DESVENLAFAXINE SANDOZ desvenlafaxine 100mg modified release tablets blister
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, Quantity: 100 mg
Available from:
Medis Pharma Pty Ltd
INN (International Name):
Desvenlafaxine
Pharmaceutical form:
Tablet, modified release
Composition:
Excipient Ingredients: alginic acid; magnesium stearate; povidone; purified talc; hypromellose; citric acid monohydrate; microcrystalline cellulose; titanium dioxide; macrogol 8000; iron oxide red; iron oxide black
Administration route:
Oral
Units in package:
7, 14, 28
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: Dark brown to red colored, diamond shaped, biconvex tablets, debossed with 'Ll90' 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
DESVENLAFAXINE SANDOZ
1
DESVENLAFAXINE SANDOZ
DESVENLAFAXINE MODIFIED RELEASE TABLETS
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Desvenlafaxine
Sandoz.
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 Sandoz against the
expected benefits it will have for
you.
IF YOU HAVE ANY QUESTIONS ABOUT
DESVENLAFAXINE SANDOZ, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
DESVENLAFAXINE SANDOZ TABLETS.
You may need to read it again.
WHAT DESVENLAFAXINE
SANDOZ 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
DESVENLAFAXINE SANDOZ HAS BEEN
PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
_HOW IT WORKS _
Desvenlafaxine Sandoz 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.
Desvenlafaxine Sandoz tablets
increase the level of these two
messengers. Experts think this is how
it helps to restore your feeling of
wellness.
Desvenlafaxine Sandoz is not
addictive. It is available only with a
doctor's prescription.
BEFORE YOU TAKE
DESVENLAFAXINE
SANDOZ
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE DESVENLAFAXINE SANDOZ
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 NO
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Summary of Product characteristics
_Product Information Page 1 _
_Desvenlafaxine Sandoz 50 mg, 100 mg tablet _
_04/2019 _
_Sandoz Pty Ltd _
_Version 11 Nov 2019 _
AUSTRALIAN PRODUCT INFORMATION - DESVENLAFAXINE
SANDOZ
®
(DESVENLAFAXINE) 50MG, 100MG TABLET
1.
NAME OF THE MEDICINE
Desvenlafaxine
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Two strengths of DESVENLAFAXINE SANDOZ 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
DESVENLAFAXINE SANDOZ is formulated as a modified release tablet for
once-a-day oral
administration.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of major depressive disorder, including the prevention of
relapse. 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 PRECAUTIONS 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
_Product Information Page 2 _
_Desvenlafaxine Sandoz 50 mg, 100 mg tablet _
_04/2019 _
_Sandoz Pty Ltd _
_Version 11 Nov 2019 _
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
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