Unknown

If you MISS 2 yellow “active” pills in a row in the 3RD WEEK:
Percentage of women experiencing an unintended pregnancy during
1. If you are a Day 1 Starter:
the first year of typical use and first year of perfect use of
Brief Summary Patient Package Insert
HOW TO TAKE THE PILL
contraception and the percentage continuing use at the end of the
THROW OUT the rest of the pill pack and start a new pack that same IMPORTANT POINTS TO REMEMBER
first year: United States. (Continued)
YASMIN ® 28 TABLETS
BEFORE YOU START TAKING YOUR PILLS
If you are a Sunday Starter:
Keep taking one pill every day until Sunday. On Sunday, THROW OUT the rest of the pack and start a new pack of pills that same day.
Anytime you are not sure what to do.
2. You may not have your period this month but this is expected.
2. THE RIGHT WAY TO TAKE THE PILL IS TO TAKE ONE PILL EVERY However, if you miss your period two months in a row, call your This product (like all oral contraceptives) is intended to prevent
doctor or healthcare provider because you might be pregnant.
pregnancy. It does not protect against HIV infection (AIDS) and other
If you miss pills you could get pregnant. This includes starting the 3. You MAY BECOME PREGNANT if you have sex in the 7 days after sexually transmitted diseases.
pack late. The more pills you miss, the more likely you are to get you miss pills. You MUST use another birth control method (such YASMIN is different from other birth-control pills because it contains
as condoms or spermicides) as a back-up for those 7 days.
the progestin drospirenone. Drospirenone may increase potassium.
If you MISS 3 OR MORE yellow “active” pills in a row (during the first Therefore, you should not take YASMIN if you have kidney, liver or
3. MANY WOMEN HAVE SPOTTING OR LIGHT BLEEDING, OR MAY adrenal disease because this could cause serious heart and health
FEEL SICK TO THEIR STOMACH DURING THE FIRST 1-3 PACKS OF problems. Other drugs may also increase potassium. If you are
1. If you are a Day 1 Starter:
currently on daily, long-term treatment for a chronic condition with
If you do have spotting or light bleeding or feel sick to your THROW OUT the rest of the pill pack and start a new pack that same any of the medications below, you should consult your healthcare
stomach, do not stop taking the pill. The problem will usually go provider about whether YASMIN is right for you, and during the first
away. If it does not go away, check with your doctor or healthcare month that you take YASMIN, you should have a blood test to check
If you are a Sunday Starter:
your potassium level.
Keep taking 1 pill every day until Sunday. On Sunday, THROW OUT 4. MISSING PILLS CAN ALSO CAUSE SPOTTING OR LIGHT • NSAIDs (ibuprofen [Motrin®, Advil®], naproxen [Naprosyn®,
the rest of the pack and start a new pack of pills that same day.
BLEEDING, even when you make up these missed pills.
Aleve® and others] when taken long-term and for treatment of
2. You may not have your period this month but this is expected.
arthritis or other problems)
On the days you take two pills, to make up for missed pills, you However, if you miss your period two months in a row, call your could also feel a little sick to your stomach.
Emergency Contraceptive Pills: Treatment initiated within 72 hours after
• Potassium-sparing diuretics (spironolactone and others)
doctor or healthcare provider because you might be pregnant.
5. IF YOU HAVE VOMITING OR DIARRHEA, or IF YOU TAKE SOME unprotected intercourse reduces the risk of pregnancy by at least 75%.9 • Potassium supplementation
3. You MAY BECOME PREGNANT if you have sex in the 7 days after MEDICINES, including some antibiotics and some herbal products Lactational Amenorrhea Method: LAM is highly effective, temporary
you miss pills. You MUST use another birth control method (such • ACE inhibitors (Capoten®, Vasotec®, Zestril® and others)
such as St. John’s Wort, your pills may not work as well.
as condoms or spermicides) as a back-up for those 7 days.
Source: Trussell J, Contraceptive efficacy. In Hatcher RA, Trussell J, • Angiotensin-II receptor antagonists (Cozaar®, Diovan®, Avapro®
Use a back-up method (such as condoms or spermicides) until you Stewart F, Cates W, Stewart GK, Kowal D, Guest F, Contraceptive and others)
check with your doctor or healthcare provider.
If you forget any of the 7 white “reminder” pills in Week 4:THROW AWAY the pills you missed.
