Reporting Side Effects to LEO Pharma UK and Ireland

Please fill in the fields as accurate as possible. It 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-2022). If you do not know the exact date, please state as close as possible (Example FEB-2022).

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

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Reporting side effects on LEO Pharma products

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? *

Name of LEO Pharma drug used: *

Lot/batch no. of LEO Pharma drug (if available):

Name of the disease 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?

List the side effect(s) experienced by the patient? *

On which date did the side effect(s) start? *

Describe what happened (how did the side effect(s) start):

Has the patient suffered from the same side effect(s) previously?

If yes, please specify which drug(s) was taken at the time:

What is the current outcome of the side effect(s)?

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 the death of the patient, please specify the date on which the patient died

Were other drugs taken at the same time as the side effect(s) occurred?

If yes, please describe the following: a) Disease: b) Date started: c) Treatment prescribed:

Please use this field for any additional information you would like to provide:

Your name: *

Country:

Are you a Health Care Professional?

If yes, please specify type (doctor, pharmacist nurse):

E-mail address (a copy of the form will be sent to this e-mail):

Consent *I hereby certify that I am 18 years of age or older

Data protection *I understand that LEO Pharma will keep and store personal identifiable information as described here.

Report side effects by email

If you experience any side effects, please talk to your doctor, pharmacist or nurse. If you wish to report side effects regarding a LEO Pharma product via email, please address it to: medical-info.uk@leo-pharma.com. Alternatively, you can call +44 (0) 1844 347 333 and press ‘2’ for Medical Information. For LEO Pharma IE, contact +353 1 4908924.

You can also report side effects directly via the national reporting systems:

For the United Kingdom, via the Yellow Card Scheme, visit www.mhra.gov.uk/yellowcard, or search MHRA Yellow Card in the Google Play or Apple App Store.

For Ireland, via HPRA Pharmacovigilance, please email medsafety@hpra.ie

LEO Pharma UK and Ireland are required to record all relevant data to ensure the safety of our products. You can find more information about which data we record, your rights and how data privacy is ensured etc. at www.leo-pharma.co.uk/Home/Terms-of-use/Pharmacovigilance-Notice.aspx and at www.leo-pharma.com. If you have any questions, please contact us via email at medical-info.uk@leo-pharma.com or by telephone on +44 (0) 1844 347 333, pressing '2' for Medical Information. For LEO Pharma IE, contact +353 1 4908924.

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Reporting Side Effects to LEO Pharma UK and Ireland

Reporting side effects on LEO Pharma products

Report side effects by email