VENLAFAXINE AN SR venlafaxine (as hydrochloride) 37.5 mg modified release capsule blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

venlafaxine hydrochloride

Available from:

Amneal Pharma Australia Pty Ltd

INN (International Name):

Venlafaxine hydrochloride

Authorization status:

Registered

Patient Information leaflet

________________________________________________________________________________
Venla/CMIAN 20170117
Page 1 of 6
VENLAFAXINE AN SR
_Venlafaxine Hydrochloride Modified Release Capsules _
CONSUMER MEDICINE INFORMATION
_ _
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Venlafaxine AN
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 Venlafaxine
AN SR against the expected
benefits it will have for you.
IF YOU HAVE ANY QUESTIONS ABOUT
VENLAFAXINE AN SR, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
VENLAFAXINE AN SR MODIFIED
RELEASE CAPSULES.
You may need to read it again.
WHAT VENLAFAXINE AN
SR IS FOR
_WHAT IT DOES _
Venlafaxine AN 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.
_HOW IT WORKS _
Venlafaxine AN SR contains the
active ingredient called venlafaxine
hydrochloride. It belongs to a class
of medications for depression and
anxiety, called Serotonin-
Noradrenaline Reuptake Inhibitors
(SNRIs

Summary of Product characteristics

PI Venlafaxine AN SR 20170808
Page 1 of 35
PRODUCT INFORMATION
VENLAFAXINE AN SR
(MODIFIED RELEASE CAPSULES)
NAME OF THE MEDICINE
PROPRIETARY NAME:
Venlafaxine AN SR
NON PROPRIETARY NAME:
Venlafaxine (as hydrochloride) 37.5 mg, 75 mg and 150 mg
modified release capsules.
Its chemical structure is:
CAS Number: 99300-78-4
DESCRIPTION
Venlafaxine AN 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 Venlafaxine AN SR capsules are available containing
37.5 mg, 75 mg
or 150 mg of venlafaxine (as hydrochloride).
The full chemical name for Venlafaxine hydrochloride is
1-[(R/S)-2-(2-dimethylamino)-1-
(4-methoxyphenyl)ethyl]cyclohexanol hydrochloride. It 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).
Its molecular weight is 313.9 and its molecular formula is C
17
H
27
NO
2
,HCl.
Other ingredients are microcrystalline cellulose, povidone, purified
talc, colloidal
anhydrous silica, magnesium stearate, ethylcellulose and copovidone.
For each strength,
the capsule shells contain:
37.5 mg: gelatin, titanium dioxide, iron oxide black, iron oxide red
and iron oxide
yellow. The printing uses TekPrint SB-1033 Red Ink.
PI Venlafaxine AN SR 20170808
Page 2 of 35
75 mg: gelatin, titanium dioxide, iron oxide black and iron oxide red.
The printing uses
TekPrint SB-1033 Red Ink.
150 mg: gelatin, titanium dioxide, Brilliant Blue FCF, Allura Red AC
and Sunset Yellow
FCF. The printing uses TekPrint SB-0007P White Ink.
PHARMACOLOGY
_ACTIONS _
Venlafaxine is a structurally novel antidepressant for oral
administration; it is chemically
unrelated to tricyclic, tetracyclic, or other available antidepressant
agents.
_PHARMACODYNAMICS _
The antidepressant action of venlafaxine in humans is believed to be
associated with its
potentiat