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MIRCETTE DRUG INFORMATION, ABOUT MIRCETTE®

IMPORTANT WARNING

WHAT IS MIRCETTE?

Mircette is an oral contraceptive used to prevent pregnancy.

HOW TO USE MIRCETTE

Use an alternative contraception method for the first month after you begin taking Mircette.

Begin taking your Mircette tablets on the first Sunday after you begin your period or on the first day of your period.

Take Mircette tablets by mouth. Decide on a suitable time of day to take the tablets. This will help you remember to take them. Always take them at the same time of day and in the order directed. (Start with tablet #1 and continue sequentially.)

Swallow the tablets with a glass of water. Take with food if they cause stomach upset. Do not take Mircette more often than directed.

Keep an extra month's supply on hand to ensure that you will not miss the first day of the next cycle.

Contact your pediatrician or health care professional regarding the use of this medicine in children or teenagers. Special care may be needed.

MIRCETTE SIDE EFFECTS

Severe Mircette side effects are relatively rare in women who are healthy and do not smoke while taking oral contraceptives. Many of the minor side effects will go away as your body adjusts. The potential for severe Mircette side effects does exist, however. Discuss the risks with your health care provider.

The following possible Mircette side effects may be related to blood clots. Get medical help immediately. Call 911.

• chest pain
• leg, arm or groin pain
• dizziness or fainting spells
• coughing up blood
• stomach pain (severe)
• severe or sudden headaches
• sudden loss of coordination, especially on one side of the body
• sudden shortness of breath
• rapid weight gain
• swelling of the hands, feet or ankles
• weakness or numbness in the arms or legs, especially on one side of the body.
• vision or speech problems

Other serious Mircette side effects are rare. Contact your doctor as soon as you can if the following side effects occur

• headaches or migraines
• breast tissue changes or discharge
• changes in vaginal bleeding during your period or between your periods
• increases in blood pressure, especially if you are known to have high blood pressure
• increases in blood sugar, especially if you have diabetes
• symptoms of vaginal infection (unusual discharge, itching or irritation)
• yellowing of the eyes or skin
• vomiting
• tenderness in the upper abdomen

Report these Mircette side affects to your doctor if they continue or are bothersome:

• breakthrough bleeding and spotting that continues beyond the first 3 cycles of pills
• breast tenderness
• mild stomach upset or nausea
• mood changes, anxiety, depression, anger, frustration or emotional outbursts
• increase or decrease in appetite
• weight gain
• increased sensitivity to sun or ultraviolet light
• acne, skin rash or brown spots on your skin
• fatigue

PRECAUTIONS

Tobacco smoking increases the risk of developing a blood clot or having a stroke while you are taking Mircette. This is especially true if you are more than 35 years old. You are strongly advised not to smoke.

Visit your doctor for regular monitoring of your progress at least every 6 to 12 months.

If you have any unusual vaginal bleeding contact your doctor for advice.

If you miss a period, there is a possibility you are pregnant. See your doctor as soon as you can.

Use an additional method of contraception during the first month that you take Mircette.

If you stop taking Mircette and want to become pregnant, a return to normal ovulation can take some time, possibly 3 to 6 months. Discuss your pregnancy plans with your doctor.

If you are taking oral contraceptives for the treatment of acne, endometriosis, other hormone related problems or hirsutism (male-like hair growth), it may take several months of continued treatment to notice improvement.

The use of oral contraceptives can increase sensitivity to the sun and you may burn more easily. Use sunscreen and protective clothing if you are outside for long periods. Tanning booths should be used with great caution.

If you wear contact lenses, you may notice visual changes. Or the lenses begin to feel uncomfortable. Consult your eye doctor.

Swelling, tenderness or minor bleeding of the gums may occur. Notify your dentist if this happens. Brush and floss your teeth regularly to help limit this. Make regular visits to your dentist. Inform him or her of the medicines you are taking.

You may develop a vaginal yeast infection. If you have had yeast infections before and are comfortable with self-medicating, get and use a nonprescription medication to treat the yeast infection. Otherwise, see your doctor to confirm the problem and get treatment.

If you have scheduled elective surgery, you may need to stop taking your contraceptive pills one month ahead. Consult your doctor for advice prior to scheduling the surgery.

Contraceptive pills do not protect against HIV infection (AIDS) or any other sexually transmitted diseases.

MIRCETTE DRUG INTERACTIONS

• antibiotics or medicines for infections, especially:
  
  
  • rifampin
  • rifabutin
  • rifapentine
  • griseofulvin
    
    
• aprepitant
• bosentan
• barbiturate medicines for producing sleep or treating seizures (convulsions)
• caffeine
• carbamazepine
• cyclosporine
• clofibrate
• dantrolene
• hydrocortisone
• anxiety or sleeping disorder medicines, such as diazepam or temazepam
• depression medicines
• diabetes medicines, including troglitazone and pioglitazone
• itonavir or other medicines for the treatment of the HIV virus or AIDS
• modafinil
• mineral oil
• mycophenolate
• nefazodone
• oxcarbazepine
• phenytoin
• rednisolone
• selegiline
• soy isoflavones supplements
• St. John's wort
• tamoxifen or raloxifene
• topiramate
• theophylline
• warfarin

Tell your doctor about all other medicines you are taking, including non-prescription medicines, herbal products and nutritional supplements. Also tell your doctor if you frequently drink beverages with caffeine or alcohol, if you smoke, or if you use illegal drugs. These may affect the way Mircette works.

Check before stopping or starting any of your medications.

MIRCETTE DIETARY PRECAUTIONS

Avoid grapefruit juice and caffeine.

NOTES

Your doctor needs to know if you have or ever had any of these conditions

• blood sugar problems, such as diabetes
• blood clots
• cancer of the breast, ovary, cervix, uterus or vagina
• depression
• fibroids
• gallbladder disease
• high blood pressure
• heart or circulation problems
• jaundice
• liver disease
• migraine headaches
• menstrual problems
• stroke
• tobacco smoker
• unusual vaginal bleeding that has not been evaluated by a doctor
• an unusual or allergic reaction to estrogen/progestin or other hormones
• an unusual or allergic reaction to any medicines, foods, dyes or preservatives

MIRCETTE and PREGNANCY

Tell your doctor if you are pregnant or trying to get pregnant.

MIRCETTE and BREAST FEEDING

Tell your doctor if you are breast feeding.

MISSED DOSE

It is important not to miss a dose. However, if you do, you will need to contact your doctor for specific instructions based on which tablets have been missed, how many days they have been missed based on what week of your current cycle you are taking tablets.

STORAGE

Keep out of the reach of children.

Store at room temperature between 59 and 86 degrees F (15 and 30 degrees C). Keep container tightly closed. Throw away any unused Mircette after the expiration date.

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