Trittico tablets prolonged-release

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

trazodone

Available from:

Aziende Chimiche Riunite Angelini Francesco ACRAF S.p.A.

ATC code:

N06AX05

INN (International Name):

trazodone

Dosage:

150mg

Pharmaceutical form:

tablets prolonged-release

Units in package:

(20/2x10) in blister

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2019-10-11

Summary of Product characteristics

SUMMARY OF THE PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Trittico 75 mg prolonged-release tablets
Trittico 150 mg prolonged-release tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ _
Trittico 75 mg prolonged-release tablets
_ _
Each tablet contains_: _
_ _75 mg trazodone hydrochloride corresponding to 68,3 mg trazodone _
_
_ _
_ _
Trittico 150 mg prolonged-release tablets
Each tablet contains: _ _
150 mg trazodone hydrochloride corresponding to 136,6 mg
trazodone
Excipient(s) with known effect:
Saccharose
For the full list of excipients, see section 6.1._ _
3.
PHARMACEUTICAL FORM
Prolonged-release tablets
Tablets of color from white to yellowish-white, biconvex,
lozenge-shaped, with double breack
line on both sides.
The tablet can be divided into three equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS:
Depressive disorders with or without anxiety
4.2
POSOLOGY AND METHOD OF ADMINISTRATION:
The use of the drug is restricted to adult patients.
The scored tablets can be divided into three parts in order to permit
a gradual dose increase
depending on the severity of the disease, weight, age and general
condition of the patient.
Therapy should begin with an evening administration and with
increasing daily doses.
Trittico prolonged-released tablets could be administered on an empty
stomach or after a
meal (see section 5.2).
The drug should be administered for therapeutic cycles of at least one
month.
Adults
75-150 mg/day to be administered in a single dose in the evening
before bedtime.
The dose can be increased up to 300 mg/day divided in two
administrations.
In hospitalized patients the dose can be further increased up to 600
mg/day in repeated
doses.
Elderly:
For very elderly, or frail patients, the recommended initial dose is
reduced to 100 mg a day,
administered in divided doses or as a single night time dose (See
Section 4.4). This may be
incrementally
increased,
as
described
under
Adults,
under
supervision,
according
to
tolerance and efficacy. In general, single doses above 100