ESTROGENSAND PROGESTINS ORAL CONTRACEPTIVES (Systemic)

Some commonly used brand names are:

In the U.S.?

• Alesse ³
• Brevicon ⁵
• Cyclessa ¹
• Demulen 1/35 ²
• Demulen 1/50 ²
• Desogen ¹
• Estrostep ⁴
• Estrostep Fe ⁴
• Genora 0.5/35 ⁵
• Genora 1/35 ⁵
• Genora 1/50 ⁶
• Intercon 0.5/35 ⁵
• Intercon 1/35 ⁵
• Intercon 1/50 ⁶
• Jenest ⁵
• Levlen ³
• Levlite ³
• Levora 0.15/30 ³
• Loestrin 1/20 ⁴
• Loestrin Fe 1/20 ⁴
• Loestrin 1.5/30 ⁴
• Loestrin Fe 1.5/30 ⁴
• Lo/Ovral ⁸
• Mircette ¹
• ModiCon ⁵
• Necon 0.5/35 ⁵
• Necon 1/35 ⁵
• Necon 1/50 ⁶
• Necon 10/11 ⁵
• N.E.E. 1/35 ⁵
• N.E.E. 1/50 ⁵
• Nelova 0.5/35E ⁵
• Nelova 1/35E ⁵
• Nelova 1/50M ⁶
• Nelova 10/11 ⁵
• Nordette ³
• Norethin 1/35E ⁵
• Norethin 1/50M ⁶
• Norinyl 1+35 ⁵
• Norinyl 1+50 ⁵
• Ortho-Cept ¹
• Ortho-Cyclen ⁷
• Ortho-Novum 1/35 ⁵
• Ortho-Novum 1/50 ⁶
• Ortho-Novum 7/7/7 ⁵
• Ortho-Novum 10/11 ⁵
• Ortho Tri-Cyclen ⁷
• Ovcon-35 ⁵
• Ovcon-50 ⁵
• Ovral ⁸
• Tri-Levlen ³
• Tri-Norinyl ⁵
• Triphasil ³
• Trivora ³
• Zovia 1/35E ²
• Zovia 1/50E ²

In Canada?

• Brevicon 0.5/35 ⁵
• Brevicon 1/35 ⁵
• Cyclen ⁷
• Demulen 30 ²
• Demulen 50 ²
• Loestrin 1.5/30 ⁴
• Marvelon ¹
• Minestrin 1/20 ⁴
• Min-Ovral ³
• Norinyl 1/50 ⁵
• Ortho 0.5/35 ⁵
• Ortho 1/35 ⁵
• Ortho 7/7/7 ⁵
• Ortho 10/11 ⁵
• Ortho-Cept ¹
• Ortho-Novum 1/50 ⁶
• Ovral ⁸
• Select 1/35 ⁵
• Synphasic ⁵
• Tri-Cyclen ⁷
• Triphasil ³
• Triquilar ³

Other commonly used names are:

• Ethinylestradiol [Ethinyl estradiol]
• Ethinyloestradiol [Ethinyl estradiol]
• Ethynodiol [Ethynodiol diacetate]
• Etynodiol [Ethynodiol diacetate]
• Etynodiol acetate [Ethynodiol diacetate]
• Norethindrone [Norethisterone]

Category

• Antiacne agent, systemic?Norgestimate and Ethinyl Estradiol, triphasic formulationonly; Norethindrone and Ethinyl Estradiol,triphasic formulation only
• Antiendometriotic?Desogestrel and Ethinyl Estradiol; Ethynodiol Diacetate and Ethinyl Estradiol; Levonorgestrel and Ethinyl Estradiol; Norethindrone and Ethinyl Estradiol; Norethindrone and Mestranol; NorethindroneAcetate and Ethinyl Estradiol; Norgestimateand Ethinyl Estradiol; Norgestrel and EthinylEstradiol
• Contraceptive, postcoital, systemic?Levonorgestrel and Ethinyl Estradiol; Norgestrel and Ethinyl Estradiol
• Contraceptive, systemic?Desogestrel and EthinylEstradiol; Ethynodiol Diacetate and EthinylEstradiol; Levonorgestrel and Ethinyl Estradiol; Norethindrone and Ethinyl Estradiol; Norethindrone and Mestranol; Norethindrone Acetate and Ethinyl Estradiol; Norgestimate and Ethinyl Estradiol; Norgestreland Ethinyl Estradiol
• Estrogen-progestin?Desogestrel and Ethinyl Estradiol; Ethynodiol Diacetate and Ethinyl Estradiol; Levonorgestrel and Ethinyl Estradiol; Norethindrone and Ethinyl Estradiol; Norethindroneand Mestranol; Norethindrone Acetate andEthinyl Estradiol; Norgestimate and EthinylEstradiol; Norgestrel and Ethinyl Estradiol
• Gonadotropin inhibitor, female, noncontraceptiveuse?Desogestrel and Ethinyl Estradiol; Ethynodiol Diacetate and Ethinyl Estradiol; Levonorgestrel and Ethinyl Estradiol; Norethindrone and Ethinyl Estradiol; Norethindrone and Mestranol; NorethindroneAcetate and Ethinyl Estradiol; Norgestimateand Ethinyl Estradiol; Norgestrel and EthinylEstradiol

