Consumer information: Haloette®

What is Haloette Used For?

• Haloette® is a vaginal contraceptive ring used for:
  • Preventing pregnancy.
  • It delivers 120 mcg etonogestrel and 15 mcg ethinyl estradiol per day.

How Does Haloette Work?

• Prevents ovulation: Stops the release of an egg from the ovaries.
• Thickens cervical mucus: Makes it harder for sperm to reach the egg.
• Alters the uterine lining: Reduces the likelihood of implantation of a fertilized egg.

Effectiveness:

• Perfect use: Haloette is over 99% effective when used correctly.
• Typical use: Missed usage or incorrect insertion may reduce effectiveness.
• Haloette does not protect against sexually transmitted infections (STIs). Use condoms for protection against STIs.

Who Should Not Use Haloette?

• Contraindications include:
  • History of blood clots, stroke, or heart attack.
  • Severe liver disease, breast cancer, or other estrogen-dependent cancers.
  • Uncontrolled high blood pressure, diabetes with vascular complications, or women over 35 who smoke.

Warnings and Precautions:

• Smoking increases the risk of serious cardiovascular side effects, especially in women over 35.
• Increased risk of blood clots, stroke, and heart attack, particularly in women with risk factors such as hypertension, obesity, and diabetes.
• Hepatic dysfunction: Women with liver disease or tumors should not use Haloette.

Possible Side Effects:

• Common side effects include:
  • Vaginitis, headaches, and nausea.
  • Irregular bleeding, breast tenderness, and weight changes.
• Serious side effects (less common):
  • Blood clots, stroke, and heart attack.
  • Liver tumors and gallbladder disease.

When to Start Haloette:

1. No previous hormonal contraceptive use:
   • Insert Haloette within the first 5 days of the menstrual cycle (Day 1-5).
   • Use backup contraception for the first 7 days of the first cycle.
2. Switching from another hormonal contraceptive:
   • Insert Haloette on the first day after the previous contraceptive (pill, patch, or implant) is discontinued.
   • Do not extend the hormone-free interval of the previous contraceptive.
3. After childbirth:
   • Non-breastfeeding women can start 21-28 days after delivery.
   • Use backup contraception for the first 7 days.
4. After miscarriage or abortion:
   • Haloette can be started immediately after a first-trimester miscarriage or abortion for immediate protection.

Missed Doses or Expulsion:

1. Less than 3 hours:
   • If Haloette is expelled for less than 3 hours, rinse and reinsert as soon as possible. No backup contraception is required.
2. More than 3 hours (Weeks 1 or 2):
   • Reinsert the ring as soon as possible.
   • Use backup contraception for 7 days.
3. More than 3 hours (Week 3):
   • Discard the ring and insert a new one immediately or after a 7-day withdrawal bleed.
   • Use backup contraception for 7 days.

Other Considerations:

• Breastfeeding: Haloette is not recommended during breastfeeding as it may reduce breast milk production.
• Take care to check the position of the ring regularly, especially before and after intercourse or bowel movements.

Storage Information:

• Store Haloette between 15°C and 30°C, protected from light and moisture.