AC, modified release tablets, 150 mg
OF THE MEDICAL PRODUCT
and quantitative composition
Active substance: Trazodone hydrochloride: 150 mg
Pharmaceutical form and content
Market Authorisation Holder
Contraindications and side effects
effects: Occasionally in patients treated with trazodone, there was
a decrease in leucocytes, normally without any clinical meaning and without
the need to interrupt treatment. This procedure should only be adopted
if the number of leucocytes is decreased to levels below normal values,
in such a way, that there is the need to
It was reported cases of insomnia, headaches, asthenia, vertigo, confusion, tremor, hypotension, tachycardia, bradycardia, cardiac arrhythmia, decrease of concentration, convulsions and very rarely, alteration in transaminases levels. It was rarely reported gastric disorders, nauseas, vomits, diarrhoea and loss of appetite.
Like with other drugs which present alfa-adrenolitic effects, trazodone was rarely associated to the occurrence of priapism. In such situation, the patient should discontinue treatment immediately.
Triticum AC is an antidepressant with sedative properties, which can cause drowsiness, normally in the first days of the treatment.
Drug interactions and other forms of interaction
Moreover, it can enhance the effect of alcohol, barbiturates and other depressants of the Central Nervous System.
The association with other psycopharms requires the special caution and monitoring of the doctor, in order to avoid the occurrence of undesirable effects resulting from the interaction.
was occasionally observed situations of possible interaction with monoaminoxidase
Studies carried out in laboratory animals suggest that trazodone may considerably inhibit the hypotensive effect of clonidine.
The association of trazodone with digoxin or phenytoin, may increase serum levels of these substances.
and special precautions for use
In the presence of another drug, trazodone should be administered with caution in patients with hepatic or renal dysfunction.
The frequency of the side effects of Triticum AC® , may increase during the concomitant use of naturopathic products or preparations based on vegetable extracts that contain Hypericum perforatum in their composition
The administration of trazodone to epileptic patients should be carefully performed.
Since the tablets contain saccarosis, the treatment of individuals with diabetes or submitted to a hypocaloric diet, should be carefully performed.
possibility of suicide is inherent to depression and it may persist until
the significant remission of the symptoms.
Effects in pregnant women, breast-feeding
women, children, elderly patients and patients with special pathologies
During lactation, the fact that tradozone may be excreted in the milk should be considered.
Its use during pregnancy and breastfeeding should be limited to exceptional cases and only after the assessment of the benefit-risk relation by the doctor.
Effects on the ability to drive and use
List of excipients
Posology and administration mode
It is recommended to begin the therapeutic cycle with one administration before going to sleep at night and increasing daily doses.
Indication of the most favourable moment
for the administration of the medicine
Duration of the average treatment when it
should be limited
Instructions about what to do if you forget
to take one or more doses
Indication of how to discontinue the treatment
when its discontinuation causes withdrawal effects
Measures to adopt in case of overdosage
and/or intoxication, emergency measures and antidotes
There is no specific antidote for trazodone. In case of accidental ingestion of high doses a stomach lavage should be performed as soon as possible. If hypotension or sedation occurs, treatment is symptomatic.
Advice to the patient
Check if the product is within the expiry date mentioned in the package.
Keep the medicine out of reach and sight of children.
Special precautions for storage
Date of the revision of the leaflet