- Active Ingredient
- Black triangle
- New document
- Retired document
- Section 1. Name of the medicinal product
- Section 2. Qualitative and quantitative composition
- Section 3. Pharmaceutical form
- Section 4. Clinical particulars
- Section 4.1 Therapeutic indications
- Section 4.2 Posology and method of administration
- Section 4.3 Contraindications
- Section 4.4 Special warnings and precautions for use
- Section 4.5 Interactions with other medicinal products and other forms of interaction
- Section 4.6 Pregnancy and lactation
- Section 4.7 Effects on ability to drive and use machines
- Section 4.8 Undesirable effects
- Section 4.9 Overdose
- Section 5. Pharmacological properties
- Section 5.1 Pharmacodynamic properties
- Section 5.2 Pharmacokinetic properties
- Section 5.3 Preclinical safety data
- Section 6. Pharmaceutical properties
- Section 6.1 List of excipients
- Section 6.2 Incompatibilities
- Section 6.3 Shelf life
- Section 6.4 Special precautions for storage
- Section 6.5 Nature and contents of container
- Section 6.6 Special precautions for disposal and other handling
- Section 7. Marketing authorisation holder
- Section 8. Marketing authorisation number(s)
- Section 9. Date of first authorisation/renewal of the authorisation
- Section 10. Date of revision of the text
- Section 11. Dosimetry
- Section 12. Instructions for preparation of radiopharmaceuticals
- Legal category
- Updated document
The active ingredient is the chemical in the medicine that makes the medicine work. The active ingredient is also known as the generic name or the non proprietary name. Medicines can have more than one active ingredient.
Some Summaries of Product Characteristics and Patient Information Leaflets have an inverted black triangle symbol displayed at the top of the document and next to the medicine name. This symbol shows that the medicine is under 'additional monitoring', probably because it is new or is being used to treat new medical conditions. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. The black triangle is removed when the safety of the medicine is well established.
CHM stands for the Commission on Human Medicines. The CHM monitor the safety of medicines and encourage healthcare professionals and patients to report all suspected adverse drug reactions using the Yellow Card Scheme. The CHM used to be called the CSM - the Committee on Safety of Medicines.
EMA stands for the European Medicines Agency. This is a government agency which approves and licenses medicines, allowing them to be prescribed in European countries.
GSL stands for general sales list. If a medicine has this legal category, it can be bought in a shop without a pharmacist, for example in a supermarket.
MHRA stands for Medicines and Healthcare products Regulatory Agency. This is a UK government agency which approves and licenses medicines, allowing them to be prescribed in the UK.
A new document is an SPC or PIL which has never been published on the eMC website before. This could be because it is a brand new product or it is an existing product which the pharmaceutical company has just decided to add.
P stands for pharmacy. If a medicine has this legal category, it can be bought from a retail pharmacy shop in the presence or under the supervision of a pharmacist.
PIL stands for Patient Information Leaflet (known as Package Leaflet or PL) and is the leaflet that is included in the pack with a medicine. The PIL is written by the pharmaceutical company and is a patient-friendly version of the Summary of Product Characteristics. All PILs are checked and approved by the UK or European medicines licensing agency. If you are unsure about anything or have any questions about the PIL, always speak to a healthcare professional such as a doctor, pharmacist or nurse.
PILs have to contain specific headings, but sometimes the order might differ. These are the usual headings and the information that is included in each section.
What is your medicine and what it is used for
- What type of medicine is it?
- What diseases or medical conditions is it approved to treat?
Before you take or use your medicine
- Do not take or use - situations where a medicine should not be taken or used.
- Take special care - situations where the prescriber needs to be extra careful when prescribing a medicine.
- Taking or using other medicines - if this medicine interacts or interferes with any other medicines, herbal or dietary supplements.
- Taking or using your medicine with food and drink - if you should take the medicine with or without certain foods or drinks.
- Pregnancy and breast-feeding - if you can use or take this medicine if you are pregnant, thinking of getting pregnant or are breast-feeding a baby.
- Driving and using machines - if the medicine can affect your ability to drive or use any tools or machines.
- Important information about some of the ingredients in your medicine.
How to take or use your medicine
- How to take or use the medicine.
- How often it should be used or taken.
- How long it should be used or taken for.
- What to do if you take or use more than you should.
- What to do if you forget a dose.
- What might happen if you stop taking or using the medicine.
Possible side effects
All medicines can cause side effects, although not everybody gets them. This section tells you about the side effects and what you should do if you get them.
How to store your medicine
- How to check the expiry date of the medicine.
- How to store your medicine.
- How to dispose of your medicine.
- What your medicine contains - both the active and inactive ingredients.
- The amount of active ingredient.
- What the medicine looks like.
- The pack size.
- The name of the company that makes and sells the medicine.
- The date the leaflet was approved by the authorities.
- Any further information about the medicine.
POM stands for prescription only medicine. If a medicine has this legal category it can only be obtained on a prescription from a healthcare professional.
The eMC contains two types of regulated information - the Summary of Product Characteristics (SPC or SmPC) and the Patient Information Leaflet (PIL). Both the SPC and PIL are approved by the medicines' regulators.
There are two medicines' regulators. The MHRA (Medicines and Healthcare products Regulatory Agency) is a UK government agency which approves and licenses medicines, allowing them to be prescribed in the UK. The EMA (European Medicines Agency) is a government agency which approves and licenses medicines, allowing them to be prescribed in European countries.
A retired document is an SPC or PIL which has been removed from the eMC website, either by the pharmaceutical company or occasionally by Datapharm. There are many reasons why an SPC or PIL would be removed and a summary is given on the document history page.
SPC, or SmPC, stands for Summary of Product Characteristics. The SPC is used by healthcare professionals, such as doctors, nurses and pharmacists, and explains how to use and prescribe a medicine.
SPCs are written and updated by pharmaceutical companies and are based on their research and product knowledge. The SPC is then checked and approved by the UK or European medicines licensing agency. SPCs have to contain certain numbered headings and information. We now explain, in simple terms, what the headings mean and what each section contains.
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 4.1 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 5. Pharmacological properties
How does the medicine affect your body and what does your body do to the medicine?
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 6.6 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 SPC 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 SPCs 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 SPCs 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.
If the information in an SPC or PIL changes, the pharmaceutical company publishes an updated version. There are many reasons why an SPC or PIL would be updated and a summary of the changes is given on the document history page.
An X-PIL is a text only version of the original patient information leaflet, which is formatted for use by the visually impaired. X-PILs are created in XML (Extensible Mark-up Language) format. XML is an industry standard computer file format that allows data to be shared between systems and displayed in different ways. This enables screen readers to read the X-PILs; in addition the X-PILs can be converted to Braille, audio CD and large print formats.