Lestace 2.5 mg tablets

国家: 爱尔兰

语言: 英文

来源: HPRA (Health Products Regulatory Authority)

有效成分:

Lisinopril dihydrate

可用日期:

Accord Healthcare Ireland Ltd.

ATC代码:

C09AA; C09AA03

INN（国际名称）:

Lisinopril dihydrate

剂量:

2.5 milligram(s)

药物剂型:

Tablet

治疗领域:

ACE inhibitors, plain; lisinopril

授权状态:

Not marketed

授权日期:

2009-01-23

资料单张

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 Type II diabetes in people with 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 Tablets
(ACE inhibitors)
-
if you have previously been t

产品特点

Health Products Regulatory Authority
31 January 2020
CRN009JZH
Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lestace 2.5 mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2.5 mg, of lisinopril as lisinopril dihydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
2.5 mg tablets are white, round and biconvex with a diameter of 6 mm.
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 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