LESTACE

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

LISINOPRIL DIHYDRATE

Available from:

Actavis Group PTC ehf

ATC code:

C09AA03

INN (International Name):

LISINOPRIL DIHYDRATE

Dosage:

10 Milligram

Pharmaceutical form:

Tablets

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

lisinopril

Authorization status:

Marketed

Authorization date:

2009-01-23

Patient Information leaflet

Lestace 2.5 mg, 5 mg, 10 mg & 20 mg Tablets. PA1380/7/1-4
V024 April 2017
PACKAGE LEAFLET: INFORMATION FOR THE USER
LESTACE 2.5 MG, 5 MG, 10 MG AND 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 Lestace Tablets are and what they are used for
2.
What you need to know before you take Lestace Tablets
3.
How to take Lestace Tablets
4.
Possible side effects
5.
How to store Lestace Tablets
6.
Contents of the pack and other information
1.
WHAT LESTACE TABLETS IS AND WHAT IT IS USED FOR
Lestace Tablets belong to a group of medicines called ACE inhibitors
(Angiotensin Converting
Enzyme inhibitors). It acts by widening the blood vessels, which helps
reduce your blood pressure and
makes it easier for the heart to pump blood to all parts of your body.
Lestace Tablets are used for the treatment of:
-
High blood pressure (hypertension)
-
Symptomatic heart failure, a condition where the heart does not pump
the blood through your
body as well as it should.
-
Heart attack (acute myocardial infarction) that may lead to a
weakening of your heart.
-
Kidney problems related to diabetes and high blood pressure.
Lestace is recommended in children and adolescents (6 to 16 years old)
only for the treatment of high
blood pressure (hypertension).
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LESTACE TABLETS
DO NOT TAKE LESTACE TABLETS
-
if you are allergic to lisinopril or any of the other ingredients of
this medicine (listed in section
6) or any other medicine in the same group of drugs as Lestace T

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lestace
10 mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg, of lisinopril as lisinopril dihydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
10 mg tablets are light pink, round and biconvex with a diameter of 7
mm, and scored on one side.
The tablet can be divided into equal halves.
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
Posology
Lestace should be administered orally in a single daily dose.
As with all
other medication taken once daily,
Lestace
should be taken at approximately the same time each day. The
absorption of Lestace tablets is not affected by food.
The dose should be individualised according to patient profile and
blood pressure response (see section 4.4).
Hypertension
Lestace 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
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