Instruction leaflets & instructions for use: small product with big effect!
With thin paper 25g/m2 and 10x3 fractions to the target.
Playing it safe at every stage of the printing process: We are experts in the production of leaflets. We can print a lot of information in a very small space (folded) on very thin paper.
very thin paper. For pharmaceuticals & cosmetics. Likewise for instruction manuals.
Instruction leaflet - flat or folded?
That depends on your packaging machine! The folds of the lightweight printing papers are as varied as our customers' requirements. Hardly any leaflet has the same format. We can produce
up to 10 parallel folds and 3 horizontal folds and produce individually for you, from small to large runs.
Package insert or package leaflet - both! A package leaflet is enclosed with finished medicinal products as a package insert. The consumer can obtain all the important information from the package leaflet, e.g. about
information, e.g. on the correct intake and use, the recommended dosage, but also on the possible side effects or dangers associated with the intake and use of the medicinal product.
of the medicine. The package leaflet is often also called patient information leaflet or directions for use, and sometimes colloquially also "wash leaflet". In most
In most countries, such a leaflet is mandatory as a package leaflet. In the EU, there are guidelines and requirements for the use of package inserts.
Pharmaceutical manufacturers know the necessary specifications - we produce and print efficiently on lightweight paper (up to 40g/m2) with multiple parallel and cross breaks.
Characteristics of an instruction leaflet.
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.
Must the BBD - the best-before date - be included on the package insert?
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.
Advertising information on an instruction leaflet?
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.
Formal design specifications for a package insert in DE/AT/CH.
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.