BRIEF SUMMARY PATIENT PACKAGE INSERT YAZ (drospirenone
Contents
1. drospirenone amp ethinyl estradiol Detailed Patient Labeling PATIENTS SHOULD BE COUNSELED THAT THIS PRODUCT DOES NOT PROTECT AGAINST HIV INFECTION AIDS AND OTHER SEXUALLY TRANSMITTED DISEASES BRIEF SUMMARY PATIENT PACKAGE INSERT YAZ drospirenone and ethinyl estradiol Tablets containing the following 24 light pink active tablets 4 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 YAZ is different from other birth control pills because it contains the progestin drospirenone Drospirenone may increase potassium Therefore you should not take YAZ 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 YAZ is right for you and during the first month that you take YAZ you should have a blood test to check your potassium level e NSAIDs ibuprofen Motrin Advil naprosyn Aleve and others when taken long term and daily for treatment of arthritis or other problems e Potassium sparing diuretics spironolactone and others e Potassium supplementation e ACE inhibitors Capoten Vasotec Zestril and others e2. Angiotensin Il receptor antagonists Cozaar Diovan Avapro and others e Heparin e Aldosterone antagonists YAZ is an oral contraceptive also known as a birth control pill or the Pill Oral contraceptives are taken to prevent pregnancy and when taken correctly without missing any pills have a failure rate of approximately 1 per year 1 pregnancy per 100 women per year of use The typical failure rate in pill users is approximately 5 per year 5 pregnancies per 100 women per year of use when women who miss pills are included Forgetting to take pills considerably increases the chances of pregnancy YAZ may also be taken to treat premenstrual dysphoric disorder PMDD if you choose to use the Pill for birth control Unless you have already decided to use the Pill for birth control you should not start YAZ to treat your PMDD because there are other medical therapies for PMDD that do not have the same risks as the Pill PMDD is a mood disorder related to the menstrual cycle PMDD significantly interferes with work or school or with usual social activities and relationships with others Symptoms include markedly depressed mood anxiety or tension mood swings and persistent anger or irritability Other features include decreased interest in usual activities difficulty concentrating lack of energy change in appetite or sleep and feeling out of control Physical symptoms associated with PMDD may include breast tenderness head
3. 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 provider Your healthcare provider will take a medical and family history before prescribing oral contraceptives and will examine you The physical examination may be delayed to another time if you request it and the healthcare provider believes that it is appropriate to postpone it You should be reexamined at least once a year while taking oral contraceptives The detailed patient information booklet gives you further information which you should read and discuss with your healthcare provider This product like all oral contraceptives is intended to prevent pregnancy Oral contraceptives do not protect against HIV infection 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 YAZ CAN BE TAKEN WITHOUT REGARD TO MEALS 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 See WHAT TO DO IF YOU M
4. as condoms or spermicides anytime you have sex KEEP TAKING ONE ACTIVE LIGHT PINK PILL EACH DAY until you contact your healthcare provider 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 other oral contraceptives by young children Overdosage of YAZ may cause nausea and withdrawal bleeding in females and may increase blood levels of potassium or decrease blood levels of sodium which could be dangerous In case of overdosage contact your healthcare provider OTHER INFORMATION Your healthcare provider will take a medical and family history before prescribing oral contraceptives and will examine you The physical examination may be delayed to another time if you request it and the healthcare provider believes that it is appropriate to postpone it You should be re examined at least once a year Be sure to inform your healthcare provider if there is a family history of any of the conditions listed previously in this leaflet B
5. 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 See BOLDED TEXT AT BEGINNING 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 YAZ CAN BE TAKEN WITHOUT REGARD TO MEALS 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 See WHAT TO DO IF YOU MISS PILLS below 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 usua
6. healthcare provider to show you how to examine your breasts e Severe pain or tenderness in the stomach area indicating a possibly ruptured liver tumor e Difficulty in sleeping weakness lack of energy fatigue or change in mood possibly indicating severe depression e Jaundice or a light 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 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
7. 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 nausea vomiting 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 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 Stop taking oral contraceptives if pregnancy is confirmed 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 cont
