药物信息为Junel ™ 21 Day (norethindrone acetate and ethinyl estradiol tablets, USP) Junel ™ Fe28 Day (norethindrone acetate and ethinyl estradiol tablets, USP and ferrous fumarate tablets*)*Ferrous fumarate tablets are not USP for dissolution and assay. (BARR LABORATORIES, INC.): BRIEF SUMMARY PATIENT PACKAGE INSERT

Ads
  • Oral contraceptives, also known as “birth control pills” or “the pill,” are taken to prevent pregnancy and, when taken correctly, have a failure rate of about 1% per year when used without missing any pills. The typical failure rate of large numbers of pill users is less than 3% per year when women who miss pills are included. For most women, oral contraceptives are also free of serious or unpleasant side effects. However, forgetting to take pills considerably increases the chances of pregnancy.

    For the majority of women, oral contraceptives can be taken safely. But there are some women who are at high risk of developing certain serious diseases that can be life-threatening or may cause temporary or permanent disability. The risks associated with taking oral contraceptives increase significantly if you:

    • Smoke
    • Have high blood pressure, diabetes, high cholesterol
    • Have or have had clotting disorders, heart attack, stroke, angina pectoris, cancer of the breast or sex organs, jaundice, or malignant or benign liver tumors.

    You should not take the pill if you suspect you are pregnant or have unexplained vaginal bleeding.

  • Cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptive use. This risk increases with age and with heavy smoking (15 or more cigarettes per day) and is quite marked in women over 35 years of age. Women who use oral contraceptives are strongly advised not to smoke.

  • Most side effects of the pill are not serious. The most common side effects are nausea, vomiting, bleeding between menstrual periods, weight gain, breast tenderness, and difficulty wearing contact lenses. These side effects, especially nausea, vomiting, and breakthrough bleeding may subside within the first three months of use.

    The serious side effects of the pill occur very infrequently, especially if you are in good health and are young. However, you should know that the following medical conditions have been associated with or made worse by the pill:

    • Blood clots in the legs (thrombophlebitis), lungs (pulmonary embolism), stoppage or rupture of a blood vessel in the brain (stroke), blockage of blood vessels in the heart (heart attack or angina pectoris) or other organs of the body. As mentioned above, smoking increases the risk of heart attacks and strokes and subsequent serious medical consequences.
    • Liver tumors, which may rupture and cause severe bleeding. A possible but not definite association has been found with the pill and liver cancer. However, liver cancers are extremely rare. The chance of developing liver cancer from using the pill is thus even rarer.
    • High blood pressure, although blood pressure usually returns to normal when the pill is stopped.

    The symptoms associated with these serious side effects are discussed in the detailed leaflet given to you with your supply of pills. Notify your doctor or health care provider if you notice any unusual physical disturbances while taking the pill. In addition, drugs such as rifampin, as well as some anticonvulsants and some antibiotics, may decrease oral contraceptive effectiveness.

    Most of the studies to date on breast cancer and pill use have found no increase in the risk of developing breast cancer, although some studies have reported an increased risk of developing breast cancer in certain groups of women. However, some studies have found an increase in the risk of developing cancer of the cervix in women taking the pill, but this finding may be related to differences in sexual behavior or other factors not related to use of the pill. Therefore, there is insufficient evidence to rule out the possibility that the pill may cause cancer of the breast or cervix.

    Taking the pill provides some important non-contraceptive benefits. These include less painful menstruation, less menstrual blood loss and anemia, fewer pelvic infections, and fewer cancers of the ovary and the lining of the uterus.

    Be sure to discuss any medical condition you may have with your health care provider. Your health care provider will take a medical and family history and examine you before prescribing oral contraceptives. The physical examination may be delayed to another time if you request it and the health care provider believes that it is a good medical practice to postpone it. You should be reexamined at least once a year while taking oral contraceptives. The detailed patient information leaflet gives you further information which you should read and discuss with your health care provider.

