APO-ESCITALOPRAM escitalopram (as oxalate) 10 mg tablet blister

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

escitalopram oxalate, Quantity: 12.74 mg

Available from:

Arrotex Pharmaceuticals Pty Ltd

INN (International Name):

escitalopram oxalate

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: colloidal anhydrous silica; purified talc; croscarmellose sodium; macrogol 400; hypromellose; titanium dioxide; microcrystalline cellulose; magnesium stearate

Administration route:

Oral

Units in package:

28

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Treatment of major depression. Treatment of social anxiety disorder (social phobia). Treatment of generalised anxiety disorder. Treatment of obsessive-compulsive disorder

Product summary:

Visual Identification: White to off-white, oval, biconvex, film-coated tablet with 'C4' debossed on one side and a notch break-line on the other side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 48 Months; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2013-11-06

Patient Information leaflet

APO-ESCITALOPRAM
1
APO-ESCITALOPRAM
_Contains the active ingredient, escitalopram (as escitalopram
oxalate) _
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-
Escitalopram. It contains the active
ingredient, escitalopram (as
escitalopram oxalate).
Escitalopram is used to treat
•
depression
•
obsessive-compulsive disorder.
It belongs to a group of medicines
called Selective Serotonin Reuptake
Inhibitors (SSRIs). Escitalopram and
other SSRIs are thought to help by
increasing the amount of serotonin in
your brain.
Depression is longer lasting or more
severe than the "low moods"
everyone has from time to time due
to the stress of everyday life. It is
thought to be caused by a chemical
imbalance in parts of the brain. This
imbalance affects your whole body
and can cause emotional and physical
symptoms such as feeling low in
spirit, loss of interest in activities,
being unable to enjoy life, poor
appetite or overeating, disturbed
sleep, often waking up early, loss of
sex drive, lack of energy and feeling
guilty over nothing.
Escitalopram corrects this chemical
imbalance and may help relieve the
symptoms of depression.
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
escitalopram is addictive. However,
if you sudd

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
APO-ESCITALOPRAM
(ESCITALOPRAM OXALATE) TABLETS
1
NAME OF THE MEDICINE
Escitalopram oxalate.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg or 20 mg escitalopram (as oxalate) as the
active ingredient.
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS
3
PHARMACEUTICAL FORM
10 MG TABLETS:
White to off-white, oval, biconvex, film-coated tablets with “C4”
debossed on one side and a
notch break-line on the other side.
20 MG TABLETS:
White to off-white oval, biconvex, film-coated tablets with “C3”
debossed on one side and a
notch break-line on the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
•
Treatment of major depression.
•
Treatment of obsessive-compulsive disorder.
4.2
DOSE AND METHOD OF ADMINISTRATION
APO-Escitalopram tablets are intended for oral administration.
DOSAGE
ADULTS
Escitalopram is administered as a single oral dose and may be taken
with or without food.
Major Depression
Usually 2 – 4 weeks are necessary for antidepressant response,
although the onset of
therapeutic effect may be seen earlier.
The recommended dose is 10 mg (one 10 mg tablet) once daily. Depending
on individual
patient response, the dose may be increased to a maximum of 20 mg (one
20 mg tablet) daily.
The treatment of a single episode of depression requires treatment
over the acute and the
medium term. After the symptoms resolve during acute treatment, a
period of consolidation of
the response is required. Therefore, treatment of a depressive episode
should be continued
for a minimum of 6 months.
2
Obsessive-Compulsive Disorder
The recommended starting dose is 10 mg (one 10 mg tablet) once daily.
Depending on
individual patient response, the dose may be increased to 20 mg (one
20 mg tablet) daily.
Long-term treatment has been studied for a maximum of 40 weeks.
Patients responding to a
16-week open-label treatment phase were randomised to a 24-week
placebo-controlled
relapse-prevention phase, receiving 10 or 20 mg escitalopram daily. A