1 7000000946 2016-08-25T11:51:07+01:00 Provides information on terms such as 'safety alerts' and 'black triangles' 7000002145 false Definitions 4 2016-08-25T11:51:07+01:00 1 1 2016-08-26T12:18:38+01:00 53 56 Side effects, also known as adverse drug reactions (ADRs), are unwanted symptoms that are linked with taking a medicine. They can range from mild, for example feeling sick (nausea) to severe, which can be life-threatening. All medicines can cause side effects, and their frequency can vary from ‘very common’ (more than 1 in 10 people affected) to ‘very rare’ (fewer than 1 in 10,000 people affected). The risk of side effects can be reduced by taking your medicine as instructed by your doctor, pharmacist or other healthcare professional. Always read the patient information leaflet provided with your medicine as this provides information to help you take your medicine correctly.   If you have experienced a side effect when using a medicine, you should report it to the Yellow Card Scheme, which is run by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK. <div dir="ltr"><div dir="ltr"> <p><br>Side effects, also known as adverse drug reactions (ADRs), are unwanted symptoms that are linked with taking a medicine. They can range from mild, for example feeling sick (nausea) to severe, which can be life-threatening. All medicines can cause side effects, and their frequency can vary from ‘very common’ (more than 1 in 10 people affected) to ‘very rare’ (fewer than 1 in 10,000 people affected).</p> <p><br></p> <p>The risk of side effects can be reduced by taking your medicine as instructed by your doctor, pharmacist or other healthcare professional. Always read the patient information leaflet provided with your medicine as this provides information to help you take your medicine correctly.</p> <p><span style="font-size: 13px;"> </span></p> <p><span style="font-size: 13px;">If you have experienced a side effect when using a medicine, you should report it to the </span><a href="https://yellowcard.mhra.gov.uk/" style="font-size: 13px;" target="">Yellow Card Scheme</a><span>, which is run by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK.</span></p> </div></div> 7000002145 1572 7000007647 2017-11-01T15:53:00+00:00 7000355077 1 2 53 56 What is a side effect? 2016-08-26T12:18:38+01:00 7000355077 1 2016-09-01T10:38:57+01:00 10 29 Discontinued products are medicines that are no longer marketed. Pharmaceutical companies will often leave their SmPCs and PILs for discontinued medicines on emc for information purposes as the medicines are still licensed and may still be available for use. These are highlighted by a discontinued icon  in the medicines A-Z list, or via a blue banner at the top of a discontinued SmPC or PIL. A list of discontinued medicines can be found by clicking on 'MEDICINES' in the top navigation menu, then 'DISCONTINUED MEDICINES' from the drop down list.   <div dir="ltr"><div dir="ltr"><p><span><span rel="tempredactor">Discontinued products are medicines that are no longer marketed. Pharmaceutical companies will often leave their SmPCs and PILs for discontinued medicines on emc for information purposes as the medicines are still licensed and may still be available for use. These are highlighted by a discontinued icon <img src="https://s3-eu-west-1.amazonaws.com/eu-cdn.freshdesk.com/data/helpdesk/attachments/production/7000444442/original/icon-discontinued.png?1472722669" class="inline-image fr-dii" data-id="7000444442"> in the medicines A-Z list, or via a blue banner at the top of a discontinued SmPC or PIL.</span></span></p><p><span><span rel="tempredactor"><br></span></span></p><p><span><span rel="tempredactor">A list of discontinued medicines can be found by clicking on 'MEDICINES' in the top navigation menu, then 'DISCONTINUED MEDICINES' from the drop down list.<br> </span><br></span></p></div></div> 7000002145 869 7000007766 2019-08-23T10:47:48+01:00 7012886723 2 2 10 29 What is a discontinued product? 2016-09-01T10:38:57+01:00 7000355077 1 2016-09-01T10:41:31+01:00 3 67 Some Summaries of Product Characteristics (SmPCs) and Patient Information Leaflets (PILs) have an inverted black triangle symbol  displayed at the top of the document and next to the medicine name in the A-Z list. 