DILTIAZEM AN diltiazem hydrochloride 60mg tablet blister pack

Land: Australië

Taal: Engels

Bron: Department of Health (Therapeutic Goods Administration)

Werkstoffen:

diltiazem hydrochloride, Quantity: 60 mg

Beschikbaar vanaf:

Arrotex Pharmaceuticals Pty Ltd

INN (Algemene Internationale Benaming):

diltiazem hydrochloride

farmaceutische vorm:

Tablet, film coated

Samenstelling:

Excipient Ingredients: lactose monohydrate; hydrogenated castor oil; aluminium hydroxide; methacrylic acid copolymer; purified talc; magnesium stearate; titanium dioxide; indigo carmine; methylcellulose; macrogol 400

Toedieningsweg:

Oral

Eenheden in pakket:

90 tablets

Prescription-type:

(S4) Prescription Only Medicine

therapeutische indicaties:

Moderate to severe angina pectoris due to atherosclerotic coronary artery disease or coronary artery spasm (vasospastic angina).

Product samenvatting:

Visual Identification: White, film coated, capsule shaped, scored tablet with one face embossed DL/60; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 4 Years; Container Temperature: Store below 25 degrees Celsius

Autorisatie-status:

Registered

Autorisatie datum:

2012-07-20

Bijsluiter

_Diltiazem AN tablets – Consumer Medicine Information _
_ _
DILTIAZEM AN TABLETS
_Diltiazem hydrochloride _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This
leaflet
answers
some
common
questions
about
DILTIAZEM
AN.
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
DILTIAZEM
AN
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 DILTIAZEM AN
IS USED FOR
The name of your medicine is
DILTIAZEM AN. It contains the
active ingredient called diltiazem
hydrochloride.
DILTIAZEM
AN
belongs
to
a
group
of
medicines
called
calcium
channel
blockers
or
calcium antagonists. They work
by
opening
up
blood
vessels,
which lowers blood pressure and
lets
more
blood
and
oxygen
reach
the
heart.
They
do
not
change the amount of calcium in
your blood or bones.
DILTIAZEM
AN
is
used
to
prevent angina.
Angina
is
a
pain
or
uncomfortable sensation in the
chest,
often
spreading
to
the
arms or neck and sometimes to
the
shoulders
and
back.
The
pain
of
angina
is
due
to
a
shortage of oxygen to the heart.
Your
doctor
may
have
prescribed
DILTIAZEM
AN
for
another reason. Ask your doctor
if you have any questions about
why DILTIAZEM AN has been
prescribed for you.
There
is
no
evidence
that
DILTIAZEM AN is addictive.
This medicine is available only
with a doctor’s prescription.
BEFORE YOU TAKE
DILTIAZEM AN
_WHEN YOU MUST NOT TAKE _
_IT _
DO NOT USE DILTIAZEM AN IF:
1.
YOU
HAVE
AN
ALLERGY
TO
DILTIAZEM HYDROCHLORIDE
OR
ANY
OF
THE
INGREDIENTS
LISTED
AT
THE
END
OF
THIS
LEAFLET
Symptoms of an allergic reaction
to these medicines may include:
•
asthma,
wheezing
or
shortness of breath
•
swelling of the face, lips or
tongue
which
may
cause
difficulty
in
swallowing
or
breathing
•
hives, itching or skin rash
•
fainting
2.
YOU ARE P

Productkenmerken

Doc ID: 56.AN.P.2.0
Page 1
_Diltiazem AN tablets Product Information _
_ _
_ Amneal Pharma Australia Pty Ltd _
DILTIAZEM AN
_ _
_(DILTIAZEM HYDROCHLORIDE TABLETS) _
_ _
PRODUCT INFORMATION
_ _
NAME OF THE MEDICINE
The name of the medicine is diltiazem hydrochloride
CHEMICAL NAME: (2S, 3S)-5-(2-dimethylaminoethyl)-2, 3, 4,
5-tetrahydro-2-(4-methoxyphenyl)-4-
oxo-1, 5-benzothiazepin-3-yl acetate
MOLECULAR FORMULA: C
22
H
26
N
2
O
4
S, HCl
MOLECULAR WEIGHT: 450.98
CAS REGISTRY NUMBER: _[33286-22-5] _
DESCRIPTION
It is a white to off white crystalline powder with a bitter taste,
soluble in water, methanol and
chloroform.
Diltiazem AN tablets also contain: lactose, hydrogenated castor oil,
dried aluminium hydroxide,
methacrylic acid copolymer, talc, magnesium stearate, opadry white
Y-1-7000B (hypromellose,
titanium dioxide, macrogol 400, indigo carmine).
Actions - Calcium ion influx inhibitor (slow channel blocker or
calcium antagonist).
PHARMACOLOGY
The therapeutic benefits achieved with diltiazem are believed to be
related to its ability to inhibit the
influx of calcium ions during membrane depolarisation of cardiac and
vascular smooth muscle.
_MECHANISMS OF ACTION: _Although precise mechanisms of its antianginal
actions are still being
delineated, diltiazem is believed to act in the following ways:
1.
_Vasospastic Angina: _ diltiazem has been shown to be a potent dilator
of coronary arteries both
epicardial and subendocardial. Spontaneous and ergometrine induced
coronary artery spasm are
inhibited by diltiazem.
2.
_Exertional _
_Angina: _
diltiazem
has
been
shown
to
produce
increases
in
exercise
tolerance,
probably due to its ability to reduce myocardial oxygen demand and
increase oxygen supply.
This is accomplished via reductions in heart rate and systemic blood
pressure at submaximal
and maximal exercise work loads and by dilating coronary arteries.
Doc ID: 56.AN.P.2.0
Page 2
_Diltiazem AN tablets Product Information _
_ _
_ Amneal Pharma Australia Pty Ltd _
In animal models, diltiazem interferes with the slow in