MICROGYNON

What it is

Microgynon is a combined oral contraceptive tablet containing the synthetic progestogen levonorgestrel and the synthetic estrogen ethinylestradiol. Each pink active tablet contains ethinylestradiol 20 μg and levonorgestrel 100 μg.

Approved indications

— Oral contraception.

Dosing overview

One tablet is to be taken daily in the order directed on the package at about the same time each day, with some liquid as needed. Daily tablet taking should be continuous for 28 consecutive days, starting with a pink active tablet marked with the corresponding day of the week from the green area of the pack. A withdrawal bleed usually starts on day 2 to 3 after starting the white placebo tablets and may not have finished before the next pack is started.

Key safety warnings

Epidemiological studies have suggested an association between the use of combined oral contraceptives containing ethinylestradiol and an increased risk of arterial and venous thrombotic and thromboembolic diseases such as myocardial infarction, cerebrovascular accidents, deep venous thrombosis and pulmonary embolism. The use of any combined hormonal contraceptive increases the risk of venous thromboembolism compared with no use. Women should be advised that the risk is highest in the first ever year of use and there is some evidence that the risk is increased when a combined hormonal contraceptive is re-started after a break in use of 4 weeks or more. Venous thromboembolism associated with combined hormonal contraceptive use is rare in average-risk women. Products that contain levonorgestrel such as Microgynon are associated with the lowest risk of venous thromboembolism. Epidemiological studies have associated the use of combined hormonal contraceptives with an increased risk for arterial thromboembolism such as myocardial infarction, angina pectoris, stroke or transient ischaemic attack. Arterial thromboembolic events may be fatal. The risk of arterial thromboembolic complications increases in women with risk factors. Women with hypertriglyceridaemia, or a family history thereof, may be at an increased risk of pancreatitis when taking combined oral contraceptives. In women with hereditary angioedema, exogenous estrogens may induce or exacerbate symptoms of angioedema.

Contraindications

Microgynon should not be used in the presence of current venous thromboembolism or history of deep venous thrombosis or pulmonary embolism. Known hereditary or acquired predisposition for venous thromboembolism, such as APC-resistance, antithrombin-III-deficiency, protein C deficiency or protein S deficiency, is a contraindication. Current or history of arterial thromboembolism such as myocardial infarction or stroke, or prodromal conditions such as angina pectoris or transient ischaemic attack, are contraindications. History of migraine with focal neurological symptoms is a contraindication. High risk of arterial thromboembolism due to multiple risk factors or the presence of one serious risk factor such as diabetes mellitus with vascular symptoms, severe hypertension or severe dyslipoproteinaemia is a contraindication. Pancreatitis or a history thereof if associated with severe hypertriglyceridaemia is a contraindication. Presence or history of severe hepatic disease as long as liver function values have not returned to normal is a contraindication. Microgynon is contraindicated for concomitant use with glecaprevir, pibrentasvir, sofosbuvir, velpatasvir, voxilaprevir, ombitasvir, paritaprevir or dasabuvir and combinations of these. Known or suspected malignant conditions of the genital organs, the breasts, or other organs, if sex steroid-influenced, are contraindications. Undiagnosed vaginal bleeding is a contraindication. Known or suspected pregnancy is a contraindication. Hypersensitivity to any of the ingredients is a contraindication.

PBS listing

In November 2017, the PBAC recommended an amendment to the current PBS listing to allow levonorgestrel and ethinylestradiol to be used for oral contraception.

Regulatory history

Microgynon 20 ED was first listed on the ARTG on 16 November 1998.