CARVEDILOL SANDOZ

Riik: Austraalia

keel: inglise

Allikas: Department of Health (Therapeutic Goods Administration)

Osta kohe

Laadi alla Infovoldik (PIL)
10-06-2024
Laadi alla Toote omadused (SPC)
10-06-2024

Toimeaine:

Carvedilol

Saadav alates:

Sandoz Pty Ltd

Klass:

Medicine Registered

Infovoldik

                                _ _
 
CARVEDILOL SANDOZ
®
 
CARVEDILOL TABLETS 
 
CONSUMER MEDICINE INFORMATION (CMI) 
 
WHAT IS IN THIS LEAFLET 
This leaflet answers some common questions about Carvedilol
Sandoz. 
 
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 risk of you taking 
Carvedilol Sandoz against the
benefits it is expected to 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 want to read it again. 
 
WHAT CARVEDILOL SANDOZ IS USED FOR 
 
The name of your medicine is Carvedilol Sandoz. It contains the
active ingredient 
carvedilol. 
 
Carvedilol Sandoz is used to treat heart failure.  
 
Your doctor may have prescribed Carvedilol Sandoz for
another reason. ASK YOUR 
DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE WAS
PRESCRIBED FOR YOU. 
 
_HOW CARVEDILOL SANDOZ WORKS _
Carvedilol Sandoz belongs to a
group of medicines called beta-blockers. 
 
It works by slowing down the heart
rate and relaxing blood vessels if they are too tight. 
Additionally, it works as an antioxidant. 
 
There is no evidence that Carvedilol Sandoz is addictive. 
 
This medicine is available
only with a doctor’s prescription. 
 
_ _
 
BEFORE YOU  TAKE CARVEDILOL SANDOZ 
_WHEN YOU MUST NOT TAKE IT _
Do not take this medicine if: 
•  you are allergic to the active ingredient or any of the
inactive ingredients mentioned 
at the end of this leaflet under Product Description. Symptoms of an allergic reaction 
may include an itchy skin rash,
shortness of breath or swelling of the face or tongue. 
•  you are pregnant or breastfeeding, unless permitted by
your doctor 
•  you have asthma or
                                
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Toote omadused

                                _Product Information _
_ _
_Page 1 of _23_ _
_Carvedilol Sandoz 6.25/12.5/25mg tablets _
_02/2012_ 
 
 
_Sandoz Pty Ltd _
PRODUCT INFORMATION 
CARVEDILOL SANDOZ 6.25 / 12.5 / 25 MG TABLETS 
 
 
NAME OF THE MEDICINE 
_ _
_Carvedilol _
_ _
_ _
DESCRIPTION 
 
_Chemical Name: _(+/-)-1-(9
H-carbazol-4-yloxy)-3-{[2-(2-methoxyphenoxy) 
ethyl]amino}propan-2-ol.  
 
 
 
 
 
 
 
_Molecular formula_: C
24
H
26
N
2
O
4
 
 MW: 
406.5 
 CAS: 
72956-09-3._ _
_ _
It is a white crystalline powder and has low solubility in water
(0.01mg/mL). It is 
soluble in ethanol (22.7 mg/mL). 
_ _
_Carvedilol Sandoz tablets also contain inactive ingredients: _
Lactose, microcrystalline cellulose, crospovidone, povidone K 30,
colloidal 
anhydrous silica, magnesium stearate, yellow iron oxide (6.25 mg and
12.5mg), red 
iron oxide (12.5mg). 
_ _
_Actions_ 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
-adrenoreceptors. 
_ _
 
PHARMACOLOGY 
 
Pharmacodynamics 
Carvedilol is a racemic mixture. In animal models, both enantiomers
have alpha-
adrenergic receptor blocking properties. The beta-adrenergic receptor
blocking 
properties are nonselective for beta
1
 and beta
2
-adrenoreceptors and are associated with 
the laevorotatory enantiomer of carvedilol. Carvedilol has no
intrinsic 
sympathomimetic activity and, like propranolol, it has membrane
stabilising 
_Product Information _
_ _
_Page 2 of _23_ _
_Carvedilol Sandoz 6.25/12.5/25mg tablets _
_02/2012_ 
 
 
_Sandoz Pty Ltd _
properties. Carvedilol suppresses the renin/ angiotensin/ aldosterone
system through 
beta-blockade. 
 
The mechanism for the beneficial effects of carvedilol in congestive
heart failure has 
not been established. Possible mechanisms include neurohormonal
inhibition, beta-
blockade, balanced vasodilation (red
                                
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