A patient leaflet often has several pages of small print. But most leaflets follow the same plan. Once you know the plan, you can quickly find the dose, the side effects or when not to take the medicine.
The patient information leaflet (PIL) is written for the person taking the medicine. Almost every medicine pack must include one. The main exception is when all the information fits on the pack itself. In the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) approves the leaflet as part of the medicine’s licence (also called a marketing authorisation).
The law sets out what a leaflet must contain and in which order. The leaflet must be clear and easy to use. The company must also consult patients about it before it is approved. Most UK leaflets we have looked at use the same six numbered sections. Older leaflets may differ in the details.
This page explains what you will usually find in each section. It is not advice about your treatment – for that, ask your doctor or pharmacist.
The top of the leaflet
At the top is the name of the medicine, its strength (how much active substance is in one tablet or dose, for example 500 mg) and its form (for example film-coated tablets). Below that is the active substance – the part of the medicine that works. Several companies often sell the same active substance under different names. So two medicines with different names can contain the same active substance. Their strength and form may still differ.
A black triangle pointing down (▼) with a sentence such as “This medicine is subject to additional monitoring” means the medicine is being monitored even more closely for safety. This applies mainly to medicines with a new active substance and to new biological medicines, typically for the first 5 years after approval. It does not mean the medicine is unsafe. The MHRA asks for all suspected side effects of these medicines to be reported.
1. What the medicine is and what it is used for
This section says which group of medicines it belongs to and which conditions it is approved to treat (the medical term is indication).
2. What you need to know before you take the medicine
This section has important safety information that matters before you start. It usually has these parts:
- Do not take … (or Do not use …) – when you must not take the medicine, for example if you are allergic to any of its ingredients or have certain conditions (the medical term is contraindication).
- Warnings and precautions – when you need to be careful and when to talk to your doctor or pharmacist first.
- Children and adolescents – whether children can take the medicine and how.
- Other medicines and … – which medicines affect each other when taken together (the medical term is interaction). The leaflet asks you to tell your doctor or pharmacist about any other medicines you are taking, have recently taken or might take.
- … with food, drink and alcohol – whether you should avoid certain foods, drinks or alcohol while taking the medicine. (Whether to take it on an empty stomach or with food is in section 3.)
- Pregnancy and breast-feeding (in some leaflets also fertility).
- Driving and using machines – whether the medicine can affect your concentration or reactions.
- … contains lactose / sodium / … – a note about excipients (other ingredients) that can matter for some people, for example with an intolerance or a special diet.
3. How to take the medicine
This section gives the usual dose: how much, how often and for how long (often separately for adults and children). It also says how to take the medicine (for example with water, or whether you can split the tablet) and whether to take it on an empty stomach or with food.
The end of this section usually has short parts such as these. It is worth reading them before you start:
- If you take more … than you should – what to do if you take too much (an overdose).
- If you forget to take … – what to do if you miss a dose. Many leaflets say not to take a double dose to make up for a missed one.
- If you stop taking … – what can happen when you stop the medicine.
4. Possible side effects
These are effects that have been seen with the medicine. Not everybody gets them. Serious side effects come first, with what to do if you get one – for example to stop the medicine and see a doctor straight away.
The other side effects are grouped by how often they happen. Most current leaflets use these groups (the exact wording varies a little between leaflets):
| In the leaflet | 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 | how often it happens cannot be estimated from the available data |
For example, a side effect described as “rare” may affect up to 1 in 1,000 people who take the medicine.
You can report a side effect yourself, even if it is not listed in the leaflet. Use the Yellow Card scheme of the MHRA – on its website or in the free Yellow Card app. Anyone can report, including on behalf of someone they care for. You do not need to be sure that the medicine caused the problem. Your report helps the MHRA to collect more information on the safety of the medicine.
5. How to store the medicine
This section says what temperature to keep the medicine at, whether to protect it from light or moisture, and how long you can use it. The expiry date is on the pack, usually after the letters EXP. The leaflet usually says that the expiry date refers to the last day of that month. For some medicines the leaflet also says how long you can use them after opening.
Do not put unwanted or out-of-date medicines in the bin. Do not flush them down the toilet. Take them to a pharmacy so they can be disposed of safely.
6. Contents of the pack and other information
- What the medicine contains – the active substance and how much of it, then all the excipients (for example fillers, colourings, the tablet coating). This matters if you have an allergy.
- What the medicine looks like and contents of the pack – the colour, shape and markings of the tablets, and the pack sizes.
- Marketing authorisation holder and manufacturer – the company that holds the licence for the medicine, and the company that makes it.
- Date of revision – the sentence “This leaflet was last revised in …” with a month and year. The law requires a date of revision. The date shows you which version of a leaflet is newer.