8. of the 4 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 of birth control 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 LIGHT PINK PILL EACH DAY until you can contact your healthcare provider For additional information see Detailed Patient Labeling 4 po DETAILED PATIENT PACKAGE INSERT This product like all oral contraceptives is intended to prevent pregnancy Oral contraceptives do not protect against HIV infection AIDS and other sexually transmitted diseases YAZ is different from other birth control pills because it contains the progestin drospirenone Drospirenone may increase potassium Therefore you should not take YAZ 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 YAZ is right for you and during the first month that you take YAZ you should have a blood test to check your potassium level e NSAIDs ibuprofen Motrin Advil naprosyn Aleve and others when taken long term and daily for treatment of arthritis or othe
9. 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 to six 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 In rare cases oral contraceptives can cause benign but dangerous liver tumors These benign liver tumors can rupture and cause fatal internal bleeding In addition a possible but not definite association has been found with the pill and liver cancers in two studies in which a few women who developed these very rare cancers w
10. the skin jaundice during preg nancy or during previous use of the Pill or other hormonal contraceptives e Liver tumor benign or cancerous e Known or suspected pregnancy e Heart valve or heart rhythm disorders that may be associated with formation of blood clots e Diabetes with complications of the kidneys eyes nerves or blood vessels e Severe high blood pressure e A need for surgery with prolonged bedrest e Headaches with neurological symptoms e Allergy or hypersensitivity to any of the components of YAZ In addition you should not use YAZ if you have any of the following conditions e Kidney Disease e Liver Disease e Adrenal Disease 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 YAZ e NSAIDs ibuprofen naprosyn and others e Potassium sparing diuretics spironolactone and others e Potassium supplementation e ACE inhibitors captopril enalapril lisinopril and others e Angiotensin Il receptor antagonists Cozaar Diovan Avapro and others e Heparin e Aldosterone antagonists OTHER CONSIDERATIONS BEFORE TAKING ORAL CONTRACEPTIVES Tell your healthcare provider if you have or ever had e Breast nodules fibrocystic disease of the br
11. ISS PILLS below 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 healthcare provider 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 within 3 to 4 hours after you take your pill you should follow the instructions for WHAT TO DO IF YOU MISS PILLS IF YOU HAVE DIARRHEA or IF YOU TAKE CERTAIN 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 healthcare provider 6 IF YOU HAVE TROUBLE REMEMBERING TO TAKE THE PILL talk to your healthcare provider about how to make pill taking easier or about using another method of birth control 7 1F YOU HAVE ANY QUESTIONS OR ARE UNSURE ABOUT THE INFOR MATION IN THIS LEAFLET call your healthcare provider BEFORE YOU START TAKING YOUR PILLS 1 DECIDE WHAT TIME OF DAY YOU WANT TO TAKE YOUR PILL It is important to take YAZ at about the same time every day YAZ can be taken without regard to meals 2 LOOK AT YOUR PIL
12. J 07470 Manufactured in Germany 2007 Bayer HealthCare Pharmaceuticals Inc All Rights Reserved 80247177 6700400 Web PPI US April 2007
13. L PACK IT HAS 28 PILLS The YAZ pill pack has 24 light pink active pills with hormones to be taken for 24 days followed by 4 white reminder pills without hormones to be taken for four days 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 as shown in the diagram below oN TUE WED THU FST SUN J wei O OOOO OO Le 0000060 DROSPIRENONE ETHINYL ESTRADIOL TY YX YY YS 3 MG 0 02 MG mO 060000 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 F RST PACK OF PILLS You have a choice for which day to start taking your first pack of pills Decide with your healthcare provider 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 light pink 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 light pink 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 m
14. ache joint and muscle pain bloating and weight gain These symptoms occur regularly before menstruation starts and go away within a few days following the start of the period Diagnosis of PMDD should be made by healthcare providers You should only use YAZ for treatment of PMDD if you e Have already decided to use oral contraceptives for birth control and e Have been diagnosed with PMDD by your healthcare provider YAZ has not been shown to be effective for the treatment of premenstrual syndrome PMS a less serious cluster of symptoms occurring before menstruation If you or your healthcare provider believes you have PMS you should only take YAZ if you want to prevent pregnancy and not for the treatment of PMS YAZ may also be taken to treat moderate acne in women who are able to and wish to use the Pill for birth control Any woman who needs contraception birth control and chooses to use an oral contraceptive should understand the benefits and risks of using the Pill This leaflet will give you much of the information you will need to help you decide if you should use the Pill for contraception 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 leaflet is not a replacement for a Careful discussion between you and your healthcare professional You should discuss the infor
