a) What is Pharmacovigilance?
Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem [World Health Organization (WHO). The importance of pharmacovigilance: safety monitoring of medicinal products. Genève: WHO; 2002].
The purpose of pharmacovigilance is preventing harm from adverse reactions in humans arising from the use of authorised medicinal products within or outside the terms of marketing authorisation or from occupational exposure; and promoting the safe and effective use of medicinal products, in particular through providing timely information about the safety of medicinal products to patients, healthcare professionals and the public. to monitor medicinal products in order to prevent harm from adverse reactions arising from their potential or proven use. This consists in collecting information useful for the monitoring of medicinal products, such as information on suspected adverse reactions arising from the use of a given product, in accordance with the conditions of use established by the doctor or his marketing authorization, as well as any other use resulting from overdose, misuse, abuse, administration error, occupational exposure, use during pregnancy or breastfeeding or paternal exposure.
b) What is an adverse event?
An adverse event is any untoward medical occurrence in a patient administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
c) What is an adverse reaction to the drug or a side effect?
An adverse drug reaction or side effect is a harmful and unintentional reaction that occurs in a patient after taking or using a medication. In the case of an adverse reaction or side effect there is at least a possible causal relationship with the intake or use of the drug.
d) Why report an adverse event/adverse reaction or side effect?
By reporting adverse events/side effects, you will help to ensure the safety of our products and therefore of our patients. Your information also helps us comply with reporting obligations to health authorities. Please also report any case of overdose, misuse, abuse, administration error, occupational exposure, use during pregnancy or breastfeeding or paternal exposure even if no adverse event/side effect occurred.

e) What information is required to report an adverse event/side effect?
Where possible, the report should include the following information:

• Information about the person who had the adverse reaction (such as age and gender);
• A description of the adverse reaction;
• The dose and name of the medicinal product suspected of causing the adverse reaction;
• The batch number of the medicinal product (indicated on the package);
• Any other medicinal product/vaccine taken/administered during the same period (including non-prescription medicines, herbal medicines and contraceptives);
• Any other health problem of the person who had the adverse reaction.

f) What happens to the information/data provided when reporting a side effect?
Ensuring patient safety is extremely important to Dr. Reddy's, and so we take steps to ensure the safety of our products. Dr. Reddy's must be able to contact people who ask us for information about our products for follow-up purposes, collect additional information, answer questions or send requested information material. Our pharmacovigilance privacy policy applies to all information collected about the user of our products online, by telephone, e-mail, fax, post or by third parties, such as doctors, relatives etc. in relation to the reporting of any adverse event, side effect or quality issue on Dr. Reddy's products.

Data Protection Notice: All information and personal data provided will be collected, processed, and stored by Dr. Reddy's to the extent necessary in accordance with the statutory provisions on data protection. If you do not wish to do so, you can object to this data processing at any time. In this case, please contact us.