LISINOPRIL STADA 5MG TABLET

Šalis: Malaizija

kalba: anglų

Šaltinis: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Veiklioji medžiaga:

LISINOPRIL

Prieinama:

DKSH MALAYSIA SDN BHD

INN (Tarptautinis Pavadinimas):

LISINOPRIL

Vienetai pakuotėje:

50 Tablets; 30 Tablets; 100Tablet Tablets

Pagaminta:

STELLAPHARM J.V. Co., LTD. - BRANCH 1

Pakuotės lapelis

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
LISINOPRIL STADA® 5MG TABLET
Lisinopril 5.445mg (equivalent to 5mg lisinopril)
1
WHAT IS IN THIS LEAFLET
1.
What Lisinopril STADA® 5 mg is
used for
2.
How
Lisinopril
STADA®
5
mg
works
3.
Before
you
take
Lisinopril
STADA® 5 mg
4.
How to take Lisinopril STADA® 5
mg
5.
While
you
are
using
Lisinopril
STADA® 5 mg
6.
Side effects
7.
Storage and Disposal of Lisinopril
STADA® 5 mg
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT
LISINOPRIL
STADA®
5
MG
IS
USED FOR
•
Treatment of high blood pressure
(arterial hypertension)
•
Treatment
of
symptomatic
heart
failure (cardiac insufficiency)
•
Acute heart attack (acute myocardial
Infarction) – of patients with a stable
cardiocirculatory
situation
(haemodynamically stable patients
with a systolic blood pressure above
100mmHg, serum-creatinine below
177μmol/l
(2.0mg/dl)
and
proteinuria
less
than
500mg/24hours.
Lisinopril
should
be administered additionally to the
usual
standard
heart
attack
treatment, preferably together with
nitrates.
HOW LISINOPRIL STADA® 5 MG WORKS
•
Lisinopril
STADA®
5
mg
is
an
angiotensin-converting
enzyme
inhibitor
(ACE
inhibitor)
for
the
treatment of high blood pressure.
BEFORE YOU TAKE LISINOPRIL STADA® 5
MG
_When you must not take it _
•
If
you
are
allergic
(hypersensitive)
to
lisinopril
or
any of the other ingredients of
Lisinopril STADA® 5 mg or to
another
angiotensin
converting
enzyme (ACE) inhibitor
•
if you have had a tissue swelling
(angioneurotic edema) related to
previous treatment with an ACE
inhibitor
•
if
you
are
suffering
from
an
inherited
or
idiopathic
(without
identifiable
cause)
angioedema
(serious allergic reaction which
causes
swelling
of
the
face
or
throat)
•
In the second and third trimester
of pregnancy.
_Before you start to take it _
•
Always take Lisinopril STADA®
5 mg exactly as your doctor has
told you. You should check with
your doctor or pharmacist if you
are not sure.
•
It is recommended to initi

Prekės savybės

STADAPHARM GMBH, Stadastr, 2-18, 61118 Bad Vilbel, Germany
LISINOPRIL STADA
®
5 MG
USE IN PREGNANCY – When used in pregnancy during the second and
third trimesters, ACE inhibitors can cause injury and even death to
developing
foetus. When pregnancy is detected this drug should be discontinued as
soon as possible.
COMPOSITION
Active ingredient: Each tablet contains 5.445 mg Lisinopril dihydrate,
equivalent to 5mg Lisinopril.
Excipients: Mannitol, maize starch, calcium hydrogen phosphate
dihydrate, pregelatinized starch, colloidal anhydrous silica,
magnesium stearate
PHARMACOLOGICAL PROPERTIES
Lisinopril is an inhibitor of the angiotensin-converting enzyme. The
angiotensin converting enzyme (ACE) is a peptidyl dipeptidase, which
catalyses the
conversion of angiotensin I into the vasoconstricting peptide,
angiotensin II. Inhibition of ACE results in lower concentration of
plasma angiotensin II, which
causes an increase of the plasma renin activity (caused by the
elimination of the negative feedback of angiotensin II on the
reninsecretion) and reduced
aldosterone secretion.
ACE is identical with kininase II. That is why lisinopril can block
bradykinin, a strong vasodepressive peptide. Although it is still not
clear, which part this plays
in the therapeutic effect of lisinopril.
Although the blood pressure reducing mechanism of lisinopril
supposedly works primarily by suppression of the
renin-angiotensin-aldosterone system, which
plays an essential role in the blood pressure regulation, lisinopril
has an antihypertensive effect also in patients with a low plasma
renin level.
PHARMACOKINETICS
In clinical trials the maximum plasma concentration was achieved
within about 7 hours of oral administration. Patients with an acute
myocardial infarction
showed a tendency towards a slightly longer time to peak plasma
concentration. With repeated doses lisinopril proved to have an
effective half-life of 12.6
hours.
The major part of the active agent is eliminated during the early
phase, in lower concentrations a prolonged term