Instruction leaflet or package insert - both! An instruction leaflet is enclosed with finished medicinal products as a package insert. The consumer can provide the package leaflet with all the important information e.g. about the correct intake and use, the recommended dosage, but also about the possible side effects or dangers associated with taking and using the product. of the drug. The patient information leaflet is often also called patient information or instructions for use, in the vernacular or colloquial sometimes also "wash note". In the In most countries, such an instruction leaflet is mandatory as a package insert. In the EU there are guidelines and requirements regarding the use and application of the package leaflet. Pharmaceutical manufacturers know the necessary specifications - we produce and print efficiently on lightweight papers with multiple parallel and cross breaks. 

Thin paper: We print package inserts, instructions for use and operating instructions for the industry on thin paper. Whether obligatory information, which is required by the legislator for medicines to the description of technical devices, to the correct operation of a product / a device. Consumer information serves the technical documentation, the explanation explanation of the functionality or contain information on the correct operation or maintenance of products. We offer our industrial customers security and perfection in the production and printing of leaflets. We are one of the leading manufacturers in this segment for Germany, Austria and Switzerland and beyond throughout Europe. 

With production sites in Austria / Vorarlberg and Germany we offer reliable and certified print production for any size of company and industry. Package insert printing and further processing, even of very large quantities, are among our strengths. As an industrial customer, you can benefit from our well thought-out and process-optimised production of products in compliance with even the strictest safety standards. Ultimately, what counts is: cost-optimised production, transparent communication, adherence to delivery times and deadlines. deadlines. 

The package insert often contains the following topics: "Characteristics of the medicinal product", pharmaceutical form, pharmaceutical-therapeutic class, areas of application, contraindications, Precautions, interactions with other substances such as alcohol or tobacco, general warnings, dosing, risk groups, side effects, ingredients. 

The BBD - Best before date - is usually printed or embossed on the packaging itself. Thus, after the release of the drug by the corresponding The "Best before date" is completed inline in the production line and the "Best before date" is also added to. 

The package leaflet must not contain any promotional information or information of an advertising nature. Formal design specifications contain corresponding guidelines of the EU Commission. These range from Recommendations about minimum font size, contrast or line spacing, but also limitations: Small caps (capital letters), for example, as well as illustrations in the text are to be used as far as possible. for the time being. There are also standardized terms about the frequency or rarity specifically of side effects. The term "very frequent" means, for example, more than 10% of those treated. On the other hand, "very rare" means that less than one patient in 10,000 has this side effect. 

In Germany, Austria and Switzerland, these guidelines are regulated by corresponding drug laws. Each country has its own specific requirements, which are set out in an instruction leaflet, must be fulfilled. Studies on comprehensibility, comprehensibility of side-effect risks and legibility round off the requirements.

As an experienced manufacturer of package inserts and instruction leaflets, you benefit from our many years of experience and know-how. Arrange a consultation appointment - request our callback service. We look forward to receiving your inquiry or your Call.