BRIEF SUMMARY PATIENT PACKAGE INSERT
This product (like all oral contraceptives) does not
protect against HIV infection (AIDS) and other sexually transmitted diseases.
Oral contraceptives, also known as “birth control
pills ” or “the pill, ” are taken to prevent pregnancy. When taken
correctly to prevent pregnancy, oral contraceptives have a failure rate of
approximately 1% per year (1 pregnancy per 100 women per year of use) when used
without missing any pills. The typical failure rate is approximately 5% per
year (5 pregnancies per 100 women per year of use) 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.
ORTHO TRI-CYCLEN® may also be taken to treat moderate acne
in females at least 15 years of age, who have started having menstrual periods,
are able to take the pill and want to use the pill for birth control.
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 fatal or may cause temporary or permanent
disability. The risks associated with taking oral contraceptives increase
significantly if you:
Although cardiovascular disease risks may be increased with
oral contraceptive use after age 40 in healthy, non-smoking women (even with
the newer low-dose formulations), there are also greater potential health risks
associated with pregnancy in older women.
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 such 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:
- 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.
- 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, some studies report an increased risk of developing liver cancer.
However, liver cancers are rare.
- 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 healthcare professional 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.
Oral contraceptives may interact with lamotrigine
(LAMICTAL®), an anticonvulsant used for epilepsy. This may increase the risk of
seizures so your healthcare professional may need to adjust the dose of
lamotrigine. Various studies give conflicting reports on the relationship
between breast cancer and oral contraceptive use. Oral contraceptive use may
slightly increase your chance of having breast cancer diagnosed, particularly
after using hormonal contraceptives at a younger age. After you stop using
hormonal contraceptives, the chances of having breast cancer diagnosed begin to
go back down. You should have regular breast examinations by a healthcare
professional and examine your own breasts monthly. Tell your healthcare
professional 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
usually a hormone-sensitive tumor.
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.
There is insufficient evidence to rule out the possibility that the pill may
cause such cancers.
Taking the combination 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 healthcare professional. Your healthcare 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 healthcare professional believes that it is a good medical practice to
postpone it. You should be reexamined at least once a year while taking oral
contraceptives. Your pharmacist should have given you the detailed patient
information labeling which gives you further information which you should read
and discuss with your healthcare professional.
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 feel sick to your stomach or have
spotting or light bleeding, do not stop taking the pill. The problem will
usually go away. If it doesn't go away, check with your healthcare professional.
- 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, OR IF YOU TAKE SOME MEDICINES, including
some antibiotics, your pills may not work as well.
Use a back-up method (such as condoms or spermicide) until you check with
your healthcare professional.
- IF YOU HAVE TROUBLE REMEMBERING TO TAKE THE PILL, talk to your healthcare
professional 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 healthcare professional.
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
The pill pack has 21 “active” pills (with hormones) to take for 3 weeks. This
is followed by 1 week of “reminder” dark green pills (without hormones).
ORTHO TRI-CYCLEN®: There are 7 white “active” pills, 7 light blue
“active” pills, 7 blue “active” pills, and 7 dark green “reminder” pills.
ORTHO-CYCLEN®: There are 21 blue “active “ pills, and 7 dark
green “reminder” pills.
- ALSO FIND:
1) where on the pack to start taking pills,
2) in what order to take the pills.
- BE SURE YOU HAVE READY AT ALL TIMES:
ANOTHER KIND OF BIRTH CONTROL (such as condoms or spermicide) to use as a
back-up method 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. ORTHO TRI-CYCLEN® and ORTHO-CYCLEN® are available in the
DIALPAK® Tablet Dispenser which is preset for a Sunday Start. Day 1 Start is
also provided. Decide with your healthcare professional which is the best day
for you. Pick a time of day which will be easy to remember.
Sunday Start:
ORTHO TRI-CYCLEN®: Take the first white “active” 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.