Technology: Seventeenth Revised Edition. New York NY: Irvington • Heparin
6. IF YOU HAVE TROUBLE REMEMBERING TO TAKE THE PILL, talk to your doctor or healthcare provider about how to make pill-taking Keep taking one pill each day until the pack is empty.
Oral contraceptives, also known as “birth-control pills” or “the pill,” are 1 Among typical couples who initiate use of a method (not easier or about using another method of birth control.
taken to prevent pregnancy, and when taken correctly, have a failure necessarily for the first time), the percentage who experience an rate of less than 1% per year when used without missing any pills. The 7. IF YOU HAVE ANY QUESTIONS OR ARE UNSURE ABOUT THE FINALLY, IF YOU ARE STILL NOT SURE WHAT TO DO ABOUT THE accidental pregnancy during the first year if they do not stop use for typical failure rate of large numbers of pill users is less than 5% per INFORMATION IN THIS LEAFLET, call your doctor or healthcare year when women who miss pills are included. However, forgetting to Use a BACK-UP METHOD (such as condoms or spermicides) anytime 2 Among couples who initiate use of a method (not necessarily for take pills considerably increases the chances of pregnancy.
the first time) and who use it perfectly (both consistently and BEFORE YOU START TAKING YOUR PILLS
For the majority of women, oral contraceptives can be taken safely. But correctly), the percentage who experience an accidental pregnancy 1. DECIDE WHAT TIME OF DAY YOU WANT TO TAKE YOUR PILL.
KEEP TAKING ONE ACTIVE PILL EACH DAY until you can reach your there are some women who are at high risk of developing certain during the first year if they do not stop use for any reason.
serious diseases that can be life-threatening or may cause temporary It is important to take it at about the same time every day.
3 Among couples attempting to avoid pregnancy, the percentage who For additional information see Detailed Patient Labeling Please Use The Day Label Sheet On The Back Of This Insert
or permanent disability or death. The risks associated with taking oral 2. LOOK AT YOUR PILL PACK — IT HAS 28 PILLS: continue to use a method for one year.
contraceptives increase significantly if you: DETAILED PATIENT PACKAGE INSERT
4 The percents becoming pregnant in columns (2) and (3) are based The YASMIN pill pack has 21 yellow “active” pills (with hormones)
This product (like all oral contraceptives) is intended to prevent
on data from populations where contraception is not used and from to be taken for three weeks, followed by 7 white “reminder” pills pregnancy. It does not protect against HIV infection (AIDS) and other
women who cease using contraception in order to become • have high blood pressure, diabetes, high cholesterol (without hormones) to be taken for one week.
sexually transmitted diseases.
pregnant. Among such populations, about 89% become pregnant • have or have had clotting disorders, heart attack, stroke, angina YASMIN is different from other birth-control pills because it contains
within one year. This estimate was lowered slightly (to 85%) to pectoris, cancer of the breast or sex organs, jaundice, or malignant the progestin drospirenone. Drospirenone may increase potassium.
represent the percentage who would become pregnant within one 1) where on the pack to start taking pills, Therefore, you should not take YASMIN if you have kidney, liver or
year among women now relying on reversible methods of You should not take the pill if you suspect you are pregnant or have 2) in what order to take the pills (follow the arrows) adrenal disease because this could cause serious heart and health
contraception if they abandoned contraception altogether.
PATIENTS SHOULD BE COUNSELED THAT THIS PRODUCT DOES NOT PROTECT AGAINST HIV INFECTION (AIDS) AND OTHER SEXUALLY TRANSMITTED DISEASES.
3) the week numbers as shown in the diagram below problems. Other drugs may also increase potassium. If you are
5 Foams, creams, gels, vaginal suppositories, and vaginal film.
currently on daily, long-term treatment for a chronic condition with
6 Cervical mucus (ovulation) method supplemented by calendar in Cigarette smoking increases the risk of serious adverse effects
any of the medications below, you should consult your healthcare
the pre-ovulatory and basal body temperature in the post-ovulatory on the heart and blood vessels from oral contraceptive use. This
provider about whether YASMIN is right for you, and during the first
risk increases with age and with heavy smoking (15 or more cig-
month that you take YASMIN, you should have a blood test to check
arettes per day) and is quite marked in women over 35 years of
your potassium level.
age. Women who use oral contraceptives should not smoke.