Description

Oral contraceptives are known also as the Pill, OCs, BCs, BCtablets, or birth control pills. This medicine usually contains two typesof hormones, estrogens (ES-troh-jenz ) and progestins (proh-JES-tins) and, when taken properly, prevents pregnancy.It works by stopping a woman's egg from fully developing each month. The eggcan no longer accept a sperm and fertilization is prevented. Although oralcontraceptives have other effects that help prevent a pregnancy from occurring,this is the main action.

Sometimes a woman's egg can still develop even though the medication istaken once each day, especially when more than 24 hours pass between two doses.In almost all cases when the medicine was taken properly and an egg develops,fertilization can still be stopped by oral contraceptives. This is becauseoral contraceptives also thicken cervical mucus at the opening of the uterus.This makes it hard for the partner's sperm to reach the egg. In addition,oral contraceptives change the uterus lining just enough so that an egg willnot stop in the uterus to develop. All of these effects make it difficultto become pregnant when properly taking an oral contraceptive.

No contraceptive method is 100 percent effective. Studies show that fewer than one of each one hundred women correctly usingoral contraceptives becomes pregnant during the first year of use.Birth control methods such as having surgery to become sterile or not havingsex are more effective. Using condoms, diaphragms, progestin-only oral contraceptives,or spermicides is not as effective as using oral contraceptives containingestrogens and progestins. Discuss with your health care professional youroptions for birth control.

The triphasic cycle product of norgestimate and ethinyl estradiol (thebrand name Ortho Tri-Cyclen) and norethindroneacetate and ethinyl estradiol (the brand name Estrostep) can be used for the treatment of moderate acne only if the patientis at least 15 years old, has acne that has not improved with topical anti-acnemedicines, has gotten approval from her doctor, has begun to have menstrualperiods, desires an oral contraceptive for birth control, and plans to stayon it for at least 6 months.

Sometimes these preparations can be used for other conditions as determinedby your doctor.

Oral contraceptives are available only with your doctor's prescription,in the following dosage forms:

Oral
• Desogestrel and Ethinyl Estradiol
  • Tablets (U.S. and Canada)
• Ethynodiol Diacetate and Ethinyl Estradiol
  • Tablets (U.S. and Canada)
• Levonorgestrel and Ethinyl Estradiol
  • Tablets (U.S. and Canada)
• Norethindrone Acetate and Ethinyl Estradiol
  • Tablets (U.S. and Canada)
• Norethindrone and Ethinyl Estradiol
  • Tablets (U.S. and Canada)
• Norethindrone and Mestranol
  • Tablets (U.S. and Canada)
• Norgestimate and Ethinyl Estradiol
  • Tablets (U.S. and Canada)
• Norgestrel and Ethinyl Estradiol
  • Tablets (U.S. and Canada)

Before Using This Medicine

In deciding to use a medicine,the risks of taking the medicine must be weighed against the good it willdo. If you are using oral contraceptives for contraception you should understandhow their benefits and risks compare to those of other birth control methods.This is a decision you, your sexual partner, and your doctor will make. Fororal contraceptives, the following should be considered:

Allergies?Tell your doctor if you have ever had any unusual orallergic reaction to estrogens or progestins. Also tell your health care professionalif you are allergic to any other substances, such as foods, preservatives,or dyes.

