Sinequan 25mg capsule

Država: Australija

Jezik: engleski

Izvor: Department of Health (Therapeutic Goods Administration)

Aktivni sastojci:

doxepin hydrochloride

Dostupno od:

Pfizer Australia Pty Ltd

Razred:

Medicine Registered

Status autorizacije:

Registered

Uputa o lijeku

SINEQUAN
® 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.
Sinequan should not be used in
children under the age of 18 years.
The safety and efficacy of Sinequan
in this age group has not been
satisfactorily established.
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:
•
shortness of breath
•
wheezing or difficulty breathing
•
skin rash, itching or hives on the
skin
•
swelling of the face, lips, tongue
or other parts of the body
•
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,
ext

Svojstava lijeka

Version: pfpsinec11114
Supersedes: pfpsinec10914
Page 1 of 12
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 25 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: pfpsinec11114
Supersedes: pfpsinec10914
Page 2 of 12
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 of noradrenaline by reuptake into the nerve
terminal is prevented.
Animal
studies
suggest
that
doxepin
hydrochloride
does
not
appreciably
antagonize
the
antihypertensive action of guanethidine. In animal studies
anticholinergic, antiserotonin and
antihistamine effects on smooth muscle have been demonstrated. At
higher than usual clinical
doses, noradrenaline response was potentiated in animals