The Leaflet For A Drug

The leaflet for a drug

The leaflet gives a detailed description of the medicinal product. The instructions for use - it is also known as the package insert - is important for patients so that they can use the medicine correctly. A precise description of the composition, use and mode of action as well as an examination of the effects and side effects are required for the approval of a drug in Austria.

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• Which active ingredient is used?
• Where and how does the medicine work?
• What are interactions?
• How are side effects and contraindications described?
• This is how you can search for instructions for use
• How does a drug get its name?
• What is the difference between a trade name and an active ingredient name?
• This is how you can recognize the active ingredient in drugs
• Getting the right medication abroad

Which active ingredient is used?

The chemical or biological agent is the substance that is used in a specific therapy in a specific area of the body. The composition of the active ingredient, the molecular structure, the auxiliary substances used and other detailed chemical-biological information are precisely described in a formulation for each drug.

Where and how does the medicine work?

The field of application describes in which body regions and body systems the drug works: e.g. in the cardiovascular, blood, skin, nervous or immune systems. The therapeutic application describes how the drug works, for example pain reliever, antihypertensive or antipyretic.

What are interactions?

Not every drug can be taken at the same time as another drug. The effect of two or more active substances can influence one another. This is known as an interaction. The effect of a drug can be increased or weakened by taking another drug at the same time. The duration of action can also change as a result. Possible interactions that may occur when taking the drug together with other drugs are listed in the information for use.

In order to avoid undesirable interactions, it is important to inform the doctor about all medication you have taken and to comply with your doctor's prescription. Doctors and pharmacists can use special computer programs to check drug interactions. Food and luxury foods - such as milk, fruit juices or alcohol - can also cause undesirable interactions.

How are side effects and contraindications described?

In the leaflet, the known possible side effects are listed and an indication of the approximate frequency with which they can occur.

The instructions for use must also contain the contraindications that preclude the use of the drug. They describe illnesses or circumstances (e.g. pregnancy) in which the drug may not be used or only under certain conditions. The contraindications are often supplemented by further warnings and precautionary measures.

This is how you can search for instructions for use

In the medicinal specialties register of the Federal Office for Safety in Health Care (BASG) you can query and download all the instructions for use of medicinal products approved in Austria. You can find the pharmaceutical specialties register of the BASG under drug search.

How does a drug get its name?

Years of research are often necessary to develop a new active ingredient for a specific area of application. If a new active ingredient has been discovered, pharmaceutical companies have the substance protected by patent for a limited time under the international nonproprietary names (INN). The exact description and production method of an active ingredient must be disclosed by the inventor when applying for a patent.

For medical use, an active ingredient is processed with auxiliary substances into a drug. For the approval of a drug, which is necessary in every country, the composition must be disclosed and evidence of the quality, efficacy and safety of the product must be provided. Medicines are available under their trade names after approval. The trade name of the drug is also protected as a brand name (® - protected word mark).

After the patent protection expires, other manufacturers can produce drugs (generics) with the same active ingredients. Medicinal products with the same active ingredients can therefore be available under different trade names. Similar to twins who have different names.

What is the difference between a trade name and an active ingredient name?

Trade name: All approved medicinal products have a trade name. In addition to the trade name, the strength and dosage form must be stated on the packaging and in the instructions for use. Trade names or parts of names can be protected as word marks with the ® symbol. The trade names can be different in different countries.

Active ingredient or non-proprietary name (INN): Each medicinal product has a so-called international unbranded name (non-proprietary name), which was established by the WHO and is the same worldwide. An application to the WHO is required for new medicinal products, which must contain a precise description of the chemical properties, the mode of action and the therapeutic application. The discoverer of the drug can suggest a name.

Non-proprietary names consist of an abbreviation or a constant ending that identifies the substance group to which the active ingredient belongs. International non-proprietary names make it easier to assign an active pharmaceutical ingredient. They help travelers abroad to get the same medicine if needed. Each non-proprietary name is a unique, internationally used name. The World Health Organization (WHO) administers INN (international non-proprietary names or active substance names) in accordance with its mandate to develop, establish and publish international standards.

This is how you can recognize the active ingredient in drugs

In addition to the trade name, the strength of the active ingredient and the dosage form are stated on the packaging and in the instructions for use. Generic manufacturers often use the active ingredient name (non-proprietary name) of a drug with an addition (e.g. the company name) as the trade name.

Examples of common drugs with trade names and non-proprietary names are:

Trade name (s)	Active ingredient name (INN)
Aspirin, Aspro, Thrombo Ass, Heart Ace and others	Acetylsalicylic acid, short: ASA
Voltaren, Diclofenac “Genericon”, Diclostad, Deflamat and others	Diclofenac sodium (oral)
Zocor, Gerosim, Simvastatin “Sandoz”, Simvastad et al	Simvastatin
Augmentin, AmoxiPlus “ratiopharm“, Xiclav, Clavamox and others	Amoxicillin 500 mg + clavulanic acid 125 mg
Ospen, Penbene, Penstad, Pen V “Genericon”	Phenoxymethylpenicillin
Urosin, Zyloric, Purinol, Gichtex and others	Allopurinol
Concor, Concor Cor, Rivacor, Bisostad, Bisocor, Bisoprolol “Arcana” and others	Bisoprolol
Renitec, Enac, Alapril, Mepril, Enalapril “1A Pharma” and others	Enalapril
Aeromuc, Fluimucil, Mucoben, Acc “Hexal” and others	Acetylcysteine

A medicine can be sold under different names in different countries. This case can arise if approval has been granted in a national procedure. It is possible that the composition of a drug from the same manufacturer differs slightly in different countries, for example in terms of excipients or colorants.

If a central approval has been granted by the European Medicines Agency (EMA), the product may be available in several countries under the same name. The instructions for use may list the various trade names under which a drug is available in EU countries.

Getting the right medication abroad

The name of a particular drug in a country can be important if a patient has to buy it when they are abroad. The name of the active ingredient can also be useful in order to get the usual medicine abroad. In connection with the name of the manufacturer, the probability of getting a corresponding drug is very high. The active ingredient name (INN) is valid worldwide.

additional Information

Questions and answers on the subject of generics can be found on the website of the Federal Office for Safety in Health Care (BASG).