Escitalopram B&B escitalopram (as oxalate) 10mg tablet blister pack

Country: Awstralja

Lingwa: Ingliż

Sors: Department of Health (Therapeutic Goods Administration)

Ingredjent attiv:

escitalopram oxalate, Quantity: 12.78 mg (Equivalent: escitalopram, Qty 10 mg)

Disponibbli minn:

Micro Labs Pty Ltd

INN (Isem Internazzjonali):

escitalopram oxalate

Għamla farmaċewtika:

Tablet, film coated

Kompożizzjoni:

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

Rotta amministrattiva:

Oral

Unitajiet fil-pakkett:

28 tablets

Tip ta 'preskrizzjoni:

(S4) Prescription Only Medicine

Indikazzjonijiet terapewtiċi:

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

Sommarju tal-prodott:

Visual Identification: White to off-white, capsule shaped, biconvex, film-coated tablets engraved with 10 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

L-istatus ta 'awtorizzazzjoni:

Licence status A

Data ta 'l-awtorizzazzjoni:

2017-03-14

Karatteristiċi tal-prodott

AUSTRALIAN PRODUCT INFORMATION ESCITALOPRAM B&B (ESCITALOPRAM
OXALATE) FILM-COATED TABLETS
1. NAME OF THE MEDICINE
Escitalopram oxalate
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
ESCITALOPRAM B&B 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
ESCITALOPRAM B&B 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.
ESCITALOPRAM B&B 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