Cabergolin-BP

Cabergolinum

Each tablet contains cabergoline 0.5 mg. Excipient with known effect: lactose 75.1 mg.

Indication: Prevention of physiological lactation shortly after delivery; treatment of hyperprolactinaemia, including associated disorders (amenorrhoea, oligomenorrhoea, anovulation, galactorrhoea), and in patients with prolactin-secreting pituitary adenomas (micro- and macroprolactinomas), idiopathic hyperprolactinaemia or empty sella syndrome with associated hyperprolactinaemia.

Contraindications (SmPC sec. 4.3): 4.3 Contraindications Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. History of pulmonary, pericardial and retroperitoneal fibrosis (see section 4.4). Long-term treatment: anatomical evidence of valvulopathy of any heart valve as determined by echocardiogram, showing leaflet thickening, restriction, or mixed restriction-stenosis of the valve(s) (see section 4.4).

Special warnings and precautions (SmPC sec. 4.4, excerpt): 4.4 Special warnings and precautions for use General As with other ergot derivatives, cabergoline should be administered with caution to patients with severe cardiovascular disease, Raynaud's syndrome, haemorrhagic peptic ulcer or gastrointestinal haemorrhage, or with a history of severe mental disorders, particularly psychotic disorders. Hepatic impairment Reduced doses are recommended in patients with severe hepatic impairment receiving prolonged cabergoline treatment. Compared with healthy volunteers and patients with mild or moderate hepatic impairment, an increase in AUC was observed in patients with severe hepatic impairment (Child-Pugh score >10) who received a single 1 mg dose. Postural hypotension Postural hypotension may occur after administration of cabergoline. Caution is advised when cabergoline is administered concomitantly with other hypotensive medicinal products. […]