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Vyfemla

PATIENT INFORMATION

BRIEF SUMMARY PATIENT PACKAGE INSERT

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

Oral contraceptive use is associated with 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:

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 should be
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 and vomiting, 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.

Studies to date of women taking the pill have not shown
an increase in the incidence of cancer of the breast or cervix. There is,
however, insufficient evidence to rule out the possibility that the pill may cause
such cancers.

Taking the pill provides some important noncontraceptive
effects. 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 before prescribing oral contraceptives and will examine you.
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 labeling booklet gives you further information
which you should read and discuss with your health care professional.

Dosage And Administration

How To Take The Pill

The instructions given in the COMBINATION DETAILED
PATIENT LABELING AND BRIEF SUMMARY
insert are included inside each foil
pouch. The instructions include the directions on starting the first pack on
Day-One (first choice) of her period and the Sunday start (Sunday after period starts).
The patient is advised that, if she used the Sunday start, she should use a
back-up method in the first cycle if she has intercourse before she has taken
seven pills. The patient is also instructed as to what she should do if she
misses a pill or pills. The patient is warned that she may become pregnant if she
misses a pill or pills and that she should use a back-up method of birth
control in the event she has intercourse any time during the seven day period
following the missed pill or pills. Instructions on how to use the wallet for
the (28 Tablets) are included in the BRIEF SUMMARY PATIENT PACKAGE
INSERT.

Detailed Patient Labeling

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

Introduction

Any woman who considers using oral contraceptives (the
“birth control pill” or “the pill”) should understand the
benefits and risks of using this form of birth control.

Although the oral contraceptives have important
advantages over other methods of contraception, they have certain risks that no
other method has and some of these risks may continue after you have stopped using
the oral contraceptive. This brochure will give you much of the information you
will need to make this decision and will also help you determine if you are at
risk of developing any of the serious side effects of the pill. It will tell
you how to use the pill properly so that it will be as effective as possible.
However, this brochure is not a replacement for a careful discussion between
you and your health care professional.

You should discuss the information provided in this
brochure with him or her, both when you first start taking the pill and during
your revisits. You should also follow your health care professional’s advice with
regard to regular check-ups while you are on the pill.

Effectiveness Of Oral Contraceptives

Oral contraceptives or “birth control pills” or
“the pill” are used to prevent pregnancy and are more effective than
other nonsurgical methods of birth control. The chance of becoming pregnant is
less than 1% (1 pregnancy per 100 women per year of use) when the pills are
used correctly and no pills are missed. Typical failure rates are actually 3%
per year. The chance of becoming pregnant increases with each missed pill
during a menstrual cycle.

In comparison, typical accidental pregnancy rates for
other nonsurgical methods of birth control during the first year of use are as
follows:

IUD: 3%
Diaphragm with spermicides: 18%

Spermicides alone: 21%

Vaginal Sponge: 18% to 28%

Condom alone: 12%
Periodic abstinence: 20%

Injectable progestogen: 0.3% to 0.4%

Implants: 0.03% to 0.04%

No methods: 85%.

Who Should Not Take Oral Contraceptives

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 should
not smoke.

Some women should not use the pill. For example, you
should not take the pill if you are pregnant or think you may be pregnant. You
should also not use the pill if you have or have ever had any of the following
conditions:

  • A history of heart attack or stroke
  • Blood clots in the legs (thrombophlebitis), lungs
    (pulmonary embolism), or eyes
  • A history of blood clots in the deep veins of your legs
  • Chest pain (angina pectoris)
  • Known or suspected breast cancer or cancer of the lining
    of the uterus
  • Unexplained vaginal bleeding (until a diagnosis is
    reached by your doctor)
  • Yellowing of the whites of the eyes or of the skin
    (jaundice) during pregnancy or during previous use of the pill
  • Liver tumor (benign or cancerous)

Tell your health care professional if you have ever had
any of these conditions. Your health care professional can recommend a safer
method of birth control.

