• By electronic means using the online form at www.polpharma.pl 
• By phone at: +48 22 364 61 00
• By email to the address: phv@polpharma.com
• By letter to the address:

Zakłady Farmaceutyczne „POLPHARMA”, office in Warsaw
6 Bobrowiecka Str.
00-728 Warsaw, Poland
Dział Nadzoru Nad Bezpieczeństwem Farmakoterapii (Pharmacovigilance & Medical Information Department)

• By fax:+48 22 364 61 66

Details of the person experiencing the adverse reaction

Specify patient’s identifiers, e.g. initials, gender or age. Also, information on height and body mass are helpful – in particular for children and adults with atypical height or body mass.

Product details

Specify the name of the drug, cosmetic or medical device suspected of causing the adverse reaction. A situation may arise where the patient is taking more than one product. In such a situation, specify the names of all used products. Information on the product dose is important, e.g. 200 mg tablet or 5 mg/ml syrup, and the manner of drug use – how many times a day and in what doses. Some products are used chronically. It is worth mentioning this. It is important because if the patient has been taking the relevant product for years without experiencing any adverse reactions, and if such adverse reactions occur with the start of use of another product, it may be suspected that the adverse reaction is caused by the new product or that the reaction has been caused e.g. by interaction between the products.

Description of the adverse reaction

Describe the reaction in as much detail as possible, including its severity, duration – and, if it subsided, describe whether the reaction subsided on its own or as a result of the administered treatment. It is important to provide the reason for drug use, e.g. toothache, stomach ailments, hypertension, etc. If the reaction did not subside, specify whether it is receding or intensifying, whether any treatment is being administered, whether the product has caused any lasting effects in the patient.

Reporting person’s details

Specify the details, including forename, surname, full address or telephone number or email.

Additional information

If such details are available, specify whether the product which caused the adverse reaction had already been used in the past and whether also then it caused a similar reaction. Information on patient’s allergies is important as well. If the report concerns an adverse reaction in a newborn, specify the names of the products taken by the child’s mother during pregnancy. Not always all the details are available at the time of submitting the case report. In such a case, any additional information should be provided once it becomes available. It is recommended to specify whether this information is supplementary to any case report that has already been submitted.

source: website of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

Patients or their caregivers may report adverse events to:

• a physician, pharmacist, nurse or other healthcare professionals
• the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (www.urpl.gov.pl)
• a pharmaceutical company responsible for the drug

Healthcare professionals (a physician, pharmacist, nurse) are required to report adverse events to:

• the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (www.urpl.gov.pl)
• a pharmaceutical company responsible for the drug.