PIL
121107AdalatAUCMI
1
ADALAT
®
(ADD·A·LAT)
_nifedipine _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some common
questions about Adalat tablets. It
does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
This leaflet is for Adalat tablets. It
is different from the leaflet for
another form of Adalat known as
Adalat Oros.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Adalat
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE.
You may need to read it again.
WHAT ADALAT IS
USED FOR
Adalat tablets are used either to
treat high blood pressure or to
manage a type of angina (chest
pain), known as chronic stable
angina.
ADALAT TABLETS ARE NOT USED FOR THE
RELIEF OF A SUDDEN ATTACK OF ANGINA
OR TO MANAGE UNSTABLE ANGINA.
Adalat tablets contain the active
substance nifedipine which belongs
to a group of medicines called
calcium channel blockers. They
work by opening up blood vessels
in the body to lower blood pressure
and improve the supply of blood
and oxygen to the heart.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
BEFORE YOU TAKE
ADALAT
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE ADALAT IF YOU HAVE AN
ALLERGY TO:
nifedipine, the active ingredient
in Adalat
any of the ingredients listed at
the end of this leaflet.
Some of the symptoms of an
allergic reaction may include:
shortness of breath
wheezing or difficulty breathing
swelling of the face, lips, tongue
or other parts of the body
rash, itching or hives on the skin.
DO NOT TAKE ADALAT IF YOU
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SPC
111215 Adalat PI
1
ADALAT® 10 AND ADALAT® 20 TABLETS
PRODUCT INFORMATION
NAME OF THE MEDICINE
Nifedipine
is dimethyl-1,4-dihydro-2,6-dimethyl-4-(2'-nitrophenyl)-3,5-pyridine
dicarboxylate,
C
17
H
18
N
2
O
6
, MW 346.3, CAS Registry No. [21829-25-4]. Its structural formula is shown
below.
Nifedipine is a yellow crystalline substance
practically insoluble in water, and sparingly
soluble
in absolute
ethanol. It is sensitive to light.
DESCRIPTION
Adalat tablets are round, pink-grey, film-coated
tablets containing micronised nifedipine
10 mg or 20 mg. Adalat tablets also contain the
following inactive ingredients:
microcrystalline cellulose, maize starch, polysorbate
80, magnesium stearate,
hypromellose, macrogol 4000, titanium dioxide, iron oxide
red (CI 77491), and lactose.
PHARMACOLOGY
Adalat (nifedipine) 10 or 20 is a
calcium ion influx inhibitor (calcium channel blocker or
calcium antagonist).
PHARMACOKINETICS
After oral administration, the absorption of nifedipine from the
tablet is delayed (t
max
1.5 to
4.2 hours) compared to a liquid capsule formulation (t
max
0.5 to 2.17 hours). The
bioavailability of the tablet is 45 – 56%.
Nifedipine is about 95% bound to plasma protein (albumin). Protein
binding may be greatly
reduced in patients with renal or hepatic impairment.
Nifedipine is almost completely metabolised in the
body with only traces detected in the
urine in an unchanged form. 70-80% of the dose is excreted via
the kidneys in the form of
highly water-soluble pharmacologically inactive metabolites. The
remainder is excreted in
the faeces, also in a metabolised form
.
The half-life of an immediate release dose form
shows a mean of approximately 1.7 - 3.4 hours. Administration
of the tablet results in a
half-life
of a
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