You can easily search for information about medicines authorised by the HPRA.
Their human medicines product database is a comprehensive and up-to-date listing of all medicines that have been assessed by the HPRA and granted a licence so that they can be marketed in Ireland.
The list includes all prescription and over-the-counter medicines whether they are original brand-name medicines or generic versions.
The summary of product characteristics document (known as SPC) is also provided for each medicine. The SPC is typically used by healthcare professionals. The package leaflet which includes information for patients and members of the public is also available for a number of medicines.
All medicines centrally authorised by the European Medicines Agency are also listed.
ATC (Anatomical Therapeutic Chemical) Code
Information on the ATC code is published for each medicine.
You can use the second search option above to search the list of interchangeable medicines.
It is the role of the HPRA to establish, publish and maintain a list of interchangeable medicines on our website. Interchangeable medicines are defined as those medicines that (1) contain the same active ingredient in the same strength, (2) are in the same pharmaceutical form, and (3) have the same route of administration.
Search for groups of interchangeable medicines using the trade name (brand name) of a medicine or the active substance.
To get the most relevant results, you will also need to confirm the strength of the medicine and whether it is a tablet, capsule or some other pharmaceutical form.
ADVANCED SEARCH
The advanced search function* allows users to search for medicines information using one or more of the following fields:
• Trade Name
• Active Substances
• Licence Holder
• Licence or Transfer Date
• Licence Number
• Dispensing Status
• Supply Status
In addition to the detail listed above, the information provided for each medicine includes the strength and the dosage form. Examples of the dosage form include tablet, cream and solution for injection.
*The advance search function is not available for Interchangeable and Generic Medicines
The definition of a shortage is when the supply of a medicine is does not meet the needs of the patient.
The World Health Organisation recognises medicine shortages are a global problem. They represent an increased focus for governments given their potential public health impact.
WHYT SO MEDICINES SHORTAGES OCCUR?
A medicine shortage can occur for many reasons. Each shortage represents an individual set of circumstances. From industry information received by the HPRA, we know that:
• Over 60% of shortages relate to delays or breakdowns during manufacturing or a product quality issue.
• Manufacturing can also be delayed when an active substance or other ingredient is in short supply. Shortages in packaging materials can also lead to delays.
• Unexpected demand can cause certain shortages. This could be due, for example, to an unanticipated increase in prescribing of a particular medicine. Greater than anticipated levels of seasonal illness can also result in shortages of medicines needed to treat those illnesses.
HOW ARE MEDICINES SHORTAGES HANDLED IN IRELAND?
The HPRA oversees a multi-stakeholder framework intended to address the issue of human medicine shortages in Ireland.
The aim of the framework is to:
1. Help avoid potential shortages from occurring in the first place.
2. Reduce the impact on patients when shortages do occur.
The framework sets out the roles of different stakeholder groups in managing shortages. Participants in the framework include:
• Marketing authorisation holders (companies that have an authorisation to market a medicine in Ireland)
• Manufacturers
• Wholesale distributors
• Healthcare professionals
• The HSE
• Patient representative groups
Representatives of the above stakeholders all participate in the framework. The HPRA co-ordinates and oversees its operation.
The framework outlines procedures for notification of shortages, their evaluation and communication. It also looks to further develop strategies that can help prevent shortages.
The framework does not cover commercial activities such as:
• Pricing of medicines.
• Sourcing of medicines from suppliers.
• Clinical management of patients in the event of a shortage.
WHAT IS THE ROLE OF THE HPRA IN MEDICINES SHORTAGES?
Under the medicines shortages framework, the HPRA publishes a list of shortages currently affecting the Irish market. This regularly updated list, is published on our website. It includes information on shortages* notified to them, which may have a medium or high impact on patients.
Marketing authorisation holders should notify shortages or potential shortages of medicines to the HPRA and the HSE. Wholesalers, patients, and healthcare professionals can also assist by reporting possible shortages not currently included on the HPRA list.
*Where a product is not listed as a shortage on the HPRA website, availability may differ across wholesale supply. As a result, pharmacists may need to check with other distributors.
The HPRA also maintains a list of shortages resolved in the last six months.
CAN THE HPRA TAKE REGULATORY ACTIONS TO REDUCE THE IMPACT OF A SHORTAGE?
Yes, where regulatory flexibility can ease a supply issue without impacting patient safety, the HPRA will be as practical as possible. In particular, they focus on actions to address acute and urgent patient needs.
