Apo-Carvedilol

País: Austràlia

Idioma: anglès

Font: Department of Health (Therapeutic Goods Administration)

Compra'l ara

Descargar Fitxa tècnica (SPC)
09-06-2024

ingredients actius:

Carvedilol

Disponible des:

Apotex Pty Ltd

clase:

Medicine Registered

Informació per a l'usuari

                                APO-CARVEDILOL
 
_Contains the active ingredient, carvedilol_
CONSUMER MEDICINE INFORMATION
   
 
 
_FOR A COPY OF A LARGE PRINT LEAFLET, PH 1800 195 055_
 
WHAT IS IN THIS LEAFLET
Read this leaflet carefully before
taking your medicine.
This leaflet answers some common
questions about carvedilol. It does
not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
The information in this leaflet was
last updated on the date listed on the
last page. More recent information on
the medicine may be available.
ASK YOUR DOCTOR OR PHARMACIST:
•
if there is anything you do not
understand in this leaflet,
•
if you are worried about taking
your medicine, or
•
to obtain the most up-to-date
information
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using this medicine
against the benefits they expect it
will have for you.
Pharmaceutical companies cannot
give you medical advice or an
individual diagnosis.
Keep this leaflet with the medicine.
You may need to read it again
WHAT THIS MEDICINE IS
USED FOR
The name of your medicine is APO-
Carvedilol. It contains the active
ingredient, carvedilol.
It is used to treat high blood pressure
and, together with other medicines,
to help treat congestive heart failure.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed this
medicine for another reason.
This medicine is available only with
a doctor's prescription.
_HOW IT WORKS_
Carvedilol belongs to a group of
medicines called beta-blockers.
These medicines work by relaxing
tightened blood vessels and slowing
the heart rate. Carvedilol has the
additional effect of being an
antioxidant.
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 l
                                
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Fitxa tècnica

                                Product Information – Australia 
APO-Carvedilol Tablets 
Page 1 
 
APO-CARVEDILOL TABLETS  
 
 
NAME OF THE MEDICINE 
Carvedilol. 
 
Chemical Name:  
(+/-)-1-(9
H-carbazol-4-yloxy) -3-{[2-(2-methoxyphenoxy) ethyl]amino}propan-2-ol.  
 
Structural Formula: 
 
 
Molecular Formula:    
C
24
H
26
N
2
0
4
 
 
Molecular Weight:    
406.5 
 
CAS Registry Number:   72956-09-3 
 
 
DESCRIPTION 
Carvedilol is a white crystalline powder and
has low solubility in water (0.01 mg/mL). It is soluble in 
ethanol (22.7 mg/mL). 
 
Carvedilol tablets are intended for oral administration. 
Each tablet contains 3.125 mg, 6.25 mg, 12.5 mg or 25 mg
of carvedilol as the active ingredient. 
 
3.125 MG TABLETS 
White oval shaped, film-coated tablets, imprinted with « P »
logo on one side and plain on the other side. 
 
6.25 MG TABLETS  
White oval shaped, film-coated tablets, imprinted « 6.25 » on
one side and « P » logo on the other side  
 
12.5 MG TABLETS 
White oval shaped, film-coated tablets, imprinted « 12.5 »
on one side and « P » logo on the other side 
 
25 MG TABLETS 
White oval shaped, film-coated tablets, imprinted « 25 »
on one side and « P » logo on the other side 
 
In addition, each tablet contains the following inactive
ingredients: cellulose microcrystalline, lactose, 
crospovidone, povidone, silica-colloidal anhydrous, magnesium stearate, opadry II complete
film coating 
system YS-22-18096 white. 
Product Information – Australia 
APO-Carvedilol Tablets 
Page 2 
PHARMACOLOGY 
PHARMACODYNAMICS 
Carvedilol is a dual action cardiovascular agent.  
 
It is a vasodilating, nonselective beta-blocking agent with
antioxidant properties. Vasodilation has been 
shown to be mediated primarily by selective blockade of alpha
1
-adenoreceptors. 
 
Carvedilol is a racemic mixture. In animal models, b
                                
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