ORTHO-CYCLEN®: Take the first blue “active” 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 such as condoms or
spermicide as a back-up method if you have sex anytime from the Sunday you
start your first pack until the next Sunday (7 days).
Day 1 Start:
ORTHO TRI-CYCLEN®: Take the first white “active” pill
of the first pack during the first 24 hours of your period.
ORTHO-CYCLEN®: Take the first blue “active” 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.
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:
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
ORTHO TRI-CYCLEN®:
If you MISS 1 white, light blue or blue “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 white or light blue “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 BECOME 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 for those 7 days.
If you MISS 2 blue “active” pills in a row in THE
3RD WEEK:
- 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.
If you are a Day 1 Starter:
THROW OUT the rest of the pill pack and start a new pack 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 healthcare professional
because you might be pregnant.
- You COULD BECOME 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 for those 7 days.
If you MISS 3 OR MORE white, light blue or blue
“active” pills in a row (during the first 3 weeks):
- 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.
If you are a Day 1 Starter:
THROW OUT the rest of the pill pack and start a new pack 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 healthcare professional
because you might be pregnant.
- You COULD BECOME 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 for those 7 days.
ORTHO-CYCLEN®:
If you MISS 1 blue “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 blue “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 BECOME 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 for those 7 days.
If you MISS 2 blue “active” pills in a row in THE
3RD WEEK:
- 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.
If you are a Day 1 Starter:
THROW OUT the rest of the pill pack and start a new pack 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 healthcare professional
because you might be pregnant.
- You COULD BECOME 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 for those 7 days.
If you MISS 3 OR MORE blue “active” pills in a row
(during the first 3 weeks):
- 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.
If you are a Day 1 Starter:
THROW OUT the rest of the pill pack and start a new pack 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 healthcare professional
because you might be pregnant.
- You COULD BECOME 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 for those 7 days.
A REMINDER:
If you forget any of the 7 dark green “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 healthcare professional.
INSTRUCTIONS FOR USING YOUR DIALPAK® TABLET DISPENSER
PLEASE READ ME!
Sunday Start or
Day 1 Start
There are two ways to start taking birth control pills, Sunday
Start or Day 1 Start.
Your healthcare professional will tell you which to use.
SAVE THESE INSTRUCTIONS.
1. If this is the first time you are taking birth
control pills, or if you have not taken birth control pills for 10 days or
more, your first step is to wait until the first day you get your menstrual
period. Then, follow these instructions for either Sunday Start or Day 1
Start.
2. When you get your period:
- You will use a Sunday Start if your doctor told you to take your
first pill on a Sunday. Take pill “1” on the Sunday after your period starts.
If your period starts on a Sunday, take pill “1” that day.
- You will use a Day 1 Start if your doctor told you to take pill “1”
on the first day of your period.
3. SET THE DAY:
- Sunday Start: the arrow on your empty Dialpak should point to SU
(Sunday).
- Day 1 Start: turn the dial on your empty Dialpak until the arrow
points to the first day of your period (if your period starts on Tuesday,
the arrow will point to TU).
4. Insert the new refill by lining up the “V” shape
on the refill with the “V” shape at the top of your Dialpak. Snap the refill in
place. You are ready to take pill “1.” You should always begin your pill cycle
with pill “1,” as shown on the inner part of the refill ring.
5. Remove pill “1” by pushing down on the pill. The
pill will come out through a hole in the back of the Dialpak.
6. Swallow the pill. You will take one pill each day.
If you use a Sunday Start and you are taking the pill for the FIRST TIME, YOU
MUST USE A BACK-UP METHOD OF BIRTH CONTROL FOR THE FIRST 7 DAYS. If you use a
Day 1 Start, you are protected from becoming pregnant as soon as you take your
first pill.
7. Wait 24 hours to take your next pill. To take pill “2,” turn
the dial on your Dialpak to the next day. Continue to take one pill each
day until all the pills have been taken.
8. Take your pill at the same time every day. It is
important to take the correct pill each day and not miss any pills. To help you
remember, take your pill at the same time as another daily activity, like
turning off your alarm clock or brushing your teeth.
