Product Related Issues

Reporting an Adverse Event (Side Effect)

An adverse event (or side effect) is any unwanted medical occurrence in a patient who has been given a pharmaceutical product. This can be any unfavourable and unintended sign, symptom, or disease associated with the use of the product. Adverse events should be reported.

If you experience a side effect that causes you concern, please tell your healthcare professional immediately.

Patients and healthcare professionals should report adverse events to the Medicines and Healthcare Products Regulatory Authority (MHRA). Reporting forms and information can be found on the MHRA website.

Adverse events associated with a Novartis product should also be reported to Novartis using the following criteria listed below to ensure it is handled in a manner consistent with the applicable local laws.

• Name of the drug: Description of when the patient started the medication, including dosing strength and frequency (amount and how often, e.g. 40mg twice daily). Any action taken with the medication (e.g. reduced dose, stopped) and impact of that action on the side effect.
• The side effect associated with the drug: Symptom evolution over time. Description of any treatment needed for the side effect. Name of healthcare provider who provided treatment and contact information.
• Your name (optional): Please note that your personal identifying information (e.g. name, email address) will not be shared with the health authorities. Novartis or its agents may contact you for further information about the side effect. If you do not wish to be contacted, you should indicate this in your email.
• Information about the person who experienced the side effect: Any other medical conditions currently ongoing. Medications currently taken (name, dosing strength, frequency, and when medication was started). Gender and age of the person taking medication (optional).
• Country Of incidence: Please specify the country of incidence; Great Britain (GB) or Northern Ireland (NI)

Please report any adverse events to Novartis using the relevant contact details below.