Company: Astellas Pharma Co Ltd.
Legal category: Prescription. GMS reimbursable. Sport permitted.
Active ingredients: Solifenacin succinate/ tamsulosin hydrochloride 6/0.4mg.
Description: Round red film-coated modified release tablet marked 6/0.4.
Presentation: 30.
Indications: Treatment of moderate to severe storage symptoms (urgency, increased micturition frequency) and voiding symptoms associated with benign prostatic hyperplasia (BPH) in men who are not adequately responding to treatment with monotherapy.
Pharmacology: Solifenacin and tamsulosin have independent and complementary mechanisms of action. Solifenacin is a competitive and selective antagonist of muscarinic receptors, in particular, M3-, M1– and M2-receptors. Tamsulosin is an alpha1adrenoceptor (AR) antagonist. It binds selectively and competitively to postsynaptic alpha1-ARs, in particular to subtypes alpha1A and alpha1D and is a potent antagonist in lower urinary tract tissues.
Dosage: Adult: Swallow whole. One tablet once daily (maximum). Elderly: As per adults. Children: No relevant use.
Contraindications: Hypersensitivity to the active substance(s) or to any of the excipients. Severe gastrointestinal (GI) conditions (including toxic megacolon), myasthenia gravis or narrow-angle glaucoma and patients at risk for these conditions, haemodialysis, severe hepatic impairment, severe renal impairment or moderate hepatic impairment with concurrent strong CYP3A4 inhibitor, history of orthostatic hypotension.
Special precautions: Exclude other conditions with similar symptoms to benign prostatic hyperplasia. Assess other causes of frequent urination (heart failure or renal disease) before treatment. Start antibacterial therapy if urinary tract infection occurs. Not recommended: Cataract or glaucoma surgery. Caution: Risk of urinary retention, GI obstructive disorders, risk of decreased GI motility, severe renal impairment, hiatus hernia/ gastroesophagal reflux, autonomic neuropathy. Angioedema with airway obstruction reported; permanently discontinue if occurs. Anaphylactic reactions (discontinue), patients for whom cataract or glaucoma surgery is scheduled (Intraoperative Floppy Iris Syndrome observed). May occur: QT prolongation and Torsade de Pointes (in patients with risk factors), syncope. Ejaculation disorders reported. Driving/using machines.
Drug interactions: Do not use strong CYP3A4 inhibitors (poor CYP2D6 metabolisers, concomitant strong CYP2D6 inhibitors). Caution: Moderate to strong CYP3A4 inhibitors, agents that can cause or exacerbate oesophagitis (such as bisphosphonates), other anticholinergics within one week, GI motility stimulants, CYP3A4 inducers. Diclofenac and warfarin, other α1-adrenoceptor antagonists.
Adverse drug reactions: Dizziness, blurred vision, GI disorders, ejaculation disorders, fatigue.
Full prescribing information and references available from Astellas Pharma Co Ltd. Telephone: (01) 4671555.