SINEQUAN doxepin 10 mg (as hydrochloride) capsule blister pack

Χώρα: Αυστραλία

Γλώσσα: Αγγλικά

Πηγή: Department of Health (Therapeutic Goods Administration)

Δραστική ουσία:

doxepin hydrochloride

Διαθέσιμο από:

Pfizer Australia Pty Ltd

Kατηγορία:

Medicine Registered

Καθεστώς αδειοδότησης:

Registered

Φύλλο οδηγιών χρήσης

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

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AUSTRALIAN
PRODUCT
INFORMATION
-
SINEQUAN
® (DOXEPIN (AS HYDROCHLORIDE)) CAPSULES
1 NAME OF THE MEDICINE
Doxepin (as hydrochloride)
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
SINEQUAN capsules contain doxepin hydrochloride equivalent to 10 mg
and 25 mg of
doxepin.
EXCIPIENT WITH KNOWN EFFECT
Each 10 mg and 25 mg capsule contains lactose monohydrate. For the
full list of excipients, see
Section 6.1 List of excipients.
3 PHARMACEUTICAL FORM
Capsule, hard
SINEQUAN 10 mg capsules are supplied as natural, size #4 capsules
printed with “Sinequan
10” and the Pfizer logo. The capsules contain a white, homogenous
powder free from foreign
matter.
SINEQUAN 25 mg capsules are supplied as natural, size #4 capsules
printed with “Sinequan
25” and the Pfizer logo. The capsules contain a white, homogenous
powder free from foreign
matter.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of major depression
4.2 DOSE AND METHOD OF ADMINISTRATION
The optimum oral dose depends on the severity of the condition and the
individual patient's
response. The dose varies from 30 to 300 mg daily.
The daily dose is usually administered on t.i.d. regimen. When the
optimum dose has been
reached it may be given as a single daily dose up to a maximum of 150
mg.
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For patients whose presenting symptoms are mild in nature, it is
advisable to initiate
treatment at a dose of 30 mg daily. A good clinical response is
obtained in many of these
patients at a daily dose of 30 to 50 mg. The dose may be adjusted
according to the individual
response.
For the majority of patients with moderate or severe symptoms, it is
recommended that
treatment commences with an initial dose of not more than 75 mg daily
in divided doses.
Many of these patients will respond satisfactorily at this dose level.
For patients who do not,
the dose may be adjusted according to individual response. In more
severely ill patients,
particularly whe