15. centage who experience an accidental pregnancy during the first year if they do not stop use for any reason 3 Among couples attempting to avoid pregnancy the percentage who continue to use a method for one year 4 The percents becoming pregnant in columns 2 and 3 are based on data from populations where contraception is not used and from women who cease using contraception in order to become pregnant Among such populations about 89 become pregnant within one year This estimate was lowered slightly to 85 to represent the percentage who would become pregnant within one year among women now relying on reversible methods of contraception if they abandoned contraception altogether 5 Foams creams gels vaginal suppositories and vaginal film 6 Cervical mucus ovulation method supplemented by calendar in the pre ovulatory and basal body temperature in the post ovulatory phases 7 With spermicidal cream or jelly 8 Without spermicides 9 The treatment schedule is one dose within 72 hours after unprotected intercourse and a second dose 12 hours after the first dose The Food and Drug Administration has declared the following brands of oral contraceptives to be safe and effective for emergency contraception Ovral 1 dose is 2 white pills Alesse 1 dose is 5 pink pills Nordette or Levien 1 dose is 2 light orange pills Lo Ovral 1 dose is 4 white pills Triphasil or Tri Levien 1 dose is 4 yellow pills 10 However to maintain
16. concentrating lack of energy change in appetite or sleep and feeling out of control Physical symptoms associated with PMDD may include breast tenderness headache joint and muscle pain bloating and weight gain These symptoms occur regularly before menstruation starts and go away within a few days following the start of the period Diagnosis of PMDD should be made by healthcare providers You should only use YAZ for treatment of PMDD if you e Have already decided to use oral contraceptives for birth control and e Have been diagnosed with PMDD by your healthcare provider YAZ has not been shown to be effective for the treatment of premenstrual syndrome PMS a less serious cluster of symptoms occurring before menstruation If you or your healthcare provider believes you have PMS you should only take YAZ if you want to prevent pregnancy and not for the treatment of PMS YAZ may also be taken to treat moderate acne in women who are able to and wish to use the Pill for birth control INTRODUCTION Any woman who needs contraception birth control and chooses to use an oral contraceptive should understand the benefits and risks of using the Pill This leaflet will give you much of the information you will need to help you decide if you should use the Pill for contraception 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 wi
17. e at One Year Method Typical Perfect 1 Use 2 Use 3 4 Chance 85 85 Spermicides 26 6 40 Periodic abstinence 25 63 Calendar 9 Ovulation method 3 Sympto thermal 2 Post ovulation 1 Withdrawal 19 4 Cap Parous women 40 26 42 Nulliparous women 20 9 56 Sponge Parous women 40 20 42 Nulliparous women 20 9 56 Diaphragm 20 6 56 Condom Female Reality 21 5 56 Male 14 3 61 Pill 5 71 progestin only 0 5 combined 0 1 IUD Progesterone T 2 1 5 81 Copper T 380A 0 8 0 6 78 Lng 20 0 1 0 1 81 Depo Provera 0 3 0 3 70 Norplant and Norplant 2 0 05 0 05 88 Female sterilization 0 5 0 5 100 Male sterilization 0 15 0 1 100 Emergency Contraceptive Pills Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75 9 Lactational Amenorrhea Method LAM is a highly effective temporary method of contraception 10 Source Trussell J Contraceptive efficacy In Hatcher RA Trussell J Stewart F Cates W Stewart GK Guest F Kowal D Contraceptive Technology Seventeenth Revised Edition New York NY Irvington Publishers 1998 1 Among typical couples who initiate use of a method not necessarily for the first time the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason 2 Among couples who initiate use of a method not necessarily for the first time and who use it perfectly both consistently and correctly The per
18. e sure to keep all appointments with your healthcare provider 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 oral contraceptives may provide certain benefits They are e Menstrual cycles may become more regular e Blood flow during menstruation may be lighter and less iron may be lost Therefore anemia due to iron deficiency is less likely to occur e Pain or other symptoms during menstruation may be encountered less frequently e Ovarian cysts may occur less frequently e Ectopic tubal pregnancy may occur less frequently e Noncancerous cysts or lumps in the breast may occur less frequently e Acute pelvic inflammatory disease may occur less frequently e 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 doctor or pharmacist They have a more technical leaflet called the Prescribing Information which you may wish to read Manufactured for B Bayer HealthCare R Pharmaceuticals Bayer HealthCare Pharmaceuticals Inc Wayne N
19. east an abnormal breast X ray or mammogram e Diabetes e Elevated cholesterol or triglycerides e High blood pressure e A blood test indicating a higher risk of having blood clots e Migraine or other headaches or epilepsy e Mental depression e Gallbladder heart or kidney disease e History of scanty or irregular menstrual periods 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 are on any medications recently had a baby or miscarriage or are breast feeding 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 In particular a clot in the legs deep vein thrombosis can cause pain and swelling 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
20. effective protection against pregnancy another method of contraception must be used as soon as menstruation resumes the frequency or duration of breastfeeds is reduced bottle feeds are introduced or the baby reaches six months of age YAZ may also be taken to treat moderate acne if all of the following are true e Your doctor says it is safe for you to use the Pill e You are at least 14 years old e You have started having menstrual periods e You want to use the Pill for birth control WHO SHOULD NOT TAKE YAZ or 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 YAZ For example you should not take YAZ if you are pregnant or think you may be pregnant You should also not use YAZ if you have had any of the following conditions e A history of heart attack or stroke e A history of blood clots in the legs deep vein thrombosis lungs pulmonary embolism or eyes retinal thrombosis e Chest pain angina pectoris e Known or suspected breast cancer or cancer of the lining of the uterus cervix or vagina e Unexplained vaginal bleeding until a diagnosis is reached by your doctor e Yellowing of the whites of the eyes or of
