Zestril 10mg Tablets

Ülke: İrlanda

Dil: İngilizce

Kaynak: HPRA (Health Products Regulatory Authority)

Aktif bileşen:

Lisinopril

Mevcut itibaren:

PCO Manufacturing Ltd.

ATC kodu:

C09AA; C09AA03

INN (International Adı):

Lisinopril

Doz:

10 milligram(s)

Farmasötik formu:

Tablet

Reçete türü:

Product subject to prescription which may be renewed (B)

Terapötik alanı:

ACE inhibitors, plain; lisinopril

Yetkilendirme durumu:

Authorised

Yetkilendirme tarihi:

2001-07-13

Bilgilendirme broşürü

_ _
_ _
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ZESTRIL
® 5MG TABLETS
ZESTRIL
® 10MG TABLETS
ZESTRIL
® 20MG TABLETS
lisinopril
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 Zestril is and what it is used for
2.
What you need to know before you take Zestril
3.
How to take Zestril
4.
Possible side effects
5.
How to store Zestril
6.
Contents of the pack and other information
1.
WHAT ZESTRIL IS AND WHAT IT IS USED FOR
Zestril contains a medicine called lisinopril. This belongs to a group
of medicines called ACE
inhibitors.
Zestril can be used for the following conditions:

To treat high blood pressure (hypertension).

To treat heart failure.

If you have recently had a heart attack (myocardial infarction).

To treat kidney problems caused by Type II diabetes in people with
high blood pressure.
Zestril works by making your blood vessels widen. This helps to lower
your blood pressure. It
also makes it easier for your heart to pump blood to all parts of your
body.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ZESTRIL
DO NOT TAKE ZESTRIL:

If you are allergic to lisinopril or any of the other ingredients of
this medicine (listed in
Section 6).

If you have ever had an allergic reaction to another ACE inhibitor
medicine. The allergic
reaction may have caused swelling of the hands, feet, ankles, face,
lips, tongue or throat. It
may also have made it difficult to swallow or breathe (angioedema).

If a member of your family has had severe allergic reactions
(angioedema) to

Ürün özellikleri

Health Products Regulatory Authority
30 September 2020
CRN009Z0M
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Zestril 10mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains lisinopril dihydrate equivalent to 10 mg
anhydrous lisinopril.
_For a full list of excipients, see section 6.1._
3 PHARMACEUTICAL FORM
Tablets
_Product sourced in the UK and The Netherlands_
Pink, round biconvex uncoated tablets, impressed with a heart shape
plus ‘10’ on one side and plain on the other or pink,
round biconvex uncoated tablets, impressed with a heart shape plus '10
Zestril' on one side and plain on the other.
4 CLINICAL PARTICULARS
As per PA1019/026/002
5 PHARMACOLOGICAL PROPERTIES
As per PA1019/026/002
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
_Product sourced in The UK and The Netherlands:_
Mannitol (E421)
Calcium hydrogen phosphate dihydrate
Red Iron oxide (E172)
Maize starch
Pregelatinised maize starch
Magnesium stearate
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date of this product shall be the date shown on
the container and outer package of the product on the
market in the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 30ºC.
6.5 NATURE AND CONTENTS OF CONTAINER
Blister packs of 14, 28 and 30 tablets.
Health Products Regulatory Authority
30 September 2020
CRN009Z0M
Page 2 of 2
Not all pack sizes may be marketed.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING
No special requirements
7 PARALLEL PRODUCT AUTHORISATION HOLDER
PCO Manufacturing Ltd.
Unit 10, Ashbourne Business Park
Rath
Ashbourne
Co. Meath
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA0465/066/003
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 13 July 2001
Date of last renewal: 13 July 2006
10 DATE OF REVISION OF THE TEXT
September 2020