Zestril 5 mg Tablets

Land: Irland

Sprache: Englisch

Quelle: HPRA (Health Products Regulatory Authority)

Wirkstoff:

Lisinopril

Verfügbar ab:

PCO Manufacturing Ltd.

ATC-Code:

C09AA; C09AA03

INN (Internationale Bezeichnung):

Lisinopril

Dosierung:

5 milligram(s)

Darreichungsform:

Tablet

Verschreibungstyp:

Product subject to prescription which may be renewed (B)

Therapiebereich:

ACE inhibitors, plain; lisinopril

Berechtigungsstatus:

Authorised

Berechtigungsdatum:

2013-10-11

Gebrauchsinformation

_ _
_ _
_ _
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ZESTRIL
® 5 MG 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 you have taken or are currently taking sacubitril/valsartan, a
medicine used to treat
a type of long-term (chronic)

Fachinformation

Health Products Regulatory Authority
12 July 2022
CRN00D0PR
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Zestril 5 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains lisinopril dihydrate equivalent to 5 mg anhydrous
lisinopril.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
_Product imported from Portugal:_
Round, pink, uncoated, biconvex tablets with a heart shape and “5”
on one side and bisected on the other side. Diameter 6mm.
The tablet can be divided into equal halves.
4 CLINICAL PARTICULARS
As per PA23140/002/001
5 PHARMACOLOGICAL PROPERTIES
As per PA 23140/002/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Mannitol
Calcium Hydrogen Phosphate dihydrate
Red Iron Oxide (E172)
Maize Starch
Pregelatinised 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 30°C
Health Products Regulatory Authority
12 July 2022
CRN00D0PR
Page 2 of 2
6.5 NATURE AND CONTENTS OF CONTAINER
Aluminium/PVC-PVDC, Aluminium/PVC or Aluminium/Aluminium foil blister
packs of 28 tablets.
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
PPA0465/066/005
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 11
th
October 2013
10 DATE OF REVISION OF THE TEXT
July 2022