Sinupret

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Sinupret is the brand name of a herbal combination preparation for use particularly in the case of inflammation of the sinuses . It is manufactured by the German company Bionorica SE in Neumarkt in the Upper Palatinate and is available in various dosage forms such as coated tablets , juice and drops .

According to the company, the product is the best-selling phytotherapeutic in Germany (as of 2009).

ingredients

Sinupret contains: Active Ingredients verbena , gentian root , elderberry blossom , sorrel herb and key petals in powdered form or as an extract . The combination is intended to combine various effects, including mucus solution . Areas of application are chronic and acute sinusitis . Sinupret drops and juice contain ethanol . Sinupret forte contains u. a. Gelatine and aluminum hydroxide , Sinupret extract contains u. a. Aluminum salt.

Development and marketing

Sinupret was developed in 1933 by the company's founder Josef Popp in Nuremberg . In 1997, the approval (drops, Liquitabs) or new approval (coated tablets, juice) took place according to the German Medicines Act . Sinupret is also approved in a number of other European countries, such as Denmark (2003), Austria (1984), Sweden (2001), Switzerland, the Czech Republic (1997) and Hungary (1997). In the United States Sinupret is not a drug but as a dietary supplement marketed ( "Dietary Supplement").

In 1998 the preparation was prescribed 3.8 million times in Germany. In 2009 the turnover in Germany was 52 million euros, Sinupret was the best-selling herbal preparation and the best-selling non - prescription cold medicine in Germany .

In 2012, the product range was expanded to include Sinupret extract , which, unlike the older preparations, contains a new, concentrated plant extract. Dispersible tablets ( Liquitabs ) were removed from the range in 2013.

After years of legal disputes with Bionorica, Hexal AG launched a Sinupret forte preparation with the same active ingredient in October 2016 , which is approved as a traditional herbal medicine .

effectiveness

A secretolytic effect was confirmed in the classic Percy and Boyd model. Positive results have been obtained from various blind studies . There is no substance-specific positive contribution from verbena for the combination of the plant extracts. The drug prescription report criticized the lack of pharmacological assignment of the five active ingredients, which are supposed to have an antiviral , anti-inflammatory and secretolytic effect. In 1997, the drug received reauthorisation without the submitted data being able to withstand a strict scientific review.

Sinupret extract , which was approved in 2012, was investigated in a double-blind, randomized , placebo-controlled clinical study on 386 patients. The main outcome criterion (a symptom value that takes into account nasal secretion, retronasal secretion, nasal congestion, headache and facial pressure ) was significantly improved after treatment with the active drug ( verum ) compared to treatment with an active drug ( placebo ). The quality of this proof of benefits was criticized in the arznei-telegram .

Web links

Individual evidence

  1. a b c Instructions for use Sinupret forte, status May 2010.
  2. Origin secures the future - Sinupret® celebrated its 75th anniversary. (No longer available online.) Bionorica SE, August 14, 2009, archived from the original on January 27, 2011 ; accessed on November 5, 2017 (press release). Info: The archive link was inserted automatically and has not yet been checked. Please check the original and archive link according to the instructions and then remove this notice. @1@ 2Template: Webachiv / IABot / www.bionorica.de
  3. Instructions for use Sinupret drops / juice, as of May 2010.
  4. Sinupret forte instructions for use, as of September 2014.
  5. Instructions for use Sinupret extract, as of August 2012.
  6. a b company history of Bionorica. ( Memento of the original from December 15, 2010 in the Internet Archive ) Info: The archive link was inserted automatically and has not yet been checked. Please check the original and archive link according to the instructions and then remove this notice. @1@ 2Template: Webachiv / IABot / www.bionorica.de
  7. Product summary for Sinupret, overtrukne tabletter. October 2009.
  8. Specialist information Sinupret drops (for Austria). September 2010.
  9. Product summary Sinupret, dragerad tray, February 2009.
  10. Souhrn údajů o přípravku Sinupret Perorální kapky, roztok. November 2010.
  11. ALKALMAZÁSI ELŐÍRÁS SINUPRET bevont tabletta. November 2010.
  12. ^ Bionorica USA> Sinupret Adult Strength . USA product page.
  13. Maike Telgheder: Rösler's plans slow down research. In: Handelsblatt . July 27, 2010, accessed February 18, 2017 .
  14. Daniel Rücker: Proven extract, new concentration . In: Pharmazeutische Zeitung , issue 39, 2012
  15. Benjamin Wessinger: Herbal cold remedies: "SolvoHexal is not a generic". In: Deutsche Apothekerzeitung online (DAZ.online). October 14, 2016, accessed February 18, 2017 .
  16. Volker Fintelmann , Rudolf Fritz Weiss : Textbook of Phytotherapy. Georg Thieme Verlag, 2005, ISBN 978-3-8304-5345-1 , p. 227 ( books.google.com )
  17. ^ Marilyn Barrett: The Handbook of Clinically Tested Herbal Remedies. 2004, ISBN 978-0-7890-1068-1 ( books.google.com )
  18. Norbert Rietbrock: herbal VI: research and clinical application. 2000, ISBN 978-3-7985-1277-1 ( books.google.com )
  19. Ernst E., March RW, Sieder Ch .: Acute bronchitis: Use of Sinupret . In: Fortschr. Med. Band 115 , 1997, pp. 52-53 . quoted according to Ulrich Schwabe, Dieter Paffrath: Drug Prescription Report 2015 . Current figures, costs, trends and comments. Springer, 2015, ISBN 978-3-662-47186-9 , pp. 990 ( limited preview in Google Book search).
  20. Jund et al .: Clinical efficacy of a dry extract of five herbal drugs in acute viral rhinosinusitis . In: Rhinology , 2012 Dec, 50 (4), pp. 417-426, PMID 23193534 .
  21. Jund, R., Mondigler, M., Steindl, H. et al .: Clinical effectiveness of a herbal combination preparation in the treatment of acute viral rhinosinusitis . In: MMW advances in medicine . tape 157 , Suppl 4, 2015, p. 6-11 , doi : 10.1007 / s15006-015-2934-4 .
  22. Sinupret Extract against sinusitis? In: arznei-telegram . tape 43 , no. 11 , 2012, ISSN  0066-8192 , p. 91 ( arznei-telegramm.de [accessed on February 18, 2017]).