Consumer Information: Mirvala

What is Mirvala Used For?

• Mirvala® is a combination oral contraceptive (COC) used to prevent pregnancy.
• It contains 0.150 mg desogestrel (a progestin) and 0.030 mg ethinyl estradiol (an estrogen).

How Does Mirvala 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: When taken exactly as directed, Mirvala is more than 99% effective at preventing pregnancy.
• Typical use: Missed or late pills can reduce effectiveness. In typical use, about 1-2 women out of 100 may become pregnant.
• Mirvala does not protect against sexually transmitted infections (STIs). Use condoms for STI protection.

Who Should Not Use Mirvala?

• Pregnant women or those who suspect pregnancy.
• Women with a history of or current blood clots, heart attack, stroke, or liver disease.
• Those with breast cancer or estrogen-dependent tumors.
• Women with undiagnosed abnormal vaginal bleeding, severe high blood pressure, or diabetes with vascular complications.
• Smokers over the age of 35, as smoking increases the risk of serious cardiovascular events.

Warnings and Precautions:

• Smoking increases the risk of serious cardiovascular side effects, especially in women over 35.
• There is an increased risk of blood clots, stroke, and heart attack, particularly in women with other risk factors such as obesity, hypertension, and diabetes.
• Liver disease: Women with liver problems should not use Mirvala, and those with a history of liver tumors should avoid this medication.

Possible Side Effects:

• Common side effects include:
  • Nausea, vomiting, and headaches.
  • Irregular bleeding or spotting between periods.
  • Breast tenderness or enlargement.
  • Weight changes and mood swings.
• Serious side effects (less common):
  • Blood clots (deep vein thrombosis, pulmonary embolism).
  • Stroke or heart attack.
  • Liver tumors.

When to Start Mirvala:

1. Starting after a period:
   • Begin taking Mirvala on Day 1 of the menstrual cycle for immediate contraceptive protection.
   • If starting between Day 2 and Day 7, use backup contraception (e.g., condoms) for the first 7 days.
2. After childbirth:
   • For non-breastfeeding women, start Mirvala 21 to 28 days after delivery. Use backup contraception for the first 7 days if starting later.
3. After miscarriage or abortion:
   • Mirvala can be started immediately after a first-trimester miscarriage or abortion.

Missed Pills:

1. Missed one pill:
   • Take the missed pill as soon as you remember, then take the next pill at your usual time (you may need to take two pills in one day). No backup contraception is needed.
2. Missed two pills in a row:
   • Take two pills on the day you remember, and two pills the next day. Use backup contraception for 7 days.
3. Missed three or more pills:
   • Discard the rest of the pack and start a new one. Use backup contraception for 7 days.

What to Do if You Vomit or Have Diarrhea:

• If you vomit or have severe diarrhea within 3-4 hours of taking a pill, take another pill as soon as possible.
• Use backup contraception for 7 days.

Other Considerations:

• Breastfeeding: Mirvala may reduce breast milk production and is not recommended for breastfeeding women.
• Take the pill at the same time every day to maintain maximum effectiveness.

Storage Information:

• Store Mirvala at 15°C to 30°C in its original packaging, protected from light and moisture.