BPH
Outcomes Study Educational Visualisation Tool
Scan the QR codes to access the BPH Outcomes Study and associated Educational Visualisation Tool to understand the outcomes in different individual profiles Discover more about how risk factors for disease progression interact and affect treatment response in individual profiles with moderate to severe LUTS/ BPH at the risk of progression.
BPH Outcomes Study - Educational Visualisation Tool is intended for educational purposes and not for clinical use. The BPH tool is solely intended to inform healthcare professionals to help visualise and understand the results of the statistical modelling published by Gravas S et al 2022. The BPH Tool has not been validated for and is not intended for clinical use with individual patients. It is not intended to substitute for medical advice or intended to drive or inform to take decisions with diagnosis or therapeutic purposes of any condition for any individual patients. References: 1. Gravas S, et al. EAU Guidelines on the Management of Non-Neurogenic Male Lower Urinary Tract Symptoms (LUTS), incl. Benign Prostatic Obstruction (BPO), 2021. Available at: http://uroweb.org/guideline/treatment- of-non-neurogenic-maleluts/ Accessed January 2023. 2. Avodart Italy SmPC Summary of Product Characteristics (SmPC) effective 22 October 2020. 3. Combodart Italy SmPC Summary of Product Characteristics (SmPC) effective 22 October 2020. Abbreviations: BPH, benign prostatic hyperplasia; LUTS/BPH, lower urinary tract symptoms secondary to benign prostatic hyperplasia. In Italy the registered trade name for dutasteride is Avodart and for dutasteride-tamsulosin is Combodart.
Abbreviated Product Information – Combodart Hard capsules 0,5 mg No prescription SSN Class C* Price € 32,70** *Providing system: medicinal product subject to medical prescription (RR) ** Without prejudice to any reductions and/or modifications imposed authoritatively by the competent Health Authority. Therapeutic Indications Combodart is indicated for the treatment of moderate to severe symptoms of benign prostatic hyperplasia (BPH). Reduction of the risk of acute urinary retention and surgery with moderate to severe symptoms of benign prostatic hyperplasia Posology and method of administration The recommended dose of Combodart is one capsule (0.5 mg/0.4 mg) once a day. When appropriate, Combodart can be used to replace dutasteride and tamsulosin hydrochloride used together in current dual therapy to simplify treatment.
Abbreviated Product Information – Avodart Soft Capsules 0,5 mg Prescription SSN Class A* Price € 11,78** *Providing system: medicinal product subject to medical prescription (RR) ** Without prejudice to any reductions and/or modifications imposed authoritatively by the competent Health Authority. Therapeutic Indications Avodart is indicated for the treatment of moderate to severe symptoms of benign prostatic hyperplasia (BPH). Reduction of the risk of acute urinary retention and surgery with moderate to severe symptoms of benign prostatic hyperplasia Posology and method of administration Avodart can be administrated alone or in combination with the alpha blocker tamsulosin (0,4 mg). Adults (including the elderly): The recommended dose is one capsule (0.5 mg) taken orally per day. The capsules must be swallowed whole and must not be chewed or opened as contact with the contents of the capsule may cause
irritation of the oropharyngeal mucosa. The capsules can be taken with or without food. Although early improvement can be seen, it may take up to 6 months before a response to treatment is achieved. No dose adjustment is required in the elderly. The most commonly observed adverse reactions include impotence, altered (decreased) libido, ejaculation disorder, breast disorder.
When clinically appropriate, a direct switch from dutasteride or tamsulosin hydrochloride monotherapy to Combodart may be considered. The most commonly observed adverse reactions include dizziness, impotence, altered (decreased) libido, ejaculation disorder, breast disorder. Full SmPC of COMBODART (23 November 2017) for EU is available at - https://mri.cts-mrp.eu/portal/details?productnumber=DE/H/2251/001 Scan the QR code to access the Italian SmPC of Combodart
Full SmPC of AVODART (23 November 2017) for EU is available at - https://mri.cts-mrp.eu/portal/details?productnumber=SE/H/0304/001 Scan the QR code to access the Italian SmPC of Avodart
For the use of registered medical practitioner or a Hospital or a Laboratory only. Avodart/Duodart is for use in men only. Avodart/Duodart trade marks are owned by or licensed to the GSK group of companies.
Adverse events should be reported. Reporting forms and information can be found at https://yellowcard.mhra.gov.uk/ or search for MHRA Yellowcard in the Google Play or Apple App Store. Adverse events should also be reported to GlaxoSmithKline on 0800 221 441.
European Urology Today Submitted to AIFA on 23/01/2023 GlaxoSmithKline S.p.A. Viale dell’Agricoltura, 7 37135 Verona Italy PM-GBL-DUT-ADVT-230001 | Date of preparation: January 2023.
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February/March 2023
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