OCELLA (Page 8 of 9)

HOW SUPPLIED

OCELLA Tablets (drospirenone and ethinyl estradiol) are available in 28 tablets ( BLISTER pack) (NDC 54868-5922-0).

Each pack contains 21 active yellow round, unscored, film coated tablets each containing 3 mg drospirenone and 0.03 mg ethinyl estradiol, and 7 inert white round, unscored, film coated tablets.

Store at 25° C (77°F); excursions permitted to 15–30°C (59–86°F). [See USP Controlled Room Temperature.]

REFERENCES

1. Dinger JC, Heinemann LAJ, et al: The safety of a drospirenone-containing oral contraceptive: final results from the European active surveillance study on oral contraceptives based on 142,475 women-years of observation. Contraception 2007;75:344-354.

2. Seeger JD, Loughlin J, Eng PM, et al: Risk of thromboembolism in women taking ethinylestradiol/drospirenone and other oral contraceptives. Obstetrics & Gynecology 2007;110(3):587-593.

3. van Hylckama Vlieg A, Helmerhorst FM, Vandenbroucke JP, et al: The venous thrombotic risk of oral contraceptives, effects of oestrogen dose and progestogen type: results of the MEGA case-control study. BMJ 2009;339:b2921.

4. Lidegaard O, Lokkegaard E, Svendsen AL, et al: Hormonal contraception and risk of venous thromboembolism: national follow-up study. BMJ 2009; 339:b2890.

Manufactured by:

Bayer HealthCare Pharmaceuticals Inc.

Manufactured in: Germany

Relabeling of “Additional” label by:
Physicians Total Care, Inc.
Tulsa, OK 74146

BRIEF SUMMARY PATIENT PACKAGE INSERT

OCELLA ® 28 Tablets

(drospirenone and ethinyl estradiol)

28 tablets containing the following:

21 yellow — “active” tablets

7 whit — “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.

OCELLA is different from other birth-control pills because it contains the progestin drospirenone. Drospirenone may increase potassium. Therefore, you should not take OCELLA 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 OCELLA is right for you, and during the first month that you take OCELLA, you should have a blood test to check your potassium level.

  • NSAIDs (ibuprofen [Motrin® , Advil® ], naproxen [Naprosyn® , Aleve® and others] when taken long-term and for treatment of arthritis or other problems)
  • Potassium-sparing diuretics (spironolactone and others)
  • Potassium supplementation
  • ACE inhibitors (Capoten® , Vasotec® , Zestril® and others)
  • Angiotensin-II receptor antagonists (Cozaar® , Diovan® , Avapro® and others)
  • Heparin

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. The risks associated with taking oral contraceptives increase significantly if you:

  • smoke
  • have high blood pressure, diabetes, high cholesterol
  • have or have had clotting disorders, heart attack, stroke, angina pectoris, 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.

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.

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.

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 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.

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. ln 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 provides some important non-contraceptive benefits. These include less painful menstruation, less menstrual blood loss and anemia, fewer pelvic infections, and fewer cancers of the ovary and the lining of the uterus.

Be sure to discuss any medical condition you may have with your healthcare 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. 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 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 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 healthcare provider.

6. IF YOU HAVE TROUBLE REMEMBERING TO TAKE THE PILL, talk to your doctor or healthcare provider 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 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 it at about the same time every day.

2. LOOK AT YOUR PILL PACK — IT HAS 28 PILLS:
The OCELLA 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 as shown in the diagram below

Ocella Trade Blister
(click image for full-size original)

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 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 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 healthcare provider 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 healthcare provider 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 healthcare provider.

For additional information see Detailed Patient Labeling

DETAILED PATIENT PACKAGE INSERT

This product (like all oral contraceptives) is intended to prevent pregnancy. It does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

OCELLA is different from other birth-control pills because it contains the progestin drospirenone. Drospirenone may increase potassium. Therefore, you should not take OCELLA 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 OCELLA is right for you, and during the first month that you take OCELLA, you should have a blood test to check your potassium level .