9. When your refill is empty, keep your Dialpak case.
You will start a new refill on the day after pill “28.”
10. Turn the dial to the pill “1” position to remove the
empty refill and insert a new refill. THE FIRST PILL IN EVERY REFILL WILL
ALWAYS BE TAKEN ON THE SAME DAY OF THE WEEK, NO MATTER WHEN YOUR NEXT PERIOD
STARTS.
DETAILED PATIENT LABELING
PLEASE NOTE: This labeling is revised from time to time
as important new medical information becomes available. Therefore, please
review this labeling carefully.
This product (like all oral contraceptives) does not
protect against HIV infection (AIDS) and other sexually transmitted diseases.
ORTHO TRI-CYCLEN® Regimen
Each white tablet contains 0.180 mg norgestimate and 0.035
mg ethinyl estradiol. Each light blue tablet contains 0.215 mg norgestimate and
0.035 mg ethinyl estradiol. Each blue tablet contains 0.250 mg norgestimate and
0.035 mg ethinyl estradiol. Each dark green tablet contains inert ingredients.
ORTHO-CYCLEN® Regimen
Each blue tablet contains 0.250 mg norgestimate and 0.035 mg
ethinyl estradiol. Each dark green tablet contains inert ingredients.
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. This patient labeling 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 labeling is not a replacement for a careful
discussion between you and your healthcare professional. You should discuss the
information provided in this labeling with him or her, both when you first
start taking the pill and during your revisits. You should also follow your
healthcare professional's advice with regard to regular check-ups while you are
on the pill.
EFFECTIVENESS OF ORAL CONTRACEPTIVES FOR CONTRACEPTION
Oral contraceptives or “birth control pills” or “the pill”
are used to prevent pregnancy and are more effective than most other non-surgical
methods of birth control. When they are taken correctly without missing any
pills, the chance of becoming pregnant is approximately 1% per year (1
pregnancy per 100 women per year of use). Typical failure rates, including
women who do not always take the pill correctly, are approximately 5% per year
(5 pregnancies per 100 women per year of use). The chance of becoming pregnant
increases with each missed pill during a menstrual cycle.
In comparison, typical failure rates for other non-surgical
methods of birth control during the first year of use are as follows:
| Implant: < 1% |
Male sterilization: < 1% |
| Injection: < 1% |
Cervical Cap with spermicides: 20 to 40% |
| IUD: 1 to 2% |
Condom alone (male): 14% |
| Diaphragm with spermicides: 20% |
Condom alone (female): 21% |
| Spermicides alone: 26% |
Periodic abstinence: 25% |
| Vaginal sponge: 20 to 40% |
Withdrawal: 19% |
| Female sterilization: < 1% |
No methods: 85% |
ORTHO TRI-CYCLEN® may also be taken to treat moderate acne
if all of the following are true:
- You have started having menstrual cycles
- You are at least 15 years old
- Your healthcare professional says it is safe for you to use the pill
- You want to use the pill for birth control
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 are strongly
advised not to smoke.
Some women should not use the pill. For example, you should
not take the pill if you have 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,
cervix or vagina
- Unexplained vaginal bleeding (until a diagnosis is reached by your healthcare
professional)
- 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) or active liver disease
- Known or suspected pregnancy
- Valvular heart disease with complications
- Severe hypertension
- Diabetes with vascular involvement
- Headaches with focal neurological symptoms
- Major surgery with prolonged immobilization
- Hypersensitivity to any component of this product
Tell your healthcare professional if you have had any of
these conditions. Your healthcare professional can recommend a safer method of
birth control.
OTHER CONSIDERATIONS BEFORE TAKING ORAL CONTRACEPTIVES
Tell your healthcare professional if you have or have had:
- Breast nodules, fibrocystic disease of the breast, an abnormal breast x-ray
or mammogram
- Diabetes
- Elevated cholesterol or triglycerides
- High blood pressure
- Migraine or other headaches or epilepsy
- Mental depression
- Gallbladder, liver, heart or kidney disease
- History of scanty or irregular menstrual periods
Women with any of these conditions should be checked often
by their healthcare professional if they choose to use oral contraceptives.
