Reporting an Event (or suspected Adverse Reaction) to Teva Pharmacovigilance / medicines safety

Patients are in an ideal position to identify the impact of medicines they have taken, particularly on their quality of life. Systems for patients/caregivers/consumer reporting are an important tool to facilitate and encourage ‘spontaneous reporting’, which in turn contributes to the overall knowledge of the safety of a medicine and the patient experience. The patients’ role in reporting adverse reactions due to medicinal products is a key element in building an improved system of pharmacovigilance and the participation of patients is now at the core of the new medicines safety monitoring in Europe.

Most of us will not experience any problems when using medicines. However, all medicines have some risks associated with their use and so a small number of people may experience an adverse reaction (also known as a side effect).

What is an adverse reaction (side effect)?
An adverse reaction is formally defined as a ‘response to a medicinal product which is noxious and unintended’.

Of note, the scope of the definition also includes other important safety information (often referred to as ‘special situations’ or ‘special safety reporting situations’) which is considered valuable information to be reported, even if a side effect has not occurred. This includes; Pregnancy/Breastfeeding (including paternal exposure), Misuse/abuse, Overdose, Medication error, Lack of effect, Off-label use, Occupational exposure and transmission of an infectious agent.

Where can I get information on 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 chances 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 I know if I 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.

 

Why should I report a side effect?

Patients/caregivers and consumers are encouraged to report suspected side effects so that we have more information available about the use of medicines. This helps us to monitor their safety. When we get a report of a suspected side effect, we review all the details including the possible impact of the medicine. If we think that the medicine has played a part, we examine to see if this may be a new safety concern or if similar cases have been reported. Anonymised information concerning side effects is also shared with the Regulatory Authorities in order to identify emerging safety issues regarding medicinal products. Where a serious safety issue emerges with a medicine, the Authorities work with the Marketing Authorization Holders in order to change the way the medicine is used. If there is a risk to public health, the Authorities may suspend the use of a medicine.

 

What can I 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 Teva medicine that has a black triangle, please report it to your doctor, pharmacist or directly to Teva Ireland. It is important that all safety information about the use of the medicine is quickly reviewed.

 

What should I do if I think I have had a side effect due to a Teva medicine?

If you are worried that you may have had a side effect to a Teva 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 Health Products Regulatory Authority (HPRA) in Ireland.

 

You can also report a side effect concerning a Teva medicinal product directly to Teva Ireland as follows;

 

Web: www.teva.ie line reporting form: Patient/Caregiver Reporting form or Healthcare Professional Reporting form

Email: safety.ireland@teva.ie

Phone: +353(51) 321538

Fax: +353(51) 359805

Post: Teva Pharmaceuticals Ireland, Pharmacovigilance Department, Floor 1, Wing A, Building 1, Finnabair Business & Technology Park, Dundalk, Co. Louth.