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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 an asterisk 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".

To understand how LEO Pharma handles the personal information you provide, please click here to view our privacy statement.

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 * :	Male
	Female
Pregnant? *	Yes
	No

Age at the time of the side effect * :

Weight * :
Are you the patient?	Yes – I am the patient
	No – I am reporting on behalf of someone else

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? *	Yes
	No

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? *	Yes
	No

If yes, please specify which drug(s) were taken at the time:
How are the side effect(s) right now? *	Recovered
	Recovering
	They are still ongoing
	I do not know
Did the side effect(s) following use of the LEO Pharma drug lead to any of the following? *	Admittance to hospital
	Prolongation of an existing hospitalization
	Permanent disability or incapacity that affects daily life and that is not going to improve further
	Birth defect
	Life-threatening situation
	Death of the patient
	None of the above

If the side effect(s) following use of the LEO Pharma drug led to death, please specify the date the patient died. If this does not apply, please leave blank.

OTHER DRUG INFORMATION
Were other drugs taken at the same time as the one where the side effect(s) occurred? *	Yes
	No

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? *	Yes
	No

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? *	Yes
	No

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? *	Yes
	No

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