Also, be sure to inform your healthcare professional if you
smoke or are on any medications.
RISKS OF TAKING ORAL CONTRACEPTIVES
1. Risk of Developing Blood Clots
Blood clots and blockage of blood vessels are one of the
most serious side effects of taking oral contraceptives and can cause death or
serious disability. 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. 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 injury or have recently delivered a baby, you
may be at risk of developing blood clots. You should consult your healthcare
professional about stopping oral contraceptives 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
breast feeding. If you are breast feeding, you should wait until you have weaned
your child before using the pill. (See also the section on Breast Feeding in
General Precautions.)
The risk of circulatory disease in oral contraceptive users
may be higher in users of high-dose pills and may be greater with longer
duration of oral contraceptive use. In addition, some of these increased risks
may continue for a number of years after stopping oral contraceptives. The risk
of abnormal blood clotting increases with age in both users and nonusers of
oral contraceptives, but the increased risk from the oral contraceptive appears
to be present at all ages. For women aged 20 to 44 it is estimated that about 1
in 2,000 using oral contraceptives will be hospitalized each year because of
abnormal clotting. Among nonusers in the same age group, about 1 in 20,000
would be hospitalized each year. For oral contraceptive users in general, it
has been estimated that in women between the ages of 15 and 34 the risk of
death due to a circulatory disorder is about 1 in 12,000 per year, whereas for
nonusers the rate is about 1 in 50,000 per year. In the age group 35 to 44, the
risk is estimated to be about 1 in 2,500 per year for oral contraceptive users
and about 1 in 10,000 per year for nonusers.
2. 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 serious 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.
3. 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.
4. 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, some studies report an increased risk of
developing liver cancer. However, liver cancers are rare.
5. Cancer of the Reproductive Organs and Breasts
Various studies give conflicting reports on the relationship
between breast cancer and oral contraceptive use. Oral contraceptive use may
slightly increase your chance of having breast cancer diagnosed, particularly
after using hormonal contraceptives at a younger age. After you stop using
hormonal contraceptives, the chances of having breast cancer diagnosed begin to
go back down. You should have regular breast examinations by a healthcare
professional and examine your own breasts monthly. Tell your healthcare
professional 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
usually a hormone-sensitive tumor.
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.
There is insufficient evidence to rule out the possibility that the pill may
cause such cancers.
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 |
15-19 |
20-24 |
25-29 |
30-34 |
35-39 |
40-44 |
| 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 |
*Deaths are birth-related
**Deaths are method-related
Adapted from H.W. Ory, ref. #35. |
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. It can be seen in the table that for women aged 15 to 39, the risk
of death was highest with pregnancy (7 to 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 less than
40. Over the age of 40, the risk increases to 32 deaths per 100,000 women,
compared to 28 associated with pregnancy in that age group. 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 do not smoke should
not take oral contraceptives is based on information from older, higher-dose
pills. An Advisory Committee of the FDA discussed this issue in 1989 and
recommended that the benefits of low-dose oral contraceptive use by healthy,
non-smoking women over 40 years of age may outweigh the possible risks. Older
women, as all women, who take oral contraceptives, should take an oral
contraceptive which contains the least amount of estrogen and progestogen that
is compatible with the individual patient needs.
WARNING SIGNALS
If any of these adverse effects occur while you are taking
oral contraceptives, call your healthcare professional 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 healthcare professional 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)
SIDE EFFECTS OF ORAL CONTRACEPTIVES
In addition to the risks and more serious side effects
discussed above, the following may also occur:
1. Irregular 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 healthcare professional.
2. Contact Lenses
If you wear contact lenses and notice a change in vision or
an inability to wear your lenses, contact your healthcare professional.
3. 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 healthcare professional.
