ADALAT

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Nifedipine

Available from:

Bayer Australia Ltd

Class:

Medicine Registered

Patient Information leaflet

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

Summary of Product characteristics

 
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