Medicine information
Uses & overview
RELUGOLINE 40/1/0.5 is a hormonal combination formulation from Steris Healthcare containing Relugolix 40 mg, Estradiol 1 mg, and Norethindrone Acetate 0.5 mg per tablet. This combination contains a gonadotropin-releasing hormone (GnRH) receptor antagonist alongside oestrogen and progestin components. Relugolix reduces hormonal signals that stimulate ovarian hormone production, while estradiol and norethindrone acetate provide add-back hormones intended to mitigate certain effects associated with reduced oestrogen levels. Key Product Features Brand Name: RELUGOLINE 40/1/0.5 Composition: Relugolix 40 mg + Estradiol 1 mg + Norethindrone Acetate 0.5 mg Company Name: Steris Healthcare Dosage Form: Tablets Therapeutic Category: GnRH receptor antagonist with hormonal add-back therapy Route of Administration: Oral, subject to the approved product label Use: For approved indications under medical supervision Uses of RELUGOLINE 40/1/0.5 Tablets Relugolix combined with estradiol and norethindrone acetate is used in certain approved markets for the management of heavy menstrual bleeding associated with uterine fibroids. Related relugolix combination formulations may have additional approved indications, depending on the product and country. Uterine fibroids are non-cancerous growths of the uterus that can contribute to heavy menstrual bleeding, pelvic discomfort, and anaemia. Treatment suitability depends on symptom severity, medical history, reproductive plans, and the healthcare professional's assessment. The approved indications for RELUGOLINE 40/1/0.5 must be confirmed against the product's local registration and prescribing information before publication. How the Ingredients Work Relugolix 40 mg: Relugolix blocks GnRH receptors in the pituitary gland, reducing hormonal signals involved in ovarian hormone production. Estradiol 1 mg: Estradiol is an oestrogen that helps replace some of the oestrogen reduced by GnRH antagonist treatment. Norethindrone Acetate 0.5 mg: Norethindrone acetate is a progestin included alongside oestrogen as part of hormone add-back therapy. The combination is designed to balance treatment effects and certain risks associated with reduced oestrogen levels. Important Safety Information This combination is not suitable for everyone. Depending on the approved product information, contraindications may include pregnancy, undiagnosed abnormal uterine bleeding, certain hormone-sensitive cancers, osteoporosis, liver disease, and an increased risk of blood clots or cardiovascular events. Possible adverse effects may include hot flushes, headache, mood changes, abnormal uterine bleeding, and changes in bone mineral density. Oestrogen-containing medicines can increase the risk of blood clots in certain patients. Before starting treatment, inform your healthcare professional about your medical history, smoking status, migraine history, blood pressure, bone health, liver function, and all medicines or supplements you use. Your doctor may recommend pregnancy testing and appropriate monitoring during treatment. Seek urgent medical attention if you develop sudden chest pain, difficulty breathing, severe headache, sudden visual changes, or painful swelling in one leg.
How to use
Take RELUGOLINE 40/1/0.5 Tablets exactly as prescribed by your healthcare professional. Follow the approved product label for the dosage, timing, and duration of treatment. Your doctor may recommend pregnancy testing and monitoring of bone health or other clinical parameters. Do not change the dose or discontinue treatment without medical advice, and inform your healthcare professional about all other medicines you take.
Storage
Store RELUGOLINE 40/1/0.5 Tablets according to the storage instructions printed on the product packaging. Keep the tablets in their original packaging and protect them from excessive heat and moisture. Keep the medicine out of the reach of children. Do not use the tablets after the expiry date or if the packaging is damaged.
