Zestril 10mg Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

LISINOPRIL DIHYDRATE

Available from:

Atnahs Pharma Netherlands B.V. Copenhagen Towers Ørestads Boulevard 108, 5.tv DK-2300 København S , Denmark

ATC code:

C09AA03

INN (International Name):

LISINOPRIL DIHYDRATE 10 mg

Pharmaceutical form:

TABLET

Composition:

LISINOPRIL DIHYDRATE 10 mg

Prescription type:

POM

Therapeutic area:

AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM

Authorization status:

Authorised

Authorization date:

2006-03-29

Patient Information leaflet

Page 1
of 12
Package leaflet: Information for the patient
ZESTRIL 5 MG TABLETS
ZESTRIL 10 MG TABLETS
ZESTRIL 20 MG TABLETS
lisinopril
Page 2
of 12
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
Page 3
of 12
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
reac

Summary of Product characteristics

Summary of Product Characteristics
Page 1 of 22
1.
NAME OF THE MEDICINAL PRODUCT
Zestril, 10 mg, tablets.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains lisinopril dihydrate equivalent to 10 mg
anhydrous
lisinopril.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Round, pink, uncoated, biconvex tablet with “♥ 10” on one side
and plain on
the other side. Diameter 8 mm.
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).
Summary of Product Characteristics
Page 2 of 22
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
the
presence of renal impairment (see Table 1 belo