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April 16, 2002 - Image 14

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Text
Publication:
The Michigan Daily, 2002-04-16

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14A- The Michigan Daily - Tuesday, April 16, 2002

ESTROSTEP* (Norethindrone Acetate and Ethinyl Estradiol Tablets, USP)
PATIENT BRIEF SUMMARY - JULY 2001
PARKE-DAVIS
ESTROSTEP*21
(Each white triangular tablet contains 1 mg norethindrone acetate and 20 mcg ethinyl estradiol; each white square tablet contains
1 mg norethindrone acetate and 30 mcg ethinyl estradiol; each white round tablet contains 1 mg norethindrone acetate and
35 mcg ethinyl estradiol)
ESTROSTEP*Fe
(Each white triangular tablet contains 1 mg norethindrone acetate and 20 mcg ethinyl estradiol; each white square tablet contains 1 mg
norethindrone acetate and30 mcg ethinyl estradiol; each white round tablet contains 1 mg norethindrone acetate and 35 mcg ethinyl
estradiol; each brown tablet contains 75 mg ferrous fumarate.)
Rx only
BRIEF SUMMARY PATIENT PACKAGE INSERT
ESTROSTEP (like all oral contraceptives) is intended to prevent pregnancy. It does not protect against transmission of HIV (AIDS)
and other sexually transmitted diseases.
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.
ESTROSTEP may also be taken to treat moderate acne in females who are at least 15 years of age, have started having menstrual
periods, are able to use the pill and want the pill for birth control, plan to stay on the pill for at least 6 months, and have not improved
with acne medicines that are put on the skin.
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.

3. ALSO FIND:
1) where on the pack to start taking pills,
2) in what order to take the pills (follow the arrows), and
3) the week numbers as shown in the following pictures:
START HERE FOR BOTH SUNDAY
STARTERS AND DAY-1 STARTERS

DAY-1 STARTERS: If your period begins on a day
other than Sunday, place the day label strip that
starts with the first day of

svx isON N __fIL _tp)_. F81 ..Sdi
WEEK 1 J1, ' \a. N2r ;
WEEK2 -
TAKE PILLS IN THIS ~EEKS
DIRECTION FROM Estrostep┬░21
LEFT TO RIGHTan

your period here.

Each ESTROSTEP 21 tablet dispenser contains five white triangular tablets, seven white square tablets, and nine white round
tablets. These tablets are to be taken in the following order: one triangular tablet each day for five days, followed by one square
tablet each day for seven days, and then one round tablet each day for nine days.
ESTROSTEP 21 WILL CONTAIN: ALL WHITE PILLS

6
I
0

DAY-i STARTERS
START HERE FOR BOTH SUNDAY / other than Sund
STARTERS AND DAY-1 STARTERS
SN MON TUE wEO_ Thu FRI saT
WEEK ,'c3 ~~
TAKE PILLS IN THIS
DIRECTION FROM ,

5:If your period begins on a day
iy, place the day label strip that
starts with the first day of
1 your period here.

LEFT TO RIGHT

p.

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.

I

I

Most side effects of the pill are not serious. The most common side effects are nausea, vomiting, bleeding between menstrual periods,
weight gain, breast tendemess, 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:
1. 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.
2. 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.
3. 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.
Breast cancer has been diagnosed slightly more often in women who use the pill than in women of the same age who do not use
the pill. This very small increase in the number of breast cancer diagnoses gradually disappears during the 10 years after stopping
use of the pill. It is not known whether the increase in breast cancer diagnoses is caused by the pill. You should have regular breast
examinations by a health care provider and examine your own breasts monthly. Tell your health care provider if you have a family
history of breast cancer or if you have had breast nodules or an abnormal mammogram. Women who currently have or have had
breast cancer should not use oral contraceptives because breast cancer is a hormone-sensitive tumor. Some studies have found
an increase in the incidence of precancerous lesions of the cervix in women who use oral contraceptives. However, this finding
may be related to factors other than the use of oral contraceptives.
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 your 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.
ESTROSTEP (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 ESTROSTEP 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 above the first row of
tablets.
If your TABLET DISPENSER contains: You are taking:
21 white tablets ESTROSTEP 21
21 white tablets and 7 brown tablets ESTROSTEP Fe
Each tiangle tablet contains 1 mg norethindrone acetate and 20 mcg ethinyl estradiol.
Each square tablet contains 1 mg norethindrone acetate and 30 mcg ethinyl estradiol.
Each roundtablet contains 1 mg norethindrone acetate and 35 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 with your thumbnail, fingernail, or any other sharp object
HOW TO TAKE THE PILL
IMPORTANT POINTS TO REMEMBER
BEFORE YOU START TAKING YOUR PILLS:
1. BE SURE TO READ THESE DIRECTIONS:
Before you start taking your pills.
Anytime you are not sure what to do.
2. 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.
3. 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*Ao away, check with your doctor or clinic.
4. 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.
5. 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 spermicide) until you check with your
doctor or clinic.
6. 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.
7. 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

Each ESTROSTEP* Fe tablet dispenser contains five white triangular tablets, seven white square tablets, nine white round tablets,
and seven brown tablets. These tablets are to be taken in the following order: one triangular tablet each day for five days, then one
square tablet each day for seven days, followed by one round tablet each day for nine days, and then one brown tablet each day for
seven days.
ESTROSTEP Fe will contain: 21 WHITE PILLS for Weeks 1,2, and 3. Week 4 will contain BROWN PILLS ONLY.
4. BE SURE YOU HAVE READY AT ALL TIMES:
ANOTHER KIND OF BIRTH CONTROL (such as condoms or spermicide) 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:
1. Pick the day label strip 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.)
2. Place this day label strip on the tablet dispenser over the area that has the days of the week (starting with Sunday) printed on the
plastic.
3. Take the first "active" white pill of the first pack during the first 24 hours of your period.
4. 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:
1. Take the first "active" white 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.
2. 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 spermicide are good back-up methods of birth control.
WHAT TO DO DURING THE MONTH
1. 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.
2. 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: Startthe next pack on the day after your last "reminder" pill. Do not wait any days between packs.
WHAT TO DO IF YOU MISS A PILL
If you MISS 1 white "active" pill:
1. Take it as soon as you remember. Take the next pill at your regular time. This means you maytake 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 white "active" pills in a row in Week 10R Week 2 of your pack
1. Take 2 pills on the day you remember and 2 pills the next day.
2. Then take 1 pill a day until you finish the pack.
3. 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 spermicide) as a back-up method of birth control until you have taken a white "active" pill every day for 7 days.
If you MISS 2 white "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.
0 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.
1. 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
2. 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 spermicide) as a back-up method of birth control until you have taken a white "active" pill every day for 7 days.
If you MISS 3 OR MORE white "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.
1. 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
2. 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 spermicide) as a back-up method of birth control until you have taken a white "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 WHITE "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.
Rx only
Storage-Do not store above 250 C (770F).

a

0

0l

Protect from light.
Store tablets inside pouch when not in use.

Rev. 0 July 2001.

1. DECIDE WHAT TIME OF DAY YOU WANT TO TAKE YOUR PILL It is importantto take it at aboutthe same time every day.
2. LOOK AT YOUR PILL PACK TO SEE IF IT HAS 21 OR 28 PILLS:

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