Zoely Portal

Minimum product information: Zoely® 2.5mg Nomegestrol acetate / 1.5mg estradiol (as hemihydrate). Indication: Oral contraception. Contraindications: Presence or risk of the following: venous thromboembolism (VTE); arterial thromboembolism (ATE); severe hepatic disease as long as liver function values have not returned to normal; liver tumours (benign or malignant); meningioma. History of migraine with focal neurological symptoms, pancreatitis or a history thereof if associated with severe hypertriglyceridaemia. Known or suspected: sex steroid-influenced malignancies (e.g., of the genital organs or the breasts); pregnancy; hypersensitivity to any of the active substances of ZOELY® or to any of the excipients. Precautions: A medical history/examination prior to initiation. Exclude pregnancy before use. Medical check-ups during use. If any of conditions/risk factors below is present, benefits of the use of ZOELY® should be weighed against possible risks and discussed before using ZOELY®. Risk of VTE, risk of ATE, Neoplasms, Meningioma, Hepatitis C, hypertriglyceridaemia, hypertension, jaundice and/or pruritus related to cholestasis; gallstone formation; porphyria; systemic lupus erythematosus; haemolytic uraemic syndrome; Sydenham’s chorea; herpes gestationis; otosclerosis related hearing loss; (hereditary) angioedema, acute or chronic disturbances of liver function, diabetics, Crohn’s disease, chloasma and galactose intolerance. Interactions: Hepatic metabolism, antibiotics, others: ombitasvir/paritaprevir/ritonavir. Adverse Events: Acne, abnormal withdrawal bleeding, decreased libido, depression, migraine, nausea, metrorrhagia, menorrhagia, breast pain, pelvic pain, weight increase, see PI for others. Dosage: One tablet daily at about the same time. Take with some liquid as needed, and in the order as directed on the package. Based on product information last amended 25th August, 2025.

Sponsored in Australia by Theramex Australia Pty Ltd, ABN 37 623 186 845, 60 Margaret Street, Sydney, NSW 2000. www.theramex.com.au; Date of preparation, September 2025; ZOELY_AU_EN_24429_v1