  • NSAIDs (ibuprofen [Motrin® , Advil® ], naproxen [Naprosyn® , Aleve® and others] when taken long-term and for treatment of arthritis or other problems)
  • Potassium-sparing diuretics (spironolactone and others)
  • Potassium supplementation
  • ACE inhibitors (Capoten® , Vasotec® , Zestril® and others)
  • Angiotensin-II receptor antagonists (Cozaar® , Diovan® , Avapro® and others)
  • Heparin

INTRODUCTION

Any woman who considers using oral contraceptives (the birth-control pill or “the pill”) should understand the benefits and risks of using this form of birth control. This leaflet will give you much of the information you will need to make this decision and will also help you determine if you are at risk of developing any of the serious side effects of the pill. It will tell you how to use the pill properly so that it will be as effective as possible. However, this leaflet is not a replacement for a careful discussion between you and your healthcare provider. 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 provider’s advice with regard to regular check-ups while you are on the pill.

EFFECTIVENESS OF ORAL CONTRACEPTIVES

Oral contraceptives or “birth-control pills” or “the pill” are used to prevent pregnancy and are more effective than 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.
Source: Trussell J, Contraceptive efficacy. In Hatcher RA, Trussell J, Stewart F, Cates W, Stewart GK, Kowal D, Guest F, Contraceptive Technology: Seventeenth Revised Edition. New York NY: Irvington Publishers, 1998.
*
With spermicidal cream or jelly.

% of Women Experiencing an

Accidental Pregnancy

% of Women

Continuing Use

At One Year

Method

Typical Use

Perfect Use

(4)
Chance 8585
Spermicides 26640
Periodic abstinence2563
Calendar9
Ovulation method3
Sympto-thermal 2
Post-ovulation1
Withdrawal194
Cap *
Parous women402642
Nulliparous women20956
Sponge
Parous women402042
Nulliparous women20956
Diaphragm *20656
Condom
Female (Reality)21556
Male14361
Pill571
progestin only0.5
combined0.1
IUD
Progesterone T:21.581
Copper T 380A0.80.678
Lng 200.10.181
Depo Provera0.30.370
Norplant and Norplant-20.050.0588
Female Sterilization0.50.5100
Male Sterilization 0.150.1100
Emergency Contraceptive Pills: Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%
Lactational Amenorrhea Method: LAM is highly effective, temporary method of contraception

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 OCELLA should not smoke.

Some women should not use the pill. For example, you should not take OCELLA if you are pregnant or think you may be pregnant. You should also not use OCELLA if you have had any of the following conditions:

  • A history of heart attack or stroke
  • Blood clots in the legs (thrombophlebitis), lungs (pulmonary embolism), brain (stroke) or eyes
  • A history of blood clots in the deep veins of your legs
  • Chest pain (angina pectoris)
  • Known or suspected breast cancer or cancer of the lining of the uterus, cervix or vagina
  • Unexplained vaginal bleeding (until a diagnosis is reached by your doctor)
  • Yellowing of the whites of the eyes or of the skin (jaundice) during pregnancy or during previous use of the pill
  • Liver tumor (benign or cancerous)
  • Known or suspected pregnancy

In addition, you should not use OCELLA if you have any of the following conditions:

  • Kidney Disease
  • Liver Disease
  • 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 OCELLA:

  • NSAIDs (ibuprofen, naproxen and others)
  • Potassium-sparing diuretics (spironolactone and others)
  • Potassium supplementation
  • ACE inhibitors (captopril, enalapril, lisinopril and others)
  • Angiotensin-II receptor antagonists (Cozaar® , Diovan® , Avapro® and others)
  • Heparin

OTHER CONSIDERATIONS BEFORE TAKING ORAL CONTRACEPTIVES

Tell your healthcare provider if you or any family member has ever had:

  • Breast nodules, fibrocystic disease of the breast, an abnormal breast X-ray or mammogram
  • Diabetes
  • Elevated cholesterol or triglycerides
  • High blood pressure
  • Migraine or other headaches or epilepsy
  • Mental depression
  • Gallbladder, heart or kidney disease
  • 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 or take 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

