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Why is there alcohol (ethanol) in herbal medicinal products which are in liquid form?

Many herbal medicinal products available in liquid form contain alcohol (ethanol) in order to ensure a better shelf life. Alcohol is also contained naturally in many foods. The amount of alcohol consumed when using these preparation is comparable to or even less than the amount consumed in foods such as fruit juice. Therefore, the alcohol consumed, for instance, in a single dose of Sinupret drops (19 vol. %) can be considered harmless. The quantity of alcohol contained is not relevant. No harmful physical effects are expected, even under the most critical assessment. This also applies to use by children. There is one more thing to consider: solubilising agents, stabilisers and preservatives are used in place of alcohol in many alcohol-free pharmaceuticals. These are chemical substances for which there is much less experience than with the natural substance ethanol.

Why is it necessary to add dyes and excipients in solid dosage formats?

Currently, it is desirable that users (physicians, pharmacists, patients) be able to differentiate between different pharmaceuticals by their colour, for instance for reasons of drug safety. In general, Bionorica attempts to use dyes and excipients as sparingly as possible. The dyes and excipients contained in Bionorica's medicinal products are food dyes specifically permitted for use in drug manufacturing. These materials are also contained in countless other foods, stimulants and body care products. Often, the quantities added to these products are much higher than those consumed in our medicinal products.

Are Bionorica pharmaceuticals gluten-free and lactose-free?

Lactose is used as an excipient in all lozenges, film-coated tablets and other tablets except for Sinupret eXtract. Liquid forms such as drops and juices are lactose-free. The following pharmaceuticals are gluten-free and do not contain wheat starch:
Agnucaston® film-coated tablets, Canephron® Uno lozenges, Canephron® N lozenges, Canephron® N drops, Imupret® N drops, Imupret® N lozenges, Klimadynon® film-coated tablets, Mastodynon® blend, Mastodynon® tablets, Silimarit® soft capsules, Sinupret eXtract coated tablets, Sinupret® forte coated tablets, Sinupret® coated tablets, Sinupret® drops, Tonsipret® drops, Tonsipret® tablets.
The preparations Sinupret® juice, Bronchipret® juice TE and Bronchipret® Thymian pastilles contain maltitol in liquid form (maltitol solution, maltitol syrup) for improved taste. Maltitol is produced through an enzymatic conversion of corn and wheat starch. Our supplier has tested this excipient for the presence of gluten using the best analytic procedure currently available. Based on this test, these materials are gluten-free.
However, if you do have concerns, we recommend using one of the aforementioned forms (such as: Sinupret® drops as an alternative to Sinupret® juice). This will allow you to exclude any possible remaining risk.

Is genetic engineering an issue in Bionorica's phytotherapies?

Bionorica does not use genetically modified plants. The company begins its selection process with the seed. Medical plants from which active ingredients are derived are subject to permanent controls. Patented technologies ensure that active ingredients can be processed quickly and carefully. All of this work results in high-quality products. If the extracts need to be optimised, Bionorica works to improve cultivation conditions instead of changing the genetics of these medicinal plants.

What are phytopharmaceuticals, and how do they differ from other medicinal products?

Phytopharmaceuticals are medications that contain only plant-based active ingredients. Parts of medicinal plants are processed using pharmaceutical processes to extract these ingredients. Rational phytotherapy uses the healing potential of medicinal plants, unlocking them with modern methods. Usually, phytopharmaceuticals are available as drops, tablets, lozenges or capsules, and are subject to the legal regulations of the Medicines Act, just like all other pharmaceuticals. The advantages of phytopharmaceuticals, in comparison to many medicinal products produced through chemical and synthetic processes, are that they are well-tolerated and have a wide range of therapeutic applications. Bionorica engages in extensive scientific testing to ensure the therapeutic effectiveness and quality of its preparations, as well as to ensure they are not harmful in any way.

Effective: May 28th, 2021