Products Regulatory Authority
22 February 2021
CRN00C4RN
Page 2 of 2
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 30°C. Store in the original package in order to
protect from moisture.
6.5 NATURE AND CONTENTS OF CONTAINER
Cardboard carton containing blister strips. Each blister strip
contains 14 tablets. Pack size 28 tablets.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR
WASTE MATERIALS DERIVED FROM SUCH MEDICINAL
PRODUCT AND OTHER HANDLING OF THE PRODUCT
Any unused medicinal product or waste material should be disposed of
in accordance with local requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
IMED Healthcare Ltd.
Unit 625 Kilshane Avenue
Northwest Business Park
Ballycoolin
Dublin 15
Ireland
8