    This product (like all oral contraceptives) is intended to prevent pregnancy. It does not protect against transmission of HIV (AIDS) and other sexually transmitted diseases such as chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B and syphilis.

    INSTRUCTIONS TO PATIENT

    Tablet Dispenser:

    The Junel ™tablet dispenser has been designed to make oral contraceptive dosing as easy and as convenient as possible. The tablets are arranged in either three or four rows of seven tablets each, with the days of the week appearing on the tablet dispenser above the first row of tablets.

    If your tablet dispenser contains:You are taking:
    21 light yellow tabletsJunel 21 1/20
    21 pink tabletsJunel 21 1.5/30
    21 light yellow tablets and 7 brown tabletsJunel Fe 1/20
    21 pink tablets and 7 brown tabletsJunel Fe 1.5/30

    Each light yellow tablet contains 1 mg norethindrone acetate and 20 mcg ethinyl estradiol.

    Each pink tablet contains 1.5 mg norethindrone acetate and 30 mcg ethinyl estradiol.

    Each brown tablet contains 75 mg ferrous fumarate, and is intended to help you remember to take the tablets correctly. These brown tablets are not intended to have any health benefit.

    DIRECTIONS:

    To remove a tablet, press down on it with your thumb or finger. The tablet will drop through the back of the tablet dispenser. Do not press on the tablet with your thumbnail, fingernail, or any other sharp object.

    HOW TO TAKE THE PILL

    IMPORTANT POINTS TO REMEMBER

    BEFORE YOU START TAKING YOUR PILLS:

    • BE SURE TO READ THESE DIRECTIONS:Before you start taking your pills.Anytime you are not sure what to do.
    • THE RIGHT WAY TO TAKE THE PILL IS TO TAKE ONE PILL EVERY DAY AT THE SAME TIME. If you miss pills you could get pregnant.This includes starting the pack late. The more pills you miss, the more likely you are to get pregnant.
    • MANY WOMEN HAVE SPOTTING OR LIGHT BLEEDING, OR MAY FEEL SICK TO THEIR STOMACH DURING THE FIRST 1-3 PACKS OF PILLS. If you do have spotting or light bleeding or feel sick to your stomach, do not stop taking the pill. The problem will usually go away. If it doesn't go away, check with your doctor or clinic.
    • MISSING PILLS CAN ALSO CAUSE SPOTTING OR LIGHT BLEEDING, even when you make up these missed pills. On the days you take 2 pills to make up for missed pills, you could also feel a little sick to your stomach.
    • IF YOU HAVE VOMITING OR DIARRHEA, for any reason, or IF YOU TAKE SOME MEDICINES, including some antibiotics, your birth control pills may not work as well. Use a back-up birth control method (such as condoms or foam) until you check with your doctor or clinic.
    • IF YOU HAVE TROUBLE REMEMBERING TO TAKE THE PILL, talk to your doctor or clinic about how to make pill-taking easier or about using another method of birth control.
    • IF YOU HAVE ANY QUESTIONS OR ARE UNSURE ABOUT THE INFORMATION IN THIS LEAFLET, call your doctor or clinic.

    BEFORE YOU START TAKING YOUR PILLS

    • DECIDE WHAT TIME OF DAY YOU WANT TO TAKE YOUR PILL. It is important to take it at about the same time every day.
    • LOOK AT YOUR PILL PACK TO SEE IF IT HAS 21 OR 28 PILLS:The 21-pill pack has 21 “active” light yellow or pink pills (with hormones) to take for 3 weeks, followed by 1 week without pills.The 28-pill pack has 21 “active” light yellow or pink pills (with hormones) to take for 3 weeks, followed by 1 week of reminder brown pills (without hormones).
    • ALSO FIND:1) where on the pack to start taking pills,2) in what order to take the pills.3) see Instructions for Use in the Combination Detailed Patient Labeling and Brief Summary.
    • BE SURE YOU HAVE READY AT ALL TIMES:ANOTHER KIND OF BIRTH CONTROL (such as condoms or foam) to use as a back-up in case you miss pills.AN EXTRA, FULL PILL PACK.

