ESCITALOPRAM GH escitalopram (as oxalate) 20 mg tablet blister

Krajina: Austrália

Jazyk: angličtina

Zdroj: Department of Health (Therapeutic Goods Administration)

Aktívna zložka:

escitalopram oxalate, Quantity: 25.47 mg

Dostupné z:

Generic Health Pty Ltd

Forma lieku:

Tablet, film coated

Zloženie:

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

Spôsob podávania:

Oral

Počet v balení:

28

Typ predpisu:

(S4) Prescription Only Medicine

Terapeutické indikácie:

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

Prehľad produktov:

Visual Identification: White to off-white, oval, biconvex, film-coated tablet with 'C3' embossed 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

Stav Autorizácia:

Registered

Dátum Autorizácia:

2018-02-23

Príbalový leták

CONSUMER MEDICINE INFORMATION
ESCITALOPRAM GH
(ESCITALOPRAM OXALATE) FILM-COATED TABLET
WHAT IS IN THIS LEAFLET
This leaflet contains answers to
some common questions about
Escitalopram GH.
It does not contain all the
information that is known about
Escitalopram GH. It does not
take the place of talking to your
doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has
weighed the risk of you using
this medicine against the
benefits they expect it will have
for you.
IF YOU HAVE ANY CONCERNS
ABOUT USING THIS MEDICINE,
ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE.
You may need to read it again.
WHAT ESCITALOPRAM GH IS
USED FOR
Escitalopram GH is used to treat
depression.
It belongs to a group of
medicines called selective
serotonin reuptake inhibitors
(SSRIs). They are thought to
work by their actions on brain
chemicals called amines which
are involved in controlling mood.
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 GH corrects this
chemical imbalance and may
help relieve the symptoms of
depression.
Escitalopram GH may also be
used to treat patients who may
avoid and/or are fearful of social
situations.
Escitalopram GH may also be
used to treat patients who have
excessive anxiety and worry.
Escitalopram GH 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
a

Súhrn charakteristických

AUSTRALIAN PRODUCT INFORMATION – ESCITALOPRAM GH
(ESCITALOPRAM OXALATE) FILM COATED TABLET
1
NAME OF THE MEDICINE
Escitalopram (as oxalate).
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg and 20 mg escitalopram (as oxalate).
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Escitalopram GH 10 mg tablets are white to off-white, oval, biconvex,
film-coated tablets embossed with
’C4’ on one side and a notch breakline on the other side.
Escitalopram GH 20 mg tablets are white to off-white, oval, biconvex,
film-coated tablets embossed with
’C3’ on one side and scored notch breakline on the other side.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
•
Treatment of major depression.
•
Treatment of social anxiety disorder (social phobia).
•
Treatment of generalised anxiety disorder.
•
Treatment of obsessive-compulsive disorder.
4.2 DOSE AND METHOD OF ADMINISTRATION
ADULTS
Escitalopram is administered as a single oral dose and may be taken
with or without food.
_ _
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 2-4 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 6 months.
_ _
Escitalopram GH v4
Page 2 of 30
(escitalopram oxalate) film coated tablet
Social anxiety disorder
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. Social anxiety
disorder is a disease with a chronic course and long-term treatment is
therefore