The patient leaflet and the SmPC
Licensed medicines also have a Summary of Product Characteristics (SmPC). It is a technical text for doctors, pharmacists and nurses. It covers the same topics in more detail and explains how to use and prescribe the medicine. The patient leaflet is based on the SmPC and explains the same things in everyday language. It is the text written for you. On this site you can also read the SmPC of many medicines.
Large print, braille and audio
The name of the medicine must usually be in braille on the outer packaging. If you ask, the company that holds the licence must also give you the leaflet in a format for blind and partially sighted people – for example large print, braille or audio. Some leaflets give a phone number for this.
Patient leaflets on this site
- We take the texts from the MHRA Products website (for some medicines from the European Medicines Agency) and do not change them. We only turn them into a web page and split them into the same sections as the original.
- The list of sections at the top of a leaflet links straight to each section – for example the dose or the side effects.
- Below the text you will find the date of the last revision of the document and, for most medicines, a box called “Facts about …”. We explain what it shows in Medicine facts explained.
- The leaflet in your pack is the one that applies to you. A medicine with the same name may come in several strengths or forms, and leaflets change over time. Compare the name, strength and form with your pack.
You can read where our data comes from in About this site and our sources. You will find all the leaflets in the list of patient leaflets.
More guides: Glossary · Medicine facts explained · Brand-name and generic medicines · How to read ATC codes
Sources
We based this page on these documents and checked the facts against them on 4 November 2026. For each one we say what we took from it.
- The Human Medicines Regulations 2012, Part 13 (Packaging and leaflets) – regulation 260: a leaflet must be in the pack unless all the information is on the packaging, must follow the SmPC and the order of Schedule 27, must be legible, clear and easy to use, and target patient groups must be consulted; regulation 259: the name in braille on the outer packaging and the leaflet on request in formats for blind and partially sighted people; regulation 267: the MHRA refuses an application whose leaflet does not comply.
- The Human Medicines Regulations 2012, Schedule 27 (Package leaflets) – the contents of a leaflet in their order: the group of medicines and the indications; contraindications, precautions, interactions with medicines, alcohol and food; special groups (children, pregnancy, breast-feeding); effects on driving; excipients that matter for safe use; dose, overdose, missed doses, withdrawal effects; side effects; expiry date and storage; composition; the licence holder and manufacturer; the black triangle statement; reporting of side effects; the date the leaflet was last revised.
- MHRA: Medicines: packaging, labelling and patient information leaflets – the MHRA approves the leaflet; medicines must include a leaflet if the label does not contain all the information.
- MHRA: Best practice guidance on patient information leaflets – the MHRA groups the content of Schedule 27 into six main parts (identification, indications, before taking, dosage, side effects, additional information – a different grouping from the six numbered sections used in the leaflets); side effects listed by seriousness and then by frequency; the leaflet explains the SmPC in everyday English; a contact for large print, braille or audio versions shown prominently in the leaflet.
- Patient leaflets on this site, for example Bonviva and Daptomycin, Movicol and Laxido – the six numbered section headings and the usual headings inside sections 2 and 3 (“Do not take”, “Warnings and precautions”, “If you forget to take …”), not taking a double dose (Laxido), the wording of the frequency groups in section 4 (“may affect up to 1 in 1,000 people”, “Not known”), the sentence that the expiry date refers to the last day of the month, a phone number for a leaflet with larger text and reporting side effects not listed in the leaflet (Daptomycin), telling your doctor or pharmacist about other medicines you are taking, have recently taken or might take.
- MHRA / Committee on Safety of Medicines: Always Read the Leaflet (2005, PDF) – the same five frequency groups with slightly different wording (very common more than 1 in 10 … very rare fewer than 1 in 10,000).
- MHRA: The Yellow Card scheme – guidance – the meaning of the black triangle ▼ (“It does not mean the medicine is unsafe”), reporting through the website and the free app, only a suspicion is needed; MHRA: Find product information about medicines – additional monitoring typically for new active substances and new biologicals for 5 years; all suspected side effects of these medicines should be reported.
- MHRA: Yellow Card – anyone can report; NHS: Medicines information – reports can also be made on behalf of someone you care for.
- NHS: How pharmacies can help – do not put out-of-date or unwanted medicines in the bin or flush them down the toilet, take them to a pharmacy.
- MHRA Products – patient leaflets and SmPCs published by the MHRA; leaflets are based on the SmPC.
- MHRA: Find product information about medicines – the SmPC explains how to use and prescribe a medicine and is used by healthcare professionals such as doctors, nurses and pharmacists.
This page explains how a patient leaflet is organised and does not replace advice from a doctor or pharmacist. Last updated 4 November 2026. Found a mistake? Email us at info@patient-info.co.uk.