NICARDIA-XL-30 (NIFEDIPINE EXTENDED RELEASE TABLETS USP 30MG)

País: Malasia

Idioma: inglés

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

Ingredientes activos:

NIFEDIPINE

Disponible desde:

UNIMED SDN BHD

Designación común internacional (DCI):

NIFEDIPINE

Unidades en paquete:

3 x 10's tablet Tablets

Fabricado por:

UNIQUE PHARMACEUTICAL LABORATORIES

Información para el usuario

NICARDIA-XL-30
Nifedipine Extended Release Tablets USP 30mg
1
_Consumer Medication Information Leaflet (RiMUP)_
WHAT IS IN THIS LEAFLET
1.
What
NICARDIA- XL- 30
is
used for
2.
How
NICARDIA- XL- 30
works
3.
Before you use
NICARDIA- XL-
30
4.
How to use
NICARDIA- XL- 30
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
NICARDIA- XL- 30
Product
Description
8.
Manufacturer and Product
Registration Holder
9.
Date of revision
WHAT
NICARDIA- XL- 30
IS USED
FOR
NICARDIA-XL-30
is used for treatment
of treatment of coronary heart disease;
chronic stable angina pectoris (angina of
effort). Treatment of hypertension.
HOW
NICARDIA- XL- 30
WORKS
NICARDIA-XL-30 is a tablet contains
nifedipine. NICARDIA-XL-30 works by
relaxing and expanding the arteries
supplying the heart. This allows more
blood and oxygen to reach the heart and
decrease the strain on it. NICARDIA-
XL-30 also works by relaxing and
expanding the blood vessels. This makes
the blood to flow more easily and lower
blood pressure.
BEFORE YOU USE
NICARDIA- XL- 30
-
_When you must not use it_
•
When you are in cardiovascular
shock, with narrowing of the
aorta, with known
hypersensitivity to nifedipine,
with unstable angina and acute
myocardial infarction (within
the first 4 weeks).
•
If you are allergic to nifedipine
or to any other ingredient in
NICARDIA-XL-30.
•
If you are patients with
extremely low blood pressure
and existing heart muscle
weakness
Pregnancy and lactation
Do not take NICARDIA-XL-30 if you
are pregnant, trying to get pregnant or
think you may be pregnant.
Careful monitoring of blood pressure
must be exercise when taking
NICARDIA-XL-30 with I.V. magnesium
sulphate because an excessive falling of
blood pressure may occur which would
harm both mother and foetus.
Do not take NICARDIA-XL-30 if you
are breast-feeding. Ask your doctor or
pharmacist for advice before taking any
medicine.
-
_Before you start use it_
Please tell your doctor
•
If you are a diabetic. The
treatment for your diabetes may
need to adjusted.
•
If you are

Ficha técnica

For the use of a Registered Medical Practitioner or a Hospital or a
Laboratory only
PACKAGE INSERT
NICARDIA XL 30
Nifedipine Extended Release Tablets USP 30 mg
NAME AND STRENGTH OF ACTIVE INGREDIENT (S)
Nifedipine (30 mg)
PRODUCT DESCRIPTION
Brown colored, round biconvex tablet, plain on one side and laser
drilled hole on other side
PHARMACODYNAMICS
Nifedipine is a specific and potent calcium antagonist of the 1,
4-dihydropyridine type. Calcium antagonists reduce the transmembrane
influx of calcium ions
through the slow calcium channel into the cell. Nifedipine acts
particularly on the cells of the myocardium and the smooth muscle
cells of the coronary arteries
and the peripheral resistance vessels. In hypertension, the main
action of Nicardia XL 30 is to cause peripheral vasodilatation and
thus reduce peripheral
resistance. In angina, Nicardia XL 30 reduces peripheral and coronary
vascular resistance, leading to an increase in coronary blood flow,
cardiac output and
stroke volume, whilst decreasing after-load. Additionally, nifedipine
dilates submaximal both clear and atherosclerotic coronary arteries,
thus protecting the
heart against coronary artery spasm and improving perfusion to the
ischaemic myocardium. Nifedipine reduces the frequency of painful
attacks and the isch-
aemic ECG changes irrespective of the relative contribution from
coronary artery spasm or atherosclerosis. Nicardia XL 30 administered
twice-daily provides
24-hour control of raised blood pressure. Nicardia XL 30 causes
reduction in blood pressure such that the percentage lowering is
directly related to its initial
level. In normotensive individuals, Nicardia XL 30 has little or no
effect on blood pressure.
PHARMOCOKINETICS
ABSORPTION
After oral administration nifedipine is rapidly and almost completely
absorbed. The systemic availability of orally administered nifedipine
is 45 – 56 % owing
to a first pass effect. Maximum plasma and serum concentrations are
reached at 1.5 to 4.2 hours with Nicardia XL 30. Simultaneous food
intake leads to
d