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 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
Adapted from H.W. Ory, Family Planning Perspectives 15:57-63, 1983.
*
Deaths are birth-related
Deaths are method-related
Method of Control and Outcome15 1920 2425 2930 3435 3940 44
No fertility control methods *77.49.114.825.728.2
Oral contraceptives non­smoker 0.30.50.91.913.831.6
Oral contraceptives smoker 2.23.46.613.551.1117.2
lUD 0.80.8111.41.4
Condom *1.11.60.70.20.30.4
Diaphragm/spermicide *1.91.21.21.32.22.8
Periodic abstinence *2.51.61.61.72.93.6

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:

  • Sharp chest pain, coughing of blood, or sudden shortness of breath (indicating a possible clot in the lung)
  • Pain in the calf (indicating a possible clot in the leg)
  • Crushing chest pain or heaviness in the chest (indicating a possible heart attack)
  • Sudden severe headache or vomiting, dizziness or fainting, disturbances of vision or speech, weakness, or numbness in an arm or leg (indicating a possible stroke)
  • Sudden partial or complete loss of vision (indicating a possible clot in the eye)
  • Breast lumps (indicating possible breast cancer or fibrocystic disease of the breast; ask your doctor or healthcare provider to show you how to examine your breasts)
  • Severe pain or tenderness in the stomach area (indicating a possibly ruptured liver tumor)
  • Difficulty in sleeping, weakness, lack of energy, fatigue, or change in mood (possibly indicating severe depression)
  • Jaundice or a yellowing of the skin or eyeballs, accompanied frequently by fever, fatigue, loss of appetite, dark-colored urine, or light-colored bowel movements (indicating possible liver problems)

SIDE EFFECTS OF ORAL CONTRACEPTIVES

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 nausea, vomiting, change in appetite, headache, nervousness, depression, dizziness, loss of scalp hair, rash, and vaginal infections.

If any of these side effects occur, 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. 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 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 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.

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.

Any time 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 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 OR DIARRHEA, for any reason, 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 healthcare provider.

6. IF YOU HAVE TROUBLE REMEMBERING TO TAKE THE PILL, talk to your doctor or healthcare provider 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 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 it at about the same time every day.

2. LOOK AT YOUR PILL PACK — IT HAS 28 PILLS: The OCELLA 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 as shown in the diagram below

Ocella Trade Blister
(click image for full-size original)

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 healthcare provider which is the best day for you. Pick a time of day which will be easy to remember.

DAY 1 STAR T:

  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).
  2. Do not skip pills even if you do not have sex very often.
  3. 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 healthcare provider 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 healthcare provider 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) any time you have sex.

KEEP TAKING ONE ACTIVE PILL EACH DAY until you can reach your doctor or healthcare provider.

PREGNANCY DUE TO PILL FAILURE

The incidence of pill failure resulting in pregnancy is approximately less than 1% (one pregnancy per 100 women per year of use) if taken every day as directed, but more typical failure rates are about 5%. If failure does occur with OCELLA use, the risk to the fetus is unknown.

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 OCELLA 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. Be 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:

  • Menstrual cycles may become more regular
  • Blood flow during menstruation may be lighter and less iron may be lost. Therefore, anemia due to iron deficiency is less likely to occur.
  • Pain or other symptoms during menstruation may be encountered less frequently
  • Ovarian cysts may occur less frequently
  • Ectopic (tubal) pregnancy may occur less frequently
  • Noncancerous cysts or lumps in the breast may occur less frequently
  • Acute pelvic inflammatory disease may occur less frequently
  • Oral contraceptive use may provide some protection against developing two forms of cancer: cancer of the ovaries and cancer of the lining of the uterus

If you want more information about birth-control pills, ask your doctor or pharmacist. They have a more technical leaflet called the Prescribing Information which you may wish to read.

Mfd.for Barr Laboratories, Inc., Pomona, NY 10970

by Bayer HealthCare Pharmacueticals Inc., Wayne, NJ 07470

Made in Germany

810413xx Month 2010

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