Answers to questions about generic medicines
Does your medicine look different than usual? Do they have different packaging or name? You may have been granted a patent-free or generic medicine. You may have questions about whether this medicine is safe to use and whether it is as effective as the patented (original) medicine. This article provides answers to these questions.
What is a generic drug?
A generic medicine is a duplicate of a patented (original) medicine. The substance that makes a medicine effective or has a therapeutic effect is called an active substance. Generic or patent-free medicines contain the same active substance in the same concentration as the original medicine. In other words, generic medicines are just as effective and safe, but their appearance and packaging may be different. Generic medicines and original medicines are the same, but they can have different dosage forms. The active substance and the amount in this medicine are identical.
Is the use of generic medicines safe?
Yes. Generic medicines are equivalent to proprietary medicines. Extensive research has been done to ensure this. The package leaflet will provide information on how to use the medicine correctly. If you have any further questions, ask your doctor or pharmacist.
Identical quality and monitoring
The State Agency of Medicines carefully evaluates all data on a medicinal product and its manufacturing process both before the registration of a medicinal product and during the post-registration of a medicinal product, regardless of whether the medicinal product is patented or generic. Experts evaluate everything - from medicinal raw materials to packaging. In turn, after the registration of a medicine, all medicines are monitored equally for side effects.
Why am I receiving a generic medicine?
In most cases, your doctor or pharmacist will prefer generic medicines because they are cheaper. You can ask any pharmacist any questions you may have. Sometimes you will also be given a generic medicine because the medicine you were taking before is (possibly temporarily) not available.
Why are generic medicines often cheaper than proprietary medicines?
When developing new medicines, manufacturers of patented medicines carry out extensive clinical and other studies to prove the effectiveness and safety of the active substance. The following questions are clarified: For which patients is this medicine suitable? What is the correct dose of medicine? This mandatory study on a hitherto unknown active substance requires a long time and large financial resources. Sometimes studies show that the new active substance is not effective or cannot be used for treatment. Consequently, the manufacturer of the patented medicine will want to recoup its investment.
Generic medicines contain the same active substance or substances as a patented medicine. As the efficacy and safety of these active substances have already been studied and done by the manufacturer of the proprietary medicinal product, it is not necessary for the manufacturer of the generic medicinal product to carry out such extensive research. This means time and money are saved. Therefore, generic medicines are cheaper.
The manufacturer is developing a new medicine. This period lasts 7 to 10 years. For several years, the manufacturer will be the only one allowed to sell this medicine. These are called proprietary medicines. When a patent expires, other manufacturers can make a duplicate of the patented medicine.
The State Agency of Medicines evaluates the efficacy and safety of these generic medicines in the same way as it does for proprietary medicines. Both proprietary and generic medicines are now available on the market. During this time, they can be selected and used by professionals and patients. Generic medicines are usually cheaper. This ensures the availability of medicines and the efficient use of health care funding.
How to recognize a generic drug?
Generic medicines may not have the same trade name given by the manufacturer as the proprietary medicine, so their name and packaging are different. Often (but not always) generic manufacturers include the name of the active substance in their product name and sometimes add the company name. The name of the pharmacy chain may also be added to the name.
Why do generic medicines look different?
Manufacturers can choose what their tablets, oral suspensions, or inhalers will look like, providing an equivalent effect. Generic medicines can have a different color, shape, and taste compared to patented medicines. Manufacturers use other excipients that make this difference. However, the excipients must not affect or reduce the effect of the medicine.
Can I safely switch from a patented medicine to a generic medicine and vice versa?
Yes, in most cases it will not cause you any problems. Generic medicines are equivalent to proprietary medicines. However, you may need a short time to get used to the new medicine, especially if you are taking more than one medicine and / or change medicines from different manufacturers regularly.
Differences in use
The different packaging should not stop you from taking the medicine. Therefore, every time you start taking medicine from another manufacturer, make sure you still know how to use it properly. Can you open the medicine bottle? Can you use an inhaler (if you have a lung disease) or eye drops (if you have eye problems) without difficulty? If you have any further questions on the use of this product, ask your doctor or pharmacist for help, and more information.
Do generic medicines and proprietary medicines have different effects?
No, because generic medicines always contain the same active substance as the corresponding patented medicine. However, the excipients used in these medicines may vary. Excipients generally do not pose any risk. However, if you are allergic, for example to gluten or lactose, be vigilant, especially when starting to take another medicine. All excipients are listed in the package leaflet. Excipients that pose a risk to certain groups of people are listed separately.
Generic medicines often look different, but they have the same therapeutic effect and quality.
For information on excipients, see the Package Leaflet. Instructions for use of all medicines are available electronically in the Register of Medicinal Products.
I do not have any allergies, but I have developed symptoms when taking my new medicine as directed. How is that possible?
You may have symptoms because you are taking the medicine differently than usual. Changing medicines can make you feel insecure. Especially if you are also taking other medicines and / or change them regularly. Sometimes symptoms may occur because you are used to a certain dose of the medicine. In such cases, any changes may have significant consequences. This may happen, for example, in patients taking medicines for thyroid problems. If you get any symptoms, talk to your doctor or pharmacist. If necessary, your doctor may prescribe your usual medicine.
What should I do if I experience a side effect while taking the generic medicine?
In case of any side effects talk to your doctor or pharmacist to find a solution together. Like all medicines, generic medicines can have side effects. The National Medicines Agency collects and analyzes information on all adverse drug reactions: evaluates the reported adverse reactions and, if necessary, takes appropriate action, such as including the observed adverse reactions in the package leaflet. More information on medicines is available in the Register of Medicinal Products. Everyone who takes medicines must be able to rely on them.
Source Medicines Evaluation Board