Alesse (Levonorgestrel / Ethinyl estradiol)

Alesse (Levonorgestrel / Ethinyl Estradiol): Patient Information for Australia

Basic Product Information

Mechanism of Action

For Patients: Alesse is a combined oral contraceptive pill (COCP), containing two hormones, levonorgestrel (a progestogen) and ethinyl estradiol (an oestrogen). Together, they prevent pregnancy by stopping the release of an egg each month (ovulation), thickening the cervical mucus (making it harder for sperm to reach an egg), and changing the lining of the womb to make it less likely for an egg to implant.

For Specialists: Levonorgestrel acts as a potent progestin, exerting negative feedback on the hypothalamic-pituitary-gonadal axis, leading to suppressed luteinising hormone (LH) and follicle-stimulating hormone (FSH) secretion, and ultimately inhibiting ovulation. Ethinyl estradiol supports endometrial stability and further suppresses gonadotropin release.

Pharmacokinetics

• Absorption: Both levonorgestrel and ethinyl estradiol are nearly completely absorbed after oral administration. Bioavailability of levonorgestrel is ~100%, and ethinyl estradiol is ~40-45% due to first-pass hepatic metabolism.
• Metabolism: The main site is the liver. Levonorgestrel is mainly metabolised via CYP3A4, and ethinyl estradiol via CYP3A4 and CYP2C9.
• Elimination: Metabolites are excreted chiefly via urine and faeces.
• Half-life: Levonorgestrel ~24 hours; Ethinyl estradiol ~13 hours.
• Duration of effect: Suppressive effect on ovulation lasts throughout a 21-day active pill cycle, with contraceptive efficacy provided if pills are taken correctly and regularly.

Use in Everyday Life & Best Practices

Alesse is used to prevent pregnancy. It may also be prescribed in Australia for managing acne, regulating menstrual cycles, reducing period pain, and treating symptoms of polycystic ovary syndrome (PCOS), under clinical supervision.

1. Start taking Alesse on the first day of your period (Day 1 start) or on the first Sunday after your period begins (Sunday start).
2. Swallow one tablet daily, at the same time each day, for 21 consecutive days, followed by a 7-day tablet-free interval (or 7 days of placebo tablets, depending on the packaging).
3. Begin the next pack after the 7-day break even if you are still bleeding.
4. If you miss a pill, follow the missed pill instructions provided in the Patient Information Leaflet or contact your doctor or pharmacist for advice.

For optimal effectiveness, avoid missing doses. Using a phone alarm or daily calendar can help you stay on track.

Dosing in the Morning vs Evening

• Taking your pill at the same time daily is most important—choose a time that fits easily with your usual routine in Australia.
• Morning dose: May be easier to remember if you incorporate it with breakfast. However, some people may experience mild nausea.
• Evening dose: May reduce any stomach upset as you are less active, but risks forgetting if you are out or your routine varies.
• Consistency matters more than timing—pick one and stick with it.

Taking With Food or on an Empty Stomach

• Alesse can be taken with or without food, depending on your preference.
• Taking with food or after a meal may lessen any mild stomach upset or nausea, especially when starting.
• There are no significant diet-related restrictions in Australia, but maintaining a balanced diet supports overall health.

Interaction Warnings

• If you start a new medicine, always check with your GP or pharmacist to confirm no impact on your contraceptive pill.

Indications

Dosing According to Clinical Indications

Safety Profile & Side Effects

Most women use Alesse without significant issues. However, side effects can occur, especially during the first few cycles.

• Women who smoke and are over 35, are overweight, or have a family history of clotting disorders have a higher risk of complications.
• Avoid if current or past blood clot, certain heart conditions, or hormone-sensitive cancers (discuss with doctor).

Guidelines for Proper Use

• Always store Alesse in a cool, dry place below 25°C away from direct sunlight and children.
• If vomiting or severe diarrhoea occurs within a few hours after taking your pill, take another dose as soon as possible.
• See your GP every 12 months for a pill review and blood pressure check.
• Discuss options if you wish to switch brands or stop contraception.
• Contact your pharmacist or Family Planning NSW for further advice specific to your needs.

Alternative Treatment Options

• Other combined oral contraceptives (COCPs): Yaz, Yazmin, Norimin, Brevinor—similar efficacy and use; side effect profiles and affordability may differ.
• Progestogen-only pill (Minipill): May be suitable for those who cannot take oestrogen; must be taken at the same time daily.
• Long-acting reversible contraceptives (LARC): Implanon NXT (implant), Depo-Provera (injection), Mirena/Kyleena (IUD); highest efficacy, less reliance on daily action.
• Non-hormonal: Copper IUD, condoms—rely on patient use; may be preferred in specific medical contexts.

Considerations: All alternatives are available with prescription or through specialist clinics in Australia, often partially subsidised under the Pharmaceutical Benefits Scheme (PBS).

Legal, Registration, and Reimbursement Status in Australia

• Registered with the Therapeutic Goods Administration (TGA).
• Schedule 4 (S4): Prescription-only medicine; not available as over-the-counter.
• Partially reimbursed under the Pharmaceutical Benefits Scheme (PBS) for approved brands and indications.
• Dispensing by registered pharmacists only, upon receipt of a valid Australian prescription.
• Follow state and territory laws regarding telehealth or online prescribing.

Latest Research & Clinical Guidance (2022–2025)

• Australian clinical guidelines (RACGP, Family Planning NSW) continue to recommend combined oral contraceptives, like Alesse, as an effective first-line choice for pregnancy prevention in medically eligible women (Stewart M et al., Aust J Gen Pract 2023).
• Recent evidence supports continued review of cardiovascular risk and regular assessments of risk factors (e.g. blood pressure, migraine, smoking) while using COCPs (Faculty of Sexual and Reproductive Healthcare, UK, 2022; FSRH Guideline: Combined Hormonal Contraception).
• There is no significant new evidence of increased cancer risk compared to previous decades, and the overall benefits of reliable contraception and cycle control remain substantial (Cancer Council Australia, updated 2024).
• References:
  – Stewart M, et al. “Contraception in General Practice,” Aust J Gen Pract, 2023.
  – FSRH. “Combined Hormonal Contraception,” Faculty of Sexual & Reproductive Healthcare, 2022–2024.
  – Cancer Council Australia. “Contraceptive Hormones and Cancer Risk,” 2024 Update.

Availability and Delivery

Alesse is widely stocked across Australian pharmacies. Always have a valid prescription for new supplies.

Frequently Asked Questions (FAQ)

1. How quickly does Alesse become effective in preventing pregnancy?
   If started on Day 1 of your period, Alesse is effective immediately. If started at any other time, use additional contraception (such as condoms) for 7 days.
2. What should I do if I miss a pill?
   Take the missed pill as soon as possible, even if it means taking two on the same day. Continue your pack as usual, and use additional contraception if more than one pill is missed or for further advice consult your pharmacist or GP.
3. Can Alesse help with acne or heavy periods?
   Yes, Alesse and similar COCPs are often used to help regulate cycles, reduce flow, and manage acne. Off-label use should be under your doctor’s guidance.
4. Are there any risks with long-term use?
   Long-term use is generally safe for most healthy, non-smoking women under 50. Smokers over 35 and women with certain conditions may have increased risks; annual GP review is recommended.
5. What happens if I want to become pregnant?
   You can usually become pregnant soon after stopping Alesse. Cycles typically return to normal within a few weeks, though in some cases it may take a couple of months.

For detailed advice, consult your healthcare provider or speak with your community pharmacist for support specific to Australian regulations and your personal circumstances.