DESVEN desvenlafaxine 50mg modified release tablets blister
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
08-11-2021
Summary of Product characteristics
(SPC)
24-08-2020
Public Assessment Report
(PAR)
26-11-2017
Active ingredient:
desvenlafaxine, Quantity: 50 mg
Available from:
Medis Pharma Pty Ltd
INN (International Name):
Desvenlafaxine
Pharmaceutical form:
Tablet, modified release
Composition:
Excipient Ingredients: microcrystalline cellulose; hypromellose; povidone; magnesium stearate; purified talc; citric acid monohydrate; alginic acid; titanium dioxide; macrogol 6000; iron oxide red
Administration route:
Oral
Units in package:
14, 28, 7
Prescription type:
(S4) Prescription Only Medicine
Therapeutic indications:
For the treatment of major depressive disorder, including the preventiton of relapse. Not indicated for paediatric use.
Product summary:
Visual Identification: Light pink colored, diamond shaped, biconvex tablets, debossed with 'Ll89' on one side and plain on other side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 4 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Authorization status:
Licence status A
Authorization date:
2014-11-26
Patient Information leaflet
DESVEN
1
DESVEN MODIFIED
RELEASE TABLETS
_Desvenlafaxine _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about DESVEN.
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 DESVEN
against the expected benefits it will
have for you.
IF YOU HAVE ANY QUESTIONS ABOUT
DESVEN, ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
DESVEN TABLETS.
You may need to read it again.
WHAT DESVEN IS USED
FOR
_WHAT IT DOES _
Desvenlafaxine 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 DESVEN HAS
BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
_ _
_HOW IT WORKS _
DESVEN contains the active
ingredient called desvenlafaxine. 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.
DESVEN tablets increase the level of
these two messengers. Experts think
this is how it helps to restore your
feeling of wellness.
DESVEN is not addictive. It is
available only with a doctor's
prescription.
BEFORE YOU TAKE
DESVEN
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE DESVEN IF YOU ARE
TAKING OTHER MEDICATIONS FOR
DEPRESSION KNOWN AS MONOAMINE
OXIDASE INHIBITORS, EVEN IF YOU HAVE
STOPPED TAKING THEM, BUT HAVE
TAKEN THEM WITHIN THE LAST 14 DAYS.
DO NOT TAKE DESVEN IF YOU ARE
ALLERGIC TO DESVENLAFAXINE,
VENLAFAXINE OR TO ANY OF THE
INGREDIENTS LISTED AT THE END OF THIS
LEAFLET.
Symptoms of an allergic reaction
include:
•
Skin rash
•
Itch
Read the complete document
Summary of Product characteristics
AUSTRALIAN PRODUCT INFORMATION - DESVEN DESVENLAFAXINE
1.
NAME OF THE MEDICINE
Desvenlafaxine
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Two strengths of DESVEN tablets are available, containing 50 mg and
100 mg of desvenlafaxine.
For the full list of excipients, see section 6.1 List of excipients
3.
PHARMACEUTICAL FORM
DESVEN is formulated as a modified release tablet for once-a-day oral
administration.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
DESVEN is indicated for the treatment of major depressive disorder,
including the prevention of
relapse.
DESVEN is not indicated for paediatric use.
4.2
DOSE AND METHOD OF ADMINISTRATION
Desvenlafaxine 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 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 SPECIAL WARNINGS
AND
PRECAUTIONS
FOR
USE
FOR
USE
and
Section
4.8
ADVERSE
EFFECTS
(UNDESIRABLE EFFECTS))
.
_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 continue
on the same dose at which
they were stabilised. They should be periodically reassessed to
determine the need for continued
treatment.
CHILDREN AND ADOLESCENTS
Safety and efficacy in patients less than 18 years of age have not
been established.
DOSAGE ADJUSTMENT IN RENAL IMPAIRMENT
The recommended starting dose in patients with severe renal impairment
(24-hr C
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