Alfuzosin

Patients with severe renal impairment Alfuzosin Viatris should not be administered to patients with severe renal impairment (creatinine clearance <30 mL/min) owing to the lack of clinical safety data in this population (see sections 4.2 and 5.2). Risk of hypotension Alfuzosin should be administered with caution in patients receiving antihypertensives or nitrates. Blood pressure should be monitored regularly, particularly at the start of treatment (see section 4.5). In some patients, postural hypotension, with or without symptoms (dizziness, fatigue, asthenia, sweating), may develop within a few hours of dosing (see section 4.8). In such cases, the patient should lie down until symptoms resolve completely. These effects are usually transient, occur at the start of treatment, and do not generally warrant discontinuation of therapy. Marked decreases in blood pressure have been reported in post-marketing surveillance in patients with pre-existing risk factors (e.g. underlying cardiac disease and/or concomitant antihypertensive therapy). The risk of hypotension and related adverse reactions may be increased in elderly patients. Patients should be informed of the potential occurrence of these effects. Caution is required when administering alfuzosin to patients who have shown an exaggerated hypotensive response to other alpha1-receptor blockers. In patients with coronary artery disease, specific therapy for coronary insufficiency should be continued. If angina pectoris recurs or worsens, alfuzosin should be discontinued. Concomitant administration of specific treatment for coronary insufficiency, such as nitrates, with alfuzosin may increase the risk of hypotension (see section 4.5). Heart failure As with other alpha1-receptor blockers, alfuzosin should be used with caution in patients with acute heart failure. QTc interval prolongation Patients with congenital QTc prolongation, a history of QTc prolongation, or those taking medicinal products known to prolong the QTc interval should be evaluated before and during treatment with alfuzosin. Cerebral ischaemia Because hypotension may develop following administration of alfuzosin, patients with pre-existing symptomatic or asymptomatic cerebrovascular insufficiency are at risk of cerebral ischaemic events. History of hypersensitivity to other alpha1-receptor blockers Treatment should be initiated gradually in patients with hypersensitivity to other alpha1-receptor blockers. Concomitant use with potent CYP3A4 inhibitors Concomitant use of alfuzosin with potent CYP3A4 inhibitors (such as itraconazole, ketoconazole, protease inhibitors, clarithromycin, telithromycin, and nefazodone) should be avoided (see section 4.5). Alfuzosin should not be used concurrently with CYP3A4 inhibitors known to prolong the QTc interval (e.g. itraconazole and clarithromycin); if treatment with such medicinal products is initiated, temporary discontinuation of alfuzosin is recommended. Intraoperative floppy iris syndrome Intraoperative floppy iris syndrome (IFIS, a variant of small pupil syndrome) has been observed during cataract surgery in some patients currently or previously treated with tamsulosin. Isolated reports have also involved other alpha1-blockers, so a class effect cannot be excluded. As IFIS may lead to increased procedural complications during cataract surgery, the ophthalmic surgeon should be informed before surgery of current or previous use of alpha1-blockers. Priapism Alfuzosin, like other alpha-adrenergic antagonists, has been associated with priapism (persistent, painful penile erection unrelated to sexual activity; see section 4.8). As this condition may lead to permanent impotence if not properly managed, patients should be advised to seek immediate medical attention for any erection lasting longer than 4 hours. Lactose This medicinal product contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption should not take this medicinal product.