For example, they can provide accelerated regulatory approval to supply a medicine to Ireland initially intended for another market. This may involve allowing flexibility on labelling or packaging to support the supply of interim stocks. They can also accelerate the approval of controlled drug licences in a shortage.
WHAT IS OUTSIDE THE REMIT OF THE HPRA?
The HPRA cannot compel companies to supply or manufacture medicines.
They also have no role in:
• The purchasing of medicines.
• Commercial issues.
• The provision of clinical advice and treatment to patients.
Medicines can make the quality of our lives better in many ways. They can help cure or treat an illness or disease and can also prevent some conditions from developing in the first place. In this way, medicines can help us live longer and healthier lives.
Nearly all of us will need to take medicines at some point in our lives. These may be:
1. medicines that are only available with a prescription from a doctor, dentist or certain nurses (known as prescription-only medicines); or
2. medicines that you can buy over-the-counter without a prescription (sometimes called OTC medicines).
This webpage will tell you how to use medicines safely and effectively.
OVER-THE-COUNTER MEDICINES
You can get these medicines without a prescription. They are usually for mild conditions that you can treat yourself such as pain or a cold. You take them for a short time only.
You can buy some over-the-counter medicines in shops and supermarkets but for others you will have to go to a pharmacy. Ask your pharmacist if you have any questions about using an over-the-counter medicine.
PRESCRIPTION ONLY MEDICINES
Only doctors, dentists and certain nurses can give you a prescription for these medicines. They are sold through pharmacies.
BEFORE YOU START TAKING YOUR MEDICINES
To get the most from your medicine, it is important that you use it safely. Here are some things to consider before you start taking a medicine.
• Use the same doctor and the same pharmacy if possible. This will allow both to build a patient history for you.
• Tell your doctor and pharmacist about any other medicines that you are taking including herbal medicines. Some medicines can react with each other if taken together, and this could be a health risk.
• Always tell your doctor or pharmacist if you have any allergies to certain medicines.
• Tell your doctor or pharmacist if you have scheduled surgery, if you are pregnant or planning a pregnancy, or if you are breastfeeding.
• Check that you have received the correct medicine before you leave the pharmacy.
• Always read the package leaflet that comes with the medicine. Tell your doctor or pharmacist if you don’t understand any information about your medicines.
• Unless your doctor or pharmacist tells you differently, take your medicine at the same time every day and always take the recommended course.
• If you are travelling, make sure you carry enough of your medicine with you so you can take the correct does while you are away.
• If you are taking some medicines for a long time, ask your doctor or pharmacist to review them once a year.
GENERIC MEDICINES
Your pharmacist may give you a medicine that comes in a different shape or colour and has a different name. For example, you may be given a generic version of an original, brand-name medicine.
A generic medicine has the same active ingredient as the original medicine it is based on. The active ingredient in a medicine is what makes the medicine work.
The generic medicine has the same effect and is just as safe as the original medicine. If you have any questions about generic medicines, ask your doctor or pharmacist. You can also get more information on our Generic medicines webpage.
TAKING YOUR MEDICINES
If you don’t take your medicines properly, it may not work and may cause more harm than good. Here are some tips to help avoid mistakes.
• Don’t take more than the recommended dose. For medicines that have been prescribed for you, the dose will be on the pharmacy label. For medicines that you have bought without a prescription, the dose is written on the packet or label and in the package leaflet that comes with the medicine.
• Don’t take a medicine that is out of date.
• If you forget to take your medicine, check the package leaflet that comes with the medicine for advice or talk to your doctor or pharmacist.
• Don’t stop taking your medicine, unless your doctor or pharmacist tells you to stop.
• Don’t take a medicine for longer than your doctor or pharmacist tells you to.
• Don’t share your medicines with other people.
• Don’t take a medicine that was prescribed for somebody else.
• Don’t save a prescription to use in the future unless your doctor advises you to.
• If you take prescribed medication, never take a non-prescription medicine without first checking with your pharmacist.
• Don’t crush pills or open capsules to make them easier to swallow unless your doctor or pharmacist says it is alright to do so.
• Alcohol can interact with some medicines or reduce their effect. Check with your doctor or pharmacist if it is alright for you to drink alcohol while you are on medication.
• Don’t take medicine in front of children as they often copy what they see adults doing.
• Don’t ignore an unexpected side effect that you think may be related to the medicine you have taken. Contact your doctor or pharmacist immediately.
