País: Israel
Idioma: inglés
Fuente: Ministry of Health
TRAZODONE HYDROCHLORIDE
RAZ PHARMACEUTICS LTD, ISRAEL
N06AX05
TABLETS
TRAZODONE HYDROCHLORIDE 100 MG
PER OS
Required
AZIENDE CHIMMICHE RIUNITE ANGELINI FRANCESCO A.C.R.A.F., S.P.A, ITALY
TRAZODONE
For the treatment of depression with or without anxiety.
2023-05-30
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 Leer el documento completo