ESCITALOPRAM SANDOZ escitalopram (as oxalate) 20 mg film-coated tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

escitalopram oxalate, Quantity: 25.548 mg

Available from:

Cipla Australia Pty Ltd

INN (International Name):

escitalopram oxalate

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: croscarmellose sodium; maize starch; magnesium stearate; mannitol; microcrystalline cellulose; titanium dioxide; hypromellose; macrogol 6000

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, round, biconvex film-coated tablet with E20 debossed on one side and break line on the other side; Container Type: Blister Pack; Container Material: PVC/PVDC; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2017-08-28

Patient Information leaflet

ESCITALOPRAM SANDOZ
1
ESCITALOPRAM SANDOZ
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING ESCITALOPRAM SANDOZ?
ESCITALOPRAM SANDOZ contains the active ingredient escitalopram.
ESCITALOPRAM SANDOZ is used to treat depression.
For more information, see Section 1. Why am I using ESCITALOPRAM
SANDOZ? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE ESCITALOPRAM SANDOZ?
Do not use if you have ever had an allergic reaction to escitalopram,
citalopram or any of the ingredients listed at the end of
the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
ESCITALOPRAM SANDOZ? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with ESCITALOPRAM SANDOZ and affect how
it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE ESCITALOPRAM SANDOZ?
•
The standard dose for this medicine is 10 mg per day
More instructions can be found in Section 4. How do I use ESCITALOPRAM
SANDOZ? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING ESCITALOPRAM SANDOZ?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
ESCITALOPRAM SANDOZ.
•
If you become pregnant while taking ESCITALOPRAM SANDOZ, tell your
doctor immediately.
•
Tell your doctor immediately if you have thoughts about killing
yourself, or you experience symptoms
such as restlessness or difficulty in sitting or standing still, if
you suddenly experience an episode of
mania.
THINGS YOU
SHOULD NOT DO
•
Do not stop using this medicine suddenly.
•
Do not give the tablets to anyone else, even if they have the same
condition as you.
DRIVING OR USING
MACHINES
•
Be careful driving or operating machinery until you know how

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION - ESCITALOPRAM SANDOZ (ESCITALOPRAM
OXALATE) FILM-COATED TABLETS
1
NAME OF THE MEDICINE
ESCITALOPRAM OXALATE
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
ESCITALOPRAM SANDOZ 10 mg tablets.
Film-coated tablets containing 10mg escitalopram (as oxalate)
ESCITALOPRAM SANDOZ 20 mg tablets.
Film-coated tablets containing 20 mg escitalopram (as oxalate).
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
ESCITALOPRAM SANDOZ 10 mg tablets are white to off white, round,
biconvex film-coated
tablets, with ‘E10’ debossed on one side and break line on the
other side.
ESCITALOPRAM SANDOZ 20 mg tablets are white to off white, round,
biconvex film-coated
tablets, with ‘E20’ debossed on one side and break line on the
other side.
Escitalopram is the active enantiomer (S-enantiomer) of citalopram.
Escitalopram oxalate is a fine
white to yellow, crystalline material.
Escitalopram oxalate is sparingly soluble in water, slightly soluble
in acetone, soluble in ethanol and
freely soluble in methanol. No polymorphic forms have been detected.
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 _
Usually 2 - 4 weeks are necessary for antidepressant response,
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, 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