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, patients and carers are asked to report any side effects 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. A list of medicines that have the black triangle can be found by clicking on 'MEDICINES' in the top navigation menu, then 'MEDICINES WITH BLACK TRIANGLE' from the drop down list. <div dir="ltr"><div dir="ltr"><div dir="ltr"><div dir="ltr"><div dir="ltr"> <p><span rel="tempredactor">Some Summaries of Product Characteristics (SmPCs) and Patient Information Leaflets (PILs) have an inverted black triangle symbol </span><span style="background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;"></span><img src="https://s3-eu-west-1.amazonaws.com/eu-cdn.freshdesk.com/data/helpdesk/attachments/production/7000444481/original/icon-blacktriangle.png?1472722976" class="inline-image fr-dii fr-draggable" data-id="7000444481" data-height="15" style="width: 15px; height: 15px;"><span> </span><span>displayed at the top of the document and next to the medicine name in the A-Z list. 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, </span>patients<span> and carers are asked to report any side effects via the Yellow Card Scheme at </span><a href="http://www.mhra.gov.uk/yellowcard" target="">www.mhra.gov.uk/yellowcard</a><span>. The black triangle is removed when the safety of the medicine is well established.</span></p> <p><span><br></span></p> <p><span>A list of medicines that have the black triangle can be found by clicking on 'MEDICINES' in the top navigation menu, then 'MEDICINES WITH BLACK TRIANGLE' from the drop down list.</span><span><br></span></p> </div></div></div></div></div> 7000002145 1477 7000007767 2017-10-26T10:19:12+01:00 7000355077 3 2 3 67 What does the black triangle mean? 2016-09-01T10:41:31+01:00 7000355077 1 2016-09-01T10:42:01+01:00 11 15 Occasionally the medicines regulators (the European Medicines Agency, EMA, or the Medicines and Healthcare Products Regulatory Authority, MHRA) issue specific safety information about particular medicines.  If we are made aware that safety advice, warnings or guidance have been issued which relate to the content of documents on emc, we will provide a hyperlink from that document to the relevant information. The information will be displayed as a ‘Safety Alert’ at the top of the relevant document(s). <div dir="ltr"><p><span rel="tempredactor">Occasionally the medicines regulators (the European Medicines Agency, EMA, or the Medicines and Healthcare Products Regulatory Authority, MHRA) issue specific safety information about particular medicines.  If we are made aware that safety advice, warnings or guidance have been issued which relate to the content of documents on emc, we will provide a hyperlink from that document to the relevant information. The information will be displayed as a ‘Safety Alert’ at the top of the relevant document(s).</span></p></div> 7000002145 750 7000007768 2019-08-23T10:48:17+01:00 7012886723 4 2 11 15 What are safety alerts? 2016-09-01T10:42:01+01:00 7000355077 1 2016-09-01T10:51:14+01:00 9 16 For some medicines, the pharmaceutical company has a regulatory obligation to produce information for healthcare professionals and/or patients that will minimise the risk during use of a medicine. If any risk minimisation information is available, there will be a banner at the top of the SPC and/or PIL which will link to the risk minimisation material (RMM) or the RMM icon  will display in the medicines A-Z list.  A list of medicines that have RMMs associated to them can be found by clicking on 'MEDICINES' in the top navigation menu, then 'RMM DIRECTORY' from the drop down list. <div dir="ltr"> <p><span style="background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;"><span rel="tempredactor">For some medicines, the pharmaceutical company has a regulatory obligation to produce information for healthcare professionals and/or patients that will minimise the risk during use of a medicine. If any risk minimisation information is available, there will be a banner at the top of the SPC and/or PIL which will link to the risk minimisation material (RMM) or the RMM icon <img src="https://s3-eu-west-1.amazonaws.com/eu-cdn.freshdesk.com/data/helpdesk/attachments/production/7000444507/original/icon-rmm.png?1472723354" class="inline-image" data-id="7000444507"> will display in the medicines A-Z list. </span></span></p> <p><span style="line-height: 16px;"><br></span></p> <p><span style="line-height: 16px;">A list of medicines that have RMMs associated to them can be found by clicking on 'MEDICINES' in the top navigation menu, then 'RMM DIRECTORY' from the drop down list.