Special Warning : אזהרת שימוש

4.4. Special warnings and precautions for use

Warnings
As with all 1-blockers, orthostatic hypotension may occur during the first few hours after intake of the medicinal product, especially at the beginning of the treatment, especially in individuals treated with antihypertensive medicinal products. This may or may not be accompanied by symptoms (sensation of vertigo, fatigue, and sweating).
In this case the patient should be placed in a supine position until the symptoms have disappeared completely.
These symptoms are temporary and usually do not prevent further treatment after adjustment of the posology.

During post-marketing surveillance a marked decrease in blood pressure was reported in patients with pre-existing risk factors (such as underlying cardiac disorders and/or concomitant treatment with antihypertensive medicinal products).
Advanced age is a contributing risk factor for the development of severe hypotension.
The patient should be informed about the possibility of these incidents occurring.
Alfuzosin should be administered with caution to patients suffering from symptomatic orthostatic hypotension or treated with antihypertensive medicinal products or nitrate derivatives (see section 4.5). Blood pressure should be monitored regularly, especially at the beginning of the treatment.

Patients with congenital QTc prolongation, with a known history of acquired QTc prolongation or taking medicinal products known to prolong the QTc interval should be evaluated before and during administration of alfuzosin.

Precautions for use
People with a history of hypersensitivity to -1-blockers.
Alfuzosin should be administered with caution to patients who have previously displayed a severe hypotensive reaction after the intake of another -blocker (see section 4.5).

In coronary patients the specific treatment of coronary insufficiency should be continued. If the angina pectoris recurs or worsens, alfuzosin should be discontinued.

It is essential to rule out prostate cancer before the start of treatment, especially as its first symptoms are similar to those of benign prostatic hypertrophy.

As with all alpha-1-receptor blockers, alfuzosin should be administered with caution in patients with acute cardiac insufficiency.

Such as other alpha-adrenergic antagonists, alfuzosin has been associated with priapism (persistent painful erection unrelated to sexual activity). Because this condition may lead to permanent impotence if not treated properly, patients should be informed of the severity of the 
condition (see section 4.8).

Intraoperative Floppy Iris Syndrome (IFIS, a variant of small pupil syndrome) has been observed during cataract surgery in some patients treated with or previously treated with some alpha-1 blockers.
Although the risk of this phenomenon seems to be very low with Xatral, ophthalmic surgeons should be informed about the current or past use of alpha-1 blockers prior to cataract surgery, as IFIS may lead to an increased risk of complications during surgery. The ophthalmologists should be prepared to adjust their surgical techniques if necessary.

Concomitant use of alfuzosin and potent CYP3A4 blockers (such as itraconazole, ketoconazole, protease blockers, clarithromycin, telithromycin and nefazodone) should be avoided (see section 4.5). Alfuzosin should not be used concomitantly with CYP3A4 blockers that are known to prolong the QTc interval (e.g., itraconazole and clarithromycin); a temporary discontinuation of alfuzosin treatment is recommended when initiating a treatment with such medicinal products.

Concomitant use of phosphodiesterase-5 blockers (e.g. sildenafil, tadalafil, vardenafil) and Xatral may lead to symptomatic hypotension in some patients. To minimise the risk of developing postural hypotension the patient should be stable under an alpha-blocker treatment before starting phosphodiesterase-5 blockers.

Renal insufficiency
As no clinical safety data are available in patients with severe renal impairment (creatinine clearance <30 ml/min), alfuzosin 10 mg prolonged-release tablets should not be administered to this patient group.

Xatral XL 10 mg prolonged-release tablets contain hydrogenated castor oil which may cause stomach upset and diarrhoea.

Patients should be informed that the tablet should be taken whole.
Any other method of ingestion (chewing, crushing, biting, pulverising or grinding) should be avoided as it may lead to an inappropriate release and thus absorption of the active substance.
This may cause premature unwanted effects.

Elderly patients
Xatral should be prescribed with caution to the elderly.

Effects on Driving