ALEMBIC VENLAFAXINE XR venlafaxine (as hydrochloride) 75 mg modified release capsule blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

venlafaxine hydrochloride, Quantity: 84.9 mg (Equivalent: venlafaxine, Qty 75 mg)

Available from:

Alembic Pharmaceuticals Australia Pty Ltd

INN (International Name):

Venlafaxine hydrochloride

Pharmaceutical form:

Capsule, modified release

Composition:

Excipient Ingredients: iron oxide black; colloidal anhydrous silica; ethylcellulose; iron oxide red; magnesium stearate; microcrystalline cellulose; povidone; purified talc; titanium dioxide; Gelatin; copovidone; propylene glycol; butan-1-ol; isopropyl alcohol; purified water; Shellac; ethanol absolute; ammonia

Administration route:

Oral

Units in package:

28 capsules

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

ALEMBIC VENLAFAXINE 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.

Product summary:

Visual Identification: Peach opaque cap/ peach opaque body, size '1' hard capsule with thick and thin radial circular bands on both the cap and body in red ink.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2017-05-17

Patient Information leaflet

________________________________________________________________________________
Alembic Venlafaxine XR/CMI 20170517
Page 1 of 7
ALEMBIC VENLAFAXINE XR
_Venlafaxine Hydrochloride Modified Release Capsules _
CONSUMER MEDICINE INFORMATION
_ _
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Alembic
Venlafaxine XR 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 Alembic
Venlafaxine XR against the
expected benefits it will have for
you.
IF YOU HAVE ANY QUESTIONS ABOUT
ALEMBIC VENLAFAXINE XR, ASK
YOUR DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
ALEMBIC VENLAFAXINE XR
MODIFIED RELEASE CAPSULES.
You may need to read it again.
WHAT ALEMBIC
VENLAFAXINE XR IS FOR
_WHAT IT DOES _
Alembic Venlafaxine XR 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.
_HOW IT WORKS _
Alembic Venlafaxine XR contains
the active ingredient called
venlafaxine hydrochloride. It
belongs to a class of medications
for depression and anxiety, cal