Always read the patient information on the leaflet or packaging. It will give you important information about your medicine, including:
• what the medicine is for;
• how to take the medicine and the recommended dose;
• possible side effects;
• when you should not take the medicine;
• storage and expiry date
STORING YOUR MEDICINES
Every medicine is different so always read the storage instructions on the leaflet or packaging.
• Store medicines in a cool dry place away from strong light. You may need to store some medicines in the fridge.
• Don’t store medicines in a bathroom or car, as heat and moisture can interfere with and damage medicines.
• Always keep medicines in their original containers unless your doctor advises you to store them somewhere else.
• Don’t mix different medicines in one container.
• Don’t destroy or throw out unused or out-of-date medicines yourself. Return them to your pharmacist who can destroy them safely.
• Always keep medicines safely out of sight and reach of children.
MEDICINES AND SIDE EFFECTS
Medicines can help us live longer and healthier lives. They can help cure or treat an illness or disease and can also prevent some conditions from developing in the first place.
During the course of our lives, it is likely that we will all need to take medicines. These might include vaccines to prevent illness or prescription medicines such as antibiotics to treat serious infections. Some of us may also take over-the-counter (OTC) medicines to treat minor symptoms like headaches as well as dietary supplements such as vitamins.
Most of us will not experience any problems when using medicines. However, all medicines have some risks and a small number of people may develop side effects (also known as adverse reactions). This webpage tells you what to do if you think you have had a side effect to a medicine.
WHAT IS A SIDE EFFECT?
A side effect is when something unwanted or unintended happens after taking a medicine. In many cases, side effects to medicines are mild and you can continue to take the medicine. However, for some people the side effects can sometimes be more serious. They may need a change in their medicines or, in rare cases, some additional medical treatment.
It is important to look at the risks associated with a medicine in the context of the overall benefit of the medicine to your health and the condition being treated. Even where a reaction to a particular medicine is severe, it may still be better to continue the treatment and to manage the unwanted side effects.
WHERE CAN YOU GET INFORMATION ABOUT SIDE EFFECTS?
The package leaflet that comes with a medicine tells you about that medicine. A section of the leaflet deals with possible side effects. Some of this information may also be printed on the product packaging.
It is really important to read this information. You should also talk to your doctor or pharmacist about the possible side effects of medicines they are recommending for you.
WHAT ARE THE EFFECTS OF HAVING A SIDE EFFECT?
The package leaflet will tell you about the chances of developing side effects. For example, a very rare side effect will affect fewer than 1 in 10,000 people. A very common side effect might affect more than 1 in 10 people taking the medicine.
HOW DO YOU KNOW IF YOU HAVE HAD A SIDE EFFECT TO A MEDICINE?
Side effects vary and depend on the medicine and the person. Examples of common side effects include headaches, fever, dizziness, skin rashes, nausea, vomiting, diarrhoea and drowsiness.
Some side effects may happen immediately while others may develop over time. However, many side effects to medicines are mild and will go away within a few days as your body adjusts to the medicine.
WHAT SHOULD YOU DO IF YOU HAVE HAD A SIDE EFFECT?
If you are worried that you may have had a side effect to a medicine, contact your doctor or pharmacist. They will tell you if you need any medical care. They will also consider if you need to change your treatment or if you need a different treatment. They may report the suspected side effect to the HPRA. You can also report a side effect to them directly.
WHO CAN REPORT A SIDE EFFECT?
• Doctors, pharmacists, dentists, nurses and other healthcare professionals.
• Patients and other members of the public if the side effect happened to:
o themselves personally;
o their child;
o some other person they are responsible for, such as a spouse, a young adult or an elderly person; or
o someone who has asked that they make the report on their behalf.
HOW CAN YOU REPORT A SIDE EFFECT?
You can report a side effect by:
• contacting your doctor or pharmacist who can notify us;
• using the online report form on the HPRA website. You can also print the form and post it to them;
• calling them on (01) 676 4971.
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WHY SHOULD YOU REPORT A SIDE EFFECT?
The HPRA encourage you to report suspected side effects so that they have more information available about the use of medicines. This helps them to monitor their safety.
When they get a report of a suspected side effect, they review all the details including the possible impact of the medicine. If they think that the medicine has played a part, they examine to see if this may be a new safety concern or if similar cases have been reported. They also have access to global safety information which helps them to identify emerging safety issues.
Where a serious safety issue emerges with a medicine, they work to change the way the medicine is used. If there is a risk to public health, they may suspend the use of a medicine.
