· Treatment of functional symptoms of benign prostatic hypertrophy

· Treatment adjuvant to the sounding, bladder in the acute retention of urine, related to the benign hypertrophy of the prostate

Oral use.

The tablet must be swallowed whole, without being chewed, with a glass of water (see Warnings and Precautions for Use).
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Adults

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>
Tablet cylindrical, white.

Pharmacotherapeutic group: ALPHA-BLOQUANTS, ATC code: G04CA01.

(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 flux by an average of 30%, in patients with a flow ≤15 ml / s. This improvement is observed from the first take

· Significantly decreased the detrusor pressure and increased the volume causing the sensation of need · urinating

· Significantly reduced residual urinary volume.

These effects lead to an improvement in irritative and obstructive urinary symptoms. 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 removal 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

· Hypersensitivity to alfuzosin and / or to any of the excipients

· Orthostatic hypotension

· Hepatic impairment

· Severe renal impairment (creatinine clearance
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.

Precautions for use

Caution is advised when alfuzosin is administered to patients who have had pronounced hypotension in response to the administration of another alpha-1 blocker.

In patients with coronary artery disease, alfuzosin is not prescribed alone. The specific treatment of coronary insufficiency will be continued. In the event of recurrence or aggravation of an angina, treatment with alfuzosin will be discontinued.

Use with PDE-5 inhibitors: concomitant administration of ALFUZOSINE TEVA SANTE; 10 mg, with a phosphodiesterase-5 inhibitor (eg sildenafil, tadalafil and vardenafil) may cause symptomatic hypotension in some patients (see Interaction with other medicinal products and other forms of interaction). In order to reduce the risk of orthostatic hypotension, patients should be stabilized under treatment, alpha-blocking prior to the initiation of treatment with an inhibitor, phosphodiesterase-5. In addition, it is recommended to start treatment with phosphodiesterase-5 inhibitor at the lowest possible dosage

Patients should be advised that the tablets should be swallowed whole. The tablets should not be chewed, chewed, crushed or powdered. These actions may lead to inappropriate release and absorption of the medicinal product and consequently to undesirable effects which may occur early.

Related to excipients: This drug contains lactose. Its use is not recommended in patients with galactose intolerance, lactase deficiency or a glucose or galactose malabsorption syndrome (rare hereditary diseases).
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Medicines causing orthostatic hypotension

In addition to antihypertensive drugs, many drugs can cause hypotension, orthostatic. Examples include nitrates, inhibitors of type 5 phosphodiesterase, urologic alpha-blockers, imipraminic antidepressants and neuroleptics, phenothiazines, dopaminergic agonists and levodopa. Their joint use may therefore increase the frequency and intensity of this effect, which is undesirable. Refer to the interactions specific to each class, with the corresponding constraint levels.

Contraindicated association (see section Contraindications)

CYP3A4 (boceprevir, clarithromycin, cobicistat, erythromycin, itraconazole, ketoconazole, nelfinavir, posaconazole, ritonavir, telaprevir, telithromycin, voriconazole)
Risk of increased plasma concentrations of alfuzosin and its adverse effects

Associations advised against (see section Caveats and precautions for use)

+ Alpha blockers antihypertensive drugs (doxazosin, prazosin, urapidil)
Increase in hypotensive effect. Risk of severe orthostatic hypotension

Associations that are the subject of precautions for use

+; Phosphodiesterase type 5 inhibitors (sildenafil, tadalafil, vardenafil)

Risk of orthostatic hypotension, especially in the elderly

Start treatment at recommended minimum doses and adjust doses, gradually if necessary

Associations to be taken into account

+; Antihypertensives except alpha-blockers

Increase in hypotensive effect. Risk of increased orthostatic hypotension.

+; Dapoxetine

Risk of adverse effects including undesirable effects such as dizziness or syncope,

+; Medications lowering blood pressure

Risk of increased hypotension, especially orthostatic

Not applicable.

In case of overdose, the patient will be hospitalized and kept in a lying position. A conventional treatment for hypotension will be instituted.

Due to its high protein binding, alfuzosin is difficult to dialyze.

The therapeutic indication does not concern the woman.

The safety of alfuzosin during pregnancy and the passage of alfuzosin in maternal milk are not known.

FREQUENCY

SYSTEM, ORGAN

Frequency (≥1% -