OTHER CONSIDERATIONS BEFORE TAKING ORAL CONTRACEPTIVES

Tell your health care professional if you have:

  • Breast nodules, fibrocystic disease of the breast or an
    abnormal breast x-ray or mammogram
  • Diabetes
  • Elevated cholesterol or triglycerides
  • High blood pressure
  • Migraine or other headaches or epilepsy
  • Mental depression
  • Gallbladder, heart, or kidney disease
  • History of scanty or irregular menstrual periods

Women with any of these conditions should be checked
often by their health care professional if they choose to use oral
contraceptives.

Also, be sure to inform your doctor or health care
professional if you smoke or are on any medications.

Risks Of Taking Oral Contraceptives

Risk Of Developing Blood Clots

Blood clots and blockage of blood vessels are the most
serious side effects of taking oral contraceptives. In particular, a clot in
the legs can cause thrombophlebitis and a clot that travels to the lungs can
cause a sudden blocking of the vessel carrying blood to the lungs. Either of
these can cause death or disability. Rarely, clots occur in the blood vessels
of the eye and may cause blindness, double vision, or impaired vision.

If you take oral contraceptives and need elective
surgery, need to stay in bed for a prolonged illness, or have recently delivered
a baby, you may be at risk of developing blood clots. You should consult your doctor
about stopping oral contraceptives three to four weeks before surgery and not
taking oral contraceptives for two weeks after surgery or during bed rest. You
should also not take oral contraceptives soon after delivery of a baby. It is
advisable to wait for at least four weeks after delivery if you are not
breastfeeding. If you are breastfeeding see the section on Breastfeeding in GENERAL
PRECAUTIONS
.

Heart Attacks And Strokes

Oral contraceptives may increase the tendency to develop
strokes (stoppage or rupture of blood vessels in the brain) and angina pectoris
and heart attacks (blockage of blood vessels in the heart). Any of these conditions
can cause death or disability. Smoking greatly increases the possibility of
suffering heart attacks and strokes. Furthermore, smoking and the use of oral
contraceptives greatly increase the chances of developing and dying of heart
disease.

Gallbladder Disease

Oral contraceptive users probably have a greater risk
than nonusers of having gallbladder disease, although this risk may be related
to pills containing high doses of estrogens.

Liver Tumors

In rare cases, oral contraceptives can cause benign but
dangerous liver tumors. These benign liver tumors can rupture and cause fatal
internal bleeding. In addition, a possible, but not definite, association has
been found with the pill and liver cancers in two studies, in which a few women
who developed these very rare cancers were found to have used oral
contraceptives for long periods. However, liver cancers in general are
extremely rare and the chance of developing liver cancer from using the pill is
thus even rarer.

Cancer Of The Reproductive Organs

There is, at present, no confirmed evidence that oral
contraceptives increase the risk of cancer of the reproductive organs and
breasts in human studies. Several studies have found no overall increase in the
risk of developing breast cancer. However, women who use oral contraceptives
and have a strong family history of breast cancer, or who have breast nodules
or abnormal mammograms, should be closely followed by their doctors.

Some studies have found an increase in the incidence of
cancer of the cervix in women who use oral contraceptives. However, this
finding may be related to factors other than the use of oral contraceptives.

Estimated Risk Of Death From A Birth Control Method Or
Pregnancy

All methods of birth control and pregnancy are associated
with a risk of developing certain diseases which may lead to disability or
death. An estimate of the number of deaths associated with different methods of
birth control and pregnancy has been calculated and is shown in the following
table.