WHAT CAN YOU DO TO REDUCE THE RISK OF SIDE EFFECTS?
Always follow the advice of your doctor and pharmacist on the recommended storage, dose and length of time you should take a medicine. Make sure you tell your doctor and pharmacist about any other medicines you are taking. Some medicines can react with each other and this could be a health risk.
ADDITIONAL MONITORING
Health authorities across Europe carefully monitor the safety of all medicines. Some medicines are monitored more closely than others. These medicines have a black upside down triangle on their package leaflet together with a short sentence that reads:
▼ This medicinal product is subject to additional monitoring.
The black triangle will help you to quickly identify medicines that are being monitored more closely than others but it does not mean that these medicines are unsafe. There may be less information available about them compared to other medicines because, for example, they are new to the market.
If you think you have had a side effect after taking a medicine that has a black triangle, please report it to your doctor, pharmacist or directly to the HPRA. It is important that all safety information about the use of the medicine is quickly reviewed.
DANGERS OF BUYING PRESCRIPTION MEDICINES ONLINE
Buying prescription medicines on the internet might seem like a good idea but there is no way of knowing how safe these medicines are or if they will work properly. At best, you could simply be wasting your money. At worst, these medicines could cause you serious harm.
Here are some of the many reasons why you should never buy prescription-only medicines online.
DANGERS TO YOUR HEALTH
• Even if the medicine you buy online looks the same, there is no guarantee that it is genuine or that it is the same medicine that was prescribed for you. As a result, your condition may go untreated.
• There is no way of knowing if the medicine has been tested and approved for human use. What is sent to you may not even be the medicine that was advertised on the website.
• There is no way to be certain how or where the medicine was made. This means you cannot know if the manufacturer operates to acceptable standards of quality and hygiene.
• The medicine may not have been packaged, labelled or stored correctly and could be out-of-date. There may also be no patient information, such as how to take the medicine, or the information may simply be wrong.
• The active ingredient in a medicine is what makes it work. A medicine bought online may contain no active ingredient, too much or too little of an active ingredient, or the wrong ingredients altogether. It could be useless in treating your medical complaint.
• Some medicines bought online have been found to contain dangerous toxic substances.
• As there is no certainty about what is in the medicine you buy on the internet, you can’t be sure it is safe to use alongside medicines you may already be taking. There could be interactions with your regular medicines.
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SUPPLYING PRESCRIPTION MEDICINES ONLINE IS ILLEGAL
In Ireland, it is against the law to supply prescription medicines by mail order (including through the internet). Manufacturing fake or counterfeit medicines – known as falsified medicines – is also a criminal offence. Illegal prescription medicines that are discovered by customs officials coming into the country are destroyed. There have also been prosecutions and other actions involving website operators.
OTHER DANGERS YOU MAY FACE
Many internet sites that supply medicines hide their true identity and location to deceive people. Criminals are often behind the operation of these websites. This means that when you give your personal details, you are at risk of credit card fraud and identity theft.
BUYING SAFE, APPROVED AND EFFECTIVE MEDICINES
You should only buy your medicines from a recognised and trusted source such as your local pharmacy. In Ireland, pharmacies are regulated by the Pharmaceutical Society of Ireland (PSI). When you buy from these pharmacies, you know that your medicine has been authorised and that the safety and quality of the medicine is being monitored by the HPRA.
BUYING NON-PRESCRIPTION MEDICINES SAFELY ONLINE
Pharmacies and other retailers in Ireland can sell non-prescription medicines on their websites. These are medicines that do not require a prescription. One example is paracetamol products for pain relief.
A supplier who wants to sell non-prescription medicines over the internet in Ireland must apply to the PSI and be added to an Internet Supply List. The list is available on the PSI website. They must also display a ‘Common Logo’ on their website. The common logo is a safety feature that allows members of the public to identify legitimate online suppliers of non-prescription medicines, giving reassurance that the purchase is safe. Further information on the Internet Supply List is available on the PSI website.
ALWAYS GET EXPERT ADVICE
Only doctors, dentists and certain nurses can give you a prescription and you should only take prescription medicines under the care and supervision of a healthcare professional.
While the internet can be a good source of health information, it is always best to seek the right advice about any concerns or symptoms you may have. If you don’t, you may not have a proper diagnosis of your problem and you could end up buying the wrong medicine for your condition. Don’t put yourself at risk.