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NAME
OF THE MEDICAL PRODUCT Qualitative
and quantitative composition Active substance: Trazodone hydrochloride......................................................... 100 mg Pharmaceutical
form and content Pharmacotherapeutic
class: Market
Authorisation Holder
Therapeutic indications Major depression episodes implicate a clearly and relatively evident (almost every day for at least two weeks) depressive or dysphoric humor, which usually interferes with daily activity and includes at least four of the following symptoms: appetite disorders, sleep disorders, agitation or psychomotor slowness, lost of interest by daily activities, lost of energy and fatigue, feelings of guilty and indignity, slow thinking or decrease of the capacity of concentration, suicide ideas or suicide attempts. Contraindications
and side effects Trazodone should not be used when the patient is recovering from acute myocardial infarction. Side 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 count leucocytes and check the formula in patients experiencing fever, sore throat or other signs of infection during treatment. It was also reported cases of agranulocytosis and anaemia. 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 ?-adrenolitic effects, trazodone was rarely
associated to the occurrence of priapism. In such situation, the patient
should discontinue treatment immediately. 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. It was occasionally observed situations of possible interaction with monoaminoxidase inhibitors (MAOI). An eventual concomitant treatment with antihypertensives may require the reduction of the dosage of antihypertensive used. 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. Special
precautions for storage In
the presence of another drug, trazodone should be administered with caution
in patients with hepatic or renal dysfunction. The administration of trazodone to epileptic patients should be carefully performed. The
possibility of suicide is inherent to depression and it may persist until
the significant remission of the symptoms.
Effects in pregnant and breast-feeding women 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 machines List
of excipients Posology
and administration mode 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 excessive sedation occurs, treatment is symptomatic. Advice
to the patient Check if the product is within the expiry date mentioned in the package. Always keep medicines out of reach and sight of children. Special
precautions for storage Date
of the revision of the leaflet
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