ANNUAL NUMBER OF BIRTH-RELATED OR METHOD-RELATED
DEATHS ASSOCIATED WITH CONTROL OF FERTILITY PER 100,000 NONSTERILE WOMEN, BY FERTILITY
CONTROL METHOD ACCORDING TO AGE











Method of Control and Outcome AGE
15 to 19 20 to 24 25 to 29 30 to 34 35 to 39 40 to 44
No fertility control methods* 7.0 7.4 9.1 14.8 25.7 28.2
Oral contraceptives non-smoker† 0.3 0.5 0.9 1.9 13.8 31.6
Oral contraceptives smoker† 2.2 3.4 6.6 13.5 51.1 117.2
IUD† 0.8 0.8 1.0 1.0 1.4 1.4
Condom* 1.1 1.6 0.7 0.2 0.3 0.4
Diaphragm/spermicide* 1.9 1.2 1.2 1.3 2.2 2.8
Periodic abstinence* 2.5 1.6 1.6 1.7 2.9 3.6
Ory HW: Mortality associated with fertility and fertility
control: 1983. Fam Plann Perspect 1983; 15:50-56.

*Deaths are birth related.

†Deaths are method related.

It can be seen in the table that for women aged 15 to 39,
the risk of death was highest with pregnancy (7- 26 deaths per 100,000 women,
depending on age). Among pill users who do not smoke, the risk of death was
always lower than that associated with pregnancy for any age group, although
over the age of 40, the risk increases to 32 deaths per 100,000 women, compared
to 28 associated with pregnancy at that age. However, for pill users who smoke
and are over the age of 35, the estimated number of deaths exceeds those for
other methods of birth control. If a woman is over the age of 40 and smokes,
her estimated risk of death is four times higher (117/100,000 women) than the
estimated risk associated with pregnancy (28/100,000 women) in that age group.

The suggestion that women over 40 who don’t smoke should
not take oral contraceptives is based on information from older high-dose pills
and on less selective use of pills than is practiced today. An Advisory
Committee of the FDA discussed this issue in 1989 and recommended that the
benefits of oral contraceptive use by healthy, nonsmoking women over 40 years
of age may outweigh the possible risks. However, all women, especially older
women, are cautioned to use the lowest dose pill that is effective.

In the above table, the risk of death from any birth
control method is less than the risk of childbirth, except for oral
contraceptive users over the age of 35 who smoke and pill users over the age of
40 even if they do not smoke.

You should discuss this information with your health care
professional.

Warning Signals

  • If any of these adverse conditions occur while you are
    taking oral contraceptives, call your doctor immediately:
  • Sharp chest pain, coughing of blood, or sudden shortness
    of breath (indicating a possible clot in the lung)
  • Pain in the calf (indicating a possible clot in the leg)
  • Crushing chest pain or heaviness in the chest (indicating
    a possible heart attack)
  • Sudden severe headache or vomiting, dizziness or
    fainting, disturbances of vision or speech, weakness, or numbness in an arm or
    leg (indicating a possible stroke)
  • Sudden partial or complete loss of vision (indicating a
    possible clot in the eye)
  • Breast lumps (indicating possible breast cancer or
    fibrocystic disease of the breast; ask your doctor or healthcare provider to
    show you how to examine your breasts)
  • Severe pain or tenderness in the stomach area (indicating
    a possibly ruptured liver tumor)
  • Difficulty in sleeping, weakness, lack of energy,
    fatigue, or change in mood (possibly indicating severe depression)
  • Jaundice or a yellowing of the skin or eyeballs,
    accompanied frequently by fever, fatigue, loss of appetite, dark-colored urine,
    or light-colored bowel movements (indicating possible liver problems)
  • Abnormal vaginal bleeding [see SIDE EFFECTS OF ORAL
    CONTRACEPTIVES
    , 1. Vaginal Bleeding below.]

Side Effects Of Oral Contraceptives

In addition to the risks and more serious side effects
discussed above [see RISKS OF TAKING ORAL CONTRACEPTIVES, ESTIMATED
RISK OF DEATH FROM A BIRTH CONTROL METHOD OR PREGNANCY
and WARNING
SIGNALS
sections), the following may also occur:

Vaginal Bleeding

Irregular vaginal bleeding or spotting may occur while
you are taking the pills. Irregular bleeding may vary from slight staining
between menstrual periods to breakthrough bleeding which is a flow much like a
regular period. Irregular bleeding occurs most often during the first few
months of oral contraceptive use, but may also occur after you have been taking
the pill for some time.

