NORIDAY

What it is

NORIDAY contains 5 mg norethisterone per tablet. Norethisterone is a progestogen with negligible androgenic effects.

Approved indications

— Dysfunctional bleeding — Primary amenorrhoea — Secondary amenorrhoea — Premenstrual syndrome — Delay of menstrual period — Endometriosis — Adjunct to estrogen hormone replacement therapy

Dosing overview

Dosing varies by indication. For dysfunctional bleeding, NORIDAY 1 tablet is to be taken 3 times daily for 10 days. For primary or secondary amenorrhoea, after endometrial priming with an estrogen, 1 tablet of NORIDAY is given 1 to 2 times daily for 10 days. For premenstrual syndrome, one tablet of NORIDAY taken 1 to 3 times daily during the luteal phase of the cycle may relieve or improve premenstrual symptoms. To delay menstruation, the dosage is 1 tablet NORIDAY 2 to 3 times daily for not longer than 10–14 days, beginning about 3 days before the expected menstruation. For endometriosis, treatment should begin between the first and 5th day of the cycle with 1 tablet NORIDAY twice daily, with the dose increasing to 2 tablets twice daily in the event of spotting.

Key safety warnings

The use of oral estrogen/progestogen containing ovulation inhibitors is attended by an increased incidence of thromboembolic diseases, and the possibility of an increased thromboembolic risk should be kept in mind, particularly where there is a history of thromboembolic diseases. In rare cases, benign liver tumours, and even more rarely, malignant liver tumours have been reported in users of hormonal substances such as the one contained in NORIDAY, and in isolated cases, these tumours have led to life-threatening intra-abdominal haemorrhages. Strict medical supervision is necessary if the patient suffers from diabetes. Women with a tendency to chloasma should avoid exposure to the sun or ultraviolet radiation when taking NORIDAY. Because this drug may cause some degree of fluid retention, conditions which might be influenced by this factor, such as epilepsy, migraine, asthma or cardiac or renal dysfunction, require careful observation.

Contraindications

NORIDAY should not be used in the presence of known or suspected pregnancy, lactation, presence or history of venous or arterial thrombotic/thromboembolic events, presence or history of prodromi of a thrombosis, history of migraine with focal neurological symptoms, diabetes mellitus with vascular involvement, severe hepatic disease, presence or history of liver tumours, known or suspected sex hormone-dependent malignancies, hypersensitivity to the active substances or to any of the excipients, Dubin-Johnson syndrome, Rotor syndrome, missed abortion, undiagnosed vaginal or urinary bleeding, or undiagnosed breast pathology.

PBS listing

NORIDAY 350 microgram tablets are listed on the PBS in a pack size of 28 tablets as 1 item with unrestricted access at an ex-manufacturer price of A$10.56.

Regulatory history

NORIDAY 350 microgram tablets were first listed on the ARTG on 11 June 1991.