PHARMACOR DESVENLAFAXINE desvenlafaxine 100mg modified release tablets blister

Land: Australië

Taal: Engels

Bron: Department of Health (Therapeutic Goods Administration)

Werkstoffen:

desvenlafaxine, Quantity: 100 mg

Beschikbaar vanaf:

Medis Pharma Pty Ltd

INN (Algemene Internationale Benaming):

Desvenlafaxine

farmaceutische vorm:

Tablet, modified release

Samenstelling:

Excipient Ingredients: povidone; hypromellose; alginic acid; citric acid monohydrate; microcrystalline cellulose; magnesium stearate; purified talc; titanium dioxide; macrogol 8000; iron oxide red; iron oxide black

Toedieningsweg:

Oral

Eenheden in pakket:

28

Prescription-type:

(S4) Prescription Only Medicine

therapeutische indicaties:

For the treatment of major depressive disorder, including the preventiton of relapse. Not indicated for paediatric use.

Product samenvatting:

Visual Identification: Dark brown to red coloured, 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

Autorisatie-status:

Licence status A

Autorisatie datum:

2014-11-26

Bijsluiter

PHARMACOR DESVENLAFAXINE
1
PHARMACOR DESVENLAFAXINE

DESVENLAFAXINE MODIFIED RELEASE TABLETS
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Pharmacor
Desvenlafaxine.
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 Pharmacor
Desvenlafaxine against the expected
benefits it will have for you.
IF YOU HAVE ANY QUESTIONS ABOUT
PHARMACOR DESVENLAFAXINE, ASK
YOUR DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
PHARMACOR DESVENLAFAXINE TABLETS.
You may need to read it again.
WHAT PHARMACOR
DESVENLAFAXINE 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 PHARMACOR
DESVENLAFAXINE HAS BEEN
PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
_HOW IT WORKS _
Pharmacor Desvenlafaxine 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.
Pharmacor Desvenlafaxine tablets
increase the level of these two
messengers. Experts think this is how
it helps to restore your feeling of
wellness.
Pharmacor Desvenlafaxine is not
addictive. It is available only with a
doctor's prescription.
BEFORE YOU TAKE
PHARMACOR
DESVENLAFAXINE
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE PHARMACOR
DESVENLAFAXINE IF YOU ARE TAKING
OTHER MEDICATIONS FOR DEPRESSION
KNOWN AS MONOAMINE OXIDASE
INHIBITORS, EVEN IF YOU HAVE STOPPED
TAKING THEM, BUT HAVE TA

Productkenmerken

Dvenlafaxine -AU- PI Nov 2019
1
AUSTRALIAN PRODUCT INFORMATION- PHARMACOR
DESVENLAFAXINE (DESVENLAFAXINE)
1.
NAME OF THE MEDICINE
Desvenlafaxine
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Two strengths of PHARMACOR DESVENLAFAXINE 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
PHARMACOR DESVENLAFAXINE is formulated as a modified release tablet
for once-a-day
oral administration.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
PHARMACOR DESVENLAFAXINE is indicated for the treatment of major
depressive disorder,
including the prevention of relapse.
PHARMACOR DESVENLAFAXINE 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 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
Dvenlafaxine -AU- PI Nov 2019
2
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 esta