Such bleeding may be temporary and usually does not
indicate any serious problems. It is important to continue taking your pills on
schedule. If the bleeding occurs in more than one cycle or lasts for more than
a few days, talk to your doctor or health care provider.

Gastrointestinal Effects

The most frequent, unpleasant side effects are nausea and
vomiting, stomach cramps, bloating, and a change in appetite.

Contact Lenses

If you wear contact lenses and notice a change in vision
or an inability to wear your lenses, contact your doctor or health care
provider.

Fluid Retention

Oral contraceptives may cause edema (fluid retention)
with swelling of the fingers or ankles and may raise your blood pressure. If
you experience fluid retention, contact your doctor or health care professional.

Melasma

A spotty darkening of the skin is possible, particularly
of the face.

Other Side Effects

Other side effects may include change in appetite,
headache, nervousness, depression, dizziness, loss of scalp hair, rash, and
vaginal infections.

If any of these side effects bother you, call your doctor
or health care professional.

General Precautions

Missed Periods And Use Of Oral Contraceptives Before Or During
Early Pregnan
cy

There may be times when you may not menstruate regularly
after you have completed taking a cycle of pills. If you have taken your pills
regularly and miss one menstrual period, continue taking your pills for the
next cycle but be sure to inform your health care professional before doing so.
If you have not taken the pills daily as instructed and missed a menstrual
period, or if you missed two consecutive menstrual periods, you may be
pregnant. Check with your health care professional immediately to determine whether
you are pregnant. Do not continue to take oral contraceptives until you are
sure you are not pregnant, but continue to use another method of contraception.

There is no conclusive evidence that oral contraceptive
use is associated with an increase in birth defects, when taken inadvertently
during early pregnancy. Previously, a few studies had reported that oral
contraceptives might be associated with birth defects, but these studies have
not been confirmed.

Nevertheless, oral contraceptives or any other drugs
should not be used during pregnancy unless clearly necessary and prescribed by
your doctor. You should check with your doctor about risks to your unborn child
of any medication taken during pregnancy.

While Breastfeeding

If you are breastfeeding, consult your doctor before
starting oral contraceptives. Some of the drug will be passed on to the child
in the milk. A few adverse effects on the child have been reported, including yellowing
of the skin (jaundice) and breast enlargement. In addition, oral contraceptives
may decrease the amount and quality of your milk. If possible, do not use oral
contraceptives while breastfeeding. You should use another method of
contraception since breastfeeding provides only partial protection from
becoming pregnant and this partial protection decreases significantly as you
breastfeed for longer periods of time. You should consider starting oral
contraceptives only after you have weaned your child completely.

Laboratory Tests

If you are scheduled for any laboratory tests, tell your
doctor you are taking birth control pills. Certain blood tests may be affected
by birth control pills.

Drug Interactions

Certain drugs may interact with birth control pills to
make them less effective in preventing pregnancy or cause an increase in
breakthrough bleeding. Such drugs include rifampin, drugs used for epilepsy such
as barbiturates (for example, phenobarbital) and phenytoin (Dilantin is one
brand of this drug), phenylbutazone (Butazolidin is one brand) and possibly
ampicillin and tetracyclines (several brand names). You may need to use an
additional method of contraception when you take drugs which can make oral
contraceptives less effective.

HOW TO TAKE THE PILL

IMPORTANT POINTS TO REMEMBER

SEXUALLY-TRANSMITTED DISEASES

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

BEFORE YOU START TAKING YOUR PILLS:

