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

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

venlafaxine hydrochloride, Quantity: 84.86 mg

Available from:

Generic Health Pty Ltd

INN (International Name):

Venlafaxine hydrochloride

Pharmaceutical form:

Capsule, modified release

Composition:

Excipient Ingredients: hypromellose; magnesium stearate; sodium lauryl sulfate; ammonio methacrylate copolymer; basic butylated methacrylate copolymer; titanium dioxide; iron oxide red; potable water; Gelatin

Administration route:

Oral

Units in package:

7,14,28

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

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.

Product summary:

Visual Identification: Size No 0 hard gelatin capsule with opaque-flesh coloured body and lid, containing two round, biconvex film coated tablets; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2009-08-06

Patient Information leaflet

CONSUMER MEDICINE INFORMATION
VENLAFAXINE GENERICHEALTH XR
(VENLAFAXINE HYDROCHLORIDE) MODIFIED RELEASE CAPSULE
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Venlafaxine generichealth XR
capsules. 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
Venlafaxine generichealth 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 VENLAFAXINE
GENERICHEALTH XR IS USED
FOR
_WHAT IT DOES _
Venlafaxine generichealth XR
capsules are 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 _
Venlafaxine generichealth XR
contains the active ingredient
called venlafaxine hydrochloride.
It belongs to a class of
medications for depression and
anxiety, called Serotonin-
Noradrenaline

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION –
VENLAFAXINE GENERICHEALTH XR
(VENLAFAXINE HYDROCHLORIDE) MODIFIED RELEASE CAPSULE
1
NAME OF THE MEDICINE
Venlafaxine hydrochloride.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Venlafaxine generichealth XR 75 mg modified release capsule
contains 84.86 venlafaxine (as
hydrochloride) equivalent to 75 mg venlafaxine.
Each Venlafaxine generichealth XR 150 mg modified release capsule
contains 169.71 mg venlafaxine (as
hydrochloride) equivalent to 150 mg venlafaxine.
Venlafaxine generichealth XR capsules are a modified release
formulation which release the active
constituent venlafaxine hydrochloride from a tablet(s) within the
capsule. Drug is released by a
combination of swelling of the hydrophilic polymer (hypromellose),
diffusion and erosion.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Venlafaxine generichealth XR 75 mg modified release capsules: Size 0
hard gelatin capsule with opaque-
flesh coloured body and lid, containing two round, biconvex
film-coated tablets.
Venlafaxine generichealth XR 150 mg modified release capsules: Size 00
hard gelatin capsule with
opaque scarlet body and lid, containing three round biconvex film
coated tablets.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of:
•
Major Depression, including prevention of relapse and recurrence where
appropriate;
•
Generalised Anxiety Disorder;
•
Social Anxiety Disorder;
•
Panic Disorder, including prevention of relapse.
4.2 DOSE AND METHOD OF ADMINISTRATION
DOSAGE
Venlafaxine generichealth XR v6.0
Page 2 of 32
(venlafaxine hydrochloride) modified release capsule
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/day given once daily. After two
weeks, the dose may be increased to
150 mg/day given once daily if further clinical improvement is
required. If needed, this can be increased
up to 225 m