Sinequan

Quốc gia: Úc

Ngôn ngữ: Tiếng Anh

Nguồn: Department of Health (Therapeutic Goods Administration)

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12-06-2024

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Doxepin hydrochloride

Tờ rơi thông tin

                                SINEQUAN(R) CAPSULES
1
SINEQUAN(R) CAPSULES
_Doxepin hydrochloride_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Sinequan.  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 Sinequan
against the benefits it is expected to
have for you. 
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST. 
READ THIS LEAFLET CAREFULLY BEFORE
YOU START SINEQUAN AND KEEP IT
WITH THE MEDICINE. 
You may need to read it again. 
WHAT SINEQUAN IS USED
FOR
Sinequan is used to treat depression. 
It belongs to a group of medicines
called tricyclic antidepressants
(TCAs). 
Antidepressants are thought to work
by their action on brain chemicals
called amines which are involved in
controlling mood. 
Your doctor, however, may prescribe
Sinequan for another purpose. 
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY SINEQUAN HAS
BEEN PRESCRIBED FOR YOU. 
This medicine is only available with
a doctor's prescription. 
BEFORE YOU TAKE
SINEQUAN
_WHEN YOU MUST NOT TAKE IT_
Do not take Sinequan if you have an
allergy to: 
*
any medicine containing doxepin
hydrochloride
*
any other tricyclic antidepressant
*
any of the ingredients listed at the
end of this leaflet
Symptoms of an allergic reaction to
Sinequan may include skin rash,
itching, swelling of the face and
increased sensitivity of the skin to
the sun. 
DO NOT TAKE SINEQUAN IF YOU ARE
TAKING A MEDICINE CALLED A
MONOAMINE OXIDASE INHIBITOR
(MAOI) OR HAVE BEEN TAKING IT
WITHIN THE LAST 14 DAYS. 
Taking Sinequan with a MAOI may
cause a serious reaction with a
sudden increase in body temperature,
extremely high blood pressure and
convulsions. 
ASK YOUR DOCTOR OR PHARMACIST IF
YOU ARE NOT SURE IF YOU ARE TAKING
OR HAVE BEEN
                                
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Đặc tính sản phẩm

                                Version: pfpsinec10113 
Supersedes: pfpsinec11008 
 
Page 1 of 11 
PRODUCT INFORMATION 
SINEQUAN
®
 DOXEPIN (AS HYDROCHLORIDE) 
NAME OF THE MEDICINE 
SINEQUAN doxepin (as hydrochloride) 10 mg and 25 mg capsules. 
SINEQUAN  contains  the  tricyclic  antidepressant,  doxepin  hydrochloride,  as  the  active 
ingredient. 
The structural formula is shown below: 
 
Chemical name: 
11-[3-dimethylaminopropylidene]-6H-dibenz[b,e]oxepin 
hydrochloride 
Molecular formular: 
C
19
H
21
NO.HCl 
Molecular weight: 
316 
CAS number: 
1229-29-4. 
DESCRIPTION 
Doxepin  hydrochloride  is  a  dibenzoxepin  derivative,  and  consists  of  a  mixture  of  the  _cis_  and 
_trans_  isomers  in  a  constant  ratio  (82-85%  _trans_:  15-18%  _cis_).    It  is  a  white  crystalline  solid, 
readily soluble in water, lower alcohols and chloroform. 
SINEQUAN  capsules  contain  doxepin  hydrochloride  equivalent  to  10  mg  and  20  mg  of 
doxepin. 
The 10 mg capsules also contain Starch  - maize; Lactose; Magnesium stearate; Sodium lauryl 
sulfate;  Gelatin;  Erythrosine  CI45430;  Brilliant  Blue  FCF  CI42090;  Sunset  Yellow  FCF 
CI15985; Titanium dioxide. 
The 25 mg capsules also contain Starch  - maize; Lactose; Magnesium stearate; Sodium lauryl 
sulfate; Silica colloidal Anhydrous, Gelatin; Erythrosine CI45430; Brilliant Blue FCF CI42090; 
Titanium dioxide. 
Version: pfpsinec10113 
Supersedes: pfpsinec11008 
 
Page 2 of 11 
PHARMACOLOGY 
The mechanism of action of doxepin hydrochloride is not definitely known.  It is not a central 
nervous system stimulant nor a monoamine oxidase inhibitor. 
The current hypothesis is that the 
clinical effects are due, at least in part, to influences on the adrenergic activity at the synapses so 
that deactivation
                                
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