Diet?Make certain your health care professionalknows if you are on any special diet, such as a low-sodium or low-sugar diet.

Pregnancy?Oral contraceptives are not recommended for use duringpregnancy and should be discontinued if you become pregnant or think you arepregnant. When oral contraceptives were accidently taken early in pregnancy,problems in the fetus did not occur. Women who are not breast-feeding maybegin to take oral contraceptives two weeks after having a baby.

Breast-feeding?Oral contraceptives pass into the breast milk andcan change the content or lower the amount of breast milk. Also, they mayshorten a woman's ability to breast-feed by about 1 month, especially whenthe mother is only partially breast-feeding. Because the amount of hormonesis so small in low-dose contraceptives, your doctor may allow you to beginusing an oral contraceptive after you have been breast-feeding for a while.However, it may be necessary for you to use another method of birth controlor to stop breast-feeding while taking oral contraceptives.

Adolescents?This medicine is frequently used for birth controlin teenage females and has not been shown to cause different side effectsor problems than it does in adults. Some teenagers may need extra informationon the importance of taking this medication exactly as prescribed.

Other medicines?Although certain medicines should not be usedtogether at all, in other cases two different medicines may be used togethereven if an interaction might occur. In these cases, your doctor may want tochange the dose, or other precautions may be necessary. When you are takingoral contraceptives, it is especially important that your health care professionalknow if you are taking any of the following:

• Amiodarone (e.g., Cordarone) or
• Anabolic steroids (nandrolone [e.g., Anabolin], oxandrolone [e.g.,Anavar], oxymetholone [e.g., Anadrol], stanozolol [e.g., Winstrol]) or
• Androgens (male hormones) or
• Anti-infectives by mouth or by injection (medicine for infection)or
• Barbiturates or
• Carbamazepine (e.g., Tegretol) or
• Carmustine (e.g., BiCNU) or
• Dantrolene (e.g., Dantrium) or
• Daunorubicin (e.g., Cerubidine) or
• Disulfiram (e.g., Antabuse) or
• Divalproex (e.g., Depakote) or
• Estrogens (female hormones) or
• Etretinate (e.g., Tegison) or
• Gold salts (medicine for arthritis) or
• Griseofulvin (e.g., Fulvicin) or
• Hydroxychloroquine (e.g., Plaquenil) or
• Mercaptopurine (e.g., Purinethol) or
• Methotrexate (e.g., Mexate) or
• Methyldopa (e.g., Aldomet) or
• Naltrexone (e.g., Trexan) (with long-term, high-dose use) or
• Phenothiazines (acetophenazine [e.g., Tindal], chlorpromazine [e.g.,Thorazine], fluphenazine [e.g., Prolixin], mesoridazine [e.g., Serentil],perphenazine [e.g., Trilafon], prochlorperazine [e.g., Compazine], promazine[e.g., Sparine], promethazine [e.g., Phenergan], thioridazine [e.g., Mellaril],trifluoperazine [e.g., Stelazine], triflupromazine [e.g., Vesprin], trimeprazine[e.g., Temaril]) or
• Phenylbutazone (e.g., Butazolidin) or
• Phenytoin (e.g., Dilantin) or
• Plicamycin (e.g., Mithracin) or
• Primidone (e.g., Mysoline) or
• Rifabutin (e.g., Mycobutin) or
• Rifampin (e.g., Rifadin) or
• Troleandomycin (e.g., TAO)?These medicines may increase thechance of liver problems if taken with oral contraceptives; also, these medicinesmay decrease the effect of oral contraceptives and increase your chance ofpregnancy. Use of an additional form of birth control is recommended unlessdirected otherwise by your health care professional

• Corticosteroids (cortisone-like medicine) or
• Theophylline?Oral contraceptives may increase the effects ofthese medicines and increase the chance of problems occurring

• Cyclosporine?Oral contraceptives increase the effect of cyclosporineand increase the chance of problems occurring

• Ritonavir (e.g., Norvir) or
• Troglitazone (e.g., Rezulin)?These medicines may decrease theeffect of oral contraceptives and increase your chance of pregnancy. Use ofan additional form of birth control is recommended unless directed otherwiseby your health care professional

• Smoking, tobacco?Smoking may decrease the effect of oral contraceptivesand increase the chance of causing serious blood clot, vein, or heart problems

