VOLIROP 12.5 carvedilol 12.5mg tablets Blister pack
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
14-05-2018
Summary of Product characteristics
(SPC)
14-05-2018
Public Assessment Report
(PAR)
29-11-2017
Active ingredient:
carvedilol
Available from:
Fair-Med Healthcare Australia Pty Ltd
INN (International Name):
Carvedilol
Authorization status:
Registered
Patient Information leaflet
VOLIROP
CONSUMER MEDICINE INFORMATION
Ver 1.1
Page 1 of 5
VOLIROP 3.125, 6.25, 12.5 & 25
Carvedilol
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This
leaflet
answers some
common
questions about VOLIROP.
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
VOLIROP
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 VOLIROP USED FOR
VOLIROP
contains
the
active
ingredient carvedilol.
VOLIROP is used to treat
•
heart failure,
•
high blood pressure, which is called
hypertension.
VOLIROP
belongs
to
a
group
of
medicines called beta-blockers. These
medicines work by relaxing tightened
blood vessels and slowing the heart
rate.
VOLIROP
has
the
additional
effect of being an antioxidant.
HEART FAILURE:
Heart failure occurs when the heart
can no longer pump blood strongly
enough for the body's needs. Often the
heart grows in size to try to improve
the blood flow but this can make the
heart failure worse.
Symptoms
of
heart
failure
include
shortness of breath and swelling of
the feet or legs due to fluid build-up.
VOLIROP reduces the pressure that
the heart has to pump against as well
as controlling your heart rate. Over 6
months or more this will reduce the
size of an oversized heart and increase
its efficiency.
VOLIROP reduces the chances of you
being
admitted
to
hospital
and/
or
dying from this condition.
VOLIROP is often used with other
medicines to treat heart failure.
HYPERTENSION:
All people have blood pressure. This
pressure
helps
to
push
blood
all
around
your
body.
Your
blood
pressure
changes
during
the
day,
depending on how busy you are or
how you are feeling.
You have hypertension (high blood
pressure) when your blood pressure
stays
higher
than
is
needed,
even
when you are calm and relaxed.
Regula
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Summary of Product characteristics
Product Information:
VOLIROP (Carvedilol Tablets 3.125, 6.25, 12.5 & 25 mg)
Ver 1.2
Page 1 of 22
PRODUCT INFORMATION
VOLIROP 3.125 (3.125MG CARVEDILOL TABLETS)
VOLIROP 6.25 (6.25MG CARVEDILOL TABLETS)
VOLIROP 12.5 (12.5MG CARVEDILOL TABLETS)
VOLIROP 25 (25MG CARVEDILOL TABLETS)
NAME OF THE MEDICINE
The name of the medicine is carvedilol.
O
H
N
O
HN
OCH
3
H
OH
CHEMICALNAME:
(2RS)-1-(9H-Carbazol-4-yloxy)-3-[[2-(2-methoxyphenoxy)ethyl]amino]propan-
2-ol
MOLECULAR FORMULA:
C
24
H
26
N
2
O
4
MOLECULAR WEIGHT:
406.5
CAS REGISTRY NUMBER:
_[72956–09–3] _
DESCRIPTION
Carvedilol is a white or almost white, crystalline powder. It is
slightly soluble in alcohol,
practically insoluble in water and dilute acids.
VOLIROP is available as tablets containing 3.125, 6.25, 12.5 & 25 mg
of carvedilol.
_VOLIROP 3.125 _
White to off-white, oval shaped, film-coated tablets debossed with
‘E’ on one side and ‘01’ on
the other side.
_ _
_VOLIROP 6.25_
White to off-white, oval shaped, film-coated tablets debossed with
‘F 57’ on one side and deep
break line on the other side.
_ _
_VOLIROP 12.5_
White to off-white, oval shaped, film-coated tablets debossed with
‘F 58’ on one side and deep
break line on the other side.
_ _
Product Information:
VOLIROP (Carvedilol Tablets 3.125, 6.25, 12.5 & 25 mg)
Ver 1.2
Page 2 of 22
_VOLIROP 25_
White to off-white, oval shaped, film-coated tablets debossed with
‘F 59’ on one side and deep
break line on the other side.
VOLIROP tablets contain the following inactive ingredients: Lactose,
colloidal anhydrous silica,
crospovidone (Type A & Type B), povidone, sucrose, magnesium stearate,
macrogol 400,
polysorbate 80, titanium dioxide & hypromellose.
PHARMACOLOGY
PHARMACODYNAMICS
Carvedilol is a dual action cardiovascular agent; a vasodilating,
non-selective beta-blocking agent
with antioxidant properties. Vasodilation has been shown to be
mediated primarily by selective
blockade of alpha
1
-adrenoreceptors.
Carvedilol is a racemic mixture. In animal models, both enantiomers
have alpha-adre
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