NORVASC TABLET 10MG

Država: Malezija

Jezik: angleščina

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

Aktivna sestavina:

AMLODIPINE BESYLATE

Dostopno od:

VIATRIS SDN. BHD.

INN (mednarodno ime):

AMLODIPINE BESYLATE

Enote v paketu:

100 Tablet Tablets; 30Tablet Tablets; 30 Tablets; 100 Tablets

Izdeluje:

VIATRIS PHARMACEUTICALS LLC

Navodilo za uporabo

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
NORVASC
® TABLETS
Amlodipine besilate (5 mg and 10 mg)
1
WHAT IS IN THIS LEAFLET
1.
What Norvasc is used for
2.
How Norvasc works
3.
Before you use Norvasc
4.
How to use Norvasc
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Norvasc
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
11.
Serial Number
WHAT NORVASC IS USED FOR
Norvasc is under the group of
medicines called calcium antagonists.
Norvasc is used to treat high blood
pressure (hypertension) or a certain
type of chest pain called angina
(Prinzmetal’s or variant angina).
HOW NORVASC WORKS
In patients with high blood pressure
Norvasc works by relaxing blood
vessels, so that blood passes through
them more easily.
In patients with angina, Norvasc
works by improving blood supply to
the heart muscle which then receives
more oxygen and as a result, chest
pain is prevented. Norvasc does not
provide immediate relief of chest pain
from angina.
BEFORE YOU USE NORVASC
-
_When you must not use it_
Do not use Norvasc if you are
allergic to dihydropyridines (the
active ingredient in amlodipine), or
to the inactive ingredients. Your
doctor or pharmacist can give you a
list of these ingredients.
_Pregnancy and lactation_
The safety of amlodipine in human
pregnancy has not been established. If
you are pregnant, trying to get
pregnant or think you may be
pregnant, ask your doctor or
pharmacist for advice before taking
any medicine.
Amlodipine has been shown to pass
into breast milk in small amounts.
Ask your doctor or pharmacist for
advice before taking any medicine.
-
_Before you start to use it_
Tell your doctor if you:
•
ever had heart disease
•
ever had liver problems
-
_Taking other medicines_
Please tell your doctor or pharmacist
if you are taking or have recently
taken any other medicines,
including medicines obtained
without a prescription, including
natural or herbal remedies like:
•
Simvastatin
•
CYP3A4 Inhibitors such as
ketoconazole, itrac

Lastnosti izdelka

1
1
.
NAME OF THE MEDICINAL PRODUCT
NORVASC
®
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient: amlodipine besilate.
The tablets contain amlodipine besilate equivalent to 5 mg and 10 mg
amlodipine.
3.
PHARMACEUTICAL FORM
Tablets
The 5 mg strength tablets are white to off-white, emerald-shaped
tablets engraved
“AML 5” and breaker score on one side and “Pfizer” logo on the
other side.
The 5 mg tablet can be divided into equal halves.
The 10 mg strength tablets are white to off-white, emerald-shaped
engraved “AML-10” on
one side and “Pfizer” logo on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_Hypertension_
Amlodipine is indicated for the first-line treatment of hypertension
and can be used as the
sole agent to control blood pressure in the majority of patients.
Patients not adequately
controlled on a single antihypertensive agent (other than amlodipine)
may benefit from
the addition of amlodipine, which has been used in combination with a
thiazide diuretic,
alpha blockers, beta adrenoceptor blocking agent, or an
angiotensin-converting enzyme
(ACE) inhibitor.
_Chronic Stable Angina_
Amlodipine is indicated for the first-line treatment of myocardial
ischemia, whether due
to fixed obstruction (stable angina) and/or vasospasm/vasoconstriction
(Prinzmetal’s or
variant angina) of coronary vasculature. Amlodipine may be used where
the clinical
presentation suggests a possible vasospastic/vasoconstrictive
component but where
vasospasm/vasoconstriction has not been confirmed. Amlodipine may be
used alone, as
monotherapy, or in combination with other antianginal drugs in
patients with angina that
is refractory to nitrates and/or adequate doses of beta-blockers.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
For both hypertension and angina, the usual initial dose is 5 mg
amlodipine once daily,
which may be increased to a maximum dose of 10 mg depending on the
individual
patient’s response.
2
No dose adjustment of amlodipine is required upon concomitant
administration of
th