</span></p> <p style="margin: 0cm 0cm 0.0001pt;"><span lang="EN-US" style="background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;"></span></p> </div> 7000002145 1001 7000007770 2016-09-01T10:51:14+01:00 7000355077 5 2 9 16 What are risk minimisation materials? 2016-09-01T10:51:14+01:00 7000355077 1 2016-09-01T11:06:34+01:00 9 10 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: 1. 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? 2. 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. 3. 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. 4. 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. 5. 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. 6. Further Information 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. <div dir="ltr"> <div> <div> <p><span rel="tempredactor">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.</span><br></p> <p><span rel="tempredactor"><br></span></p> <p></p> <p><span rel="tempredactor" style='font-family: "Helvetica Neue", Helvetica, Arial, sans-serif; font-size: 13px;'>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:</span></p> <p><b><br></b></p> <p><b>1. What is your medicine and what it is used for</b></p> <ul> <li><span style="text-align: initial;">What type of medicine is it?</span></li> <li><span style="text-align: initial;">What diseases or medical conditions is it approved to treat?</span></li> </ul> <b>2. Before you take or use your medicine</b><b><br></b><ul> <li><span style="text-align: initial;">Do not take or use - situations where a medicine should not be taken or used.</span></li> <li><span style="text-align: initial;">Take special care - situations where the prescriber needs to be extra careful when prescribing a medicine.</span></li> <li><span style="text-align: initial;">Taking or using other medicines - if this medicine interacts or interferes with any other medicines, herbal or dietary supplements.</span></li> <li><span style="text-align: initial;">Taking or using your medicine with food and drink - if you should take the medicine with or without certain foods or drinks.</span></li> <li><span style="text-align: initial;">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.</span></li> <li><span style="text-align: initial;">Driving and using machines - if the medicine can affect your ability to drive or use any tools or machines.</span></li> <li><span style="text-align: initial;">Important information about some of the ingredients in your medicine.</span></li> </ul> <div> <b>3. How <span>to take or use your medicine</span></b><br> </div> <ul> <li><span style="text-align: initial;">How to take or use the medicine.</span></li> <li><span style="text-align: initial;">How often it should be used or taken.</span></li> <li><span style="text-align: initial;">How long it should be used or taken for.</span></li> <li><span style="text-align: initial;">What to do if you take or use more than you should.</span></li> <li><span style="text-align: initial;">What to do if you forget a dose.</span></li> <li><span style="text-align: initial;">What might happen if you stop taking or using the medicine.</span></li> </ul> <div><b>4. Possible side effects</b></div> <ul><li> <span style="text-align: initial;">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.</span><br> </li></ul> <div><b>5. How to store your medicine</b></div> <ul> <li><span style="text-align: initial;">How to check the expiry date of the medicine.</span></li> <li><span style="text-align: initial;">How to store your medicine.</span></li> <li><span style="text-align: initial;">How to dispose of your medicine.</span></li> </ul> <div><b>6. Further Information</b></div> <ul> <li><span style="text-align: initial;">What your medicine contains - both the active and inactive ingredients.</span></li> <li><span style="text-align: initial;">The amount of active ingredient.