MICRONELLE

What it is

Micronelle 20 ED 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. The product comprises plain, round, pink film-coated active tablets and plain, round, white film-coated placebo tablets.

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, taken continuously for 28 consecutive days, starting with a pink active tablet from the green area of the pack. Each subsequent pack is to be started the day after the last tablet of the previous 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

The use of any combined hormonal contraceptive increases the risk of venous thromboembolism (VTE) compared with no use, with the highest risk in the first year of use and some evidence of increased risk when restarting after a break of 4 weeks or more. Products containing levonorgestrel, such as Micronelle 20 ED, are associated with the lowest risk of VTE. Epidemiological studies have associated combined hormonal contraceptive use with an increased risk for arterial thromboembolism such as myocardial infarction, angina pectoris, stroke or transient ischaemic attack, which may be fatal, and this risk increases in women with risk factors. A meta-analysis reported a slightly increased relative risk of having breast cancer diagnosed in women currently taking combined oral contraceptives, with the excess risk gradually disappearing during the 10 years after cessation of use. In rare cases, benign liver tumours and even more rarely malignant liver tumours have been reported in users of combined oral contraceptives, and in isolated cases these have led to life-threatening intra-abdominal haemorrhages. The efficacy of combined oral contraceptives may be reduced in the event of missed pink active tablets, vomiting or diarrhoea during active tablet taking, or concomitant medication.

Contraindications

Micronelle 20 ED should not be used in the presence of current or history of venous thromboembolism, known hereditary or acquired predisposition for venous thromboembolism, major surgery with prolonged immobilisation, or a high risk of venous thromboembolism due to multiple risk factors. It is also contraindicated in current or history of arterial thromboembolism, known hereditary or acquired predisposition for arterial thromboembolism, history of migraine with focal neurological symptoms, or a high risk of arterial thromboembolism due to multiple risk factors or serious risk factors such as diabetes with vascular symptoms, severe hypertension or severe dyslipoproteinaemia. Micronelle 20 ED is contraindicated in the presence or history of severe hepatic disease as long as liver function values have not returned to normal. It is contraindicated for concomitant use with hepatitis C antiviral medicinal products including glecaprevir, pibrentasvir, sofosbuvir, velpatasvir, voxilaprevir, ombitasvir, paritaprevir or dasabuvir and combinations of these. Micronelle 20 ED should not be used in the presence or history of malignant conditions of the genital organs, breasts or other organs if sex steroid-influenced, undiagnosed vaginal bleeding, known or suspected pregnancy, or hypersensitivity to any ingredients.

Regulatory history

Micronelle 20 ED was first registered on the Australian Register of Therapeutic Goods on 31 January 2014 with ARTG number 211154.