ADEFIN XL 30 nifedipine 30mg modified release tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

nifedipine

Available from:

Alphapharm Pty Ltd

Authorization status:

Registered

Patient Information leaflet

ADEFIN XL
_nifedipine modified release tablets_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about ADEFIN XL 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 ADEFIN XL. It is
different from the leaflet for other
forms of ADEFIN products.
It is not to be used in relation to any
other product, which may also
contain the same active ingredient.
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 (chest pain).
ADEFIN XL IS NOT USED TO RELIEVE
SUDDEN ATTACKS OF ANGINA OR TO
MANAGE UNSTABLE ANGINA.
ADEFIN XL contains the active
ingredient nifedipine which 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. The active substance
contained in them has been absorbed
by the body before excretion.
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

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
ADEFIN XL30
ADEFIN XL 60
_Nifedipine modified release tablet _
1
NAME OF THE MEDICINE
Nifedipine
_ _
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
ADEFIN XL tablets are a controlled release formulation (GITS,
GastroIntestinal Therapeutic System)
containing nifedipine USP 30 mg or 60 mg as the active ingredient.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Adefin XL 30
:
Round, biconvex, rose-pink, film-coated tablet with “30” printed
in black on one
side, the tablet diameter being 9 mm.
Adefin XL 60
:
Round, biconvex, rose-pink, film-coated tablet with “60” printed
in black on one
side, the tablet diameter being 11 mm.
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.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ADEFIN XL is indicated for:
1.
the treatment of mild to moderate hypertension
2.
the prophylaxis of chronic stable angina pectoris.
4.2
DOSE AND METHOD OF ADMINISTRATION
As far as possible the treatment must be tailored to the needs of the
individual and depending on the
clinical picture in each case, the basic dose must be introduced
gradually. In patients with impaired liver
function, careful monitoring is advised and, in severe cases, a dose
reduction may be necessary.
As a rule, the tablets are swallowed whole
WITHOUT CHEWING OR BEING BROKEN UP
with a little liquid.
They may be taken with or without