21. ere 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 o
22. ethod if you have sex anytime from the Sunday you start your first pack until the next Sunday 7 days WHEN YOU SWITCH FROM A DIFFERENT BIRTH CONTROL PILL When switching from another birth control pill YAZ should be started on the same day that a new pack of the previous birth control pills would have been started Week 2 Week 3 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 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 light pink active pill in Week 1 of your pack 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 contro method if you have sex If you MISS 2 light pink 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 COULD BECOME PREGNANT if you have sex in the 7 days after you restart your pills You MUST use another birth control method such as condoms or spermicides as a back up f
23. f 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 15 19 and Outcome years No fertility control 7 methods 1 Oral contraceptives 03 non smoker 2 Oral contraceptives 99 smoker 2 IUD 2 0 8 Condom 1 11 Diaphragm 19 spermicide 1 Periodic abstinence 1 2 5 f 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
24. ill YAZ should be started on the same day that a new pack of the previous birth control pill would have been started 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 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 light pink 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 light pink 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 COULD BECOME PREGNANT if you have sex in the 7 days after you restart your 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 light pink active pills in a row in WEEK 3 or Week 4 of your pack 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 Sunda
25. ll be as effective as possible However this leaflet is not a replacement for a Careful discussion between you and your healthcare professional You should discuss the information provided in this leaflet 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 YAZ FOR PREVENTION OF PREGNANCY Oral contraceptives or birth control pills or the Pill are used to prevent pregnancy and are more effective than most other nonsurgical methods of birth control When they are taken correctly the chance of becoming pregnant is less than 1 one pregnancy per 100 women per year of use when used perfectly without missing any pills Typical failure rates including women who don t always follow the instructions exactly are about 5 per year The chance of becoming pregnant increases with each missed pill during a menstrual cycle In comparison typical failure rates for other nonsurgical methods of birth control during the first year of use are as follows Percentage of women experiencing an unintended pregnancy during the first year of typical use and first year of perfect use of contraception and the percentage continuing use at the end of the first year United States of Women Experiencing an Unintended Pregnancy of Women Continuing Use Within the First Year of Us
26. lly go away If it does not go away check with your healthcare provider 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 within 3 to 4 hours after you take your pill you should follow the instructions for WHAT TO DO IF YOU MISS PILLS IF YOU HAVE DIARRHEA or IF YOU TAKE CERTAIN 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 healthcare provider 6 IF YOU HAVE TROUBLE REMEMBERING TO TAKE THE PILL talk to your healthcare provider about how to make pill taking easier or about using another method of birth control 7 1F YOU HAVE ANY QUESTIONS OR ARE UNSURE ABOUT THE IN FORMATION IN THIS LEAFLET call your healthcare provider BEFORE YOU START TAKING YOUR PILLS 1 DECIDE WHAT TIME OF DAY YOU WANT TO TAKE YOUR PILL It is important to take YAZ at about the same time every day YAZ can be taken without regard to meals 2 LOOK AT YOUR PILL PACK IT HAS 28 PILLS The YAZ pill pack has 24 light pink active pills with hormones to be taken for 24 days followed by 4 white reminder pills without hor mones to be taken for four days 3 ALSO FIND 1 Where on the pack to start taking pil
27. ls 2 In what order to take the pills follow the arrows 3 The week numbers as shown in the diagram below MON TUE WED THU FRI SAT SUN wer O O O O OOO lo 00 Week 2 i o DROSPIRENONE ETHINYL ESTRADIOL 10000000 AN AN 7 7 7 N weka DO oQoo0o0 c 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 healthcare provider 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 light pink 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 light pink 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 anytime from the Sunday you start your first pack until the next Sunday 7 days WHEN YOU SWITCH FROM A DIFFERENT BIRTH CONTROL PILL When switching from another birth control p
28. mation provided in this leaflet 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 up while you are on the Pill 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 The risks associated with taking oral contraceptives increase significantly if you e smoke e have high blood pressure diabetes high cholesterol or are obese e have or have had clotting disorders heart attack stroke angina pectoris Severe chest pains cancer of the breast or sex organs jaundice or malignant or benign liver tumors You should not take the Pill if you suspect you are pregnant or have unexplained vaginal bleeding 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 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
