Napp Pharmaceuticals Ltd Medicines Information for Members of the Public and Patients

It is important to emphasise that if you (or a family member) are being treated with a Napp product and you have a question or concern about your treatment, it is recommended that you speak to your Healthcare Professional in the first instance, as they will be best-placed to assist you.

Reporting of Side Effects

Patients, their family members, or carers

If you get any side-effects, talk to your doctor, nurse or pharmacist. You can report side effect directly to Napp via email drugsafetyUKandROI@mundipharma.com or to the Medicines and Healthcare  Regulatory Agency (MHRA) via their Yellow card reporting scheme at www.yellowcard.mhra.gov.uk . By reporting side-effects you can help provide more information on the safety of medicines.

Please provide as much information as you can:

• About the person who experienced the adverse event: initials, gender, age or date or birth
• About the person contacting us for this report: your name, contact details and confirmation that we can contact you to request additional information
• About the adverse event: the symptom(s) experienced, when it started, when it stopped or if it is still ongoing
• About the Napp medicinal product involved: product name, dose being taken, Lot or Batch Number, and date treatment was started and/or stopped.

Napp, Mundipharma and companies within the Mundipharma global network of independent associated companies are required by law to collect certain minimum information relating to persons who have suffered an adverse event to the company’s medicinal product in order to monitor the safety of its medicinal products. This includes reviewing safety data from clinical studies and collecting reports of adverse events. Drug safety staff may contact you if additional information is required to fully document the adverse event report.

All the information and personal data you share with us will be protected and kept confidential in line with our Data Privacy Policy and local regulations and guidance. Your information will be used for the purpose of drug safety surveillance and to enable us to deal with your enquiry appropriately.

The information that you share may be shared with health authorities and other third parties who are also responsible for drug safety surveillance. If you are a patient, you can ask someone else (e.g., your doctor or pharmacist) to send the report if you do not wish to give us your name.

The medicines are listed by alphabetical order of the active ingredient. Patient Information Leaflets (PILs) are the most suitable information for patients and public, however you may also review the Summary of Product Characteristics (SmPC) and/or regulatory Assessment Report (AR) if you wish, although both of the document types are primarily intended for Healthcare Professionals.

Due to the UK’s recent exit from the European Union, some medicines now have separate information available for Northern Ireland (NI) and Great Britain (GB), whereas the information for some products is still applicable across the United Kingdom (UK). Please ensure you select the link corresponding to the part of the UK where you are resident.

Medicines marked with an exclamation mark (!) are in the process of being discontinued and may have limited availability. Please speak to your Healthcare Professional if you have any concerns.