4. Melasma
A spotty darkening of the skin is possible, particularly of
the face, which may persist.
5. Other Side Effects
Other side effects may include nausea and vomiting, change
in appetite, headache, nervousness, depression, dizziness, loss of scalp hair,
rash, vaginal infections, and allergic reactions.
If any of these side effects bother you, call your
healthcare professional.
GENERAL PRECAUTIONS
1. Missed Periods and Use of Oral Contraceptives
Before or During Early Pregnancy
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 healthcare professional. 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
healthcare professional immediately to determine whether you are pregnant. Stop
taking your pills if you are pregnant.
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 findings have
not been seen in more recent studies. Nevertheless, oral contraceptives should
not be used during pregnancy. You should check with your healthcare
professional about risks to your unborn child of any medication taken during
pregnancy.
2. While Breast Feeding
If you are breast feeding, consult your healthcare
professional 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, combination oral contraceptives may decrease the
amount and quality of your milk. If possible, do not use combination oral
contraceptives while breast feeding. You should use another method of
contraception since breast feeding provides only partial protection from
becoming pregnant and this partial protection decreases significantly as you
breast feed for longer periods of time. You should consider starting
combination oral contraceptives only after you have weaned your child
completely.
3. Laboratory Tests
If you are scheduled for any laboratory tests, tell your
healthcare professional you are taking birth control pills. Certain blood tests
may be affected by birth control pills.
4. 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), topiramate (Topamax®),
carbamazepine (Tegretol® is one brand of this drug), or phenytoin (Dilantin® is
one brand of this drug), phenylbutazone (Butazolidin® is one brand), certain
drugs used in the treatment of HIV or AIDS, and possibly certain antibiotics.
Medicine for pulmonary hypertension, such as bosentan (Tracleer®). Pregnancies
and breakthrough bleeding have been reported by women who also used some form
of the herbal supplement St. John's Wort while using combined hormonal
contraceptives. Hormonal contraceptives may interact with lamotrigine
(LAMICTAL®), an anticonvulsant used for epilepsy. This may increase the risk of
seizures so your healthcare professional may need to adjust the dose of
lamotrigine. You may need to use additional contraception when you take drugs
which can make oral contraceptives less effective. Be sure to tell your healthcare
professional if you are taking or start taking any medications while taking
birth control pills.
5. Sexually Transmitted Diseases
ORTHO-CYCLEN® and ORTHO TRI-CYCLEN® (like all oral
contraceptives) are intended to prevent pregnancy. Oral contraceptives do not
protect against transmission of HIV (AIDS) and other sexually transmitted
diseases such as chlamydia, genital herpes, genital warts, gonorrhea, hepatitis
B, and syphilis.
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 feel sick to your stomach or have spotting or light bleeding, do not
stop taking the pill. The problem will usually go away. If it doesn't go away,
check with your healthcare professional.
- 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, OR IF YOU TAKE SOME MEDICINES, including
some antibiotics, your pills may not work as well.
Use a back-up method (such as condoms or spermicide) until you check with
your healthcare professional.
- IF YOU HAVE TROUBLE REMEMBERING TO TAKE THE PILL, talk to your healthcare
professional 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 healthcare professional.
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
The pill pack has 21 “active” pills (with hormones) to take for 3 weeks. This
is followed by 1 week of “reminder” dark green pills (without hormones).
ORTHO TRI-CYCLEN®: There are 7 white “active” pills, 7 light blue
“active” pills, 7 blue “active” pills, and 7 dark green “reminder” pills.
ORTHO-CYCLEN®: There are 21 blue “active” pills and 7 dark green
“reminder” pills.
- ALSO FIND:
1) where on the pack to start taking pills,
2) in what order to take the pills.
CHECK PICTURE OF PILL PACK AND ADDITIONAL INSTRUCTIONS FOR USING THIS PACKAGE
IN THE BRIEF SUMMARY PATIENT PACKAGE INSERT.
