GRANU FINK®: Effective and Well Tolerable for the Treatment of Mild to Moderate LUTS

Munich, Germany, 12-14 March, 2016: At the 31st Annual European Association of Urology (EAU) Congress the phytomedicine GRANU FINK® Prosta forte 500 mg was assessed as a relevant therapeutic alternative compared to prescription drugs for patients with mild to moderate LUTS (lower urinary tract symptoms)1. Besides, GRANU FINK® femina, the first and only phytomedicine for the treatment of  OAB (overactive bladde) symptoms, was introduced. GRANU FINK® medicines are well-acknowledged in daily practice by both physicians and patients for more than 25 years in Germany. They are also available in other European countries, like the UK, where they are marketed under the name UROSTEMOL™.

For about 500 years, the medicinal properties of pumpkin seeds – especially those of the variety Curcurbita pepo L – have been used to treat in Europe urological complaints. These oil seeds are soft-shelled and have a distinctive dark green coloring, in contrast to the well-known hard-shelled seeds of edible pumpkins. For more than 30 years, special interest was paid to optimizing the medicinal properties and thereby the efficacy of a certain kind of pumpkin seeds through breeding and cultivation: the Uromedic® Pumpkin seeds exclusively used in GRANU FINK® medicines. The unique characteristic of the exceptional Uromedic® Pumpkin seeds are their inherent high doses of specific phytosterols, so-called ∆7-phytosterols.2

GRANU FINK® Prosta forte 500 mg3 contains the highest concentration of prostate-active   Δ7-sterols which show structural similarities to the androgen dihydrotestosterone (DHT).2 It is the first phytomedicine ever verified in accordance with the clinical research criteria of the WHO International Consultations on BPH4 and acknowledged by the EAU Guidelines for its long-term efficacy proven in a 12 months clinical trial5. In this multi-centre, double-blind, randomized, placebo-controlled trial, a significant reduction of the IPSS by at least 5 points6 was shown, a result which is comparable to α1-receptor blockers and 5 α-reductase inhibitors.7 Also an excellent tolerability was proven compared to the afore-mentioned chemical drugs, particularly no impact on sexuality.5 No interactions with other medications are known. In addition, patients  indicated that their quality of life improved by 31.0 %.5 Based on these results, 95% of the interviewed urologists rated GRANU FINK® Prosta forte 500 mg as a relevant therapeutic alternative compared to prescription drugs at this year’s EAU congress.1

Besides, GRANU FINK® femina8 is the first and only phytomedicine for women suffering from LUTS due to OAB and/ or stress incontinence, that was presented in Munich. The medicine is characterized by its unique combination of Uromedic® Pumpkin seed oil, hop cones and fragrant sumac bark. GRANU FINK® femina strengthens and calms the bladder while having abirritant effects. In a non-interventional trial a significant reduction of pollakiuria9,10, improvements of imperative urgency11 and reduction of stress incontinence12 were shown. Excellent tolerability compared to SNRIs and muscarinic receptor antagonists were observed, which is why 97% of patients rated the tolerability with “very good” or “good”10,11. Interactions of GRANU FINK® femina with other medications are not described.

About Omega Pharma
Omega Pharma, being part of the worldwide PERRIGO group of companies, is an OTC healthcare company headquartered in Nazareth (Belgium) with operations in 35 countries across Europe and selected emerging markets. For further information please visit www.omega-pharma.com

GRANU FINK® Prosta forte 500 mg. Wirkstoff: Dickextrakt aus Kürbissamen. Zusammensetzung: 1 Hartkapsel enthält: 500mg Dickextrakt aus Kürbissamen (15–25:1), Auszugsmittel Ethanol 92 % (m/m). Sonstige Bestandteile: partiell methyliertes hochdisperses Siliciumdioxid; Gelatine; Eisen(III)-oxid (E172), Eisen (II, III)-oxid (E172), Eisen(III)-oxid-hydroxid (E172). Anwendungsgebiete: Beschwerden beim Wasserlassen infolge einer Vergrößerung der Prostata (Prostataadenom Stadium I bis II nach ALKEN bzw. Stadium II bis III nach Vahlensieck). Gegenanzeigen: Überempfindlichkeit gegen den Wirkstoff, kürbisähnliche Pflanzen wie z.B. Wassermelone, Zucchini, etc. oder einen der sonstigen Bestandteile. Nebenwirkungen: Erkrankungen des Immunsystems: Sehr selten: Überempfindlichkeitsreaktionen (Juckreiz, Hautausschlag/Nesselsucht, Gesichtsödem, Kloß- und Engegefühl mit Atemnot (allergisches Quincke-Ödem oder Angioödem)). Erkrankungen des Gastrointestinaltraktes: Sehr selten: Magen-Darm-Beschwerden.
Omega Pharma Deutschland GmbH, Benzstraße 25, 71083 Herrenberg

