· 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 MYLAN LP 10 mg with a phosphodiesterase-5 inhibitor (eg sildenafil, tadalafil and vardenafil) may cause symptomatic hypotension in some people; Patients (see Interaction with other medicines 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.

This medicinal product contains lactose and is not recommended for use in patients with galactose intolerance, lapp lactase deficiency or malabsorption syndrome, glucose or galactose (hereditary or rare diseases). Br>

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 Increase Risk of overdose, adverse reactions including dizziness, or syncope.

+; Medications lowering blood pressure

Risk of increased hypotension, especially orthostatic.



Common (≥ 1% -