Summary:

• Medicinal products containing chlormadinone acetate (5-10 mg/tablet) or nomegestrol acetate (3.75 -5 mg/tablet) are only indicated when other interventions are considered inappropriate. Treatment should be restricted to the lowest effective dose and shortest duration.
• There is an increased risk for developing meningioma (single or multiple) after use of chlormadinone acetate or nomegestrol acetate, primarily at high doses over prolonged time. The risk increases with cumulative doses.
• Products containing chlormadinone acetate or nomegestrol acetate are contraindicated in patients with a meningioma or a history of meningioma.
• Patients should be monitored for meningiomas in accordance with clinical practice.
• If a patient treated with chlormadinone acetate or nomegestrol acetate is diagnosed with meningioma, treatment must be permanently stopped.