Mircette

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

You will take your first pill on the first day of your period or on the first Sunday after your period begins. You may need to use back-up birth control, such as condoms or a spermicide, when you first start using this medicine. Follow your doctor's instructions.

Take one pill every day, no more than 24 hours apart. When the pills run out, start a new pack the following day. You may get pregnant if you do not take one pill daily. Get your prescription refilled before you run out of pills completely.

The 28-day-birth control pack contains seven "reminder" pills to keep you on your regular cycle. Your period will usually begin while you are using these reminder pills.

You may have breakthrough bleeding, especially during the first 3 months. Tell your doctor if this bleeding continues or is very heavy.

Use a back-up birth control if you are sick with severe vomiting or diarrhea.

If you need surgery or medical tests or if you will be on bed rest, you may need to stop using this medicine for a short time. Any doctor or surgeon who treats you should know that you are using birth control pills.

While taking birth control pills, you will need to visit your doctor regularly.

Store at room temperature away from moisture and heat.

Do not smoke while taking birth control pills, especially if you are older than 35 years of age.

Birth control pills will not protect you from sexually transmitted diseases--including HIV and AIDS. Using a condom is the only way to protect yourself from these diseases.

This section provides information on the proper use of a number of products that contain estrogen and progestin combination (ovarian hormone therapy). It may not be specific to Mircette. Please read with care.

Estrogens and progestins usually come with patient information or directions. Read them carefully before taking this medicine.

Take this medicine only as directed by your doctor. Do not take more of it and do not take or use it for a longer time than your doctor ordered. Try to take the medicine at the same time each day to reduce the possibility of side effects and to allow it to work better.

For patients taking estrogens and progestins by mouth:

• Nausea may occur during the first few weeks after you start taking estrogens. This effect usually disappears with continued use. If the nausea is bothersome, it can usually be prevented or reduced by taking each dose with food or immediately after food.

Dosing

The dose medicines in this class will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of these medicines. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For 17 beta-estradiol and norgestimate
• For oral dosage forms (tablets):
  • For treating a genital skin condition (vaginal or vulvar atrophy), or vasomotor symptoms of menopause:
    • Adults—Oral, 1 mg estradiol for three days followed by 1 mg of estradiol combined with 0.09 mg of norgestimate for three days. The regimen is repeated continuously without interruption.
  • To prevent loss of bone (osteoporosis):
    • Adults—Oral, 1 mg estradiol for three days followed by 1 mg of estradiol combined with 0.09 mg of norgestimate for three days. The regimen is repeated continuously without interruption.

For ethinyl estradiol and norethindrone
• For oral dosage forms (tablets):
  • For treating vasomotor symptoms of menopause:
    • Adults—Oral, 2.5 mcg (0.025 mg) ethinyl estradiol and 0.5 mg norethindrone once daily.
  • To prevent loss of bone (osteoporosis):
    • Adults—Oral, 2.5 mcg (0.025 mg) ethinyl estradiol and 0.5 mg norethindrone once daily.

For estradiol and norethindrone
• For oral dosage forms (tablets):
  • For treating vasomotor symptoms of menopause or treatment of vaginal or vulvar atrophy:
    • Adults—Oral, 1 mg estradiol and 0.5 mg norethindrone once daily.
  • To prevent loss of bone (osteoporosis):
    • Adults—Oral, 1 mg estradiol and 0.5 mg norethindrone once daily.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Do not keep outdated medicine or medicine no longer needed.

Women rarely have severe side effects from taking estrogens to replace estrogen. Discuss these possible effects with your doctor:

The prolonged use of estrogens has been reported to increase the risk of endometrial cancer (cancer of the lining of the uterus) in women after menopause. This risk seems to increase as the dose and the length of use increase. When estrogens are used in low doses for less than 1 year, there is less risk. The risk is also reduced if a progestin (another female hormone) is added to, or replaces part of, your estrogen dose. If the uterus has been removed by surgery (total hysterectomy), there is no risk of endometrial cancer, and no need to take an estrogen and progestin combination.

It is not yet known whether the use of estrogens increases the risk of breast cancer in women. Although some large studies show an increased risk, most studies and information gathered to date do not support this idea.

