Adverse Reaction Reporting

Please fill in the fields as accurately as possible. If there are fields you cannot fill in, please write "unknown". Fields marked with must be filled in.

Please use the date format DD-MMM-YYYY (Example 25-FEB-2014). If you do not know the exact date, please enter the closest possible date.

If you have further relevant information, please use the field "Additional information".

Reporting side effects on LEO Pharma products

PATIENT INFORMATION
Patient’s initials (only state the first letter in the first name and surname and not the full name):   
Gender: 
 
Pregnant? 
 
Age at the time of the side effect:   
Weight:  
Are you the patient?
 
DRUG INFORMATION
Name of LEO Pharma drug used:  
Lot/batch no. of LEO Pharma drug
(if available):  
Name of the condition for which this LEO Pharma drug was used:   
First date of treatment with the LEO Pharma drug:   
Daily dose of the LEO Pharma drug:  
Has treatment with the LEO Pharma drug been stopped? 
 
If yes, on which date did the treatment stop? 
SIDE EFFECT INFORMATION
Which side effect(s) did the patient experience?  
At what date were the side effect(s) first noticed?  
Describe what happened (how did the side effect(s) start, how did they develop, did the patient seek advice or treatment from a healthcare professional, and how were the side effect(s) treated?):  
Has the patient suffered from the same side effect(s) previously? 
 
If yes, please specify which drug(s) were taken at the time: 
How are the side effect(s) right now? 
 
 
 
Did the side effect(s) following use of the LEO Pharma drug lead to any of the following? 
 
 
 
 
 
If the side effect(s) following use of the LEO Pharma drug led to death, please specify the date the patient died  
OTHER DRUG INFORMATION
Were other drugs taken at the same time as the one where the side effect(s) occurred? 
 
If yes, please list the following information:
a) The name of the drug(s):  
b) The disease(s) for which the drug(s) were taken: 
c) The start date:  
DISEASE INFORMATION
At the time of the side effect(s) to the LEO Pharma drug, was the patient suffering from any other disease, including allergies? 
 
If yes, please describe the following:
a) Disease: 
b) Date started:  
c) Treatment prescribed: 
ADDITIONAL INFORMATION
Please use this field for further relevant information: 
REPORTER INFORMATION
Your name:  
Country:  
Are you a healthcare professional? 
 
If yes, please specify type: 
Email address (a copy of the form will be sent to this email):  
Do you agree to be contacted again for further information, if necessary? 
 

Please press the “send” button in order for LEO Pharma to receive your side effect report.