Other medical problems?The presence of other medicalproblems may affect the use of oral contraceptives. Make sure you tell yourdoctor if you have any other medical problems, especially:

• Abnormal changes in menstrual or uterine bleeding or
• Endometriosis or
• Fibroid tumors of the uterus?Oral contraceptives usually improvethese female conditions but sometimes they can make them worse or make thediagnosis of these problems more difficult

• Blood clots (or history of) or
• Heart or circulation disease or
• Stroke (or history of)?If these conditions are already present,oral contraceptives may have a greater chance of causing blood clots or circulationproblems, especially in women who smoke tobacco. Otherwise, oral contraceptivesmay help prevent circulation and heart disease if you are healthy and do notsmoke

• Breast disease (not involving cancer)?Oral contraceptives usuallyprotect against certain breast diseases, such as breast cysts or breast lumps;however, your doctor may want to follow your condition more closely

• Cancer, including breast cancer (or history of or family historyof)?Oral contraceptives may worsen some cancers, especially when breast,cervical, or uterine cancers already exist. Use of oral contraceptives isnot recommended if you have any of these conditions. If you have a familyhistory of breast disease, oral contraceptives may still be a good choicebut you may need to be tested more often

• Chorea gravidarum or
• Gallbladder disease or gallstones (or history of) or
• High blood cholesterol or
• Liver disease (or history of, including jaundice during pregnancyor oral contraceptive use) or
• Mental depression (or history of)?Oral contraceptives may makethese conditions worse or, rarely, cause them to occur again. Oral contraceptivesmay still be a good choice but you may need to be tested more often

• Diabetes mellitus (sugar diabetes)?Use of oral contraceptivesmay cause an increase, usually only a small increase, in your blood sugarand usually does not affect the amount of diabetes medicine that you take.You or your doctor will want to test for any changes in your blood sugar for12 to 24 months after starting to take oral contraceptives in case the doseof your diabetes medicine needs to be changed

• Epilepsy (seizures) (or history of) or
• Heart or circulation problems or
• High blood pressure (hypertension) or
• Migraine headaches?Oral contraceptives may cause fluid build-upand may cause these conditions to become worse; however, some people havefewer migraine headaches when they use oral contraceptives

Proper Use of This Medicine

To make usingoral contraceptives as safe and reliable as possible, you should understandhow and when to take them and what effects may be expected.

A paper with information for the patient will be givento you with your filled prescription, and will provide many details concerningthe use of oral contraceptives. Read this paper carefully and ask yourhealth care professional if you need additional information or explanation.

Take this medicine with food to help prevent nausea that might occur duringthe first few weeks. Nausea usually disappears with continued use or if themedicine is taken at bedtime.

When you begin to use oral contraceptives, yourbody will require at least 7 days to adjust before a pregnancy will be prevented.You will need to use an additional birth control method for at least 7 days.Some doctors recommend using an additional method of birth control for thefirst cycle (or 3 weeks) to ensure full protection. Follow the advice of yourdoctor or other health care professional.

Try to take the doses no more than 24 hours apart toreduce the possibility of side effects and to prevent pregnancy. Sinceone of the most important factors in the proper use of oral contraceptivesis taking every dose exactly on schedule, you should never let your tabletsupply run out. When possible, try to keep an extra month's supply of tabletson hand and replace it monthly.

It is very important that you keep the tablets in their original containerand take the tablets in the same order that they appear in the container.The containers help you keep track of which tablets to take next. Differentcolored tablets in the same package contain different amounts of hormonesor are placebos (tablets that do not contain hormones). The effectiveness of the medicine is reduced if the tablets are taken outof order.