• NSAIDs (ibuprofen [Motrin®, Advil®], naproxen [Naprosyn®,
Aleve® and others] when taken long-term and for treatment of
9 The treatment schedule is one dose within 72 hours after unprotected intercourse, and a second dose 12 hours after the first Most side effects of the pill are not serious. The most common such arthritis or other problems)
dose. The Food and Drug Administration has declared the following effects are nausea, vomiting, bleeding between menstrual periods, YASMIN 28 TABLETS
• Potassium-sparing diuretics (spironolactone and others)
brands of oral contraceptives to be safe and effective for emergency weight gain, breast tenderness, and difficulty wearing contact lenses.
contraception: Ovral (1 dose is 2 white pills), Alesse (1 dose is 5 These side effects, especially nausea and vomiting may subside within • Potassium supplementation
pink pills), Nordette or Levlen (1 dose is 2 light-orange pills), • ACE inhibitors (Capoten®, Vasotec®, Zestril® and others)
Lo/Ovral (1 dose is 4 white pills), Triphasil or Tri-Levlen (1 dose is The serious side effects of the pill occur very infrequently, especially if ANOTHER KIND OF BIRTH CONTROL (such as condoms or • Angiotensin-II receptor antagonists (Cozaar®, Diovan®, Avapro®
you are in good health and are young. However, you should know that spermicides) to use as a back-up in case you miss pills.
and others)
10 However, to maintain effective protection against pregnancy, the following medical conditions have been associated with or made another method of contraception must be used as soon as • Heparin
menstruation resumes, the frequency or duration of breastfeeds is 1. Blood clots in the legs (thrombophlebitis), lungs (pulmonary WHEN TO START THE FIRST PACK OF PILLS
INTRODUCTION
reduced, bottle feeds are introduced, or the baby reaches six embolism), blockage or rupture of a blood vessel in the brain (stroke), blockage of blood vessels in the heart (heart attack and angina You have a choice for which day to start taking your first pack of pills.
Any woman who considers using oral contraceptives (the birth-control WHO SHOULD NOT TAKE ORAL CONTRACEPTIVES
pectoris) or other organs of the body. As mentioned above, smoking Decide with your doctor or healthcare provider which is the best day pill or “the pill”) should understand the benefits and risks of using this increases the risk of heart attacks and strokes and subsequent serious for you. Pick a time of day which will be easy to remember.
form of birth control. This leaflet will give you much of the information Cigarette smoking increases the risk of serious adverse effects on
DAY 1 START:
you will need to make this decision and will also help you determine if the heart and blood vessels from oral contraceptive use. This risk
you are at risk of developing any of the serious side effects of the pill.
increases with age and with heavy smoking (15 or more cigarettes
2. Liver tumors, which may rupture and cause severe bleeding. A 1. Take the first yellow “active” pill of the first pack during the first It will tell you how to use the pill properly so that it will be as effective per day) and is quite marked in women over 35 years of age.
possible but not definite association has been found with the pill and as possible. However, this leaflet is not a replacement for a careful Women who use YASMIN should not smoke.
liver cancer. However, liver cancers are extremely rare. The chance of 2. You will not need to use a back-up method of birth control, since discussion between you and your healthcare provider. You should developing liver cancer from using the pill is thus even rarer.
Some women should not use the pill. For example, you should not take you are starting the pill at the beginning of your period.
discuss the information provided in this leaflet with him or her, both YASMIN if you are pregnant or think you may be pregnant. You should
3. High blood pressure, although blood pressure usually returns to when you first start taking the pill and during your revisits. You should also not use YASMIN if you have had any of the following conditions:
SUNDAY START:
also follow your healthcare provider’s advice with regard to regular 4. Cancer of the breast. Various studies give conflicting reports on the 1. Take the first yellow “active” pill of the first pack on the Sunday after check-ups while you are on the pill.
relationship between breast cancer and oral contraceptive use. Oral your period starts, even if you are still bleeding. If your period EFFECTIVENESS OF ORAL CONTRACEPTIVES
• Blood clots in the legs (thrombophlebitis), lungs (pulmonary contraceptive use may slightly increase your chance of having breast begins on Sunday, start the pack that same day.
