Chemmart Paroxetine

Country: Ավստրալիա

language: անգլերեն

source: Department of Health (Therapeutic Goods Administration)

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download PIL (PIL)
28-05-2024
download SPC (SPC)
28-05-2024

active_ingredient:

Paroxetine hydrochloride

MAH:

Apotex Pty Ltd

class:

Medicine Registered

PIL

                                CHEMMART PAROXETINE
TABLETS
 
_Contains the active ingredient, paroxetine hydrochloride_
CONSUMER MEDICINE INFORMATION
   
 
 
WHAT IS IN THIS LEAFLET
READ THIS LEAFLET CAREFULLY BEFORE
TAKING YOUR MEDICINE.
This leaflet answers some common
questions about paroxetine. 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 your medicine.
You may want to read it again.
WHAT THIS MEDICINE IS
USED FOR
The name of your medicine is
Chemmart Paroxetine. It contains the
active ingredient, paroxetine (as
paroxetine hydrochloride).
It is used to treat:
•
Depression
•
Obsessive Compulsive Disorder
(OCD)
•
Panic Disorder
•
Social Anxiety Disorder or Social
Phobia
•
Generalised Anxiety Disorder
•
Post-traumatic Stress Disorder.
It is also used to prevent the
symptoms of Depression, Obsessive
Compulsive Disorder and Panic
Disorder from coming back.
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_
Paroxetine belongs to a group of
medicines called selective serotonin
reuptake inhibitors (SSRIs). They are
thought to work by their action on
brain chemicals called amines which
are involved in controlling mood.
Depression is longer lasting and/or
more severe than the "low moods
                                
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SPC

                                Product Information 
– Australia 
Chemmart Paroxetine Tablets 
Page 1 
CHEMMART PAROXETINE 
 
 
NAME OF THE MEDICINE 
Paroxetine hydrochloride. 
 
Chemical Name: 
(-)-trans-4R-(4'-fluorophenyl)-3S-[(3',4'-methylenedioxyphenoxy)  methyl]-piperidine 
hydrochloride. 
 
Structural Formula: 
Molecular Formula: 
C
19
H
20
FNO
3
•HCl  
 
Molecular Weight: 
365.83 
 
CAS Registry Number: 78246-49-8 
 
 
DESCRIPTION 
Paroxetine hydrochloride is an odourless, off-white powder, with a melting point range of 120°C to 138°C 
and solubility of 5.4 mg/mL in water. It is the hydrochloride salt of a phenylpiperidine compound. 
 
Paroxetine is an orally administered antidepressant with a chemical structure unrelated to other selective 
serotonin reuptake inhibitors or to tricyclic, tetracyclic or other available antidepressant agents. 
 
 
PHARMACOLOGY 
PHARMACODYNAMICS 
Paroxetine  is  a  potent  and  selective  inhibitor  of  5-hydroxytryptamine  (5-HT,  serotonin)  uptake  and  its 
antidepressant  action  and  efficacy  in  the  treatment  of  Obsessive  Compulsive  Disorder,  Panic  Disorder, 
Social Anxiety Disorder/Social Phobia, Generalised Anxiety Disorder and Post-traumatic Stress Disorder 
is thought to be related to its specific inhibition of 5-HT uptake in brain neurones. 
 
_In vitro _studies have indicated that, in contrast to tricyclic antidepressants, paroxetine has little affinity for 

1
-, 

2
- and 

-adrenoceptors, dopamine (D
2
), 5-HT
1
-like, 5-HT
2
 and histamine (H
1
) receptors. This lack of 
interaction with post-synaptic receptors _in vitro_ is substantiated by _in vivo_ studies which demonstrate lack 
of  CNS  depressant  and  hypotensive  properties.  Paroxetine  has  low  affinity  for  muscarinic  cholinergic 
receptors and anim
                                
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