duplicate safe reliable same medicine, different name good brands switch Answers to questions about generic medicines generic medicines

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1 Answers to questions about generic medicines generic medicines safe store brand reliable same medicine, different name different packaging switch good brands duplicate

2 Does your medicine look different from what you are used to? Do you not recognise the name or packaging? Then you may have been given a generic medicine. Maybe you are wondering if it is safe for you to use this medicine, or whether it is as effective as a brand medicine. This leaflet provides you with answers to these questions. Seven in ten prescriptions filled in the Netherlands are for generic medicines (Dutch figures, 2015)

3 1 à What is a generic medicine? A generic medicine is essentially a duplicate of a brand medicine. The ingredient that makes the medicine effective is called the active substance. Generic medicines contain the same active substance, with the same strength. In other words, generic medicines are as effective as brand medicines. However, they may look different, have different packaging, or taste different. In Dutch, generic medicines are known as merkloze medicijnen or generieke medicijnen. Generic medicines are identical to brand medicines, but come in different forms. The active substance is identical, as is the amount included in the medicine. Brand medicine Generic medicine Outside u Active substance u 2 à Is it safe for me to use a generic medicine? Yes. Generic medicines are as good as brand medicines. A lot of research was carried out to ensure this. The patient information leaflet will tell you how to properly take the medicine. If you have any questions, please contact your doctor or pharmacist. Same quality and monitoring The Medicines Evaluation Board (MEB) and the Health Care Inspectorate (IGZ) of the Netherlands assess the entire registration and production process of all medicines, be they brand medicines or generic medicines. From the raw materials to the packaged medicine. Likewise, all medicines are monitored in the same way for any side effects. 3

4 3 à Why am I being given a generic medicine? Generally, your health care insurer or pharmacist will opt for this medicine because it is cheaper. You can find more information on this in your insurance policy documents. Alternatively, ask your pharmacist. Sometimes you will be given a generic medicine instead of your regular medication because the medicine you are familiar with is (temporarily) unavailable. 4 à Why are generic medicines often cheaper than brand medicines? When developing new medicines, manufacturers of brand medicines conduct research to establish the safety of the active substance. For which patients will this medicine work? What is the right dosage? Such mandatory research is expensive. Many substances turn out to be insufficiently effective, meaning they cannot be used in medicines. A manufacturer marketing a brand medicine will want to recoup the investment it has made. Generic medicines contain the same active substance(s) as brand medicines. Since their efficacy and safety have already been demonstrated, less research is required. This means that time and money are saved. This is why generic medicines are cheaper. Step 1 à Development of a new medicine by manufacturer A. This stage takes 7 to 10 years. 4

5 Step 2 à For a few years, manufacturer A will be the only party allowed to sell the product. This is called a patent. Step 3 à Once the patent has expired, other manufacturers are allowed to duplicate the brand medicine. 5

6 Step 4 à The government assesses the efficacy and safety of these generic medicines in the same way as the brand medicine. Step 5 à Now both the brand medicine and the generic medicine are for sale. Generally, this is the moment people switch brands or switch from the brand to the generic medicine. 6

7 Step 6 à Generic medicines tend to be cheaper. This is how we keep our healthcare system affordable. Brand medicine Generic medicine 5 à How do I recognise a generic medicine? Generic medicines can be hard to recognise. For instance, they are not allowed to have the same name as the brand medicine. This is why the name and packaging are different. Often (but not always) the manufacturer of a generic medicine will include the name of the active substance in the product s name. The manufacturer s name will then be added to the product s name. If the medicine can be bought without a prescription, the name that is added may be the name of a supermarket or pharmacy chain (store brand). Brand medicine Generic medicine 7

