LOXALATE escitalopram oxalate 20mg tablets blister packs

Država: Avstralija

Jezik: angleščina

Source: Department of Health (Therapeutic Goods Administration)

Aktivna sestavina:

escitalopram oxalate, Quantity: 25.56 mg (Equivalent: escitalopram, Qty 20 mg)

Dostopno od:

Alphapharm Pty Ltd

INN (mednarodno ime):

escitalopram oxalate

Farmacevtska oblika:

Tablet, film coated

Sestava:

Excipient Ingredients: colloidal anhydrous silica; microcrystalline cellulose; purified talc; croscarmellose sodium; magnesium stearate; titanium dioxide; lactose monohydrate; hypromellose; macrogol 4000

Pot uporabe:

Oral

Enote v paketu:

28 tablets, 30 Tablets

Tip zastaranja:

(S4) Prescription Only Medicine

Terapevtske indikacije:

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

Povzetek izdelek:

Visual Identification: 12.5mm x 7mm oblong normal convex white film coated tablet debossed "EC/20" on one sied and "G" on the other.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Status dovoljenje:

Licence status A

Datum dovoljenje:

2008-05-22

Navodilo za uporabo

LOXALATE
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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 LOXALATE?
LOXALATE contains the active ingredient escitalopram. LOXALATE is used
to treat depression.
For more information, see Section 1. Why am I using LOXALATE? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE LOXALATE?
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
LOXALATE? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with LOXALATE 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 LOXALATE?
•
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 LOXALATE? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING LOXALATE?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
LOXALATE.
•
If you become pregnant while taking LOXALATE, 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 LOXALATE affects you.
•
LOXALATE may cause

Lastnosti izdelka

AUSTRALIAN PRODUCT INFORMATION
LOXALATE
®
_Escitalopram oxalate tablets _
1
NAME OF THE MEDICINE
Escitalopram oxalate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg, 10 mg or 20 mg of escitalopram (as oxalate)
as the active ingredient.
Excipients with known effect: lactose and traces of sulfites.
For the full list of excipients, see
SECTION 6.1 LIST OF EXCIPIENTS
.
3
PHARMACEUTICAL FORM
LOXALATE 5 mg tablets are convex, white, film-coated tablets, marked
with “EC” over 5 on one side and
“G” on the other side.
LOXALATE 10 mg tablets are convex, white, film-coated tablets, marked
with “EC/10” on one side and
“G” on the other side.
LOXALATE 20 mg tablets are convex, white, film-coated tablets, marked
with “EC/20” on one side and
“G” on the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Escitalopram is indicated for the treatment of major depression.
4.2
DOSE AND METHOD OF ADMINISTRATION
ADULTS
Escitalopram should be administered as a single oral dose of 10 mg
once daily with or without food. Depending
on individual patient response, the dose may be increased to a maximum
of 20 mg 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.
When stopping SSRI therapy gradual dose reduction should be
considered.
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 (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