EFEXOR-XR venlafaxine (as hydrochloride) 150mg modified release capsule blister pack

国: オーストラリア

言語: 英語

ソース: Department of Health (Therapeutic Goods Administration)

有効成分:

venlafaxine hydrochloride, Quantity: 169.7 mg (Equivalent: venlafaxine, Qty 150 mg)

から入手可能:

Viatris Pty Ltd

医薬品形態:

Capsule, modified release

構図:

Excipient Ingredients: microcrystalline cellulose; hypromellose; iron oxide yellow; Gelatin; titanium dioxide; iron oxide red; ethylcellulose; purified talc; propylene glycol; ethanol; isopropyl alcohol; Shellac; povidone; tert-butyl alcohol; sodium hydroxide

投与経路:

Oral

パッケージ内のユニット:

28 capsules, 7 capsules, 14 capsules

処方タイプ:

(S4) Prescription Only Medicine

適応症:

EFEXOR-XR is indicated for the treatment of: Major depression, including prevention of relapse and recurrence where appropriate; Generalised anxiety disorder; Social Anxiety Disorder; and Panic Disorder, including prevention of relapse.

製品概要:

Visual Identification: Hard gelatin capsule with dark orange cap and body containing white to off white spheroids of about 1mm in diameter. White printing of "W" and 150; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

認証ステータス:

Licence status A

承認日:

1998-05-11

情報リーフレット

EFEXOR
®
-XR
_Venlafaxine hydrochloride_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Efexor-XR.
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 Efexor-XR
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 need to read it again.
WHAT EFEXOR-XR IS
USED FOR
_WHAT IT DOES_
Efexor-XR is used in the treatment
and prevention of relapse of
depression. It is also used in the
treatment of panic attacks and
anxiety, including avoidance or fear
of social situations.
Depression can affect your whole
body and may cause emotional and
physical symptoms such as feeling
low in spirit, being unable to enjoy
life, poor appetite or overeating,
disturbed sleep, loss of sex drive,
lack of energy and feeling guilty over
nothing.
Excessive anxiety is a condition in
which you feel constantly and
uncontrollably worried and
distressed. It may also make you feel
irritable, and cause difficulty in
thinking and sleeping. Other
common symptoms associated with
anxiety may include a dry mouth, a
lump in the throat, cold clammy
hands, diarrhoea and nausea.
Depression and anxiety are treatable
illnesses. Anxiety or tension
associated with the normal stress of
everyday life usually does not require
treatment with medicines.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
_HOW IT WORKS_
Efexor-XR contains the active
ingredient called venlafaxine
hydrochloride. It belongs to a class of
medications for depression and
anxiety, called Serotonin-
Noradrenaline Reuptake Inhibitors
(SNRIs).
Serotonin and noradrenaline are
chemical messengers that allow
certain nerves in the brain to work.
Efexor-XR capsules increas

製品の特徴

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Page 1 of 34
AUSTRALIAN PRODUCT
INFORMATION –
EFEXOR

-XR (VENLAFAXINE HYDROCHLORIDE)
1.
NAME OF THE MEDICINE
Venlafaxine hydrochloride
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
EFEXOR-XR modified release capsules contain venlafaxine (as
hydrochloride) 37.5 mg, 75
mg and 150 mg.
For the full list of excipients, See section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Modified release capsules.
Venlafaxine hydrochloride is released from spheroids within the
capsule. Drug release is
controlled by diffusion through the coating membrane on the spheroids
and is not pH
dependent.
EFEXOR-XR modified release capsules are available for oral use as:
37.5 mg, grey cap/peach body with ‘W’ on the cap and “37.5” on
the body.
75 mg, peach cap and body with ‘W’ on the cap and “75” on the
body.
150 mg, dark orange cap and body with ‘W’ on the cap and “150”
on the body.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
EFEXOR-XR is indicated for the treatment of:
•
Major Depression, including prevention of relapse and recurrence where
appropriate
•
Generalised Anxiety Disorder
•
Social Anxiety Disorder
•
Panic Disorder, including prevention of relapse.
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Supersedes: ujpefexc11021
Page 2 of 34
4.2 DOSE AND METHOD OF ADMINISTRATION
DOSAGE
_MAJOR DEPRESSION, GENERALISED ANXIETY DISORDER AND SOCIAL ANXIETY
DISORDER_
The usual recommended dose for the treatment of major depression,
generalised anxiety
disorder or social anxiety disorder is 75 mg per day given once daily.
After two weeks, the
dose may be increased to 150 mg per day given once daily if further
clinical improvement is
required. If needed, this can be increased up to 225 mg given once
daily. Dose increments
should be made at intervals of approximately 2 weeks or more, but not
less than 4 days.
The recommended dose is based on results of clinical trials in which
EFEXOR-XR was mostly
given once daily in doses from 75 to 225 mg. Antidepressant activity
with the 75