Adverse reactions : תופעות לוואי

4.8      Undesirable effects

Side effects
In clinical trials, adverse events with an incidence greater than 1% associated with the use of sertindole and significantly different from placebo were (listed in order of decreasing frequency): rhinitis/nasal congestion, abnormal ejaculation (decreased ejaculatory volume), dizziness, dry mouth, postural hypotension, weight gain, peripheral oedema, dyspnoea, paraesthesia, and prolonged QT interval (see section 4.4).

Extrapyramidal Symptoms (EPS)
The incidences of patients treated with sertindole reporting EPS-related adverse events were similar to those of patients treated with placebo. In addition, in placebo-controlled clinical trials, the percentage of sertindole-treated patients requiring anti-EPS medication was indistinguishable from that of placebo-treated patients.

Some of the adverse drug reactions will appear at the beginning of treatment and disappear with continuous treatment, e.g., postural hypotension.

The table below shows adverse reactions sorted by system organ class and frequency: Very common (≥ 1/10);
Common (≥ 1/100, < 1/10);
Uncommon (≥ 1/1,000, < 1/100);
Rare (≥ 1/10,000, < 1/1,000);
Very rare (≤ 1/10,000), Not known (cannot be estimated from the available data).


Investigations
Common         red blood cells urine positive, white blood cells urine positive 
Endocrine disorders
Uncommon        Hyperprolactinaemia

Cardiac disorders
Common        Peripheral oedema, prolonged QT interval (see section 4.4) 
Uncommon        Torsade de Pointes (see section 4.4)

Nervous system disorders
Common        Dizziness, paraesthesia
Uncommon      Syncope, convulsion, movement disorder (in particular tardive dyskinesia, see section 4.4)
Rare          Cases reported as Neuroleptic Malignant Syndrome (NMS) have been received in association with sertindole (see section 4.4)

Respiratory, thoracic and mediastinal disorders
Very common Rhinitis/nasal congestion
Common         Dyspnoea

Gastrointestinal disorders
Common         Dry mouth
Metabolism and nutrition disorders

Common          Weight gain
Uncommon        Hyperglycaemia

Vascular disorders
Common         Postural hypotension (see section 4.4)
Unknown                   Cases of venous thromboembolism, including cases of pulmonary embolism and cases of deep vein thrombosis have been reported with antipsychotic drugs.

Pregnancy, puerperium and perinatal conditions.
Unknown                 Drug withdrawal syndrome neonatal (see 4.6)

Reproductive system and breast disorders
Very common            Ejaculation failure
Common                   Ejaculation disorder , Erectile dysfunction

Uncommon                     Galactorrhoea