Although many of us do not look at it, the package leaflet is a must for every patient. This is where we find the name of the drug and its active substances, indications for use and precautions. We advise on how to read the drug leaflet and what information to pay special attention to …
Drug leaflet, what is it?
Simply put, the package insert that comes with the package is something of a “instructions for use”.
The package leaflet is a simplified set of information aimed at you. It is approved during the registration of the drug and attached to each package. Always read its content carefully before starting to use any medication. What’s more, the package leaflet should be kept – so that you can refer to it in case of doubt.
While the package leaflet may seem unnecessarily long, read each point in the table of contents carefully. Particular attention should be paid to the dosage, contraindications, possible reactions with other drugs or side effects related to the use of the drug. The consequences of using the drug not in accordance with the package leaflet may be severe poisoning, kidney and liver damage, slowing down your reflexes or concentration, which is especially important when driving a car or operating other machinery.
If the content of the leaflet seems unclear to us, we need additional advice or information, we can always ask a doctor or pharmacist for help. In such situations, you should never use advice found on the Internet or heard from people without professional medical or pharmaceutical knowledge.
Six important points
Drug leaflets must contain strictly defined information, at the beginning of which we are directed by the table of contents, consisting of 6 points. The information that can be found in each over-the-counter medicine’s leaflet may slightly differ depending on when the medicine was authorized.
So let’s take a closer look at the most important elements of the leaflet for the patient.
What X is and what it is used for
This section contains information about the active substance / substances of the drug, their action, as well as information that is extremely important from the point of view of patient safety, i.e. indications for use, i.e. when and in which cases you can take the drug.
What you need to know before taking X
This is a very important part of the leaflet, where we can find a lot of practical information on the safe use of the drug. In this part of the leaflet, we will learn about contraindications, i.e. when the medicine should not be used, about warnings and precautions, as well as interactions with other medicines, food, drink and alcohol, which are important for our safety. Therefore, after reading carefully point 2, it is worth considering again whether you can take the drug for sure, or whether there are any contraindications for it. If necessary, before buying a given drug without a prescription, we can always ask the pharmacist whether it will be safe for us while using other drugs, or about any medical conditions in which we may find ourselves.
In addition, this part of the leaflet also contains information on the use of the drug during pregnancy and breastfeeding, as well as use by the elderly. In this particular period, the decision to use a drug should always be made by the physician after careful consideration of the benefit-risk balance. Also, people driving vehicles will find in section 2 instructions on the effect of the drug on psychomotor performance (some drugs slow down the reaction time, reduce concentration, cause drowsiness), and patients with food intolerances will find out whether the drug contains substances that may be inappropriate for us ( e.g. lactose, sorbitol).
How to use X
In this section, over-the-counter medicines state that they should be used as described in the package leaflet or as directed by your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure.
This is part of the leaflet that explains the exact dosage of the medicine. In the case of over-the-counter drugs, observe the single doses and the maximum daily dose of the drugs taken in order to avoid overdosing, which can be very dangerous.
In section 3, in addition to the description of the recommended dosage, you will also find information about the route of administration, instructions for using the drug (specifying the time of day, if necessary), special recommendations for a given pharmaceutical form (e.g. whether the tablets can be divided or that the suspension should be shake the drug first before use, etc.), the duration of treatment if it should be limited. We will also find a procedure in case of taking more than the recommended dose or skipping a dose of the drug.
Possible side effect
Any drug used correctly outside of its therapeutic effect can cause side effects – most of them, however, are extremely rare. In this section, possible side effects are listed and sorted according to frequency. If you think that your health has deteriorated due to taking the drug, discomfort in your daily functioning or you have additional problems, be sure to report it to your doctor. You can also report side effects to the Department of Monitoring Undesirable Effects of Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, as well as to the responsible entity.
All contact details are also included in this section. Sometimes it may be necessary to modify your treatment, treat side effects you notice, or even stop your medication. However, if you experience side effects not listed in the leaflet, you can also report them yourself to the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products using the website: http://www.urpl.gov.pl/pl/produkty-lecznicze/monitorowanie-bezpiecze % C5% 84stwa-drug% C3% B3w / death% C5% 82o% C5% 9Bth% C5% 82no-not% C5% BC% C4% 85 data-0, or via the form available on the website: https : //smz.ezdrowie.gov.pl/. By reporting side effects, you can help provide more information on the safety of this medicine.
How to store X
In this section, we will find information on the temperature and conditions at which the medicine should be stored, as well as other storage conditions, if required. There you will also find a warning that the drug must be kept out of the sight and reach of children, and that drugs that have exceeded the expiry date should not be used, as they may be harmful or not have a therapeutic effect. If the product has an expiry date after opening, it will also be stated in this section. In this case, it is worth writing down the date of first opening the package on the packaging or in the leaflet.
Also, remember not to throw away medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines no longer required. Such behavior will help to protect the environment. In addition, pharmacies very often have special containers into which you can throw out expired drugs.
Package Contents and Other Information
In the last point of the table of contents there is a detailed description of the composition of the drug along with excipients, as well as a description of the appearance of the drug form and immediate packaging. At the very end of this leaflet you will find information on the contact details of the marketing authorization holder and the manufacturer of the medicine. If there are any questions, you can always contact the responsible entity, i.e. the company responsible for a given drug on the market, and obtain an appropriate answer.