VENLAFAXINE ARW XR venlafaxine (as hydrochloride) 37.5 mg modified release capsule blister pack

Land: Australia

Språk: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv ingrediens:

venlafaxine hydrochloride

Tilgjengelig fra:

Arrow Pharma Pty Ltd

INN (International Name):

Venlafaxine hydrochloride

Autorisasjon status:

Registered

Informasjon til brukeren

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ELAXINE SR 37.5, 75, AND 150
MODIFIED RELEASE CAPSULES
_venlafaxine hydrochloride _
CONSUMER MEDICINE INFORMATION
_ _
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Elaxine SR
modified release capsules. It does
not contain all the available
information.
It does not take the place of talking
to your doctor or pharmacist or
asking questions.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Elaxine SR
against the expected benefits it will
have for you.
IF YOU HAVE ANY QUESTIONS ABOUT
ELAXINE SR, ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
ELAXINE SR MODIFIED RELEASE
CAPSULES.
You may need to read it again.
WHAT ELAXINE SR IS FOR
The name of your medicine is
Elaxine SR. It contains the active
ingredient called venlafaxine
hydrochloride.
Elaxine SR modified release
capsules are used in the treatment
and prevention of relapse of
depression and panic attacks and in
the treatment of 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 ELAXINE SR WORKS _
Ela

Preparatomtale

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AUSTRALIAN PI – ELAXINE SR 37.5, ELAXINE SR 75 & ELAXINE SR 150
MODIFIED RELEASE CAPSULES (VENLAFAXINE (AS HYDROCHLORIDE))
1
NAME OF THE MEDICINE
Venlafaxine (as hydrochloride)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Venlafaxine hydrochloride is a white to off-white crystalline solid
with a solubility of 572 mg/mL in
water (adjusted to ionic strength of 0.2 M with sodium chloride).
Elaxine SR capsules are a modified release formulation, which release
the active constituent,
venlafaxine hydrochloride, from mini-tablets within the capsule. Drug
release is controlled by diffusion
through the coating on the mini-tablets and is not pH dependent. Three
strengths of Elaxine SR
capsules are available containing 37.5 mg, 75 mg or 150 mg of
venlafaxine (as hydrochloride).
For full list of excipients, see section 6.1 LIST OF EXCIPIENTS
3
PHARMACEUTICAL FORM
Elaxine SR 37.5, Elaxine SR 75 and Elaxine SR 150 venlafaxine (as
hydrochloride) modified release
capsules are available for oral use as:
•
37.5 mg, grey cap/peach body with thick and thin radial circular bands
on the cap and body in
red ink (size 3 capsule).
•
75 mg, peach cap and body with thick and thin radial circular bands on
the cap and body in
red ink (size 1 capsule).
•
150 mg, dark orange cap and body with thick and thin radial circular
bands on the cap and
body in white ink (size 0 capsule).
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Elaxine SR is indicated for the treatment of:
•
Major Depression, including prevention of relapse and recurrence where
appropriate;
•
Generalised Anxiety disorder;
2
•
Social Anxiety Disorder;
•
Panic Disorder, including prevention of relapse.
4.2
D
OSE AND METHOD OF ADMINISTRATION
_USUAL DOSE _
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