The adverse reactions reported with Lofepramine are listed below by system organ class. Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000) and not known (cannot be estimated from the available data).
Blood and lymphatic system disorders:
Rare: bone marrow depression including isolated reports of agranulocytosis, eosinophilia, granulocytopenia, leucopenia, pancytopenia, thrombocytopenia.
Endocrine disorders:
Rare: inappropriate secretion of antidiuretic hormone leading to hyponatraemia.
Psychiatric disorders:
Sleep disturbances, agitation, confusion, nightmares, hallucinations, hypomania, mania, psychoses, delirium. 4) It should be remembered that severely depressed patients are at risk of suicide until there is a complete remission of symptomatology.
Nervous system disorders:
Dizziness, headache, paraesthesia, tremor. Rare: drowsiness, convulsions, impairment of the sense of taste. Very rare: uncoordinated movement.
Eye disorders:
Visual disturbances including blurred vision, mydriasis, disturbances of accommodation; induction of glaucoma.
Ear and labyrinth disorders:
Very rare: tinnitus. ) Vascular disorders: Hypotension.
Gastrointestinal disorders:
Gastrointestinal disturbances including nausea, vomiting, diarrhoea; constipation and dryness of mouth.
Hepatobiliary disorders:
Raised liver enzyme levels, 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, and “photosensitivity reactions”. Rare: cutaneous bleeding, sweating.
Renal and urinary disorders:
Urinary hesitancy, urinary retention. g. testicular pain), gynaecomastia, galactorrhoea.
General disorders and administration site conditions:
Malaise, facial oedema. Rare: inflammation of mucosal membranes.
Investigations:
Changes of blood sugar level. Class effects Epidemiological studies, mainly in patients 50 years of age and older, show an increased risk of bone fractures in patients receiving SSRls 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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.