GRANU FINK® femina. Zusammensetzung: Wirkstoffe: 1 Hartkapsel enthält: Kürbissamenöl 227,3mg; Trockenextrakt aus Gewürzsumachrinde (5–7:1), Auszugsmittel: Wasser, 56,0 mg; Trockenextrakt aus Hopfenzapfen (5,5–6,5:1), Auszugsmittel: Wasser, 18,0 mg. Sonstige Bestandteile: All-rac-alpha-Tocopherolacetat, Phospholipide aus Sojabohnen, partiell hydriertes Sojaöl, gelbes Wachs, Gelatine, Glycerol, gereinigtes Wasser, Glucosesirup, Maltodextrin, Natriumdodecylsulfat, Farbstoffe: Titandioxid, Eisen(III)-oxid (E172) und Eisen(III)-hydroxid-oxid x H2O (E172). Anwendungsgebiete: Traditionelles Arzneimittel angewendet zur Stärkung oder Kräftigung der Blasenfunktion bei Blasenschwäche und zur Linderung von Blasenbeschwerden durch hyperaktive Blase (Reizblase), nachdem schwerwiegende Erkrankungen durch einen Arzt ausgeschlossen wurden. GRANU FINK® femina ist ein traditionelles Arzneimittel, das ausschließlich auf Grund langjähriger Anwendung für das Anwendungsgebiet registriert ist. Gegenanzeigen: Überempfindlichkeit gegen Hopfenzapfen, Gewürzsumachrinde, Kürbissamen, kürbisähnliche Pflanzen wie z.B. Wassermelone, Zucchini etc., Soja, Erdnuss oder einen der weiteren wirksamen oder sonstigen Bestandteile von GRANU FINK® femina. Nebenwirkungen: Bei der Anwendung von GRANU FINK® femina können Magen-Darm-Beschwerden und allergische Reaktionen wie Hautausschläge, Juckreiz, Schwellungen vorkommen. Die Häufigkeit ist nicht bekannt.
Omega Pharma Deutschland GmbH, Benzstraße 25, 71083 Herrenberg

1. Omega Pharma. Survey on the occasion of the 31st Annual EAU congress.n=98.
2. According to Müller C, Bracher F. Planta Med 2015; 81:613-620.
3. For the treatment of mild to moderate lower urinary tract symptoms (LUTS) caused by a benign prostatic hyperplasia (BPH). Available in the following countries: Germany, Austria, Switzerland and the United Kingdom where it is marketed as UROSTEMOL™ Prosta capsules.
4. According to Bach D. Urologe B. 2000; 40:437-443.
5. According to Gravas S et al. EAU Guidelines on Conservative Treatment of Non-neurogenic Male LUTS, incl. Benign Prostatic Obstruction (BPO). 2014.
6. In 64.8 % of patients after 12 months vs placebo. Bach D. Urologe B. 2000; 40:439.
7. According to Madersbacher, S.et al. European Urology 51 (2007):1522–1533.
8. For the treatment of mild to moderate lower urinary tract symptoms (LUTS) caused by an overactive bladder (OAB) or stress incontinence. Available in the following countries: Germany, Austria, Switzerland and the United Kingdom where it is marketed as UROSTEMOL™ femina capsules.
9. According to Schilcher H, Bauer HW. Ärztezeitschrift für Naturheilverfahren und Regulationsmedizin. 2003; 44:485-489.
10. According to Lenau H, Hoexter G, Mueller A, Maier-Lenz H. Therapiewoche. 1984; 34(42):6054-6059.
11. In 75.0 % of patients after 6 weeks. Lenau H et al. Therapiewoche. 1984; 34(42):6056.
12. In 58.0 % of patients after 6 weeks. Lenau H et al. Therapiewoche. 1984; 34(42):6057.

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