Adefin

Land: Australië

Taal: Engels

Bron: Department of Health (Therapeutic Goods Administration)

Werkstoffen:

Nifedipine

Beschikbaar vanaf:

Alphapharm Pty Ltd

klasse:

Medicine Registered

Bijsluiter

ADEFIN

_contains the active ingredient nifedipine_
CONSUMER MEDICINE INFORMATION

WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Adefin 10 and
Adefin 20 tablets (described below as
Adefin tablets).
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 against
the benefits expected for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, TALK TO YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
The information supplied in this
leaflet relates only to Adefin 10 and
Adefin 20. It is not to be used in
relation to any other product, which
may also contain the same active
ingredient.
WHAT ADEFIN IS USED
FOR
Adefin tablets are used either to treat
high blood pressure or to prevent
chronic stable angina (chest pain).
ADEFIN TABLETS ARE NOT USED FOR THE
RELIEF OF A SUDDEN ATTACK OF ANGINA.
Adefin tablets contain the active
substance nifedipine that 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 ADEFIN HAVE
BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed
Adefin for another reason.
Adefin is available only with a
doctor's prescription.
BEFORE YOU TAKE
ADEFIN
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE ADEFIN IF YOU ARE
ALLERGIC TO:
•
MEDICINES CONTAINING NIFEDIPINE
(EG. ADALAT, ADEFIN XL)
•
MEDICINES SIMILAR TO NIFEDIPINE
SUCH AS AMLODIPINE (NORVASC),
FELODIPINE (EG. PLENDIL,
FELODUR), LERCANIDIPINE
(ZANIDIP), NIMODIPINE
(NIMOTOP)
•
ANY OF THE INGREDIENTS LISTED AT
THE END OF THIS LEAFLET.
Some of the symptoms of an allergic
reaction may include skin rash,
itching or hives; swelling of the face,
lips or tongue which may cause
difficulty in swallowing or breathing;
wheezing or shortness of breath.
DO NOT TAKE ADEFIN IF Y

Productkenmerken

ADEFIN
® 
_Nifedipine _
PRODUCT INFORMATION 
NAME OF THE MEDICINE 
Active ingredient: 
Nifedipine 
Chemical name: 
dimethyl-1,4-dihydro-2,6-dimethyl-4-(2'-nitrophenyl)-3,5-pyridine dicarboxylate 
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 tablets are round,
pink-grey, film-coated tablets containing micronised
nifedipine 10 mg or 20 mg.  
ADEFIN tablets also contain the following inactive ingredients:  cellulose  -  microcrystalline,  polysorbate 80, 
magnesium stearate, hypromellose, macrogol 4000,
titanium dioxide, starch – maize, iron oxide red (CI 77491) 
and lactose. 
PHARMACOLOGY 
ADEFIN (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 to 
56%. 
ADEFIN – Product Information 

2 

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 to 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
to 3.4 hours.  Administ