· Treatment of functional symptoms of hypertrophy, benign prostate

· Adjuvant treatment of bladder sampling in acute urinary retention related to benign prostatic hypertrophy

Oral use.

The tablet should be swallowed whole with a glass of water (see Warnings and Precautions for Use).
The recommended dosage is 1 tablet 10 mg daily taken immediately after the evening meal
Treatment adjuvant to the sounding, bladder in the acute retention of urine, related to the benign hypertrophy of the prostate

The recommended dosage is 1 tablet, 10 mg daily, to be taken after the meal, from the first day of urethral catheterization.
The treatment is administered for 3 to 4 days, including 2 to 3 days when the catheter is placed and 1 day after removal from the catheter. Code>

(G: system, genitourinary and sex hormones)

Alfuzosin is a derivative of quinazoline, which is active orally. It is an antagonist, selective for alpha-1 adrenergic receptors, post-synaptic. In vitro pharmacology studies have confirmed the selectivity of alfuzosin for alpha-1 adrenergic receptors located in the prostate, bladder trigon and urethra.
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The alpha-blockers, by direct action on the smooth muscle of the prostatic tissue, diminish, and the infra-vesical obstruction. In vivo studies in animals have shown that alfuzosin decreases, urethral pressure and therefore resistance to urinary flow during urination. A study in the vigilant rat shows an effect on urethral pressure of amplitude, greater than the effect on arterial pressure

In placebo-controlled studies in patients with benign prostatic hypertrophy, alfuzosin

· Significantly increased urinary flow, an average of 30% in patients with a flow ≤ 15 ml / s. This improvement is observed from the first take

· Decreased significantly the pressure of the detrusor and increased the volume causing the sensation of the need to urinate

· Significantly reduced urinary volume, residual.

These effects lead to an improvement in the symptoms, urinary irritative and obstructive. They do not cause any deleterious effect on sexual functions.

Moreover, the maximum urinary flow remains significantly increased 24 hours after taking.

In the ALFAUR study, the effect of alfuzosin on micturition recovery was evaluated in 357 men over the age of 50 with a first painful episode of acute urinary retention (UAR) associated with , Benign prostatic hypertrophy (BPH) with a voiding residue of between 500 and 1500 ml during catheterization and during the first hour, according to the latter. In this multicenter, double-blind, randomized study in two parallel groups comparing 10 mg / day of alfuzosin LP to placebo, evaluation of micturition recovery was performed 24 hours after withdrawal of the catheter , In the morning after at least two days of treatment with alfuzosin.

Treatment with alfuzosin resulted in a significant increase (p '= 0.012) in micturition recovery after catheter withdrawal in patients with a first episode of RAU, ie 146, micturition (61.9% ) In the alfuzosin group compared with 58 (47.9%) in the placebo group.
Special caution should be observed by vehicle operators and machine users due to the risk of hypotension, orthostatic, dizziness, asthenia, visual disturbances especially at the beginning of treatment with alfuzosin

This product should not be administered in the following situations

· Hypersensitivity to alfuzosin and / or to any of the other ingredients

· Orthostatic hypotension

· Liver failure

· Severe renal insufficiency (creatinine clearance
As with all alpha-1 blockers, this drug should be used with caution in patients with acute heart failure.
Patients with QTc interval congenital prolongation, QTc interval prolongation, or QTc interval-mediated drugs should be monitored prior to and during treatment.

Perioperative flaccid iris syndrome (SIFP, a variant of the narrow pupil syndrome) has been observed during surgical cataract surgery in some patients treated or previously treated with tamsulosin. Isolated cases have also been reported with other α-1 blockers and the possibility of a class effect can not be ruled out. Since SIFP may cause additional technical difficulties during the operation of cataract, prior or present administration of α-1 blockers should be reported to the ophthalmologist prior to surgery, If the risk of occurrence of SIFP with alfuzosin is low.

Due to the lack of safety data in patients with severe renal impairment (clearance, creatinine