Estopram escitalopram (as oxalate) 20mg tablet blister pack

Pays: Australie

Langue: anglais

Source: Department of Health (Therapeutic Goods Administration)

Ingrédients actifs:

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

Disponible depuis:

Micro Labs Pty Ltd

DCI (Dénomination commune internationale):

escitalopram oxalate

forme pharmaceutique:

Tablet, film coated

Composition:

Excipient Ingredients: purified talc; magnesium stearate; silicified microcrystalline cellulose; croscarmellose sodium; titanium dioxide; hypromellose; macrogol 6000

Mode d'administration:

Oral

Unités en paquet:

28 tablets

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 to off-white, capsule shaped, film-coated, biconvex tablets, engraved with 20 on one face and break line on the other face.; Container Type: Blister Pack; Container Material: Other composite material; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Statut de autorisation:

Licence status A

Date de l'autorisation:

2017-03-14

Résumé des caractéristiques du produit

AUSTRALIAN PRODUCT INFORMATION ESTOPRAM (ESCITALOPRAM
OXALATE) TABLETS
1. NAME OF THE MEDICINE
Escitalopram oxalate
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
ESTOPRAM tablets 10 mg and 20 mg: Film-coated tablets containing 10 mg
and 20 mg
escitalopram (as oxalate)
For the full list of excipients, see section 6.1 List of excipients.
3. PHARMACEUTICAL FORM
ESTOPRAM 10 mg tablets are white to off-white, capsule shaped,
biconvex, film-coated tablets
engraved with 10 on one face and break line on the other face.
ESTOPRAM 20 mg tablets are white to off-white, capsule shaped,
film-coated, biconvex tablets, engraved with 20 on one face and break
line on the other face.
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
once daily. Depending on individual patient response, the dose may be
increased to a maximum
of 20 mg 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 once daily. Depending on individual
patient response, the dose
may be increased to a maximum of 20 mg daily. Social anxiety disorder
is a disease with a
chronic course and long-term treatment is therefore warranted to
consolidate response and
prevent relapse.
_Generalised anxiety disorder _
The recommended dose is 10 mg once daily. Depending on individual
patient response,