SmPC stands for Summary of Product Characteristics. An SmPC is used by healthcare professionals - such as doctors, nurses, and pharmacists - and explains how to use and prescribe a medicine

SmPCs are written and updated by pharmaceutical companies and are based on their research and product knowledge. It is then checked and approved by the UK or European medicines licensing agency


SmPCs have to contain certain numbered headings and information. See below, in simple terms, what the headings mean and what each section contains

Section 1. Name of the medicinal product

The brand or trade name of the medicine

Section 2. Qualitative and quantitative composition

The names of the active ingredients in the medicine which make it work. How much active ingredient it contains. For example paracetamol 500mg

Section 3. Pharmaceutical form

The physical form of the medicine. For example a tablet, injection, ointment, or syrup

Section 4. Clinical particulars

How the medicine should be used or taken

Section 4.1 Therapeutic indications

The diseases or medical conditions the medicine is approved to treat. Sometimes a healthcare professional might decide to use a medicine to treat conditions that are not listed on the SPC

If you are not sure why you have been given a medicine, please talk to your doctor or pharmacist

Section 4.2 Posology and method of administration

Posology means dose. The dose, or dose range, that is used

Section 4.3 Contraindications

The situations where a medicine should not be used or taken

Section 4.4 Special warnings and precautions for use

Medicines always need to be taken or used carefully. This section tells the prescriber when to be especially careful when prescribing a medicine for certain people

Section 4.5 Interactions with other medicinal products and other forms of interaction

Whether the medicine is known to react or interfere with any other medicines, herbal or dietary supplements

Section 4.6 Pregnancy and lactation

Information about taking or using a medicine if you are pregnant, thinking of becoming pregnant, or breast-feeding a child.

Section 4.7 Effects on ability to drive and use machines

The medicine's effect on your ability to drive or use machines

Section 4.8 Undesirable effects

The side effects that people can get when they take or use the medicine. How often the side effect happens, how severe they might be, how long they might last for, and what you should do

Section 4.9 Overdose

What could happen to you if you take or use too much of the medicine

Section 5. Pharmacological properties

How the medicine affects your body and what your body does to the medicine

Section 5.1 Pharmacodynamic properties

How the medicine has an effect on the body

Section 5.2 Pharmacokinetic properties

How the medicine gets into your body, how it gets to the part of the body where it needs to act, how the body changes the medicine, and then how the body removes it.

Section 5.3 Preclinical safety data

Information about the tests that were carried out in a laboratory or on animals, before the medicine was used for humans. It includes the test results which are relevant to prescribers

Section 6. Pharmaceutical properties

Information about the ingredients in a medicine, the packaging, and how it should be stored.

Section 6.1 List of excipients

Which other ingredients are in the medicine, apart from the active ingredient

Section 6.2 Incompatibilities

This section, along with section 4.5, tells you if there are any other medicines that shouldn't be mixed or taken with this medicine

Section 6.3 Shelf life

The maximum amount of time the medicine can be stored for

Section 6.4 Special precautions for storage

How and where to store your medicine

Section 6.5 Nature and contents of container

Information about the medicine's packaging

Section 6.6 Special precautions for disposal and other handling

How to make-up or give the medicine and how to get rid of any left over medicine.

Section 7. Marketing authorisation holder

The Marketing Authorisation Holder (MAH) is the name of the pharmaceutical company who owns the licence to sell the medicine. Sometimes the Marketing Authorisation Holder allows a different pharmaceutical company to sell their medicine

Section 8. Marketing authorisation number(s)

When the regulatory authority approves a medicine, they give it a number - the marketing authorization number

Section 9. Date of first authorisation/renewal of the authorisation

The date of first authorisation is the date the regulatory authorities first approved the medicine. If the marketing authorisation has been suspended and then granted again, there may also be a renewal of the authorisation date

Section 10. Date of revision of the text

If an SmPC changes, this is the date the pharmaceutical company sent the changes to the regulatory authority for their approval

Section 11. Dosimetry

This section is only on SmPCs for radiopharmaceutical products. It tells you how much radiation you are exposed to

Section 12. Instructions for preparation of radiopharmaceuticals

This section is only on SmPCs for radiopharmaceutical products. It tells you how to get rid of any unused or waste products safely

Legal category

Every medicine has a legal category.

POM (Prescription Only Medicine) - you can only get the medicine on prescription 

P (Pharmacy) - you can only get the medicine from a retail pharmacy

GSL (General Sales List) - you can buy the medicine without a pharmacist, for example in a supermarket

CE Mark - used on devices