NOUMED ESCITALOPRAM escitalopram (as oxalate) 20 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

escitalopram oxalate, Quantity: 25.54 mg (Equivalent: escitalopram, Qty 20 mg)

Available from:

AVALLON PHARMACEUTICALS PTY LTD

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: colloidal anhydrous silica; hypromellose; titanium dioxide; microcrystalline cellulose; macrogol 6000; purified talc; croscarmellose sodium; magnesium stearate; lactose monohydrate

Administration route:

Oral

Units in package:

28

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Treatment of major depression. Treatment of obsessive compulsive disorder.

Product summary:

Visual Identification: White, round film-coated tablet with cross breaking notch on both sides; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Registered

Authorization date:

2018-02-26

Patient Information leaflet

NOUMED ESCITALOPRAM
1
NOUMED ESCITALOPRAM
_escitalopram (as oxalate) tablets _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about NOUMED
ESCITALOPRAM.
It does not contain all of 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 taking this medicine
against the benefits it is expected to
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 NOUMED
ESCITALOPRAM IS
USED FOR
NOUMED ESCITALOPRAM
tablets contain the active ingredient
escitalopram.
Escitalopram belongs to a group of
medicines called selective serotonin
reuptake inhibitors (SSRI). They
work by acting on brain chemicals
called amines which are involved in
controlling mood.
Imbalances in these chemicals can
cause emotional and physical
symptoms including being low in
spirit, lacking interest in activities,
inability to enjoy life, poor appetite
or overeating, disturbed sleep or
waking up too early, loss of sex
drive, lack of energy and feelings of
guilt.
Depression is longer lasting or more
severe than the "low moods" that
everyone has from time to time due
to the stress of everyday life.
Escitalopram helps correct this brain
chemical imbalance to relieve the
symptoms of major depression.
NOUMED ESCITALOPRAM may
also be used to treat obsessive-
compulsive disorder (OCD), which
involves having both obsessions and
compulsions. Obsessions are
unwanted thoughts that occur over
and over again, while compulsions
are ongoing needs to repeat certain
actions as a result of these thoughts.
NOUMED ESCITALOPRAM
SHOULD NOT BE USED BY CHILDREN OR
ADOLESCENTS BELOW 18 YEARS OLD.
This medicine is available only with
a doctor's prescription.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.

Summary of Product characteristics

Product Information - Australia
Page 1 of 26
AUSTRALIAN PRODUCT INFORMATION -
NOUMED ESCITALOPRAM
[ESCITALOPRAM OXALATE FILM-COATED TABLETS]
1. NAME OF THE MEDICINE
Escitalopram oxalate
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
NOUMED ESCITALOPRAM film-coated tablets contain either 10 mg or 20 mg
of escitalopram (as oxalate).
Excipients with known effect: sugars (as lactose). For the full list
of excipients, see SECTION 6.1 LIST OF
EXCIPIENTS.
3. PHARMACEUTICAL FORM
NOUMED ESCITALOPRAM 10 mg tablets are oval, white, film-coated tablets
with breaking notch on one
side.
NOUMED ESCITALOPRAM 20 mg tablets are round, white, film-coated
tablets with cross-breaking notch
on both sides.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
-
Treatment of major depression.
-
Treatment of obsessive compulsive disorder.
4.2 DOSE AND METHOD OF ADMINISTRATION
DOSAGE (ADULTS)
_MAJOR DEPRESSION _
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.
Usually two to four weeks are necessary for antidepressant response,
although the onset of therapeutic
effect may be seen earlier. 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 six months.
_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 20mg (one 20mg 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,
Product Information - Australia
Page 2 of 26
receiving escitalopram 10 or 20 mg daily. As OCD is a chronic disease,
patients should be treat