TRITTICO 50 MG

Country: Ísrael

Tungumál: enska

Heimild: Ministry of Health

Virkt innihaldsefni:

TRAZODONE HYDROCHLORIDE

Fáanlegur frá:

RAZ PHARMACEUTICS LTD, ISRAEL

ATC númer:

N06AX05

Lyfjaform:

TABLETS

Samsetning:

TRAZODONE HYDROCHLORIDE 50 MG

Stjórnsýsluleið:

PER OS

Gerð lyfseðils:

Required

Framleitt af:

AZIENDE CHIMMICHE RIUNITE ANGELINI FRANCESCO A.C.R.A.F., S.P.A, ITALY

Lækningarsvæði:

TRAZODONE

Ábendingar:

For the treatment of depression with or without anxiety.

Leyfisdagur:

2023-05-30

Vara einkenni

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
T
RITTICO
50
mg
T
RITTICO
100 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
T
RITTICO
50
mg film-coated tablets
Each film coated tablet of Trittico 50 mg contains: trazodone
hydrochloride 50 mg equivalent to trazodone
45.5 mg.
Excipients with known effect: lactose monohydrate, sunset yellow (E
110), castor oil.
T
RITTICO
100
mg film-coated tablets
Each
film
coated
tablet
of
Trittico
100mg
contains:
trazodone
hydrochloride
100
mg
equivalent
to
approximately trazodone 91.1 mg.
Excipients with known effect: lactose monohydrate, castor oil.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film coated tablets.
Trittico 50 mg:
pale orange yellow, smooth, glossy, round, biconvex film-coated
tablets with one sided central score line.
The tablets can be divided into two equal halves.
Trittico 100mg:
White to off-white, smooth, glossy, round, biconvex film-coated
tablets with one sided central score line.
The tablets can be divided into two equal halves.
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
Treatment of depression, with or without anxiety.
4.2
Posology and method of administration
Posology
The dosage should be determined with caution and treatment initiated
with the minimum effective dose.
The patient should be reassessed regularly. It is recommended to start
treatment with a night-time dose
and increasing daily doses. The course of treatment should last at
least one month.
T
ABLETS
The tablets can be split to enable gradual dosing with divided doses,
depending on the severity of the
disease and the patient's weight, age and general condition.
The tablets cannot be chewed or crushed – as they are film coated.
2
Adults:
initially 75 - 150 mg daily, administered in repeated doses after
meals. The night-time dose must be taken
before going to sleep
.
The dose may be increased to up to 300 mg daily, to be taken in
repeated doses, with the largest part taken
at bedtime.
In hospitalised patients, the dose may be increa