ZESTRIL 20 TABLET

Land: Sydafrika

Sprog: engelsk

Kilde: South African Health Products Regulatory Authority (SAHPRA)

Tilgængelig fra:

AstraZeneca Pharmaceuticals (Pty) Ltd

Dosering:

See ingredients

Lægemiddelform:

TABLET

Sammensætning:

EACH TABLET CONTAINS LISINOPRIL 20,0 mg

Autorisation status:

Registered

Autorisation dato:

1989-09-11

Indlægsseddel

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PROPOSED PATIENT INFORMATION LEAFLET
SCHEDULING STATUS:
ZESTRIL® 5; ZESTRIL® 10; ZESTRIL® 20 (TABLET)
LISINOPRIL
CONTAINS SUGAR: MANNITOL 20,6 MG (ZESTRIL 5); 41,2 MG (ZESTRIL 10);
41,0 MG
(ZESTRIL 20)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING ZESTRIL
•
Keep this leaflet. You may need to read it again.
•
If you have further questions, please ask your doctor, pharmacist,
nurse or other health
care provider.
•
ZESTRIL has been prescribed for you personally and you should not
share your
medicine with other people. It may harm them, even if their symptoms
are the same as
yours.
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 belongs to a group of medicines called ACE inhibitors
(Angiotensin Converting
Enzyme inhibitors). ZESTRIL works by widening your blood vessels,
which helps reduce
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Page 2 of 11
your blood pressure and makes it easier for your heart to pump blood
to all parts of your
body.
ZESTRIL is used for:
•
Treatment of high blood pressure (hypertension) that is mild or
moderate. It can be used
together with other medications to treat your high blood pressure.
•
Management of a heart condition called congestive heart failure when
your heart does
not pump blood around your body as well as it is needed.
•
Treatment after you have had a heart attack (myocardial infarction) to
prevent heart
failure.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ZESTRIL
DO NOT TAKE ZESTRIL:
•
If you are allergic to lisinopril or any other ingredients of ZESTRIL.
•
If you have previously been treated with a medicine in the same group
as ZESTRIL (ACE
Inhibitors or ARB’s) and have had allergic reactions with itching,
hives, sudden fall in
blood pressure, swelling of the hands, feet or ankles, the face, lips,
tongue and/or throat
with difficulty in swallo

Produktets egenskaber

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PROPOSED ANNOTATED PROFESSIONAL INFORMATION
SCHEDULING STATUS
1 NAME OF THE MEDICINE
ZESTRIL® 5; ZESTRIL® 10; ZESTRIL® 20 (Tablet)
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ZESTRIL 5 tablet contains: 5 mg lisinopril as the dihydrate
Each ZESTRIL 10 tablet contains: 10 mg lisinopril as the dihydrate.
Each ZESTRIL 20 tablet contains: 20 mg lisinopril as the dihydrate.
Contains sugar: mannitol 20,6 mg (ZESTRIL 5); 41,2 mg (ZESTRIL 10);
41,0 mg (ZESTRIL
20)
For full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Tablet
ZESTRIL 5:
Round, pink, uncoated, biconvex tablet. Intagliated on one side with 5
and a heart shape,
and on the other side with a bisect line.
ZESTRIL 10:
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Page 2 of 26
Round, pink, uncoated biconvex tablet, with “

10” on one side of the tablet and plain on the
other side.
ZESTRIL 20:
Round, brownish-red, uncoated biconvex tablet, with “

20” on one side of the tablet and
plain on the other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATION
_Hypertension: _
ZESTRIL is indicated in the treatment of mild to moderate
hypertension. It may be used
alone or concomitantly with other classes of antihypertensive
medicines.
_Congestive heart failure: _
ZESTRIL is indicated in the management of congestive heart failure as
an adjunctive
treatment with diuretics and, where appropriate, digitalis.
_Acute myocardial infarction: _
ZESTRIL is indicated for the treatment of haemodynamically stable
patients, within 24 hours
after acute myocardial infarction, to prevent the subsequent
development of left ventricular
dysfunction or heart failure and to improve survival. Patients should
receive, as appropriate,
the standard recommended treatments such as thrombolytics, aspirin and
beta-blockers.
Administration is by the oral route.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
ZESTRIL should be administered in a single daily dose. ZESTRIL should
be taken at
approximately the same time each day.
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Absorption of ZESTRIL tablets is not affected by food, and