The following side effects have been reported with lofepramine:
Blood and lymphatic system disorders: Rarely, bone marrow depression including isolated reports of: agranulocytosis, eosinophilia, granulocytopenia, leucopenia, pancytopenia, thrombocytopenia.
Endocrine disorders:
Rarely, inappropriate secretion of antidiuretic hormone leading to hyponatraemia.
Psychiatric disorders:
Sleep disturbances, agitation, confusion, nightmares, hallucinations, mania, psychoses, delirium; rarely, hypomania.
Nervous system disorders:
Dizziness, headache, paraesthesia, tremor; rarely, drowsiness, convulsions, impairment of sense of taste; very rarely, uncoordinated movement.
Eye disorders:
Visual disturbances including blurred vision, mydriasis, disturbances of accommodation, induction of glaucoma.
Ear and labyrinth disorders:
Very rarely, tinnitus.
Cardiac disorders:
Tachycardia, cardiac conduction disorders, increase in cardiac insufficiency, QT- prolongation, arrhythmias (including ventricular arrhythmias or Torsades de Pointes).
Vascular:
Hypotension.
Gastrointestinal disorders:
Gastrointestinal disturbance including nausea, vomiting, diarrhoea, constipation, dryness of mouth.
Hepatobiliary disorders:
Increases in liver enzymes, sometimes progressing to clinical hepatitis and jaundice, have been reported in some patients, usually occurring within the first 3 months of starting therapy.
Skin and subcutaneous tissue disorders:
Skin rash, allergic skin reactions, photosensitivity reactions; rarely, cutaneous bleeding, sweating.
Renal and urinary disorders:
Urinary hesitancy, urinary retention. g. testicular pain); rarely, interference with sexual function, gynaecomastia, galactorrhoea.
General disorders and administration site conditions:
Malaise, facial oedema; rarely, inflammation of mucosal membranes.
Investigations:
Rarely, changes of blood sugar level. The following adverse effects have been encountered in patients under treatment with tricyclic antidepressants and should therefore be considered as theoretical hazards of lofepramine even in the absence of substantiation: psychotic manifestations, including mania and paranoid delusions may be exacerbated during treatment with tricyclic antidepressants.
4). It should be remembered that severely depressed patients are at risk of suicide until there is a complete remission of symptomatology. Class effects Epidemiological studies, mainly conducted in patients 50 years of age and older, show an increased risk of bone fractures in patients receiving SSRIs and TCAs.
The mechanism leading to this risk is unknown. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
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