cancer diagnosed, particularly after using hormonal contraceptives at Oral contraceptives or “birth-control pills” or “the pill” are used to 2. Use another method of birth control (such as condoms or • A history of blood clots in the deep veins of your legs a younger age. After you stop using hormonal contraceptives, the prevent pregnancy and are more effective than other nonsurgical spermicides) as a back-up method if you have sex any time from chances of getting breast cancer begin to go back down. You should methods of birth control. When they are taken correctly, the chance of the Sunday you start your first pack until the next Sunday (7 days).
have regular breast examinations by a healthcare provider and examine becoming pregnant is less than 1.0% (one pregnancy per 100 women • Known or suspected breast cancer or cancer of the lining of the your own breasts monthly. Tell your healthcare provider if you have a per year of use) when used perfectly, without missing any pills. Typical WHAT TO DO DURING THE MONTH
family history of breast cancer or if you have had breast nodules or an failure rates, including women who don’t always follow the 1. TAKE ONE PILL AT THE SAME TIME EVERY DAY UNTIL THE PACK
abnormal mammogram. Women who currently have or have had instructions exactly, are about 5.0% per year. The chance of becoming • Unexplained vaginal bleeding (until a diagnosis is reached by your breast cancer should not use oral contraceptives because breast pregnant increases with each missed pill during a menstrual cycle.
cancer is a hormone-sensitive tumor.
Do not skip pills even if you are spotting or bleeding between ln comparison, typical failure rates for other nonsurgical methods of • Yellowing of the whites of the eyes or of the skin (jaundice) during The symptoms associated with these serious side effects are monthly periods or feel sick to your stomach (nausea).
birth control during the first year of use are as follows: pregnancy or during previous use of the pill discussed in the detailed leaflet given to you with your supply of pills.
Do not skip pills even if you do not have sex very often.
Percentage of women experiencing an unintended pregnancy during
Notify your doctor or healthcare provider if you notice any unusual the first year of typical use and first year of perfect use of
physical disturbances while taking the pill. ln addition, drugs such as 2. WHEN YOU FINISH A PACK OR SWITCH YOUR BRAND OF PILLS:
contraception and the percentage continuing use at the end of the
rifampin, as well as some anticonvulsants, some antibiotics and some Start the next pack on the day after your last white “reminder” pill.
first year: United States.
herbal products such as St. John’s Wort, may decrease oral In addition, you should not use YASMIN if you have any of the
WHAT TO DO IF YOU MISS PILLS
Taking the pill provides some important non-contraceptive benefits.
These include less painful menstruation, less menstrual blood loss and If you MISS 1 yellow “active” pill:
anemia, fewer pelvic infections, and fewer cancers of the ovary and the 1. Take it as soon as you remember. Take the next pill at your regular time. This means you may take two pills in one day.
Be sure to discuss any medical condition you may have with your Tell your healthcare provider if you have ever had any of the above 2. You do not need to use a back-up birth control method if you healthcare provider. Your healthcare provider will take a medical and conditions (Your healthcare provider can recommend another method family history before prescribing oral contraceptives and will examine of birth control). If you are currently on daily, long-term treatment for you. The physical examination may be delayed to another time if you If you MISS 2 yellow “active” pills in a row in WEEK 1 OR WEEK 2 of
a chronic condition with any of the following medications, you should request it and the healthcare provider believes that it is appropriate to consult your healthcare provider before taking YASMIN:
postpone it. You should be reexamined at least once a year while taking 1. Take two pills on the day you remember and two pills the next day.
• NSAIDs (ibuprofen, naproxen and others) oral contraceptives. The detailed patient information booklet gives you 2. Then take one pill a day until you finish the pack.
• Potassium-sparing diuretics (spironolactone and others) further information which you should read and discuss with your 3. You MAY BECOME PREGNANT if you have sex in the 7 days after This product (like all oral contraceptives) is intended to prevent
you miss pills. You MUST use another birth control method (such • ACE inhibitors (captopril, enalapril, lisinopril and others) pregnancy. It does not protect against transmission of HIV (AIDS)
as condoms or spermicides) as a back-up for those 7 days.
and other sexually transmitted diseases such as chlamydia, genital
herpes, genital warts, gonorrhea, hepatitis B, and syphilis.
