Zestril 5mg Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Lisinopril

Available from:

Atnahs Pharma Netherlands B.V.

ATC code:

C09AA; C09AA03

INN (International Name):

Lisinopril

Dosage:

5 milligram(s)

Pharmaceutical form:

Tablet

Therapeutic area:

ACE inhibitors, plain; lisinopril

Authorization status:

Marketed

Authorization date:

1989-05-10

Patient Information leaflet

Page 1
of 9
Package leaflet: Information for the patient
ZESTRIL 5 MG TABLETS
ZESTRIL 10 MG TABLETS
ZESTRIL 20 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 use

Summary of Product characteristics

Health Products Regulatory Authority
28 July 2022
CRN00CSTX
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Zestril 5mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains lisinopril dihydrate equivalent to 5 mg anhydrous
lisinopril.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Round, pink, uncoated, biconvex tablets with “♥ 5” on one side
and bisected on the other side. Diameter 6mm.
The tablet can be divided into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
HYPERTENSION
Treatment of hypertension.
HEART FAILURE
Treatment of symptomatic heart failure.
ACUTE MYOCARDIAL INFARCTION
Short-term (6 weeks) treatment of haemodynamically stable patients
within 24 hours of an acute myocardial infarction.
RENAL COMPLICATIONS OF DIABETES MELLITUS
Treatment of renal disease in hypertensive patients with Type 2
diabetes mellitus and incipient nephropathy (see section 5.1).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Zestril should be administered orally in a single daily dose. As with
all other medication taken once daily, Zestril should be
taken at approximately the same time each day. The absorption of
Zestril tablets is not affected by food.
The dose should be individualised according to patient profile and
blood pressure response (see section 4.4).
HYPERTENSION
Zestril may be used as monotherapy or in combination with other
classes of antihypertensive therapy (see sections 4.3, 4.4, 4.5
and 5.1).
Starting dose
In patients with hypertension the usual recommended starting dose is
10 mg. Patients with a strongly activated
renin-angiotensin-aldosterone system (in particular, renovascular
hypertension, salt and /or volume depletion, cardiac
decompensation, or severe hypertension) may experience an excessive
blood pressure fall following the initial dose. A starting
dose of 2.5‑5 mg is recommended in such patients and the initiation
of treatment should take place under medical supervision.
A lower starting dose is required in t