Section 4.4: Hyperglycemia and diabetes Metabolic changes:

 Metabolic changes associated with GnRH agonist may also include fatty liver disease.

Severe cutaneous adverse reactions: severe cutaneous adverse reactions (SCARs) including StevensJohnson syndrome (SJS), and Toxic epidermal necrolysis (TEN) which can be life-threatening or fatal, have been reported in association with leuprorelin treatment. At the time of prescription patients should be advised of the signs and symptoms and monitored closely for severe skin reactions. If signs and symptoms suggestive of these reactions appear, leuprorelin should be withdrawn immediately and an alternative treatment considered (as appropriate).

Section 4.8:  unknown:  Stevens-Johnson syndrome/Toxic Epidermal Necrolysis (SJS/TEN) (see section 4.4), Toxic Skin Eruption, Erythema Multiforme

Section 10: October 2024

Section 2: • If you have fatty liver.

Severe skin rashes including Stevens-Johnson syndrome, Toxic Epidermal Necrolysis (SJS/TEN) have been reported in association with leuprorelin. Stop using leuprorelin and seek medical attention immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.

Section 4: • Reddish non-elevated, target-like or circular patches on the trunk, often with central blisters, skin peeling, ulcers of mouth, throat, nose, genitals and eyes. These serious skin rashes can be preceded by fever and flu- like symptoms (Stevens-Johnson syndrome/Toxic Epidermal Necrolysis)

• Skin redness and itchy rash (Toxic skin eruption)

• A skin reaction that causes red spots or patches on the skin, that may look like a target or "bulls-eye" with a dark red centre surrounded by paler red rings (Erythema Multiforme)

Section 6:  10/2024

Updates for new administration device

SmPC sections 6.5 and 6.6 updated with details of new administration device

section 2 - warnings and precautions - add a warning on Idiopathic intracranial hypertension

section 4 - possible side effects - amend the adverse reaction Idiopathic intracranial hypertension to a frequency of ‘Not known’

section 2 - warnings and precautions - add a warning on Idiopathic intracranial hypertension

section 4 - possible side effects - amend the adverse reaction Idiopathic intracranial hypertension with a frequency of ‘Not known’

section 4.4 - add a warning on Idiopathic intracranial hypertension

section 4.8 - amend the adverse reaction Idiopathic intracranial hypertension to a frequency of ‘Not known’