</span></li> <li><span style="text-align: initial;">What the medicine looks like.</span></li> <li><span style="text-align: initial;">The pack size.</span></li> <li><span style="text-align: initial;">The name of the company that makes and sells the medicine.</span></li> <li><span style="text-align: initial;">The date the leaflet was approved by the authorities.</span></li> <li><span style="text-align: initial;">Any further information about the medicine.</span></li> </ul> <p></p> </div> </div> </div> 7000002145 887 7000007772 2016-09-09T17:08:26+01:00 7000355077 6 2 9 10 What is a PIL? 2016-09-01T11:06:34+01:00 7000355077 1 2016-09-09T17:15:17+01:00 12 34 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. Legal category 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. <div dir="ltr"> <p><span rel="tempredactor">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.</span></p> <p><span rel="tempredactor"><br></span></p> <p><span rel="tempredactor" style='font-family: "Helvetica Neue", Helvetica, Arial, sans-serif; font-size: 13px;'>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.</span></p> <p><span rel="tempredactor"><br></span></p> <p><span rel="tempredactor" style='font-family: "Helvetica Neue", Helvetica, Arial, sans-serif; font-size: 13px;'><strong>Section 1. Name of the medicinal product</strong></span></p> <p><span rel="tempredactor" style='font-family: "Helvetica Neue", Helvetica, Arial, sans-serif; font-size: 13px;'>What is the brand or trade name of the medicine?</span></p> <p><span><br></span></p> <p><span><strong>Section 2. Qualitative and quantitative composition</strong></span></p> <p><span rel="tempredactor" style='font-family: "Helvetica Neue", Helvetica, Arial, sans-serif; font-size: 13px;'>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.</span></p> <p><span rel="tempredactor"><br></span></p> <p><span rel="tempredactor" style='font-family: "Helvetica Neue", Helvetica, Arial, sans-serif; font-size: 13px;'><strong>Section 3. Pharmaceutical form</strong></span></p> <p><span rel="tempredactor">What is the physical form of the medicine, for example a tablet, injection, ointment or syrup.</span></p> <p><span rel="tempredactor"><br></span></p> <p><span rel="tempredactor" style='font-family: "Helvetica Neue", Helvetica, Arial, sans-serif; font-size: 13px;'><strong>Section 4. Clinical particulars</strong></span></p> <p><span rel="tempredactor" style='font-family: "Helvetica Neue", Helvetica, Arial, sans-serif; font-size: 13px;'>This section explains how the medicine should be used or taken.</span></p> <p><span rel="tempredactor"><br></span></p> <blockquote style="margin: 0 0 0 40px; border: none; padding: 0px;"> <p><span rel="tempredactor"><strong>Section 4.1 Therapeutic indications</strong></span></p> <p><span rel="tempredactor">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.</span></p> </blockquote> <p><span rel="tempredactor"><br></span></p> <blockquote style="margin: 0 0 0 40px; border: none; padding: 0px;"> <p><span rel="tempredactor"><strong>Section 4.2 Posology and method of administration</strong></span></p> <p><span rel="tempredactor">Posology means dose. What dose, or dose range, is used?</span></p> </blockquote> <p><span rel="tempredactor"><br></span></p> <blockquote style="margin: 0 0 0 40px; border: none; padding: 0px;"> <p><span rel="tempredactor"><strong>Section 4.3 Contraindications</strong></span></p> <p><span rel="tempredactor">Contraindications are situations where a medicine should not be used. This section tells the prescriber when a medicine shouldn't be used or taken.</span></p> </blockquote> <p><span rel="tempredactor"><br></span></p> <blockquote style="margin: 0 0 0 40px; border: none; padding: 0px;"> <p><span rel="tempredactor"><strong>Section 4.4 Special warnings and precautions for use</strong></span></p> <p><span rel="tempredactor">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.</span></p> </blockquote> <p><span rel="tempredactor"><strong><br></strong></span></p> <blockquote style="margin: 0 0 0 40px; border: none; padding: 0px;"> <p><span rel="tempredactor"><strong>Section 4.5 Interactions with other medicinal products and other forms of interaction</strong></span></p> <p><span rel="tempredactor">Is your medicine known to react or interfere with any other medicines, herbal or dietary supplements?