LEXAPRO escitalopram (as oxalate) 10mg tablet blister pack

Negara: Australia

Bahasa: Inggris

Sumber: Department of Health (Therapeutic Goods Administration)

Bahan aktif:

escitalopram oxalate, Quantity: 12.77 mg (Equivalent: escitalopram, Qty 10 mg)

Tersedia dari:

Lundbeck Australia Pty Ltd

Bentuk farmasi:

Tablet, film coated

Komposisi:

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

Rute administrasi :

Oral

Unit dalam paket:

7 tablets, 28 tablets

Jenis Resep:

(S4) Prescription Only Medicine

Indikasi Terapi:

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

Ringkasan produk:

Visual Identification: Oval, white, film-coated tablet, scored on one side with "E" and "L" on each side of score.; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Status otorisasi:

Licence status A

Tanggal Otorisasi:

2003-09-16

Selebaran informasi

LEXAPRO
® TABLETS
L
e
x
a
p
r
o
®
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 LEXAPRO?
LEXAPRO contains the active ingredient escitalopram. LEXAPRO is used
to treat depression.
For more information, see Section 1. Why am I using LEXAPRO? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE LEXAPRO?
Do not use if you have ever had an allergic reaction to escitalopram
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
LEXAPRO? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with LEXAPRO 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 LEXAPRO?
•
Your doctor will decide what dose you will receive.
•
The standard dose for this medicine is 10 mg per day. This may be
increased by your doctor to 20 mg per day.
More instructions can be found in Section 4. How do I use LEXAPRO? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING LEXAPRO?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist, or pharmacist you visit that you are using
LEXAPRO.
•
If you become pregnant while taking LEXAPRO, tell your doctor
immediately.
•
Tell your doctor immediately if you have thoughts about killing
yourself.
THINGS YOU
SHOULD NOT DO
•
Do not stop using this medicine suddenly or lower the dosage without
telling your doctor.
•
Do not give the tablets to anyone else, even if they have the same
condition as you.
•
Do not let yourself run out of medicine over the weekend or on
holidays
DRIVING
OR USING
MACHINES
•
Be careful before you drive or use any machines or tools until you
know how LEXAPRO affects you.
•
LEXAPRO may cause visual

Karakteristik produk

LEXAPRO® (escitalopram oxalate)
_ _
_Page 1 of 35 _
AUSTRALIAN PRODUCT INFORMATION – LEXAPRO
(ESCITALOPRAM OXALATE) FILM-COATED TABLETS AND
ORAL SOLUTION
1 NAME OF THE MEDICINE
Escitalopram oxalate
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
LEXAPRO tablets 10mg and 20mg: Film-coated tablets containing 10mg and
20 mg
escitalopram (as oxalate)
LEXAPRO solution 20 mg/mL:_ _Oral solution containing 20 mg/mL
escitalopram (as oxalate)
Excipient with known effect: ethanol.
For the full list of excipients, see Section 6.1 List of excipients.
3 PHARMACEUTICAL FORM
LEXAPRO 10 mg tablets are oval, white, scored, film-coated tablets
marked with "E” and “L"
on one side.
LEXAPRO 20 mg tablets are oval, white, scored, film-coated tablets
marked with "E” and “N"
on one side.
LEXAPRO 20 mg/mL oral solution is a clear, nearly colourless to
yellowish solution.
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.
The oral solution can be mixed with water, orange juice or apple
juice.
LEXAPRO® (escitalopram oxalate)
_ _
_Page 2 of 35 _
Turn the bottle completely upside down. If no drops come out, tap the
bottle lightly to start
the flow.
_Major depression _
Usually 2 - 4 weeks are necessary for antidepressant response,_ _
The recommended dose is 10 mg (one 10 mg tablet or 10 drops of the 20
mg/mL oral
solution) once daily. Depending on individual patient response, the
dose may be increased
to a maximum of 20 mg (one 20 mg tablet or 20 drops of the 20 mg/mL
oral solution) 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