CITALOPRAM SANDOZ citalopram 40mg (as hydrobromide) film coated tablet bottle

Ülke: Avustralya

Dil: İngilizce

Kaynak: Department of Health (Therapeutic Goods Administration)

Aktif bileşen:

citalopram hydrobromide, Quantity: 49.98 mg (Equivalent: citalopram, Qty 40 mg)

Mevcut itibaren:

Sandoz Pty Ltd

INN (International Adı):

Citalopram

Farmasötik formu:

Tablet, film coated

Kompozisyon:

Excipient Ingredients: glycerol; maize starch; microcrystalline cellulose; sodium starch glycollate; copovidone; purified talc; titanium dioxide; magnesium stearate; macrogol 6000; hypromellose; lactose monohydrate

Uygulama yolu:

Oral

Paketteki üniteler:

28 tablets

Reçete türü:

(S4) Prescription Only Medicine

Terapötik endikasyonlar:

Treatment of major depression.

Ürün özeti:

Visual Identification: White, oval, biconvex, scored on one side, film-coated tablets and embossed 'C40'; Container Type: Bottle; Container Material: HDPE; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Yetkilendirme durumu:

Licence status A

Yetkilendirme tarihi:

2005-04-27

Ürün özellikleri

220412-Citalopram Sandoz-pi
Page 1 of 24
AUSTRALIAN PRODUCT INFORMATION
CITALOPRAM SANDOZ
® (CITALOPRAM HYDROBROMIDE) TABLETS
1
NAME OF THE MEDICINE
Citalopram hydrobromide
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Citalopram Sandoz 20 mg tablets contains 20 mg citalopram (as
hydrobromide).
Each Citalopram Sandoz 40 mg tablets contains 40 mg citalopram (as
hydrobromide).
_List of excipients with known effect:_
Lactose monohydrate.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Citalopram Sandoz 20 mg tablets - oval, white, biconvex film-coated
tablets with a score notch
on one side, and embossed C 20.
Citalopram Sandoz 40 mg tablets - oval, white, biconvex film-coated
tablets with a one-sided
notch and embossment C 40.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Treatment of major depression.
4.2
D
OSE AND METHOD OF ADMINISTRATION
DOSAGE
_ADULTS _
The starting dose is 20 mg/day. The dose can be increased in
increments of 10 mg until
satisfactory clinical response is achieved. The maximum dose is 40
mg/day. As the treatment
result in general can be evaluated only after 2-3 weeks' treatment, a
possible dose increase
should take place with intervals of 2-3 weeks.
_DURATION OF TREATMENT _
In treating depression, a treatment period of at least six months is
usually necessary to provide
adequate maintenance against the potential for relapse.
_WITHDRAWAL SYMPTOMS SEEN ON DISCONTINUATION OF SSRI _
Abrupt discontinuation should be avoided. When stopping treatment with
citalopram the dose
should be gradually reduced over a period of a least one to two weeks
in order to reduce the
risk of withdrawal reactions (see Section 4.4 Special warnings and
precautions for use). If
intolerable symptoms occur following a decrease in the dose or upon
discontinuation of
treatment, then resuming the previously prescribed dose may be
considered. Subsequently, the
physician may continue decreasing the dose, but at a more gradual
rate.
220412-Citalopram Sandoz-pi
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METHOD