LEXAM 20 escitalopram (as oxalate) 20 mg tablet blister pack
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
05-05-2021
Summary of Product characteristics
(SPC)
13-12-2021
Public Assessment Report
(PAR)
26-11-2017
Active ingredient:
escitalopram oxalate, Quantity: 25.548 mg (Equivalent: escitalopram, Qty 20 mg)
Available from:
Arrotex Pharmaceuticals Pty Ltd
INN (International Name):
escitalopram oxalate
Pharmaceutical form:
Tablet, film coated
Composition:
Excipient Ingredients: colloidal anhydrous silica; croscarmellose sodium; magnesium stearate; microcrystalline cellulose; purified talc; titanium dioxide; polyvinyl alcohol; macrogol 3000
Administration route:
Oral
Units in package:
28 tablets
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, oval convex shaped, coated tablet with 'E' bisect '2' on one side and plain on the other.; Container Type: Blister Pack; Container Material: PCTFE (Aclar)/AI; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius
Authorization status:
Licence status A
Authorization date:
2013-07-05
Patient Information leaflet
LEXAM- Consumer Medicine Information
Page 1 of 6
LEXAM
escitalopram oxalate
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about LEXAM.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have benefits and
risks. Your doctor has weighed the
risks of you taking LEXAM against
the benefits they expect it will have
for you.
TALK TO YOUR DOCTOR OR
PHARMACIST IF YOU HAVE ANY
CONCERNS ABOUT TAKING THIS
MEDICINE.
Keep this leaflet with your medicine.
You may need to read it again.
WHAT LEXAM IS USED FOR
LEXAM is used to treat depression.
It belongs to a group of medicines
called selective serotonin reuptake
inhibitors (SSRIs). These medicines
work by their action on brain
chemicals called amines which are
involved in controlling mood.
Depression is longer lasting and/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 like 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.
LEXAM corrects this chemical
imbalance and may help relieve the
symptoms of depression.
LEXAM may also be used to treat
patients who may avoid and/or are
fearful of social situations.
LEXAM may also be used to treat
patients who have excessive anxiety
and worry.
LEXAM may also be used to treat
irrational fears or obsessional
behaviour (obsessive-compulsive
disorder). Obsessive-compulsive
disorder involves having both
obsessions and compulsions.
Obsessions are unwanted thoughts
that occur over and over again.
Compulsions are the ongoing need
to repeat certain actions as a result
of these thoughts.
Your doctor may have prescribed
this medicine for a
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Summary of Product characteristics
1
AUSTRALIAN PRODUCT INFORMATION – LEXAM (ESCITALOPRAM (AS
OXALATE)) TABLETS
1
NAME OF THE MEDICINE
Escitalopram (as oxalate).
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
LEXAM tablets come in two strengths and contain either 10 mg or 20 mg
of escitalopram (as oxalate).
For full list of excipients, see section 6.1 LIST OF EXCIPIENTS
3
PHARMACEUTICAL FORM
LEXAM 10_ _
White, oval convex shaped, coated tablet with ‘E’ bisect ‘1’
on one side and plain on
the other side.
LEXAM 20_ _
White, oval convex shaped, coated tablet with ‘E’ bisect ‘2’
on one side and plain on
the other side.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Treatment of major depression.
4.2
D
OSE AND METHOD OF ADMINISTRATION
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 an
antidepressant response.
The recommended dose is 10 mg once daily. Depending on individual
patient response, the dose may
be increased to a maximum of 20 mg 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 six
months.
ELDERLY PATIENTS (≥ 65 YEARS OF AGE). A longer half-life and a
decreased clearance have been
demonstrated in the elderly. 10 mg is the recommended maximum
maintenance dose in the elderly
2
(see
section
5.2
PHARMACOKINETIC
PROPERTIES
and
section
4.4
SPECIAL
WARNINGS
AND
PRECAUTIONS FOR USE).
CHILDREN AND ADOLESCENTS (< 18 YEARS OF AGE). Safety and efficacy have
not been established in this
population. Escitalopram should not be used in children and
adolescents under 18 years of age (see
section 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE).
RENAL INSUFFICIENCY. Dosage adjustment is not necessary in patients
with mild or moderate renal
impairment. No information is available on the treatme
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