How to read your medicine leaflet without getting lost
A guide to understanding the leaflet: what each section says, what to read first, how to interpret side effects and what its symbols mean.
In short
- All leaflets for authorised medicines follow the same six-section structure, so once you learn to read one, you can read them all.
- When you start a medicine, read first what it is for, when you must not take it, interactions and how to take it.
- The side effects list shows how often they happen: "common" means it may affect up to 1 in 10 people, not that it will happen to you.
- If you lose the leaflet, you can check the authorised version on CIMA, the medicines information centre of the Spanish Agency of Medicines (AEMPS).
To read a leaflet without getting lost, you do not need to read it from start to finish: you just need to know that it always has the same structure and which sections hold what you need at each moment. With a new medicine, focus first on what it is for, when not to take it and how to take it.
The leaflet is the official document that comes with the medicine and it is written for you, not for health professionals. Understanding it helps you take your treatment safely and know when to ask.
| What will you find in this article? |
What sections does a leaflet have?
A leaflet starts with some general warnings (read it all, keep it, do not give the medicine to others) and then has six numbered sections, always in the same order. This example is taken from a real leaflet published on CIMA:
| Section | What you will find | When to read it |
|---|---|---|
| 1. What it is and what it is used for | Type of medicine and the conditions it is authorised for | Always, when you start |
| 2. What you need to know before you take it | When not to take it, warnings, other medicines, food and drink, pregnancy, driving and excipients | Always, when you start and if you add another medicine |
| 3. How to take it | Usual dose, timing, what to do if you forget a dose or take too much | When you start and whenever you have doubts |
| 4. Possible side effects | Unwanted effects ordered by frequency and which ones need urgent attention | When you start and if you notice something new |
| 5. Storage | Temperature, light, humidity and expiry date | When you put it away and when you travel |
| 6. Contents of the pack and other information | Ingredients, appearance, marketing authorisation holder and revision date | If you are unsure whether it is the same medicine |
What should you read first when you start a medicine?
With a new medicine, read sections 1, 2 and 3 calmly before the first dose. That is where you will find what can prevent a problem: whether there is any reason you should not take it, whether it clashes with another medicine you already use and how to take it correctly.
- Section 1: check that the use matches what your doctor explained.
- "Do not take..." (section 2): allergies and situations in which it must not be used.
- "Warnings and precautions" and "Other medicines": this is where interactions appear. Also consider over-the-counter medicines, vitamins and herbal remedies.
- "Taking it with food and drink": whether it must be taken on an empty stomach, with food or without alcohol.
- Section 3: look for the subsections "If you forget to take it" and "If you take more than you should".
The dose shown in section 3 is the usual one; if your doctor has told you something different, follow their instructions and ask if they do not match. For your first conversation at the pharmacy, our list of questions to ask your pharmacist about a new medicine may help.
How can you read the side effects without getting scared?
Section 4 lists all the side effects that have been described, but that does not mean you will have them. Each effect comes with a frequency category showing how many people it may affect.
| Category | What it means |
|---|---|
| Very common | May affect more than 1 in 10 people |
| Common | May affect up to 1 in 10 people |
| Uncommon | May affect up to 1 in 100 people |
| Rare | May affect up to 1 in 1,000 people |
| Very rare | May affect up to 1 in 10,000 people |
| Not known | Cannot be estimated from the available data |
The most important part of this section is the paragraph saying which effects mean you should stop the medicine or seek urgent medical help: find it and remember it. If you notice anything unusual, talk to your doctor or pharmacist before stopping the treatment yourself. You can also report side effects to the Spanish Pharmacovigilance System at notificaRAM.es. To know what to watch for in the first few weeks, read how to tell whether a new medicine disagrees with you.
What do the special symbols and warnings mean?
Some symbols give you useful information at a glance. The two most common are the inverted black triangle in the leaflet and the red triangle with a car on the box.
- Inverted black triangle with the sentence "This medicine is subject to additional monitoring": according to the AEMPS, it means the medicine is monitored even more closely, usually because less information is available (for example, because it is new). It does not mean it is less safe. It appears in the leaflet, not on the box.
- Red triangle with a black car and the words "Driving: see leaflet": it warns that the medicine may affect your ability to drive. Read the "Driving and using machines" subsection and, for more detail, our article on driving and medicines.
- Excipients: at the end of section 2 some ingredients worth knowing about are listed, such as lactose, if you are intolerant.
- Date of last revision: at the end of the leaflet. It tells you when the information was updated.
If you lose the leaflet or find the print too small, you can search for the medicine by name on CIMA (cima.aemps.es), where the AEMPS publishes the summary of product characteristics and the leaflet, or ask your pharmacist to explain it.
A practical example: Elena and her new medicine
Let us take the case of Elena, 57, an office worker who already takes a blood pressure tablet and has just been prescribed a new medicine. She is worried by the list of side effects and does not know whether she can keep taking the ibuprofen she sometimes uses for her back.
- She reads section 1 and confirms the use matches what her doctor explained.
- She checks "Other medicines" in section 2 and notes whether it mentions blood pressure medicines or anti-inflammatories. If in doubt, she asks at the pharmacy before combining them.
- In section 3 she underlines when to take it and what to do if she forgets a dose.
- In section 4 she focuses on the common effects and, above all, on those that need urgent attention.
- She keeps the leaflet inside the box and adds the medicine to her medication list.
In ten minutes she has the essentials, without anxiously reading every line.
How can IMA Health help you?
When you take several medicines, keeping every leaflet to hand and not mixing up times takes more effort. With IMA Health, a specialised pharmacy prepares your medication by the day and time of each dose and can answer your questions about how to take it. IMA also coordinates with the pharmacy, delivers it to your home and provides personalised follow-up.
Sources
- AEMPS, CIMA: example leaflet (Enalapril Cinfa 20 mg tablets, in Spanish)
- AEMPS: Medicines subject to additional monitoring (black triangle, in Spanish)
- AEMPS: Driving pictogram on medicine packs (in Spanish)
This article is for information only and does not replace advice from your doctor or pharmacist.