Adefin XL

Land: Australië

Taal: Engels

Bron: Department of Health (Therapeutic Goods Administration)

Werkstoffen:

Nifedipine

Beschikbaar vanaf:

Alphapharm Pty Ltd

klasse:

Medicine Registered

Bijsluiter

ADEFIN XL

_contains the active ingredient nifedipine_
CONSUMER MEDICINE INFORMATION

WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about ADEFIN XL tablets.
It is not to be used in relation to any
other product, which may also
contain the same active ingredient.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking ADEFIN XL
against the benefits expected for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
PLEASE READ THIS LEAFLET CAREFULLY
AND KEEP IT WITH YOUR MEDICINE.
You may need to read it again.
WHAT ADEFIN XL IS
USED FOR
ADEFIN XL is used to:
•
treat high blood pressure
•
prevent chronic stable angina, a
type of angina.
ADEFIN XL IS NOT USED TO RELIEVE
SUDDEN ATTACKS OF ANGINA.
ADEFIN XL belongs to a group of
medicines called calcium channel
blockers.
Calcium channel blockers work by
opening up blood vessels in the body
to lower blood pressure and improve
the supply of blood and oxygen to
the heart.
ADEFIN XL tablets are specially
designed with a strong outer shell.
This outer shell allows the medicine
to be released slowly into the body
over a longer period of time after it is
taken. The outer shell is excreted or
passed out in the faeces (or bowel
motions), as it does not dissolve in
the body. Therefore, it is normal to
find a "tablet-like" object in the
faeces.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY ADEFIN XL
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
This medicine is only available with
a doctor's prescription.
BEFORE YOU TAKE
ADEFIN XL
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE ADEFIN XL IF YOU ARE
ALLERGIC TO:
•
medicines containing nifedipine
(eg. Adalat OROS, Adefin)
•
medicines similar to nifedipine
such as amlodipine (Norvasc),
felodipine (Plendil, Felodur),
lercanidipine (Zanidip),
nimodipine (Nimotop)
•
any of

Productkenmerken

ADEFIN
®
 XL

_Nifedipine _
PRODUCT INFORMATION 
NAME OF THE MEDICINE 
Active ingredient: 
Nifedipine 
Chemical name: 
dimethyl 1,4-dihydro-2,6-dimethyl-4-(2'-nitrophenyl)-3,5-pyridinedicarboxylate

Structural formula: 

Molecular formula: 
C
17
H
18
N
2
O
6

Molecular Weight: 
346.3  
CAS Registry No: 
21829-25-4 
DESCRIPTION 
Nifedipine  is  a  yellow  crystalline  substance  practically  insoluble  in  water,  and  sparingly  soluble  in  absolute 
ethanol.  It is sensitive to light. 
ADEFIN XL tablets are a controlled release formulation containing nifedipine USP 30 mg or 60 mg.  Besides 
the  active  ingredient,  ADEFIN  XL  30 mg  and  60 mg  tablets  also  contain  the  following  inactive  ingredients: 
polyethylene  oxide,  magnesium  stearate,  sodium  chloride,  hypromellose,  iron  oxide  red  (CI  77491), 
hydroxypropylcellulose, cellulose acetate, macrogol 3350,
titanium dioxide and propylene glycol. 
ADEFIN XL tablets are similar in appearance to conventional tablets.  Each tablet consists of a semipermeable 
membrane surrounding an osmotically active core.  The core itself is divided into two layers: an "active" layer 
containing  nifedipine,  and  a  "push"  layer  containing  pharmacologically  inert  but  osmotically  active 
components.  As water from the gastrointestinal tract enters the tablet, pressure increases in the osmotic layer 
and "pushes" against the nifedipine layer, releasing nifedipine through a precision laser-drilled tablet orifice in 
the  "active"  layer.    The  coating  of  ADEFIN  XL  remains  intact  during  the  gastrointestinal  passage  and  is 
eliminated in the faeces. 
ADEFIN XL 
– Product Information 
2 

PHARMACOLOGY 
Nifedipine is a calcium ion influx inhibitor (calcium