- BE SURE YOU HAVE READY AT ALL TIMES:
ANOTHER KIND OF BIRTH CONTROL (such as condoms or spermicide) to use as a
back-up method 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. ORTHO TRI-CYCLEN® and ORTHO-CYCLEN® are available in the
DIALPAK® Tablet Dispenser which is preset for a Sunday Start. Day 1 Start is
also provided. Decide with your healthcare professional which is the best day
for you. Pick a time of day which will be easy to remember.
Sunday Start:
ORTHO TRI-CYCLEN®: Take the first white
“active ” 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.
ORTHO-CYCLEN®: Take the first blue “active ”
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 such as condoms or
spermicide as a back-up method if you have sex anytime from the Sunday you
start your first pack until the next Sunday (7 days).
Day 1 Start:
ORTHO TRI-CYCLEN®: Take the first white
“active ” pill of the first pack during the first 24 hours of your
period.
ORTHO-CYCLEN®: Take the first blue “active ”
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.
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:
Start the next pack on the day after your last &lduqo;reminder” pill. Do not
wait any days between packs.
WHAT TO DO IF YOU MISS PILLS
ORTHO TRI-CYCLEN®:
If you MISS 1 white, light blue, or blue “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 white or light blue “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 BECOME 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 for those 7 days.
If you MISS 2 blue “active” pills in a row in THE
3RD WEEK:
- 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.
If you are a Day 1 Starter:
THROW OUT the rest of the pill pack and start a new pack 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 healthcare professional
because you might be pregnant.
- You COULD BECOME 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 for those 7 days.
If you MISS 3 OR MORE white, light blue or blue “active” pills in a
row (during the first 3 weeks):
- 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.
If you are a Day 1 Starter:
THROW OUT the rest of the pill pack and start a new pack 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 healthcare professional
because you might be pregnant.
- You COULD BECOME 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 for those 7 days.
ORTHO-CYCLEN®:
If you MISS 1 blue “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 blue “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 BECOME 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 for those 7 days.
If you MISS 2 blue “active” pills in a row in THE
3RD WEEK:
- 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.
If you are a Day 1 Starter:
THROW OUT the rest of the pill pack and start a new pack 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 healthcare professional
because you might be pregnant.
- You COULD BECOME 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 for those 7 days.
If you MISS 3 OR MORE blue “active” pills in a row
(during the first 3 weeks):
- 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.
If you are a Day 1 Starter:
THROW OUT the rest of the pill pack and start a new pack 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 healthcare professional
because you might be pregnant.
- You COULD BECOME 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 for those 7 days.
A REMINDER:
If you forget any of the 7 dark green “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 healthcare professional.
PREGNANCY DUE TO PILL FAILURE
The incidence of pill failure resulting in pregnancy is
approximately 5%, including women who do not always take the pills exactly as
directed. 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.
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 healthcare professional or pharmacist.
OTHER INFORMATION
Your healthcare 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
healthcare professional believes that it is a good medical practice to postpone
it. You should be reexamined at least once a year. Be sure to inform your
healthcare 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
healthcare 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.
HEALTH BENEFITS FROM ORAL CONTRACEPTIVES
In addition to preventing pregnancy, use of combination 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
- pain or other symptoms during menstruation may be encountered less frequently
- ectopic (tubal) pregnancy may occur less frequently
- noncancerous cysts or lumps in the breast may occur less frequently
- acute pelvic inflammatory disease may occur less frequently
- oral contraceptive use may provide some protection against developing two
forms of cancer: cancer of the ovaries and cancer of the lining of the uterus.
If you want more information about birth control pills, ask
your healthcare professional or pharmacist. They have a more technical leaflet
called the Professional Labeling, which you may wish to read. The professional
labeling is also published in a book entitled Physicians' Desk Reference, available
in many book stores and public libraries.
Keep out of reach of children.
Store at 25°C (77°F); excursions permitted to 15–30°C
(59–86°F).
Protect from light.
Last updated on RxList: 8/28/2009