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Yasmin Patient, Information, Instructions - Drospirenone and Ethinyl Estradiol
PATIENT INFORMATION
YASMIN 28 tablets containing the following:
21 yellow – "active" tablets
7 white – "inert" tablets
| This product (like all oral contraceptives) is intended to prevent pregnancy. It does not protect against HIV infection (AIDS) and other sexually transmitted diseases. |
Drospirenone
YASMIN is different from other birth-control pills because it contains the progestin drospirenone. Drospirenone may increase potassium. Therefore, you should not take YASMIN if you have kidney, liver or adrenal disease because this could cause serious heart and health problems. Other drugs may also increase potassium. If you are currently on daily, long-term treatment for a chronic condition with any of the medications below, you should consult your healthcare provider about whether YASMIN is right for you, and during the first month that you take YASMIN, you should have a blood test to check your potassium level.
General
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 less than 1% per year when used without missing any pills. The typical failure rate of large numbers of pill users is less than 5% per year when women who miss pills are included. However, forgetting to take pills considerably increases the chances of pregnancy.
For the majority of women, oral contraceptives can be taken safely. But there are some women who are at high risk of developing certain serious diseases that can be life-threatening or may cause temporary or permanent disability or death.
WHO SHOULD NOT TAKE ORAL CONTRACEPTIVES
| Cigarette smoking increases the risk of serious adverse effects on the heart and blood vessels 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 YASMIN if you are pregnant or think you may be pregnant. You should also not use YASMIN if you have had any of the following conditions:
In addition, you should not use YASMIN if you have any of the following conditions:
Tell your healthcare provider if you have ever had any of the above conditions (Your healthcare provider can recommend another method of birth control). If you are currently on daily, long-term treatment for a chronic condition with any of the following medications, you should consult your healthcare provider before taking YASMIN:
OTHER CONSIDERATIONS BEFORE TAKING ORAL CONTRACEPTIVES
Tell your healthcare provider if you or any family member has ever had:
Women with any of these conditions should be checked often by their healthcare provider if they choose to use oral contraceptives.
Also, be sure to inform your doctor or healthcare provider 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 the most serious
side effects of taking oral contraceptives and can be fatal. ln particular,
a clot in the legs can cause thrombophlebitis and a clot that travels
to the lungs can cause 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 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 or a mid-trimester pregnancy loss or termination. 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.)
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
ln rare cases, oral contraceptives can cause benign but dangerous
liver tumors. These benign liver tumors can rupture and cause fatal internal
bleeding. ln 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 are extremely rare. The chance
of developing liver cancer from using the pill is thus even rarer.
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 getting breast cancer begin to go back
down. You should have regular breast examinations by a healthcare provider
and examine your own breasts monthly. Tell your healthcare provider if
you have a family history of breast cancer or if you have had breast nodules
or an abnormal mammogram. Women who currently have or have had breast
cancer should not use oral contraceptives because breast cancer is a hormone-sensitive
tumor.
Some studies have found an increase in the incidence of 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 | 15-19 | 20-24 | 25-29 | 30-34 | 35-39 | 40-44 |
| No fertility control methods 1 | 7.0 | 7.4 | 9.1 | 14.8 | 25.7 | 28.2 |
| Oral contraceptives non-smoker 2 | 0.3 | 0.5 | 0.9 | 1.9 | 13.8 | 31.6 |
| Oral contraceptives smoker 2 | 2.2 | 3.4 | 6.6 | 13.5 | 51.1 | 117.2 |
| IUD 2 | 0.8 | 0.8 | 1.0 | 1.0 | 1.4 | 1.4 |
| Condom 1 | 1.1 | 1.6 | 0.7 | 0.2 | 0.3 | 0.4 |
|
Diaphragm/spermicide 1 |
1.9 | 1.2 | 1.2 | 1.3 | 2.2 | 2.8 |
|
Periodic abstinence 1 |
2.5 | 1.6 | 1.6 | 1.7 | 2.9 | 3.6 |
| 1 Deaths are birth related 2 Deaths are method related |
||||||
|
Adapted from H.W. Ory, Family Planning Perspectives, 15:57-63, 1983. |
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 (7-26 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, except for those women over the age of 40, when 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 do not 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, non-smoking 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.
WARNING SIGNALS
If any of these adverse effects occur while you are taking oral contraceptives, call your doctor immediately:
SIDE EFFECTS OF ORAL CONTRACEPTIVES
1. 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 healthcare provider.
2. CONTACT LENSES
If you wear contact lenses and notice a change in vision or an inability
to wear your lenses, contact your doctor or healthcare provider.
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 doctor or healthcare provider.
4. MELASMA
A spotty darkening of the skin is possible, particularly of the face.
5. 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 healthcare provider.
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 provider 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 healthcare provider 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 should not be used during pregnancy. You should check with your doctor about risks to your unborn child of any medication taken during pregnancy.