• Angiotensin-II receptor antagonists (Cozaar®, Diovan®, Avapro® and compared to 28 associated with pregnancy at that age. However, for effective (also See bolded text at beginning).
as condoms or spermicides) as a back-up for those 7 days.
pill users who smoke and are over the age of 35, the estimated number 5. Sexually Transmitted Diseases
If you MISS 2 yellow “active” pills in a row in the 3RD WEEK:
of deaths exceeds those for other methods of birth control. If a woman This product (like all oral contraceptives) is intended to prevent
1. If you are a Day 1 Starter:
is over the age of 40 and smokes, her estimated risk of death is four pregnancy. It does not protect against transmission of HIV (AIDS)
THROW OUT the rest of the pill pack and start a new pack that same OTHER CONSIDERATIONS BEFORE TAKING ORAL CONTRACEPTIVES
times higher (117/100,000 women) than the estimated risk associated and other sexually transmitted diseases such as chlamydia, genital
with pregnancy (28/100,000 women) in that age group.
Tell your healthcare provider if you or any family member has ever had: herpes, genital warts, gonorrhea, hepatitis B, and syphilis.
The suggestion that women over 40 who do not smoke should not take If you are a Sunday Starter:
• Breast nodules, fibrocystic disease of the breast, an abnormal breast oral contraceptives is based on information from older high-dose pills HOW TO TAKE THE PILL
Keep taking one pill every day until Sunday. On Sunday, THROW and on less-selective use of pills than is practiced today. An Advisory IMPORTANT POINTS TO REMEMBER
OUT the rest of the pack and start a new pack of pills that same day.
Committee of the FDA discussed this issue in 1989 and recommended 2. You may not have your period this month but this is expected.
BEFORE YOU START TAKING YOUR PILLS
• Elevated cholesterol or triglycerides that the benefits of oral contraceptive use by healthy, non-smoking However, if you miss your period two months in a row, call your women over 40 years of age may outweigh the possible risks.
doctor or healthcare provider because you might be pregnant.
However, all women, especially older women, are cautioned to use the 3. You MAY BECOME PREGNANT if you have sex in the 7 days after • Migraine or other headaches or epilepsy you miss pills. You MUST use another birth control method (such Any time you are not sure what to do.
WARNING SIGNALS
as condoms or spermicides) as a back-up for those 7 days.
If any of these adverse effects occur while you are taking oral 2. THE RIGHT WAY TO TAKE THE PILL IS TO TAKE ONE PILL EVERY If you MISS 3 OR MORE yellow “active” pills in a row (during the first
contraceptives, call your doctor immediately: • History of scanty or irregular menstrual periods • Sharp chest pain, coughing of blood, or sudden shortness of breath If you miss pills you could get pregnant. This includes starting the 1. If you are a Day 1 Starter:
pack late. The more pills you miss, the more likely you are to get Women with any of these conditions should be checked often by their THROW OUT the rest of the pill pack and start a new pack that same healthcare provider if they choose to use oral contraceptives.
• Pain in the calf (indicating a possible clot in the leg) Also, be sure to inform your doctor or healthcare provider if you smoke 3. MANY WOMEN HAVE SPOTTING OR LIGHT BLEEDING, OR MAY If you are a Sunday Starter:
• Crushing chest pain or heaviness in the chest (indicating a possible FEEL SICK TO THEIR STOMACH DURING THE FIRST 1-3 PACKS OF Keep taking 1 pill every day until Sunday. On Sunday, THROW OUT RISKS OF TAKING ORAL CONTRACEPTIVES
the rest of the pack and start a new pack of pills that same day.
• Sudden severe headache or vomiting, dizziness or fainting, If you do have spotting or light bleeding or feel sick to your 2. You may not have your period this month but this is expected.
disturbances of vision or speech, weakness, or numbness in an arm stomach, do not stop taking the pill. The problem will usually go However, if you miss your period two months in a row, call your Blood clots and blockage of blood vessels are the most serious side away. If it does not go away, check with your doctor or healthcare doctor or healthcare provider because you might be pregnant.
effects of taking oral contraceptives and can be fatal. ln particular, a • Sudden partial or complete loss of vision (indicating a possible clot clot in the legs can cause thrombophlebitis and a clot that travels to the 3. You MAY BECOME PREGNANT if you have sex in the 7 days after lungs can cause sudden blocking of the vessel carrying blood to the 4. MISSING PILLS CAN ALSO CAUSE SPOTTING OR LIGHT you miss pills. You MUST use another birth control method (such lungs. Rarely, clots occur in the blood vessels of the eye and may • Breast lumps (indicating possible breast cancer or fibrocystic BLEEDING, even when you make up these missed pills.
