APO-DESVENLAFAXINE MR desvenlafaxine (as benzoate) 50 mg extended release tablets blister pack
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
24-08-2020
Summary of Product characteristics
(SPC)
24-08-2020
Public Assessment Report
(PAR)
26-11-2017
Active ingredient:
desvenlafaxine benzoate, Quantity: 73.16 mg (Equivalent: desvenlafaxine, Qty 50 mg)
Available from:
Arrotex Pharmaceuticals Pty Ltd
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
APO-DESVENLAFAXINE
MR TABLETS
_Contains the active ingredient desvenlafaxine (as benzoate)_
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055_
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about this medicine. 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 this medicine
against the benefits they expect it
will 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 THIS MEDICINE IS
USED FOR
The name of your medicine is APO-
Desvenlafaxine MR Tablets. It
contains the active ingredient
desvenlafaxine (as benzoate).
It 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.
Desvenlafaxine 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.
This medicine increases the level of
these two messengers. Experts think
this is how it helps to restore your
feeling of wellness.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed this
medicine for another reason.
This medicine is available only with
a doctor's prescription.
There is no evidence that this
medicine is addictive.
THIS MEDICINE SHOULD NOT BE USED
IN CHILDREN OR ADOLESCENTS UNDER 18
YEARS OF AGE.
The safety and effectiveness of this
medicine in this age group have not
been established.
BEFORE YOU TAKE THIS
MEDICINE
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE THIS MEDICIN
Read the complete document
Summary of Product characteristics
1
AUSTRALIAN PRODUCT INFORMATION – APO-DESVENLAFAXINE
MR (DESVENLAFAXINE (AS BENZOATE))
1
NAME OF THE MEDICINE
Desvenlafaxine (as benzoate).
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each extended release tablet contains 50 mg or 100 mg of
desvenlafaxine (as benzoate
salt) as the active ingredient.
For the full list of excipients, see section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
50 MG EXTENDED RELEASE TABLET:
A light pink, biconvex, round shaped film coated tablet debossed with
"DV" on one side and
"50"on the other side.
100 MG EXTENDED RELEASE TABLET:
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
APO-Desvenlafaxine MR tablets are indicated for the treatment of major
depressive
disorder, including the prevention of relapse.
APO-Desvenlafaxine MR tablets are not indicated for paediatric use.
4.2
DOSE AND METHOD OF ADMINISTRATION
APO-Desvenlafaxine MR extended release tablets are intended for oral
administration.
They 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 APO-Desvenlafaxine MR 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.
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 4.8 ADVERSE EFFECTS (UNDESIRABLE EFFECTS)).
2
MAINTENANCE/CONTINUATION/EXTENDED TREATMENT
It is generally agreed that acute episodes of major depressive
disorder require several
months or longer of sustained pharmacological therapy. Patients should
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