• Monophasic (one-phase) cycle dosing schedule:Most available dosing schedules are monophasic. If you are taking tabletsof one strength (color) for 21 days, you are using a monophasic schedule.For the 28-day monophasic cycle you will also take an additional 7 inactivetablets, which are another color. If you are taking the brand name Mircette, the last seven tablets of the 28-day cyclecontains two inactive tablets (for Days 22 and 23) and five tablets (for Days24 through 28) that contain a low dose of estrogen. Taking the last 7 tabletsis not required for full protection against pregnancy but they do help toreplace estrogen.
• Biphasic (two-phase) cycle dosing schedule:If you are using a biphasic twenty-one-day schedule, you are takingtablets of one strength (color) for either seven or ten days, depending onthe medication prescribed (the first phase). You then take tablets of a secondstrength (color) for the next eleven or fourteen days, depending on the medicationprescribed (the second phase). At this point, you will have taken a totalof twenty-one tablets. For the twenty-eight-day biphasic cycle you willalso take an additional seven inactive tablets, which are a third color.
• Triphasic (three-phase) cycle dosing schedule:If you are using a triphasic twenty-one-day schedule, you are takingtablets of one strength (color) for five, six or seven days, depending onthe medicine prescribed (the first phase). You then take tablets of a secondstrength (color) for the next five, seven, or nine days, depending on themedicine prescribed (the second phase). After that, you take tablets of athird strength (color) for the next five, seven, nine, or ten days, dependingon the medicine prescribed (the third phase). At this point, you will havetaken a total of twenty-one tablets. For the twenty-eight-day triphasiccycle you will also take an additional seven inactive tablets, which are afourth color.

If you are taking one of the brand name products Estrostep Fe or Loestrin Fe each of thelast seven tablets that you will take on Days 21 through 28 of your cyclecontains iron. These tablets are also a different color from the other tabletsin your package. They help to replace some of the iron you lose when you havea menstrual period.

Dosing?Your health care professional may begin yourdose on the first day of your menstrual period (called Day-1 start) or onSunday (called Sunday start). When you begin on a certainday it is important that you follow that schedule, even when you miss a dose. Do not change your schedule on your own.If the schedule that you have been put on is not convenient, check with yourhealth care professional about changing schedules.

• For oral dosage forms (monophasic, biphasic,or triphasic tablets):
  • For contraception:
    • Adults and teenagers:
      • For the twenty-one-day cycle: Take 1 tablet a day for twenty-onedays. Skip seven days. Then repeat the cycle.
      • For the twenty-eight-day cycle: Take 1 tablet a day for twenty-eightdays. Then repeat the cycle.

• For oral dosage forms (norethindroneacetate and ethinyl estradiol triphasic tablets and norgestimate and ethinylestradiol triphasic tablets :
  • To treat acne:
    • Adults and teenagers 15 years of age and over:
      • For the twenty-one-day cycle: Take 1 tablet a day for twenty-onedays. Skip seven days. Then repeat the cycle.
      • For the twenty-eight-day cycle: Take 1 tablet a day for twenty-eightdays. Then repeat the cycle.
    • Teenagers up to 15 years of age?Use and dose must be determinedby your doctor.

Missed dose?Follow your doctor's ordersor the directions on the label if you miss a dose of this medicine.The following information includes only some of the ways to handle misseddoses. Your health care professional may want you to stop taking the medicineand use other birth control methods for the rest of the month until you haveyour menstrual period. Then your health care professional can tell you howto begin taking your medicine again.

For monophasic, biphasic, or triphasic cycles:

• If you miss the first tablet of a new cycle?Take the missedtablet as soon as you remember and take the next tablet at the usual time.You may take 2 tablets in one day. Then continue your regular dosing schedule.Also, use another birth control method until you have taken seven days ofyour tablets after the last missed dose.
• If you miss 1 tablet during the cycle?Take the missed tabletas soon as you remember. Take the next tablet at the usual time. You may take2 tablets in one day. Then continue your regular dosing schedule.
• If you miss 2 tablets in a row in the first or second week?Take2 tablets on the day that you remember and 2 tablets the next day. Then continuetaking 1 tablet a day. Also use another birth control method until you begina new cycle.
• If you miss 2 tablets in a row in the third week; or
• If you miss 3 or more tablets in a row at any time during the cycle?
  • Using a Day-1 start: Throw out your current cycle and begin takinga new cycle. Also, use another birth control method until you have taken sevendays of your tablets after the last missed dose. You may not have a menstrualperiod this month. But if you miss two menstrual periods in a row, call yourhealth care professional.
  • Using a Sunday start: Keep taking one tablet a day from your currentpack until Sunday. Then, on Sunday, throw out your old pack and begin a newpack. Also use another birth control method until you have taken seven daysof your tablets after the last missed dose. You may not have a menstrual periodthis month. But if you miss two menstrual periods in a row, call your healthcare professional.