    WHEN TO START THE FIRST PACK OF PILLS

    You have a choice of which day to start taking your first pack of pills. Decide with your doctor or clinic which is the best day for you. Pick a time of day which will be easy to remember.

    DAY-1 START:

    • Pick the days of the week sticker that starts with the first day of your period. (This is the day you start bleeding or spotting, even if it is almost midnight when the bleeding begins.)
    • Place the days of the week sticker on the blister card over the area that has the days of the week (starting with Sunday) printed on the blister card.
    • Take the first “active” light yellow or pink pill of the first pack during the first 24 hours of your period.
    • You will not need to use a back-up method of birth control, since you are starting the pill at the beginning of your period.

    SUNDAY START:

    • Take the first “active” light yellow or pink pill of the first pack on the Sunday after your period starts, even if you are still bleeding. If your period begins on Sunday, start the pack that same day.
    • Use another method of birth control as a back-up method if you have sex anytime from the Sunday you start your first pack until the next Sunday (7 days). Condoms or foam are good back-up methods of birth control.

    WHAT TO DO DURING THE MONTH

    • TAKE ONE PILL AT THE SAME TIME EVERY DAY UNTIL THE PACK IS EMPTY.Do not skip pills even if you are spotting or bleeding between monthly periods or feel sick to your stomach (nausea).Do not skip pills even if you do not have sex very often.
    • WHEN YOU FINISH A PACK OR SWITCH YOUR BRAND OF PILLS:21 pills:Wait 7 days to start the next pack. You will probably have your period during that week. Be sure that no more than 7 days pass between 21-day packs.28 pills:Start the next pack on the day after your last “reminder” pill. Do not wait any days between packs.

    WHAT TO DO IF YOU MISS PILLS

    If you MISS 1 light yellow or pink “active” pill:

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

    If you MISS 2 light yellow or pink “active” pills in a row in WEEK 1 OR WEEK 2 of your pack:

    • Take 2 pills on the day you remember and 2 pills the next day.
    • Then take 1 pill a day until you finish the pack.
    • You COULD GET PREGNANT if you have sex in the 7 days after you miss pills. You MUST use another birth control method (such as condoms or foam) as a back-up method of birth control until you have taken a light yellow or pink “active” pill every day for 7 days.

    If you MISS 2 light yellow or pink “active” pills in a row in THE 3rd WEEK:

    • 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 clinic because you might be pregnant.
    • You COULD GET PREGNANT if you have sex in the 7 days after you miss pills. You MUST use another birth control method (such as condoms or foam) as a back-up method of birth control until you have taken a light yellow or pink “active” pill every day for 7 days.

    If you MISS 3 OR MORE light yellow or pink “active” 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 clinic because you might be pregnant.
    • You COULD GET PREGNANT if you have sex in the 7 days after you miss pills. You MUST use another birth control method (such as condoms or foam) as a back-up method of birth control until you have taken a light yellow or pink “active” pill every day for 7 days.

    A REMINDER FOR THOSE ON 28-DAY PACKS:

    If you forget any of the 7 brown “reminder” 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.

    FINALLY, IF YOU ARE STILL NOT SURE WHAT TO DO ABOUT THE PILLS YOU HAVE MISSED:

    Use a BACK-UP METHOD anytime you have sex.

    KEEP TAKING ONE LIGHT YELLOW OR PINK “ACTIVE” PILL EACH DAY until you can reach your doctor or clinic.

    Based on his or her assessment of your medical needs, your doctor or health care provider has prescribed this drug for you. Do not give this drug to anyone else.

    Keep this and all drugs out of the reach of children.

    Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

    This product (like all oral contraceptives) is intended to prevent pregnancy. It does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

  • Drug Information Provided by National Library of Medicine (NLM).
Ads