as condoms or spermicides) as a back-up for those 7 days.
cause blindness, double vision, or impaired vision.
disease of the breast; ask your doctor or healthcare provider to show On the days you take two pills, to make up for missed pills, you If you forget any of the 7 white “reminder” pills in Week 4: If you take oral contraceptives and need elective surgery, need to stay could also feel a little sick to your stomach.
in bed for a prolonged illness or have recently delivered a baby, you • Severe pain or tenderness in the stomach area (indicating a possibly 5. IF YOU HAVE VOMITING OR DIARRHEA, for any reason, or IF YOU Keep taking one pill each day until the pack is empty.
may be at risk of developing blood clots. You should consult your TAKE SOME MEDICINES, including some antibiotics and some doctor about stopping oral contraceptives three to four weeks before herbal products such as St. John’s Wort, your pills may not work as surgery and not taking oral contraceptives for two weeks after surgery • Difficulty in sleeping, weakness, lack of energy, fatigue, or change in FINALLY, IF YOU ARE STILL NOT SURE WHAT TO DO ABOUT THE or during bed rest. You should also not take oral contraceptives soon mood (possibly indicating severe depression) after delivery of a baby or a mid-trimester pregnancy loss or • Jaundice or a yellowing of the skin or eyeballs, accompanied Use a back-up method (such as condoms or spermicides) until you Use a BACK-UP METHOD (such as condoms or spermicides) any time termination. It is advisable to wait for at least four weeks after delivery frequently by fever, fatigue, loss of appetite, dark-colored urine, or check with your doctor or healthcare provider.
if you are not breast-feeding. If you are breast-feeding, you should wait light-colored bowel movements (indicating possible liver problems) 6. IF YOU HAVE TROUBLE REMEMBERING TO TAKE THE PILL, talk to KEEP TAKING ONE ACTIVE PILL EACH DAY until you can reach your until you have weaned your child before using the pill. (See also the your doctor or healthcare provider about how to make pill-taking section on breast-feeding in GENERAL PRECAUTIONS.)
SIDE EFFECTS OF ORAL CONTRACEPTIVES
easier or about using another method of birth control.
Irregular vaginal bleeding or spotting may occur while you are taking 7. IF YOU HAVE ANY QUESTIONS OR ARE UNSURE ABOUT THE The incidence of pill failure resulting in pregnancy is approximately Oral contraceptives may increase the tendency to develop strokes the pills. Irregular bleeding may vary from slight staining between INFORMATION IN THIS LEAFLET, call your doctor or healthcare less than 1.0% (one pregnancy per 100 women per year of use) if (stoppage or rupture of blood vessels in the brain) and angina pectoris menstrual periods to breakthrough bleeding, which is a flow much like taken every day as directed, but more typical failure rates are about and heart attacks (blockage of blood vessels in the heart). Any of these a regular period. Irregular bleeding occurs most often during the first 5%. If failure does occur with YASMIN use, the risk to the fetus is
conditions can cause death or serious disability.
BEFORE YOU START TAKING YOUR PILLS
few months of oral contraceptive use, but may also occur after you Smoking greatly increases the possibility of suffering heart attacks and have been taking the pill for some time. Such bleeding may be 1. DECIDE WHAT TIME OF DAY YOU WANT TO TAKE YOUR PILL.
strokes. Furthermore, smoking and the use of oral contraceptives temporary and usually does not indicate any serious problems. It is It is important to take it at about the same time every day.
There may be some delay in becoming pregnant after you stop using greatly increase the chances of developing and dying of heart disease.
important to continue taking your pills on schedule. If the bleeding 2. LOOK AT YOUR PILL PACK — IT HAS 28 PILLS: oral contraceptives, especially if you had irregular menstrual cycles occurs in more than one cycle or lasts for more than a few days, talk before you used oral contraceptives. It may be advisable to postpone The YASMIN pill pack has 21 yellow “active” pills (with hormones)
to your doctor or healthcare provider.
to be taken for three weeks, followed by 7 white “reminder” pills conception until you begin menstruating regularly once you have Oral contraceptive users probably have a greater risk than nonusers of (without hormones) to be taken for one week.
stopped taking the pill and desire pregnancy.
having gallbladder disease, although this risk may be related to pills There does not appear to be any increase in birth defects in newborn If you wear contact lenses and notice a change in vision or an inability to wear your lenses, contact your doctor or healthcare provider.
babies when pregnancy occurs soon after stopping the pill.
