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
