SmPC and PIL

There are different ways to communicate: using pictures or sounds. Even a human body can be applied as a tool, for instance, mimic or body language. Written and spoken language is also used for communication purpose.  But what words or phrases are chosen depends on the situation and audience.

Probably everybody has already seen (and read) the Patient Information Leaflet, shortly, the PIL. It is the leaflet included in every pack of medicinal product, for example, tablets, syrup, cream etc. It doesn’t matter whether the medicine was prescribed by a physician or bought without prescription in the pharmacy. According to the law, the PIL has to be in each package of the medicinal product in the national language. It is written for patients and gives information about taking/using a medicine safely and correctly depending on illness. The PIL is even tested for readability. Pharmaceutical companies have to prove that patients can easily find information they need and understand it correctly. For instance, how, when, what dosage the medicine has to be taken, what side effects may occur or when patients have to contact physician immediately.The PIL is written in a language every patient can easily understand, simple as possible, without complicated medical terms. Most patients do not have medical education, therefore, they should not be forced to develop themselves to so-called self-made experts.

The Summary of Product Characteristics (SmPC) is written for the health care professionals: physicians, pharmacists or nurses. The SmPC contains a lot of scientific information and terms. Of course, information in the PIL must correspond to information in the SmPC. The only difference is the amount of it and its presentation. In the SmPC health care professionals can find information regarding treatment, how a certain medicine reacts with other medicines or, for instance, what is the elimination time of the substance out of the human body. In other words, there are useful facts, which are important to know when medicines are prescribed. Information in the SmPC is given neutrally, based on facts, with a lot of terms and details compared to the PIL.

Different style in the PIL is chosen by purpose. Therefore, phrases like “you must”, “you should” or “ask your doctor or pharmacist” are written throughout the text. Because patients get commands what to do. If patients do not know something or are not sure whether they understood information properly, they have to ask their physician, nurse or pharmacist. In this way, the misuse or intake of a false dose of a medicine should be prevented.

Below a few examples are given, how differently the same information is given in the SmPC and the PIL.

Contraindications: situations, when intake/use of a certain medicine is forbidden.

SmPC	PIL
4.3 Contraindications History of upper gastrointestinal bleeding or perforation, related to previous NSAIDs therapy.	X Do not take: If you have had perforation or a bleeding stomach after taking a non-steroidal anti-inflammatory medicine (you may have been sick and it contained blood or dark particles that look like coffee grounds, passed blood in your stools or passed black tarry stools)
Information in the SmPC regarding contraindications is clear and written in short. Physicians know what symptoms may occur. In the PIL, differently, the situation is explained in detail.

SmPC	PIL
Severe hepatic failure, renal failure or heart failure (See section 4.4, special warnings and precautions for use).	If you have severe heart, kidney or liver failure.
Every physician knows what a hepatic or renal failure is, but not every patient. In contrary, everybody knows what is liver or kidney. Let’s hope, at least…

SmPC	PIL
Respiratory depression, chronic constipation.	- If you have difficulty breathing or breathing problems - If you have constipation on a regular basis or are continually constipated
Respiratory depression? What is it? How can one recognise it? A Physician knows it. A patient who has never had such problems cannot know. And what about chronic? How often must an event occur in order to call it “chronic”? Patients are not allowed to take this medicine, when they have problems continually.

Side effects: information, what can happen, when the medicine is taken/used. Usually these are effects nobody wants to have, but which have to be taken into consideration.

SmPC	PIL
Hepatic: Very rare: liver disorders.	Very rarely, yellowing of the skin or eyes, pale stools or upper abdominal pain (these may be signs of liver problems)
Liver disorder? Does it hurt? How can patients recognise their liver is not working properly? And how many liver disorders are there? Physicians can answer these questions. Patients, on the contrary, should observe their bodies and tell their physician if they notice something unusual.