1) where on the pack to start taking pills, 2) in what order to take the pills (follow the arrows) ln rare cases, oral contraceptives can cause benign but dangerous liver Oral contraceptives may cause edema (fluid retention) with swelling of Serious ill effects have not been reported following ingestion of large 3) the week numbers as shown in the diagram below tumors. These benign liver tumors can rupture and cause fatal internal the fingers or ankles and may raise your blood pressure. If you doses of other oral contraceptives by young children. Overdosage of bleeding. ln addition, a possible but not definite association has been experience fluid retention, contact your doctor or healthcare provider.
YASMIN may cause nausea and withdrawal bleeding in females and
found with the pill and liver cancers in two studies, in which a few may increase blood levels of potassium or decrease blood levels of women who developed these very rare cancers were found to have sodium, which could be dangerous. In case of overdosage, contact used oral contraceptives for long periods. However, liver cancers are A spotty darkening of the skin is possible, particularly of the face.
extremely rare. The chance of developing liver cancer from using the Other side effects may include change in appetite, headache, ner- Your healthcare provider will take a medical and family history before vousness, depression, dizziness, loss of scalp hair, rash, and vaginal 5. CANCER OF THE REPRODUCTIVE ORGANS AND BREASTS prescribing oral contraceptives and will examine you. The physical examination may be delayed to another time if you request it and the Various studies give conflicting reports on the relationship between If any of these side effects occur, call your doctor or healthcare healthcare provider believes that it is appropriate to postpone it. You breast cancer and oral contraceptive use. Oral contraceptive use may should be re-examined at least once a year. Be sure to inform your slightly increase your chance of having breast cancer diagnosed, YASMIN 28 TABLETS
healthcare provider if there is a family history of any of the conditions particularly after using hormonal contraceptives at a younger age.
GENERAL PRECAUTIONS
listed previously in this leaflet. Be sure to keep all appointments with After you stop using hormonal contraceptives, the chances of getting 1. Missed periods and use of oral contraceptives before or during your healthcare provider, because this is a time to determine if there breast cancer begin to go back down. You should have regular breast are early signs of side effects of oral contraceptive use.
examinations by a healthcare provider and examine your own breasts ANOTHER KIND OF BIRTH CONTROL (such as condoms or There may be times when you may not menstruate regularly after you monthly. Tell your healthcare provider if you have a family history of spermicides) to use as a back-up in case you miss pills.
Do not use the drug for any condition other than the one for which it have completed taking a cycle of pills. If you have taken your pills breast cancer or if you have had breast nodules or an abnormal was prescribed. This drug has been prescribed specifically for you; do regularly and miss one menstrual period, continue taking your pills for mammogram. Women who currently have or have had breast cancer not give it to others who may want birth-control pills.
the next cycle but be sure to inform your healthcare provider before WHEN TO START THE FIRST PACK OF PILLS
should not use oral contraceptives because breast cancer is a doing so. If you have not taken the pills daily as instructed and missed You have a choice for which day to start taking your first pack of pills.
a menstrual period, or if you missed two consecutive menstrual In addition to preventing pregnancy, use of oral contraceptives may Decide with your doctor or healthcare provider which is the best day Some studies have found an increase in the incidence of cancer of the periods, you may be pregnant. Check with your healthcare provider for you. Pick a time of day which will be easy to remember.
cervix in women who use oral contraceptives. However, this finding immediately to determine whether you are pregnant. Do not continue • Menstrual cycles may become more regular may be related to factors other than the use of oral contraceptives.
to take oral contraceptives until you are sure you are not pregnant, but DAY 1 START:
• Blood flow during menstruation may be lighter and less iron may be ESTIMATED RISK OF DEATH FROM A BIRTH CONTROL METHOD OR
continue to use another method of contraception.
1. Take the first yellow “active” pill of the first pack during the first lost. Therefore, anemia due to iron deficiency is less likely to occur.
PREGNANCY
There is no conclusive evidence that oral contraceptive use is asso- • Pain or other symptoms during menstruation may be encountered All methods of birth control and pregnancy are associated with a risk ciated with an increase in birth defects when taken inadvertently during 2. You will not need to use a back-up method of birth control, since of developing certain diseases which may lead to disability or death.
early pregnancy. Previously, a few studies had reported that oral you are starting the pill at the beginning of your period.