8 6 à Why do generic medicines look different? Manufacturers are free to decide what their pills, oral suspensions and inhalers look like. Therefore, generic medicines may have a different colour, shape and taste from brand medicines. Manufacturers use different excipients to achieve this effect. Such excipients are not allowed to affect or negatively affect the efficacy of a medicine 7 à Can I safely switch between a brand and a generic medicine? Generally you can switch without any problems. Generic medicines are as good as brand medicines. However, it may take you a little while to get used to the new brand, particularly if you use more than one type of medicine and/or if you regularly switch from one brand to the next. Do you have any concerns? Or do you experience symptoms when you use a particular type of medicine? If so, ask your doctor or pharmacist for help or more information. Differences in usage Different packaging should not restrict you from taking your medicine. Therefore, please check if you can still properly take your medicine every time you switch brands. Are you able to properly open the jar? Are you able to use the inhaler (if you have a lung disorder) or eyedropper (if you have eye issues) without any difficulty? If you have any doubts, please ask your doctor or pharmacist for more information and advice. 8 à Is there any difference in efficacy between the generic medicine and the brand medicine? No, because generic medicines always contain the same active substance as the brand medicines they replace. The excipients may be different, though (also see Question 6). Generally, excipients do not pose any risks. However, if you are allergic to, for example, gluten, please be alert, especially when you are switching brands. You can find all the excipients in the patient information leaflet. Excipients that pose a risk to certain groups of people are listed separately. If you are in any doubt, please consult your doctor or pharmacist. 8

9 Generic medicines often look different but they have the same efficacy and quality. Brand medicine Generic medicine Excipients You can find more information on specific excipients in medicines on the Medicines Information Bank: This is a useful site, for example if you have any allergies. 9 à I do not have any allergies, and I am taking my new medicine as directed. However, I do experience symptoms. How is this possible? You may be experiencing symptoms because you have to take the medicine in a different way from what you are used to (see Question 7). The switch may make you insecure. In particular if you also take other medicines, and/or if you regularly switch. Sometimes you may experience symptoms because you have become used to a precise dosage of a particular medicine. In such cases, any change may have severe consequences. For instance, this may occur with patients taking thyroid medication. If you experience any symptoms, please consult your doctor or pharmacist. If necessary, your doctor may decide to prescribe your usual medicine. 9

10 10 à What to do when I experience a side effect while taking my generic medicine? Please contact your doctor or pharmacist if you experience any side effects. Together, an appropriate solution will be sought. Just like brand medicines, generic medicines may have side effects. Please report side effects at Reporting side effects The Netherlands Pharmacovigilance Centre Lareb collects and analyses the side effects of all medicines in the Netherlands. If you report a side effect to Lareb, the Medicines Evaluation Board (MEB) will also be informed. The MEB assesses all side effects reported in the Netherlands and elsewhere, and takes action when necessary. For instance, by including the side effect in the patient information leaflet. 10

11 More information For more information on generic medicines, please consult the MEB s website: english.cbg-meb.nl Who produces generic medicines? There are several manufacturers in the Netherlands who mainly produce generic medicines. If the name of any of these manufacturers is on your medicine, it is likely to be a generic medicine. The names of these manufacturers can be found on the website of their interest group, called the Bogin (Dutch generic and biosimilar medicines association): Generic medicines are produced by other manufacturers as well. (Medicines Information Bank) 11

12 Anyone who uses medicines should be able to trust them. The MEB is dedicated to fulfilling this mission every single day, in the Netherlands and in Europe. Good medicines used better. This leaflet was drawn up in association with: BijnierNET (AdrenalNET) Consumentenbond (Dutch Consumers Association) Dutch Brain Council Longfonds (Lung Foundation Netherlands) Oogvereniging (Eye Association Netherlands) Patiëntenfederatie Nederland (Dutch Patients Federation) Nationale Vereniging ReumaZorg Nederland (Dutch National Association for Care to Patients Suffering from Rheumatic Disorders) Nederlandse Hypofyse Stichting (Dutch Hypophysis Foundation) Schildklier Organisatie Nederland (Dutch Thyroid Organisation) Stichting Borderline (Borderline Personality Disorder Foundation) Medicines Evaluation Board PO Box RG Utrecht The Netherlands +31 (88)