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

Pays: Australie

Langue: anglais

Source: Department of Health (Therapeutic Goods Administration)

Ingrédients actifs:

escitalopram oxalate, Quantity: 25.548 mg

Disponible depuis:

Arrotex Pharmaceuticals Pty Ltd

forme pharmaceutique:

Tablet, film coated

Composition:

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

Mode d'administration:

Oral

Unités en paquet:

28

Type d'ordonnance:

(S4) Prescription Only Medicine

indications thérapeutiques:

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

Descriptif du produit:

Visual Identification: White, round, biconvex film coated,tablets 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

Statut de autorisation:

Registered

Date de l'autorisation:

2020-08-21

Notice patient

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

Résumé des caractéristiques du produit

AUSTRALIAN PRODUCT INFORMATION - APX-ESCITALOPRAM (ESCITALOPRAM
OXALATE) FILM-COATED TABLETS
1
NAME OF THE MEDICINE
ESCITALOPRAM OXALATE
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
APX-ESCITALOPRAM 10 mg tablets.
Film-coated tablets containing 10mg escitalopram (as oxalate)
APX-ESCITALOPRAM 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
APX-ESCITALOPRAM 10 mg tablets are white, round, biconvex film coated
tablets plain on both
sides.
APX-ESCITALOPRAM 20 mg tablets are white, round, biconvex film coated
tablets plain on both
sides.
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 should be continued for a minimum of 6 months.
_Social anxiety disorder _
The recommended dose is 10 mg (one 10 mg tablet) once daily. Depend