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 antihypertensive agents or nitrates. Blood pressure should be monitored regularly, particularly at the initiation 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 administration (see section 4.8). In such cases, the patient should lie down until the symptoms have completely resolved. 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 developing hypotension and related adverse reactions may be higher 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 a pronounced hypotensive response to other alpha1-receptor blockers. In patients with coronary artery disease, specific treatment for coronary insufficiency should be continued. If angina pectoris recurs or worsens, alfuzosin therapy should be discontinued. Concomitant administration of specific therapy for coronary insufficiency, such as nitrates, with alfuzosin may increase the risk of hypotension (see section 4.5). Cardiac 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 interval prolongation, a history of QTc prolongation, or those taking medicinal products known to prolong the QTc interval should be evaluated prior to and during treatment with alfuzosin. Cerebral ischaemia As 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 a history of 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 concomitantly with CYP3A4 inhibitors known to prolong the QTc interval (e.g. itraconazole and clarithromycin); if treatment with these 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 alpha-1 blockers, and a class effect cannot therefore be excluded. As IFIS may lead to increased procedural complications during cataract surgery, the ophthalmic surgeon should be informed before surgery of any current or previous use of alpha-1 blockers. Priapism Alfuzosin, like other alpha-adrenergic antagonists, has been associated with priapism (a persistent, painful penile erection unrelated to sexual activity; see section 4.8). As this condition may lead to permanent impotence if not properly treated, patients should be advised to seek immediate medical assistance 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.