If you miss any of the last seven (inactive) tablets of a twenty-eight-daycycle, there is no danger of pregnancy. However, the first tablet (active)of the next month's cycle must be taken on the regularly scheduled day, inspite of any missed doses, if pregnancy is to be avoided. The active and inactivetablets are colored differently for your convenience.

Storage?To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store in the bathroom, near the kitchen sink, or in otherdamp places. Heat and moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Be surethat any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

It is very important that your doctor check your progress atregular visits to make sure this medicine does not cause unwanted effects.These visits will usually be every 6 to 12 months, but some doctors requirethem more often.

Tell the medical doctor or dentist in charge that youare taking this medicine before any kind of surgery (including dental surgery)or emergency treatment. Your doctor will decide whether you shouldcontinue taking this medicine.

The following medicines may reduce the effectiveness of oral contraceptives. You should use an additional method of birth controlduring each cycle in which any of the following medicines are used:

• Ampicillin
• Barbiturates
• Carbamazepine (e.g., Tegretol)
• Griseofulvin (e.g., Fulvicin)
• Penicillin V
• Phenytoin (e.g., Dilantin)
• Primidone (e.g., Mysoline)
• Rifampin (e.g., Rifadin)
• Ritonavir (e.g., Norvir)
• Tetracyclines (medicine for infection)
• Troglitazone (e.g., Rezulin)

Check with your doctor if you have any questions about this.

Vaginal bleeding of various amounts may occur between your regular menstrualperiods during the first 3 months of use. This is sometimes called spottingwhen slight, or breakthrough bleeding when heavier. If this should occur:

• Continue on your regular dosing schedule.
• The bleeding usually stops within 1 week.
• Check with your doctor if the bleeding continues for more than 1week.
• After you have been taking oral contraceptives on schedule and formore than 3 months and bleeding continues, check with your doctor.

Missed menstrual periods may occur:

• If you have not taken the medicine exactly as scheduled. Pregnancymust be considered as a possibility.
• If the medicine is not the right strength or type for your needs.
• If you stop taking oral contraceptives, especially if you have takenoral contraceptives for 2 or more years.

Check with your doctor if you miss any menstrual periods so that the causemay be determined.

In some patients using estrogen-containing oral contraceptives, tenderness,swelling, or bleeding of the gums may occur. Brushing and flossing your teethcarefully and regularly and massaging your gums may help prevent this. Seeyour dentist regularly to have your teeth cleaned. Check with your medicaldoctor or dentist if you have any questions about how to take care of yourteeth and gums, or if you notice any tenderness, swelling, or bleeding ofyour gums. Also, it has been shown that estrogen-containing oral contraceptivesmay cause a healing problem called dry socket after a tooth has been removed.If you are going to have a tooth removed, tell your dentist or oral surgeonthat you are taking oral contraceptives.

Some people who take oral contraceptives may become more sensitive to sunlightthan they are normally. When you begin taking this medicine, avoid too muchsun and do not use a sunlamp until you see how you react to the sun, especiallyif you tend to burn easily. If you have a severe reaction, check with yourdoctor. Some people may develop brown, blotchy spots on exposed areas. Thesespots usually disappear gradually when the medicine is stopped.

If you suspect that you may have become pregnant, stoptaking this medicine immediately and check with your doctor.

If you are scheduled for any laboratory tests, tell your doctor that youare taking birth control pills.

Check with your doctor before refilling an old prescription, especiallyafter a pregnancy. You will need another physical examination and your doctormay change your prescription.

Side Effects of This Medicine

Healthy women who do not smoke cigarettes have almost no chance of havinga severe side effect from taking oral contraceptives. For most women, moreproblems occur because of pregnancy than will occur from taking oral contraceptives.But for some women who have special health problems, oral contraceptives cancause some unwanted effects. Some of these unwanted effects include benign(not cancerous) liver tumors, liver cancer, or blood clots or related problems,such as a stroke. Although these effects are very rare, they can be seriousenough to cause death. You may want to discuss these effects with your doctor.

Smoking cigarettes during the use of oral contraceptiveshas been found to greatly increase the chances of these serious side effectsoccurring. To reduce the risk of serious side effects,do not smoke cigarettes while you are taking oral contraceptives. Cigarettesmoking increases the risk of serious cardiovascular side effects from oralcontraceptive use. The risk increases with age and with heavy smoking (15or more cigarettes per day) and is quite marked in women over 35 years ofage.