Check with your doctor immediately if any of the following side effects occur:

Check with your doctor as soon as possible if any of the following side effects occur:

• Breast pain or tenderness
• dizziness or light-headedness
• headache
• rapid weight gain
• swelling of feet and lower legs
• vaginal bleeding

• Breast lumps
• change in vaginal discharge
• discharge from nipple
• nausea and vomiting
• pains in chest, groin, or leg, especially calf
• pains in stomach, side, or abdomen
• pain or feeling of pressure in pelvis
• severe or sudden headache
• sudden and unexplained shortness of breath
• sudden loss of coordination
• sudden slurred speech
• sudden vision changes
• weakness or numbness in arm or leg
• yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Back pain
• bloating or gas
• dizziness
• general feeling of tiredness
• flu-like symptoms
• mental depression
• muscle aches
• nausea—taking tablet with food may decrease
• vaginitis

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
• Signs of high blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
• Coughing up blood.
• Shortness of breath.
• Chest pain or pressure.
• Very upset stomach or throwing up.
• Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
• Swelling, warmth, numbness, change of color, or pain in a leg or arm.
• Low mood (depression).
• Feeling very tired or weak.
• Very bad belly pain.
• Swelling.
• Bulging eyes.
• Change in how contact lenses feel in the eyes.
• Change in eyesight.
• Not able to pass urine or change in how much urine is passed.
• A lump in the breast, breast soreness, or nipple discharge.
• Vaginal itching or discharge.
• Spotting or vaginal bleeding that is very bad or does not go away.

Mircette® (desogestrel/ethinyl estradiol and ethinyl estradiol tablets) is indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception.

Oral contraceptives are highly effective. Table II lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. Correct and consistent use of these methods can result in lower failure rates.

Serious ill effects have not been reported following acute ingestion of large doses of oral contraceptives by young children. Overdosage may cause nausea, and withdrawal bleeding may occur in females.

Mircette® (desogestrel/ethinyl estradiol and ethinyl estradiol tablets USP), 6 Dispensers x 28 Day Regimen Carton Text

NDC 51285-120-58

6 Tablet Dispensers

28 Day Regimen

Mircette®

(desogestrel/ethinyl estradiol

and ethinyl estradiol

tablets USP)

0.15 mg/0.02 mg and 0.01 mg

TEVA Women’s Health

Mircette (ethinyl estradiol and desogestrel) contains a combination of female hormones that prevent ovulation (the release of an egg from an ovary). This medicine also causes changes in your cervical mucus and uterine lining, making it harder for sperm to reach the uterus and harder for a fertilized egg to attach to the uterus.

Mircette is a birth control pill used for contraception to prevent pregnancy.

Mircette may also be used for purposes not listed in this medication guide.

Follow the patient instructions provided with Mircette. Ask your doctor or pharmacist if you do not understand these instructions. Missing a pill increases your risk of becoming pregnant.

What to do if you miss pills

If you miss 1 "active" [white] pill:

1. Take it as soon as you remember. Take the next Mircette pill at your regular time. This means you take 2 pills in 1 day.
2. You do not need to use a back-up birth control method if you have sex.

If you miss 2 "active" [white] pills in a row in week 1 or week 2 of your pack:

1. Take 2 pills on the day you remember and 2 pills the next day.
2. Then take 1 Mircette pill a day until you finish the pack.
3. You may become pregnant if you have sex in the 7 days after you miss pills.You must use another birth control method (such as condoms, foam, or sponge) as a back-up method for those 7 days.

If you miss 2 "active" [white] pills in a row in week 3:

• If you are a day 1 starter: throw out the rest of the pill pack and start a new pack that same day.
  

• If you are a Sunday starter: keep taking 1 Mircette pill every day until Sunday. On Sunday, throw out the rest of the pack and start a new pack of pills that same day.

• You may not have your period this month but this is expected. However, if you miss your period 2 months in a row, call your doctor or healthcare provider because you might be pregnant.
• You may become pregnant if you have sex in the 7 days after you miss pills. You must use another birth control method (such as condoms, foam, or sponge) as a back-up method for those 7 days.

If you miss 3 or more "active" [white] pills in a row (during the first 3 weeks):

• If you are a day 1 starter: throw out the rest of the pill pack and start a new pack that same day.

• If you are a Sunday starter: keep taking 1 pill every day until Sunday.On Sunday, throw out the rest of the pack and start a new pack of pills that same day.

• You may not have your period this month but this is expected. However, if you miss your period 2 months in a row, call your doctor or healthcare provider because you might be pregnant.
• You may become pregnant if you have sex in the 7 days after you miss pills. You must use another birth control method (such as condoms, foam, or sponge) as a back-up method for those 7 days.

A reminder for those on Mircette 28 day packs: If you forget any of the 2 [light-green] or 5 [yellow] pills in week 4:

• throw away the pills you missed.

• keep taking 1 pill each day until the pack is empty.

• you do not need a back-up method.