</span></p> </blockquote> <p><span rel="tempredactor"><strong><br></strong></span></p> <blockquote style="margin: 0 0 0 40px; border: none; padding: 0px;"> <p><span rel="tempredactor"><strong>Section 4.6 Pregnancy and lactation</strong></span></p> <p><span rel="tempredactor">Information about taking or using a medicine if you are pregnant, thinking of becoming pregnant or are breast-feeding a child.</span></p> </blockquote> <p><span rel="tempredactor"><strong><br></strong></span></p> <blockquote style="margin: 0 0 0 40px; border: none; padding: 0px;"> <p><span rel="tempredactor"><strong>Section 4.7 Effects on ability to drive and use machines</strong></span></p> <p><span rel="tempredactor">Will the medicine affect your ability to drive or use machines?</span></p> </blockquote> <p><span rel="tempredactor"><strong><br></strong></span></p> <blockquote style="margin: 0 0 0 40px; border: none; padding: 0px;"> <p><span rel="tempredactor"><strong>Section 4.8 Undesirable effects</strong></span></p> <p><span rel="tempredactor">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.</span></p> </blockquote> <p><span rel="tempredactor"><strong><br></strong></span></p> <blockquote style="margin: 0 0 0 40px; border: none; padding: 0px;"> <p><span rel="tempredactor"><strong>Section 4.9 Overdose</strong></span></p> <p><span rel="tempredactor">What could happen to you if you take or use too much of the medicine?</span></p> </blockquote> <p><span rel="tempredactor"><strong><br></strong></span></p> <p><span rel="tempredactor" style='font-family: "Helvetica Neue", Helvetica, Arial, sans-serif; font-size: 13px;'><strong>Section 5. Pharmacological properties</strong></span></p> <p><span rel="tempredactor" style='font-family: "Helvetica Neue", Helvetica, Arial, sans-serif; font-size: 13px;'>How does the medicine affect your body and what does your body do to the medicine?</span></p> <p><span rel="tempredactor"><strong><br></strong></span></p> <blockquote style="margin: 0 0 0 40px; border: none; padding: 0px;"> <p><span rel="tempredactor"><strong>Section 5.1 Pharmacodynamic properties</strong></span></p> <p><span rel="tempredactor">How does the medicine have its effect on the body?</span></p> </blockquote> <p><span rel="tempredactor"><strong><br></strong></span></p> <blockquote style="margin: 0 0 0 40px; border: none; padding: 0px;"> <p><span rel="tempredactor"><strong>Section 5.2 Pharmacokinetic properties</strong></span></p> <p><span rel="tempredactor">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.</span></p> </blockquote> <p><span rel="tempredactor"><strong><br></strong></span></p> <blockquote style="margin: 0 0 0 40px; border: none; padding: 0px;"> <p><span rel="tempredactor"><strong>Section 5.3 Preclinical safety data</strong></span></p> <p><span rel="tempredactor">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.</span></p> </blockquote> <p><span rel="tempredactor"><strong><br></strong></span></p> <p><span rel="tempredactor" style='font-family: "Helvetica Neue", Helvetica, Arial, sans-serif; font-size: 13px;'><strong>Section 6. Pharmaceutical properties</strong></span></p> <p><span rel="tempredactor" style='font-family: "Helvetica Neue", Helvetica, Arial, sans-serif; font-size: 13px;'>This section gives information about the ingredients in a medicine, the packaging and how it should be stored.</span></p> <p><span rel="tempredactor"><strong><br></strong></span></p> <blockquote style="margin: 0 0 0 40px; border: none; padding: 0px;"> <p><span rel="tempredactor"><strong>Section 6.1 List of excipients</strong></span></p> <p><span rel="tempredactor">What other 'ingredients' are in the medicine, apart from the active ingredient?</span></p> </blockquote> <p><span rel="tempredactor"><strong><br></strong></span></p> <blockquote style="margin: 0 0 0 40px; border: none; padding: 0px;"> <p><span rel="tempredactor"><strong>Section 6.2 Incompatibilities</strong></span></p> <p><span rel="tempredactor">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.</span></p> </blockquote> <p><span rel="tempredactor"><strong><br></strong></span></p> <blockquote style="margin: 0 0 0 40px; border: none; padding: 0px;"> <p><span rel="tempredactor"><strong>Section 6.3 Shelf life</strong></span></p> <p><span rel="tempredactor">What is the maximum amount of time the medicine can be stored for?