The following side effects may be caused byblood clots. Get emergency help immediately ifany of the following side effects occur:

Rare

Abdominal or stomach pain (sudden, severe, or continuing); coughing up blood; headache (severeor sudden); loss of coordination (sudden); loss of vision or change in vision (sudden); pains in chest, groin, or leg (especially in calf of leg); shortness of breath (sudden or unexplained); slurringof speech (sudden); weakness, numbness, or pain inarm or leg (unexplained)

Check with your doctor as soon as possibleif any of the following side effects occur:

More common?usually less common after the first 3 months of oralcontraceptive use

Changes in the uterine bleeding pattern at menses or betweenmenses, such as decreased bleeding at menses, breakthrough bleeding or spottingbetween periods, prolonged bleeding at menses, complete stopping of menstrualbleeding that occurs over several months in a row, or stopping of menstrualbleeding that only occurs sometimes

Less common

Headaches or migraines (although headaches may lessen in manyusers, in others, they may increase in number or become worse); increased blood pressure; vaginal infectionwith vaginal itching or irritation, or thick, white, or curd-like discharge

For women with diabetes mellitus

Mild increase of blood sugar?Faintness, nausea, pale skin,or sweating

Rare

Mental depression; swelling, pain, ortenderness in upper abdominal area

For women who smoke tobacco

Pains in stomach, side, or abdomen; yellow eyes or skin

For women with a history of breast disease

Lumps in breast

Other sideeffects may occur that usually do not need medical attention. These side effectsmay go away during treatment as your body adjusts to the medicine. However,check with your doctor if any of the following side effects continue or arebothersome:

More common

Abdominal cramping or bloating; acne(usually less common after first 3 months and may improve if acne alreadyexists); breast pain, tenderness, or swelling; dizziness; nausea; swelling of ankles and feet; unusual tiredness orweakness; vomiting

Less common

Brown, blotchy spots on exposed skin; gain or loss of body or facial hair; increased ordecreased interest in sexual intercourse; increasedsensitivity of skin to sunlight; weight gain or loss

Other side effects notlisted above may also occur in some patients. If you notice any other effects,check with your doctor.

Additional Information

Once a medicine has been approvedfor marketing for a certain use, experience may show that it is also usefulfor other medical problems. Although these uses are not included in productlabeling, oral contraceptives are used in certain patients with the followingmedical conditions:

• Amenorrhea (stopping of menses for several consecutive months)
• Dysfunctional uterine bleeding (abnormal uterine bleeding)
• Dysmenorrhea (painful menstrual bleeding)
• Hypermenorrhea (excessive menstrual bleeding)
• Emergency contraception within 72 hours of unprotected intercourse
• Endometriosis (painful bleeding from uterine-like tissue that cangrow in different parts of the female body)
• Hirsutism in females (male-like hair growth)
• Hyperandrogenism, ovarian (excessive production of male hormones)
• Polycystic ovary syndrome (many problems that include amenorrhea,hirsutism, infertility, and many tiny cysts or sacs usually in both ovaries)

For patients taking this medicine for emergency contraception:

• Must be taken with food within 72 hours of unprotected sexual intercourse.One single course (2 doses 12 hours apart) is a one-time emergency protection.Using more than one course in a month will reduce the effectiveness.
• Because the hormones are strong, watch for danger signs. Call yourdoctor if you experience any severe pains in your leg, stomach, or chest;any vision or breathing changes; yellowing of skin; headaches; numbness; ortrouble in speaking.
• You may experience nausea so take it with food and call your doctorif you vomit the medicine.
• Your menstrual period may start earlier than usual. If it doesn'tstart, call your doctor.

For patients taking this medicine for hirsutism:

• You may need to use oral contraceptives for 6 to 12 months beforeyou see less new hair growth.

For patients taking this medicine for endometriosis:

• Sometimes instead of following the directions on the oral contraceptive'spackage, your doctor may ask you to follow different directions, such as takingthe active tablets in the package each day without stopping for 6 to 9 months.This means that after 21 days you will start a new package of pills. If youare not sure about how to take this medicine, discuss any questions with yourhealth care professional.
• Also, your symptoms of endometriosis may worsen at first but withcontinued use of the oral contraceptives your symptoms should lessen and yourcondition improve.

Other than the above information, there is no additional information relatingto proper use, precautions, or side effects for these uses.