2. While Breast-Feeding
If you are breast-feeding, 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 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 oral contraceptives only after you have weaned
your child completely.
3. 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.
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) and phenytoin (Dilantin is one
brand of this drug), phenylbutazone (Butazolidin is one brand) and possibly
certain antibiotics. Herbal products containing St. John’s Wort (hypericum
perforatum) may reduce the effectiveness of oral contraceptives. This
may also result in breakthrough bleeding. You may need to use an additional
method of contraception during any cycle in which you take drugs that
can make oral contraceptives less effective (also see Drospirenone).
5. Sexually Transmitted Diseases
| This product (like all oral contraceptives) is intended to prevent pregnancy. It does not protect against transmission of HIV (AIDS) and other sexually transmitted diseases such as chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B, and syphilis. |
INSTRUCTIONS TO PATIENTS HOW TO TAKE THE PILL
IMPORTANT POINTS TO REMEMBER BEFORE YOU START TAKING YOUR PILLS
| 1. | BE SURE TO READ THESE DIRECTIONS: Before you start taking your pills. Anytime you are not sure what to do. |
| 2. | THE RIGHT WAY TO TAKE THE PILL IS TO TAKE
ONE PILL EVERY DAY AT THE SAME TIME. If you miss pills you could get pregnant. This includes starting the pack late. The more pills you miss, the more likely you are to get pregnant. |
| 3. | MANY WOMEN HAVE SPOTTING OR LIGHT BLEEDING,
OR MAY FEEL SICK TO THEIR STOMACH DURING THE FIRST 1-3 PACKS OF PILLS. If you do have spotting or light bleeding or feel sick to your stomach, do not stop taking the pill. The problem will usually go away. If it does not go away, check with your doctor or clinic. |
| 4. | MISSING PILLS CAN ALSO CAUSE SPOTTING
OR LIGHT BLEEDING, even when you make up these missed pills. On the days you take two pills, to make up for missed pills, you could also feel a little sick to your stomach. |
| 5. | IF YOU HAVE VOMITING OR DIARRHEA, or IF
YOU TAKE SOME MEDICINES, including some antibiotics and some herbal
products such as St. John’s Wort, your pills may not work as well. Use a back-up method (such as condoms or spermicides) until you check with your doctor or clinic. |
| 6. | IF YOU HAVE TROUBLE REMEMBERING TO TAKE THE PILL, talk to your doctor or clinic about how to make pill-taking easier or about using another method of birth control. |
| 7. | IF YOU HAVE ANY QUESTIONS OR ARE UNSURE ABOUT THE INFORMATION IN THIS LEAFLET, call your doctor or clinic. |
BEFORE YOU START TAKING YOUR PILLS
| 1. | DECIDE WHAT TIME OF DAY YOU WANT TO TAKE
YOUR PILL. It is important to take it at about the same time every day. |
| 2. | LOOK AT YOUR PILL PACK — IT HAS 28 PILLS: The YASMIN pill pack has 21 yellow "active" pills (with hormones) to be taken for three weeks, followed by 7 white "reminder" pills (without hormones) to be taken for one week. |
| 3. | ALSO FIND: 1) where on the pack to start taking pills, 2) in what order to take the pills (follow the arrows) 3) the week numbers |
| 4. | BE SURE YOU HAVE READY AT ALL TIMES: ANOTHER KIND OF BIRTH CONTROL (such as condoms or spermicides) 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 for which day to start taking your first pack of pills. Decide with your doctor or clinic which is the best day for you. Pick a time of day which will be easy to remember.
| DAY 1 START: | |
| 1. | Take the first yellow "active" 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 yellow "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. |
| 2. | Use another method of birth control (such as condoms or spermicides) as a back-up method if you have sex any time from the Sunday you start your first pack until the next Sunday (7 days). |
| 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: Start the next pack on the day after your last white "reminder" pill. Do not wait any days between packs. |
| WHAT TO DO IF YOU
MISS PILLS If you MISS 1 yellow "active" pill: |
|
| 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. |
| 2. | You do not need to use a back-up birth control method if you have sex. |
| If you MISS 2 yellow "active" pills in a row in WEEK 1 OR WEEK 2 of your pack: | |
| 1. | Take two pills on the day you remember and two pills the next day. |
| 2. | Then take one 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 or spermicides) as a back-up for those 7 days. |
| If you MISS 2 yellow "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 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. |
| 2. | You may not have your period this month but this is expected. However, if you miss your period two 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 or spermicides) as a back-up for those 7 days. |
| If you MISS 3 OR MORE yellow "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 two 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 or spermicides) as a back-up for those 7 days. |
If you forget any of the 7 white "reminder" pills in Week 4:
THROW AWAY the pills you missed.
Keep taking one 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 (such as condoms or spermicides) anytime you have sex.
KEEP TAKING ONE ACTIVE PILL EACH DAY until you can reach your doctor or clinic.
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