</span></p> </blockquote> <p><span rel="tempredactor"><strong><br></strong></span></p> <blockquote style="margin: 0 0 0 40px; border: none; padding: 0px;"> <p><span rel="tempredactor"><strong>Section 6.4 Special precautions for storage</strong></span></p> <p><span rel="tempredactor">How and where to store your medicine.</span></p> </blockquote> <p><span rel="tempredactor"><strong><br></strong></span></p> <blockquote style="margin: 0 0 0 40px; border: none; padding: 0px;"> <p><span rel="tempredactor"><strong>Section 6.5 Nature and contents of container</strong></span></p> <p><span rel="tempredactor">Information about the medicine's packaging.</span></p> </blockquote> <p><span rel="tempredactor"><strong><br></strong></span></p> <blockquote style="margin: 0 0 0 40px; border: none; padding: 0px;"> <p><span rel="tempredactor"><strong>Section 6.6 Special precautions for disposal and other handling</strong></span></p> <p><span rel="tempredactor">How to make-up or give the medicine and how to get rid of any left over medicine.</span></p> </blockquote> <p><span rel="tempredactor"><strong><br></strong></span></p> <p><span rel="tempredactor" style='font-family: "Helvetica Neue", Helvetica, Arial, sans-serif; font-size: 13px;'><strong>Section 7. Marketing authorisation holder</strong></span></p> <p><span rel="tempredactor" style='font-family: "Helvetica Neue", Helvetica, Arial, sans-serif; font-size: 13px;'>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.</span></p> <p><span rel="tempredactor"><strong><br></strong></span></p> <p><span rel="tempredactor" style='font-family: "Helvetica Neue", Helvetica, Arial, sans-serif; font-size: 13px;'><strong>Section 8. Marketing authorisation number(s)</strong></span></p> <p><span rel="tempredactor" style='font-family: "Helvetica Neue", Helvetica, Arial, sans-serif; font-size: 13px;'>When the regulatory authority approves a medicine, they give it a number - the marketing authorization number.</span></p> <p><span rel="tempredactor"><strong><br></strong></span></p> <p><span rel="tempredactor" style='font-family: "Helvetica Neue", Helvetica, Arial, sans-serif; font-size: 13px;'><strong>Section 9. Date of first authorisation/renewal of the authorisation</strong></span></p> <p><span rel="tempredactor">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.</span></p> <p><span rel="tempredactor"><strong><br></strong></span></p> <p><span rel="tempredactor" style='font-family: "Helvetica Neue", Helvetica, Arial, sans-serif; font-size: 13px;'><strong>Section 10. Date of revision of the text</strong></span></p> <p><span rel="tempredactor" style='font-family: "Helvetica Neue", Helvetica, Arial, sans-serif; font-size: 13px;'>If an SmPC changes, this is the date the pharmaceutical company sent the changes to the regulatory authority for their approval.</span></p> <p><span rel="tempredactor"><strong><br></strong></span></p> <p><span rel="tempredactor" style='font-family: "Helvetica Neue", Helvetica, Arial, sans-serif; font-size: 13px;'><strong>Section 11. Dosimetry</strong></span></p> <p><span rel="tempredactor" style='font-family: "Helvetica Neue", Helvetica, Arial, sans-serif; font-size: 13px;'>This section is only on SmPCs for radiopharmaceutical products. It tells you how much radiation you are exposed to.</span></p> <p><span rel="tempredactor"><strong><br></strong></span></p> <p><span rel="tempredactor"><strong>Section 12. Instructions for preparation of radiopharmaceuticals</strong></span></p> <p><span rel="tempredactor" style='font-family: "Helvetica Neue", Helvetica, Arial, sans-serif; font-size: 13px;'>This section is only on SmPCs for radiopharmaceutical products. It tells you how to get rid of any unused or waste products safely.</span></p> <p><span rel="tempredactor"><strong><br></strong></span></p> <p><span rel="tempredactor" style='font-family: "Helvetica Neue", Helvetica, Arial, sans-serif; font-size: 13px;'><strong>Legal category</strong></span></p> <p><span rel="tempredactor">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.</span></p> </div> 7000002145 3671 7000007888 2017-10-26T10:17:24+01:00 7000355077 7 2 12 34 What is an SmPC? 2016-09-09T17:15:17+01:00 7000355077