29. of birth control Ifa 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 e Sharp chest pain coughing of blood or sudden shortness of breath indicating a possible clot in the lung e Pain in the calf indicating a possible clot in the leg e Crushing chest pain or heaviness in the chest indicating a possible heart attack e 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 e Sudden partial or complete loss of vision indicating a possible clot in the eye e Breast lumps indicating possible breast cancer or fibrocystic disease of the breast ask your doctor or
30. or those 7 days If you MISS 2 light pink active pills in a row in WEEK 3 or Week 4 of your pack 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 COULD BECOME PREGNANT if you have sex in the 7 days after you restart your pills You MUST use another birth control method such as condoms or spermicides as a back up for those 7 days 3 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 healthcare provider because you might be pregnant If you MISS 3 OR MORE light pink active pills in a row during ANY Week 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 You COULD BECOME PREGNANT if you have sex in the 7 days after you restart pills You MUST use another birth control method such as condoms or spermicides as a back up for those 7 days 3 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 healthcare provider because you might be pregnant If you MISS ANY
31. r problems e Potassium sparing diuretics spironolactone and others e Potassium supplementation e ACE inhibitors Capoten Vasotec Zestril and others e Angiotensin Il receptor antagonists Cozaar Diovan Avapro and others e Heparin e Aldosterone antagonists YAZ is an oral contraceptive also known as a birth control pill or the Pill Oral contraceptives are taken to prevent pregnancy and when taken correctly without missing any pills have a failure rate of approximately 1 per year 1 pregnancy per 100 women per year of use The typical failure rate in pill users is approximately 5 per year 5 pregnancies per 100 women per year of use when women who miss pills are included Forgetting to take pills considerably increases the chances of pregnancy YAZ may also be taken to treat premenstrual dysphoric disorder PIMDD if you choose to use the Pill for birth control Unless you have already decided to use the Pill for birth control you should not start YAZ to treat your PMDD because there are other medical therapies for PMDD that do not have the same risks as the Pill PMDD is a mood disorder related to the menstrual cycle PMDD significantly interferes with work or school or with usual social activities and relationships with others Symptoms include markedly depressed mood anxiety or tension mood swings and persistent anger or irritability Other features include decreased interest in usual activities difficulty
32. raceptives 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 con traceptives 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 light 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
33. should not 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 1 Blood clots in the legs thrombophlebitis lungs pulmonary embolism blockage or rupture of a blood vessel in the brain stroke blockage of blood vessels in the heart heart attack and 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 Women with migraine headaches also may be at increased risk of stroke when taking the Pill 2 Liver tumors which may rupture and cause severe bleeding A possible but not definite association has been found with the Pill and liver cancer However liver cancers are extremely rare The chance of developing liver cancer from using the Pill is thus even rarer 3 High blood pressure although blood pressure usually returns to normal when the Pill is stopped 4 Cancer of the breast Various studies give conflicting reports on the relationship be
34. tween 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 or precancerous lesions of the cervix in women who use the Pill However this finding may be related to factors other than the use of the Pill The symptoms associated with these serious side effects are discussed in the detailed leaflet given to you with your supply of pills Notify your doctor or healthcare provider if you notice any unusual physical disturbances while taking the Pill In addition drugs such as rifampin as well as some anticonvulsants some antibiotics and some herbal products such as St John s Wort may decrease oral contraceptive effectiveness Taking the Pill may provide some important non contraceptive benefits These include less painful menstruation less menstrual blood loss
35. y On Sunday THROW OUT the rest of the pack and start a new pack of pills that same day 2 You COULD BECOME PREGNANT if you have sex in the 7 days after you restart your pills You MUST use another birth control method such as condoms or spermicides as a back up for those 7 days 3 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 If you MISS 3 OR MORE light pink active pills in a row during ANY Week 1 If you are a Day 1 Starter THROW OUT the rest of the pill pack and start a new pack that same day If you are a Sunday Starter Keep taking 1 pill every day until Sunday On Sunday THROW OUT the rest of the pack and start a new pack of pills that same day 2 You COULD BECOME PREGNANT if you have sex in the 7 days after you restart your pills You MUST use another birth control method such as condoms or spermicides as a back up for those 7 days 3 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 If you MISS ANY of the 4 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
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