Opipramol

There are no data on exposed pregnant women for opipramol. Animal studies do not permit conclusions on harmful effects of opipramol on embryonic development or fertility. Opipramol should be prescribed during pregnancy, particularly the first trimester, only if strictly indicated.

Opipramol should not be used during the lactation period as the active substance passes into breast milk in small amounts. If strictly indicated, breast-feeding should be discontinued.

The ability to react can be altered with correct use of opipramol dihydrochloride so that the ability to drive or use machines is impaired, particularly in combination with alcohol.

Rates of incidence: common (≥1/100, <1/10); uncommon (≥1/1,000, ≤1/100); rare (≥1/10,000, ≤1/1,000); very rare (≤1/10,000).

Blood and the lymphatic system disorders

Rare: Blood count changes, especially leucopenia

Very rare: Agranulocytosis

Nervous system disorders

Common: Particularly at the start of treatment fatigue, dry mouth, blocked nose

Uncommon: Vertigo, drowsiness, disorders of micturition, disorders of accommodation, tremor, weight gain, sensation of thirst

Rare: Excitation states, headache, paraesthesias, particularly in elderly patients, confusional states and delirium, particularly with sudden discontinuation of more prolonged high-dose therapy, agitation, sweating and sleep disorders

Very rare: Cerebral seizures, motor disorders (akathisia, dyskinesias), ataxia, polyneuropathies, sudden glaucoma, anxiety states

Cardiac disorders

Common: Particularly at the start of treatment hypotension and orthostatic dysregulation

Uncommon: Tachycardia, palpitations

Rare: Collapse states, conduction disorders, intensification of existing heart failure

Gastrointestinal disorders

Uncommon: Constipation

Rare: Gastrointestinal disorders, taste disorders, paralytic ileus, particularly with sudden discontinuation of more prolonged high-dose therapy, nausea and vomiting

Hepato-biliary disorders

Uncommon: Temporary rises in liver enzyme activity

Very rare: Severe liver function disorders, after long-term treatment icterus and chronic liver damage

Skin and subcutaneous tissue disorders

Uncommon: Allergic skin reactions (exanthem, urticaria)

Rare: Oedema

Very rare: Hair loss

Renal and urinary disorders

Rare: Urinary retention

Reproductive system and breast disorders

Uncommon: Ejaculation disorders, erectile impotence

Rare: Galactorrhoea