Consumer information: Synphasic®

What is Synphasic Used For?

• Synphasic® is a combination oral contraceptive (COC) used to prevent pregnancy.
• It contains norethindrone, a progestin, and ethinyl estradiol, an estrogen.

How Does Synphasic Work?

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

Effectiveness:

• Perfect use: Synphasic is more than 99% effective at preventing pregnancy when taken as directed.
• Typical use: Effectiveness may decrease if pills are missed or taken incorrectly.
• Synphasic does not protect against sexually transmitted infections (STIs). Use condoms for protection against STIs.

Who Should Not Use Synphasic?

• Women who are:
  • Pregnant or suspect pregnancy.
  • Have a history of blood clots, stroke, or heart attack.
  • Have liver disease, breast cancer, or other estrogen-dependent tumors.
  • Have undiagnosed abnormal vaginal bleeding.
  • Over 35 and smoke, as the risk of cardiovascular events increases significantly.

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, especially in women with hypertension, obesity, or diabetes.
• Liver disease: Women with liver disease or tumors should not use Synphasic.

Possible Side Effects:

• Common side effects include:
  • Nausea, vomiting, and headaches.
  • Irregular bleeding or spotting.
  • 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 Synphasic:

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

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 take two pills in one day). No backup contraception is needed.
2. Missed two or more pills:
   • 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 remaining pills and start a new pack.
   • 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: Synphasic may reduce breast milk production and is not recommended for breastfeeding women.
• Take the pill at the same time every day for maximum effectiveness.

Storage Information:

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