SmPC, stands for Summary of Product Characteristics. The 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. The SmPC is then checked and approved by the UK or European medicines licensing agency. SmPCs have to contain certain numbered headings and information. We now explain, in simple terms, what the headings mean and what each section contains.
Section 1. Name of the medicinal product
What is the brand or trade name of the medicine?
Section 2. Qualitative and quantitative composition
What are the names of the active ingredients in the medicine, that make the medicine work? How much active ingredient does it contain? For example paracetamol 500mg.
Section 3. Pharmaceutical form
What is the physical form of the medicine, for example a tablet, injection, ointment or syrup.
Section 4. Clinical particulars
This section explains how the medicine should be used or taken.
Section 4.1 Therapeutic indications
What diseases or medical conditions is the medicine 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. What dose, or dose range, is used?
Section 4.3 Contraindications
Contraindications are situations where a medicine should not be used. This section tells the prescriber when a medicine shouldn't 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 extra careful when prescribing a medicine for some people.
Section 4.5 Interactions with other medicinal products and other forms of interaction
Is your medicine 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 are breast-feeding a child.
Section 4.7 Effects on ability to drive and use machines
Will the medicine affect your ability to drive or use machines?
Section 4.8 Undesirable effects
This section tells you about the side effects that people can get when they take or use the medicine. It tells you how often the side effect happens, how severe it might be, how long it 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 does the medicine affect your body and what does your body do to the medicine?
Section 5.1 Pharmacodynamic properties
How does the medicine have its effect on the body?
Section 5.2 Pharmacokinetic properties
How the medicine gets into your body, gets to the part of the body where it needs to act, how the body changes the medicine and then 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 in humans. It includes the test results which are relevant to prescribers.
Section 6. Pharmaceutical properties
This section gives information about the ingredients in a medicine, the packaging and how it should be stored.
Section 6.1 List of excipients
What 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
What is 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 is the name of the pharmaceutical company who own 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.
Every medicine has a legal category. POM means prescription only medicine - you can only get the medicine on prescription. P means pharmacy - you can only get the medicine from a retail pharmacy. GSL means general sales list - you can buy the medicine without a pharmacist, for example in a supermarket. CE Mark is used on devices.