BENIPROSIN Capsule Ref.[115227] Active ingredients: Tamsulosin

A decrease in blood pressure with orthostatic hypotension and syncope may occur during treatment with BENIPROSIN SR. At the first signs of orthostatic hypotension (dizziness, weakness), the patient should sit or lie down until the symptoms have disappeared.

Before therapy with BENIPROSIN SR is initiated, the patient should be examined in order to exclude the presence of other conditions, which can cause the same symptoms as benign prostatic hyperplasia.

Digital rectal examination, and when necessary, determination of prostate specific antigen (PSA) should be performed before treatment and at regular intervals afterwards.

The treatment of patients with severe renal impairment (creatinine clearance of <10 ml/min) should be approached with caution, as these patients have not been studied.

Angioedema has been rarely reported after the use of tamsulosin. In case of angioedema, treatment should be discontinued immediately, the patient should be monitored until disappearance of the oedema, and tamsulosin should not be re-administered.

The “Intraoperative Floppy Iris Syndrome” (IFIS) is a variant of small pupil syndrome and is characterized by the combination of a flaccid iris that billows in response to intraoperative irrigation currents, progressive inoperative miosis despite preoperative dilation with standard mydriatic drugs and potential prolapse of the iris toward the phacoemulsification incisions.

The “Intraoperative Floppy Iris Syndrome” (IFIS) has been observed during cataract and glaucoma surgery in some patients treated with alpha-1 blockers, including BENIPROSIN SR.). Most reports were in patients taking the alpha-1 blocker when IFIS occurred, but in some cases, the alpha-1 blocker had been stopped prior to surgery. In most of these cases, the alpha-1-blocker had been stopped recently prior to surgery (2 to 14 days), but in a few cases, IFIS was reported after the patient had been off the alpha-1 blocker for a longer period (5 weeks to 9 months

The patient’s ophthalmologist should be prepared for possible modifications to their surgical technique, such as the utilization of iris hooks, iris dilator rings, or viscoelastic substances. The initiation of therapy with BENIPROSIN SR in patients for whom cataract or glaucoma surgery is scheduled is not recommended. During pre-operative assessment, surgeons and ophthalmic teams should consider whether patients scheduled for cataract or glaucoma surgery are being or have been treated with BENIPROSIN SR in order to ensure that appropriate measures will be in place to manage the IFIS during surgery.

BENIPROSIN SR should not be given in combination with strong inhibitors of CYP3A4 in patients with poor metaboliser CYP2D6 phenotype.

BENIPROSIN SR should be used with caution in combination with strong and moderate inhibitors of CYP3A4 (see section 4.5).

BENIPROSIN SR is intended for adult male patients only.

No interactions have been seen when tamsulosin hydrochloride was given concomitantly with either atenolol,enalapril, nifedipine or theophylline.

Concomitant administration with cimetidine increases plasma levels of tamsulosin and concomitant administration with furosemide decreases the plasma levels of tamsulosin, but as levels remain within the normal range, dosage need not be changed.

In vitro neither diazepam, propanolol, amitriptyline, diclofenac, giibenclamide, simvastatin and warfarin change the free fraction of tamsulosin in human plasma.

Neither does tamsulosin change the free fractions of diazepam, propranolol, thrichlormethazide and chlormadinon

Diclofenac and warfarin, however, may increase the elimination rate of tamsulosin.

Concomitant administration of tamsulosin hydrochloride with strong inhibitors of CYP3A4 may lead to increased exposure to tamsulosin hydrochloride. Concomitant administration with ketoconazole (a known strong CYP3A4 inhibitor) resulted in an increase in AUC and C_max of tamsulosin hydrochloride by a factor of 2,8 and 2,2, respectively. Tamsulosin hydrochloride should not be given in combination with strong inhibitors of CYP3A4 in patients with poor metaboliser CYP2D6 phenotype.

Tamsulosin Hydrochloride should be given with caution in combination with strong and moderate inhibitors of CYP3A4.

Concomitant administration of tamsulosin hydrochloride with paroxetine, a strong inhibitor of CYP2D6, resulted in a C_max and AUC of tamsulosin that had increased by a factor of 1.3 and 1.6, respectively, but these increases are not considered clinically relevant.

Concurrent administration of other alpha1-adrenoceptor antagonists could lead to hypotensive effects.

BENIPROSIN SR capsules should not be used in females.

Ejaculation disorders have been observed in short and long term clinical studies with tamsulosin. Events of ejaculation disorder, retrograde ejaculation and ejaculation failure have been reported in the post authorization phase.

Dizziness which may affect the ability to drive or operate machinery may occur.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Healthcare professionals are asked to report any suspected adverse reactions to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/

Not applicable.