ADALAT OROS nifedipine 20mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

nifedipine

Available from:

Bayer Australia Ltd

Authorization status:

Registered

Patient Information leaflet

Adalat Oros® CMI vX 1.0
1
ADALAT
®
OROS
(ADD·A·LAT OR·US)
_nifedipine _
_ _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some common
questions about Adalat Oros. 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 Oros. It is
different from the leaflet for other
forms of Adalat products.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Adalat Oros
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
pressure and improve the supply of
blood and oxygen to the heart.
Adalat Oros is specially designed
to allow the slow release of the
active substance from the tablet
after it is taken. It is composed of a
strong outer shell which does not
dissolve in the body and is
excreted in the faeces. It is normal
to find these “ghost-tablets” in the
faeces. The active substance
contained in them has been
absorbed by the body before
excretion.
Your doctor, however, may
prescribe Adalat Oros for another
purpose.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY ADALAT
OROS HAS BEEN PRESCRIBED FOR
YOU.
•
rash, itching or hives on the
skin.
DO NOT TAKE ADALAT OROS IF YOU
ARE IN CARDIOGENIC SHOCK (VERY
LOW BLOOD PRESSURE DUE TO A
FAILING HEART). TELL YOUR DOCTOR IF
YOU HAVE HAD A HEART ATTACK IN
THE LAST WEEK OR SO.
DO NOT TAKE ADALAT OROS IF YOU
HAVE A KOCK POUCH OR ILEOSTOMY
(A SURGICALLY CREATED RESERVOIR IN
THE SMALL INTESTINE).
DO NOT TAKE ADALAT OROS IF YOU
ARE TAKING ANOTHER MEDICINE
CONTAINING THE ACTIVE SUBSTANCE
RIFAMPICIN, AN ANTIBIOTIC USED TO
TREAT TUBERCULOSIS AND OTHER
SERIOUS INFECTIONS.
DO NOT TAKE THIS MEDICINE IF YOU
ARE PREGNANT.
KEEP THIS LEAFLET WITH THE
It may affect your developing baby
MEDICINE.
You may need to read it again.
BEFORE YOU TAKE
ADALAT OROS
if you take it during pregnancy.
DO NOT BREAST-FEED IF YOU ARE
_ _
_ _
_WHEN YOU MUST NOT TAKE IT _
T

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
ADALAT® OROS (NIFEDIPINE) CONTROLLED RELEASE TABLETS
Adalat Oros® PI vX1.0 CCDS17
Page 1 of 19
1 NAME OF THE MEDICINE
nifedipine
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Adalat OROS tablets are a controlled release formulation (GITS,
GastroIntestinal Therapeutic
System) containing nifedipine 20 mg, 30 mg or 60 mg.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3 PHARMACEUTICAL FORM
Adalat OROS 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 Adalat OROS remains intact during the
gastrointestinal passage
and is eliminated in the faeces.
All strengths of Adalat OROS are round, biconvex shaped, rose-pink,
film-coated tablets.
Tablet diameters are 8.4 mm (20 mg), 9 mm (30 mg) and 11 mm (60 mg).
Adalat OROS 20
mg tablets are marked in black with the product name on one side
(“Adalat 20”) and the Adalat
OROS 30 mg and 60 mg tablets are marked with the dose strength on one
side (“30” or “60”).
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Adalat OROS 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.
The tablets are swallowed