Adverse reactions : תופעות לוואי

4.8 Undesirable effects

The undesirable effects of trimipramine are related, for the most part, to the pharmacological properties of imipramine antidepressants.

Cardiovascular
Hypotension, hypertension, tachycardia, palpitation, myocardial infarction, arrhythmias, heart block, stroke.
QT interval prolongation, torsade de pointes (see section 4.4).

The following are peripherally-mediated effects; they are usually benign and most often resolve in the course of treatment or after dose reduction:


•   Anticholinergic effects (in decreasing order of frequency): dry mouth, constipation, difficulty focusing, tachycardia, sweating, urination difficulties and possibly urinary retention; blurred vision.
•   Adrenolytic effects: postural hypotension, impotence.

The following are centrally-mediated effects:

•   frequent : drowsiness or sedation (antihistamine effect), more pronounced at the beginning of treatment;
•   much rarer: tremor, seizures in predisposed patients, transient confusional state.

The following effects are related to the depressive condition itself: 
•   suppression of psychomotor inhibition, with a risk of suicide;

•   mood swings with manic episodes;
•   recurrence of delusions in psychotic patients.

Cases of suicidal ideation and behavior have been reported during or shortly after treatment with Surmontil or shortly after treatment discontinuation (see Section 4.4.).

Imipramine antidepressants may also cause:
• weight gain,
• conduction disorders or arrhythmias (at high doses),
• endocrine disorders; enlargement of the breast, galactorrhoea,
• hot flushes,
• allergic skin reactions,
• dysarthria,
• rare cases of cytolytic or cholestatic hepatitis
• haematlogical disorders: hypereosinophilia, leukopenia, agranulocytosis, thrombocytopenia,
• syncope.

Prevention or treatment of some of these undesirable effects is possible using adjuvant or corrective therapy, or even dose reduction

Epidemiological studies, conducted primarily in patients aged 50 years and over, have shown an increased risk of bone fracture in patients receiving selective serotonin re- uptake inhibitors (SSRIs) or tricyclic antidepressants. This is caused by an unknown mechanism

Withdrawal Symptoms
Though not indicative of addiction, abrupt cessation of treatment after prolonged therapy may produce nausea, headache, and malaise.

Metabolism and nutrition disorders
Hyperglycemia. Epidemiologic studies have identified an increased risk of diabetes mellitus in depressed patients receiving tricyclic
antidepressants (see section 4.4).