  1. BE SURE TO READ THESE DIRECTIONS:
  2. Before you start taking your pills.
  3. Anytime you are not sure what to do.
  4. THE RIGHT WAY TO TAKE THE PILL IS TO TAKE ONE PILL EVERY
    DAY AT THE SAME TIME.
  5. 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.
  6. MANY WOMEN HAVE SPOTTING OR LIGHT BLEEDING, OR MAY FEEL
    SICK TO THEIR STOMACH DURING THE FIRST 1 to 3 PACKS OF PILLS.
  7. If you do 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.
  8. MISSING PILLS CAN ALSO CAUSE SPOTTING OR LIGHT BLEEDING,
    even when you make up these missed pills.
  9. On the days you take 2 pills to make up for missed pills,
    you could also feel a little sick to your stomach.
  10. IF YOU HAVE VOMITING OR DIARRHEA, for any reasons, or IF
    YOU TAKE SOME MEDICINES, including some antibiotics, your pills may not work as
    well.
  11. Use a back-up method (such as condoms, foam, or sponge)
    until you check with your doctor or clinic.
  12. 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.
  13. 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

  1. DECIDE WHAT TIME OF DAY YOU WANT TO TAKE YOUR PILL.
  2. It is important to take it at about the same time every
    day.
  3. LOOK AT YOUR PILL PACK TO SEE IF IT HAS 28 PILLS:
  4. The 28-pill pack has 21 “active” light peach pills
    (with hormones) to take for 3 weeks, followed by 1 week of reminder white pills
    (without hormones).

Refer to the sample of the wallet below.


For use of day labels, see WHEN TO START THE FIRST PACK
OF PILLS

3. BE SURE YOU HAVE READY AT ALL TIMES:

ANOTHER KIND OF BIRTH CONTROL (such as condoms, foam, or
sponge) 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. Vyfemla™ (norethindrone and ethinyl estradiol tablets USP) is
available in Wallet which is designed for Sunday Start. Day 1 Start is also
provided. 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. Take the first “active” light peach pill of
the first pack during the first 24 hours of your period.

2. 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” light peach 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, foam, or the sponge 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:

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 peach “active” pill:

1. 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.

2. You do not need to use a back-up birth control method
if you have sex.

If you MISS 2 light peach “active” 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 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 for those 7 days.

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

1. 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.

2. 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.

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 for those 7 days.

If you MISS 3 OR MORE light peach “active”
pills in a row (during the first 3 weeks):

1. 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.

2. 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.

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 for those 7 days.

A REMINDER FOR THOSE ON 28-DAY PACKS:

If you forget any of the 7 white “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 “ACTIVE” PILL EACH DAY until you can
reach your doctor or clinic.

GENERAL

Pregnancy Due to Pill Failure

The incidence of pill failure resulting in pregnancy is
approximately 1% (i.e., one pregnancy per 100 women per year) if taken every
day as directed, but more typical failure rates are about 3%. If failure does
occur, the risk to the fetus is minimal.

Pregnancy after Stopping the Pill

There may be some delay in becoming pregnant after you
stop using oral contraceptives, especially if you had irregular menstrual
cycles before you used oral contraceptives. It may be advisable to postpone conception
until you begin menstruating regularly once you have stopped taking the pill
and desire pregnancy.

There does not appear to be any increase in birth defects
in newborn babies when pregnancy occurs soon after stopping the pill.

Other

Overdosage

Serious ill effects have not been reported following
ingestion of large doses of oral contraceptives by young children. Overdosage
may cause nausea and withdrawal bleeding in females. In case of overdosage,
contact your poison control center, health care professional, or nearest
emergency room. KEEP THIS DRUG AND ALL DRUGS OUT OF THE REACH OF CHILDREN.

General Medical Information

Your health care professional will take a medical and
family history before prescribing oral contraceptives and will examine you. 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 per year. Be sure to inform your
health care professional if there is a family history of any of the conditions
listed previously in this leaflet. Be sure to keep all appointments with your
health care professional, because this is a time to determine if there are
early signs of side effects of oral contraceptive use.

Do not use the drug for any condition other than the one
for which it was prescribed. This drug has been prescribed specifically for
you; do not give it to others who may want birth control pills.

Noncontraceptive Effects Of Oral Contraceptives

In addition to preventing pregnancy, use of oral
contraceptives may provide certain benefits. They are:

  • Menstrual cycles may become more regular
  • Blood flow during menstruation may be lighter and less
    iron may be lost. Therefore, anemia due to iron deficiency is less likely to
    occur.

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