An estimate of the number of deaths associated with different methods contraceptives might be associated with birth defects, but these SUNDAY START:
• Ovarian cysts may occur less frequently of birth control and pregnancy has been calculated and is shown in the studies have not been confirmed. Nevertheless, oral contraceptives 1. Take the first yellow “active” pill of the first pack on the Sunday after • Ectopic (tubal) pregnancy may occur less frequently should not be used during pregnancy. You should check with yourdoctor about risks to your unborn child of any medication taken during your period starts, even if you are still bleeding. If your period ANNUAL NUMBER OF BIRTH-RELATED OR METHOD-RELATED
• Noncancerous cysts or lumps in the breast may occur less begins on Sunday, start the pack that same day.
DEATHS ASSOCIATED WITH CONTROL OF FERTILITY PER 100,000
NONSTERILE WOMEN, BY FERTILITY-CONTROL METHOD
2. Use another method of birth control (such as condoms or ACCORDING TO AGE
• Acute pelvic inflammatory disease may occur less frequently If you are breast-feeding, consult your doctor before starting oral spermicides) as a back-up method if you have sex any time from Method of Control
the Sunday you start your first pack until the next Sunday (7 days).
• Oral contraceptive use may provide some protection against contraceptives. Some of the drug will be passed on to the child in the and Outcome
milk. A few adverse effects on the child have been reported, including WHAT TO DO DURING THE MONTH
developing two forms of cancer: cancer of the ovaries and cancer of yellowing of the skin (jaundice) and breast enlargement. In addition, 1. TAKE ONE PILL AT THE SAME TIME EVERY DAY UNTIL THE PACK
oral contraceptives may decrease the amount and quality of your milk.
If you want more information about birth-control pills, ask your doctor If possible, do not use oral contraceptives while breast-feeding. You or pharmacist. They have a more technical leaflet called the Do not skip pills even if you are spotting or bleeding between should use another method of contraception since breast-feeding monthly periods or feel sick to your stomach (nausea).
Prescribing Information which you may wish to read.
provides only partial protection from becoming pregnant, and this partial protection decreases significantly as you breast-feed for longer Do not skip pills even if you do not have sex very often.
periods of time. You should consider starting oral contraceptives only 2. WHEN YOU FINISH A PACK OR SWITCH YOUR BRAND OF PILLS:
after you have weaned your child completely.
Start the next pack on the day after your last white “reminder” pill.
If you are scheduled for any laboratory tests, tell your doctor you are WHAT TO DO IF YOU MISS PILLS
taking birth-control pills. Certain blood tests may be affected by If you MISS 1 yellow “active” pill:
1. Take it as soon as you remember. Take the next pill at your regular Adapted from H.W. Ory, Family Planning Perspectives 15:57-63, 1983.
time. This means you may take two pills in one day.
Certain drugs may interact with birth-control pills to make them less In the preceding table, the risk of death from any birth-control method 2. You do not need to use a back-up birth control method if you effective in preventing pregnancy or cause an increase in breakthrough is less than the risk of childbirth, except for oral contraceptive users bleeding. Such drugs include rifampin, drugs used for epilepsy such over the age of 35 who smoke and pill users over the age of 40 even if as barbiturates (for example, phenobarbital) and phenytoin (Dilantin is If you MISS 2 yellow “active” pills in a row in WEEK 1 OR WEEK 2 of
they do not smoke. It can be seen in the table that for women aged 15 one brand of this drug), phenylbutazone (Butazolidin is one brand) and to 39, the risk of death was highest with pregnancy (7-26 deaths per possibly certain antibiotics. Herbal products containing St. John’s 1. Take two pills on the day you remember and two pills the next day.
100,000 women, depending on age). Among pill users who do not Wort (hypericum perforatum) may reduce the effectiveness of oral 2. Then take one pill a day until you finish the pack.
smoke, the risk of death was always lower than that associated with contraceptives. This may also result in breakthrough bleeding. You 2004, Berlex. All Rights Reserved.
pregnancy for any age group, except for those women over the age of 3. You MAY BECOME PREGNANT if you have sex in the 7 days after may need to use an additional method of contraception during any 40, when the risk increases to 32 deaths per 100,000 women, you miss pills. You MUST use another birth control method (such cycle in which you take drugs that can make oral contraceptives less

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