DESVENLAFAXINE GH XR desvenlafaxine (as benzoate) 50 mg extended release tablets blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

desvenlafaxine benzoate, Quantity: 73.16 mg (Equivalent: desvenlafaxine, Qty 50 mg)

Available from:

Lupin Australia Pty Limited

INN (International Name):

desvenlafaxine benzoate

Pharmaceutical form:

Tablet, modified release

Composition:

Excipient Ingredients: hypromellose; colloidal anhydrous silica; purified talc; microcrystalline cellulose; stearic acid; titanium dioxide; iron oxide yellow; iron oxide red; polyvinyl alcohol; macrogol 3350

Administration route:

Oral

Units in package:

7 , 14 , 28 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Desvenlafaxine is indicated for the treatment of major depressive disorder, including the prevention of relapse.,Desvenlafaxine is not indicated for paediatric use.

Product summary:

Visual Identification: Light pink, biconvex, round shaped film coated tablets debossed with "DV" on one side and "50"on the other side.; Container Type: Blister Pack; Container Material: PVC/PCTFE (Aclar)/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2014-11-12

Patient Information leaflet

CONSUMER MEDICINE INFORMATION
DESVENLAFAXINE GH XR
(DESVENLAFAXINE BENZOATE) EXTENDED RELEASE TABLETS
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Desvenlafaxine GH XR.
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
Desvenlafaxine GH XR against
the expected benefits it will have
for you.
IF YOU HAVE ANY QUESTIONS
ABOUT TAKING THIS MEDICINE,
ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE.
You may need to read it again.
WHAT DESVENLAFAXINE GH
XR IS USED FOR
_WHAT IT DOES _
Desvenlafaxine GH XR is used
in the treatment and prevention
of relapse of depression.
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.
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 _
Desvenlafaxine GH XR contains
the active ingredient called
desvenlafaxine benzoate. It
belongs to a class of
medications called Serotonin-
Noradrenaline Reuptake
Inhibitors (SNRIs).
Serotonin and noradrenaline are
chemical messengers that allow
certain nerves in the brain to
work.
Desvenlafaxine GH XR tablets
increase the level of these two
messengers. Experts think this
is how it helps to restore your
feeling of wellness.
Desvenlafaxine GH XR is not
addictive. It is available only with
a doctor's prescription.
_USE IN CHILDREN _
The safety and effectiveness of
Desvenlafaxine GH XR in
children or adolescents under 18
years of age have not been
established.
BEFORE YOU TAKE
DESVENLAFAXINE GH XR
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE DESVENLAFAXINE
GH XR IF YOU ARE TAKING OTHER
MEDICATIONS FOR DEPRESSION
KNOWN AS MONOAMINE OX

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION – DESVENLAFAXINE GH XR
(DESVENLAFAXINE (AS BENZOATE)) EXTENDED RELEASE TABLETS
1
NAME OF THE MEDICINE
Desvenlafaxine (as benzoate).
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Desvenlafaxine GH XR tablets are for once-a-day oral administration.
Two strengths are available,
containing 50 mg or 100 mg of desvenlafaxine as the benzoate salt.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Desvenlafaxine (as benzoate) extended-release tablets are available as
follows:
•
Desvenlafaxine GH XR 50 mg is a light pink, biconvex, round shaped
film coated tablet debossed
with "DV" on one side and "50"on the other side.
•
Desvenlafaxine GH XR 100 mg is a reddish-orange, biconvex, round
shaped film coated tablet,
debossed with "DV" on one side and "100"on the other side.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Desvenlafaxine GH XR tablets are indicated for the treatment of major
depressive disorder, including
the prevention of relapse.
Desvenlafaxine GH XR tablets are not indicated for paediatric use.
4.2 DOSE AND METHOD OF ADMINISTRATION
DOSAGE
Desvenlafaxine GH XR tablets should be taken at approximately the same
time each day. Tablets must
be swallowed whole with fluid and not divided, crushed, chewed, or
dissolved.
Initial Treatment
The recommended dose for Desvenlafaxine GH XR is 50 mg once daily,
with or without food. In clinical
trials, no additional benefit was demonstrated at doses greater than
50 mg/day. Based on clinical
judgment, if dose increases are indicated for individual patients,
they should occur gradually and at
intervals of not less than 7 days. The maximum dose should not exceed
200 mg/day.
Desvenlafaxine GH XR v5.0
Page 2 of 20
(desvenlafaxine (as benzoate)) extended release tablets
When discontinuing therapy, gradual dose reduction is recommended
whenever possible to minimise
discontinuation symptoms (see SECTION 4.4 SPECIAL WARNINGS AND
PRECAUTIONS FOR USE and SECTION 4.8
ADVERSE EFFECTS (UNDESIRABLE EFFECTS)).
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