Consumer information: Zamine™

What is Zamine Used For?

• Zamine™ is a combination oral contraceptive (COC) used for:
  • Preventing pregnancy.
  • Treatment of moderate acne vulgaris in women 16 years and older who desire contraception, have no known contraindications to oral contraceptive therapy, and have achieved menarche.

How Does Zamine 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: Zamine is more than 99% effective at preventing pregnancy when taken as directed.
• Typical use: Missed or late pills may reduce effectiveness.
• Zamine does not protect against sexually transmitted infections (STIs). Use condoms for protection against STIs.

Who Should Not Use Zamine?

• Contraindications include:
  • History or current blood clots, stroke, or heart attack.
  • Liver disease, breast cancer, or other estrogen-dependent cancers.
  • Pregnancy or suspected pregnancy.
  • Severe high blood pressure, diabetes with vascular complications.
  • Women over 35 who smoke.

Warnings and Precautions:

• Smoking increases the risk of serious cardiovascular side effects, particularly in women over 35.
• Zamine may increase potassium levels, especially in women with renal, hepatic, or adrenal insufficiency.
• Increased risk of blood clots, stroke, and heart attack, particularly in women with risk factors such as hypertension, obesity, or diabetes.

Possible Side Effects:

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

When to Start Zamine:

1. Starting after a period:
   • Begin Zamine on Day 1 of the menstrual cycle for immediate protection.
   • If starting later, use backup contraception (such as condoms) for the first 7 days.
2. After childbirth:
   • Non-breastfeeding women can start Zamine 21 to 28 days after delivery. Use backup contraception for the first 7 days if starting later.
3. After miscarriage or abortion:
   • Start Zamine immediately after a first-trimester miscarriage or abortion for immediate 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 required.
2. Missed two pills in a row:
   • Take two pills 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 vomiting or severe diarrhea occurs within 3-4 hours after taking a pill, take another pill as soon as possible.
• Use backup contraception for 7 days.

Other Considerations:

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

Storage Information:

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