Vestura

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using birth control pills and call your doctor at once if you have:

• signs of a stroke--sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;
• signs of a blood clot--chest pain, sudden cough, wheezing, coughing up blood, swelling or warmth in one or both legs;
• heart attack symptoms--chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;
• liver problems--severe stomach pain, fever, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• a change in the pattern or severity of migraine headaches;
• swelling in your hands, ankles, or feet;
• a breast lump; or
• symptoms of depression--sleep problems, weakness, tired feeling, mood changes.

Common side effects may include:

• nausea, vomiting;
• breast tenderness;
• headache, mood changes, feeling tired or irritable;
• weight gain; or
• changes in your menstrual periods, decreased sex drive.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Taking birth control pills can increase your risk of blood clots, stroke, or heart attack. You are even more at risk if you have high blood pressure, diabetes, high cholesterol, or if you are overweight. Your risk of stroke or blood clot is highest during your first year of taking birth control pills. Your risk is also high when you restart birth control pills after not taking them for 4 weeks or longer.

Smoking can greatly increase your risk of blood clots, stroke, or heart attack. Your risk increases the older you are and the more you smoke. You should not take combination birth control pills if you smoke and are over 35 years old.

Do not use if you are pregnant. Stop taking this medicine and tell your doctor if you become pregnant, or if you miss two menstrual periods in a row. If you have recently had a baby, wait at least 4 weeks before taking birth control pills.

You should not take birth control pills if you have:

• untreated or uncontrolled high blood pressure;

• heart disease (coronary artery disease, uncontrolled heart valve disorder, history of heart attack, stroke, or blood clot);

• a blood-clotting disorder or circulation problems;

• problems with your eyes, kidneys or circulation caused by diabetes;

• a history of hormone-related cancer such as breast or uterine cancer;

• unusual vaginal bleeding that has not been checked by a doctor;

• liver disease, liver cancer, history of jaundice caused by pregnancy or birth control pills; or

• severe migraine headaches (with aura, numbness, weakness, or vision changes), especially if you are older than 35.

To make sure birth control pills are safe for you, tell your doctor if you have:

• high blood pressure, varicose veins;

• high cholesterol or triglycerides, or if you are overweight;

• an electrolyte imbalance (such as high levels of potassium in your blood);

• a history of depression;

• diabetes, underactive thyroid, gallbladder disease;

• seizures or epilepsy;

• tuberculosis; or

• a history of fibrocystic breast disease, lumps, nodules, or an abnormal mammogram.

The hormones in birth control pills can pass into breast milk and may harm a nursing baby. This medicine may also slow breast milk production. Do not use if you are breast feeding.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose symptoms may include nausea, vomiting, and vaginal bleeding.

Many drugs can interact with birth control pills and make them less effective, which may result in pregnancy. Ethinyl estradiol can also affect blood levels of certain other drugs, making them less effective or increasing side effects. This includes prescription and over-the-counter medicines, vitamins, and herbal products.

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Follow how to use as you have been told by the doctor or read the package insert.
• Take Vestura at the same time of day.
• Take with or without food. Take with food if it causes an upset stomach.
• If you drink grapefruit juice or eat grapefruit often, talk with your doctor.
• Do not skip doses, even if you do not have sex very often.
• If you throw up or have diarrhea, this medicine may not work as well to prevent pregnancy. Use an extra form of birth control, like condoms, until you check with your doctor.
• If you miss 2 periods in a row, take a pregnancy test before starting a new cycle.

What do I do if I miss a dose?

• If a dose is missed, check the package insert or call the doctor to find out what to do. If using Vestura to prevent pregnancy, another form of birth control may need to be used for some time to prevent pregnancy.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

2.1 How to Take Vestura

Take one tablet by mouth at the same time every day. The failure rate may increase when pills are missed or taken incorrectly.

To achieve maximum contraceptive effectiveness, Vestura must be taken exactly as directed, in the order directed on the blister pack. Single missed pills should be taken as soon as remembered.

2.2 How to Start Vestura

Instruct the patient to begin taking Vestura either on the first day of her menstrual period (Day 1 Start) or on the first Sunday after the onset of her menstrual period (Sunday Start).

Day 1 Start

During the first cycle of Vestura use, instruct the patient to take one pink Vestura daily, beginning on Day 1 of her menstrual cycle. (The first day of menstruation is Day 1.) She should take one pink Vestura daily for 24 consecutive days, followed by one peach inert tablet daily on Days 25 through 28. Vestura should be taken in the order directed on the package at the same time each day, preferably after the evening meal or at bedtime with some liquid, as needed. Vestura can be taken without regard to meals. If Vestura is first taken later than the first day of the menstrual cycle, Vestura should not be considered effective as a contraceptive until after the first 7 consecutive days of product administration. Instruct the patient to use a non- hormonal contraceptive as back-up during the first 7 days. The possibility of ovulation and conception prior to initiation of medication should be considered.

Sunday Start

During the first cycle of Vestura use, instruct the patient to take one pink Vestura daily, beginning on the first Sunday after the onset of her menstrual period. She should take one pink Vestura daily for 24 consecutive days, followed by one peach inert tablet daily on Days 25 through 28. Vestura should be taken in the order directed on the package at the same time each day, preferably after the evening meal or at bedtime with some liquid, as needed. Vestura can be taken without regard to meals. Vestura should not be considered effective as a contraceptive until after the first 7 consecutive days of product administration. Instruct the patient to use a non-hormonal contraceptive as back-up during the first 7 days. The possibility of ovulation and conception prior to initiation of medication should be considered.

The patient should begin her next and all subsequent 28-day regimens of Vestura on the same day of the week that she began her first regimen, following the same schedule. She should begin taking her pink tablets on the next day after ingestion of the last peach tablet, regardless of whether or not a menstrual period has occurred or is still in progress. Anytime a subsequent cycle of Vestura is started later than the day following administration of the last peach tablet, the patient should use another method of contraception until she has taken a pink Vestura daily for seven consecutive days.

When switching from a different birth control pill

When switching from another birth control pill, Vestura should be started on the same day that a new pack of the previous oral contraceptive would have been started.

When switching from a method other than a birth control pill

When switching from a transdermal patch or vaginal ring, Vestura should be started when the next application would have been due. When switching from an injection, Vestura should be started when the next dose would have been due. When switching from an intrauterine contraceptive or an implant, Vestura should be started on the day of removal.

Withdrawal bleeding usually occurs within 3 days following the last pink tablet. If spotting or breakthrough bleeding occurs while taking Vestura, instruct the patient to continue taking Vestura by the regimen described above. Counsel her that this type of bleeding is usually transient and without significance; however, advise her that if the bleeding is persistent or prolonged, she should consult her healthcare provider.

Although the occurrence of pregnancy is low if Vestura is taken according to directions, if withdrawal bleeding does not occur, consider the possibility of pregnancy. If the patient has not adhered to the prescribed dosing schedule (missed one or more active tablets or started taking them on a day later than she should have), consider the possibility of pregnancy at the time of the first missed period and take appropriate diagnostic measures. If the patient has adhered to the prescribed regimen and misses two consecutive periods, rule out pregnancy. Discontinue Vestura if pregnancy is confirmed.

The risk of pregnancy increases with each active pink tablet missed. For additional patient instructions regarding missed pills, see the "WHAT TO DO IF YOU MISS PILLS" section in the FDA Approved Patient Labeling. If breakthrough bleeding occurs following missed tablets, it will usually be transient and of no consequence. If the patient misses one or more peach tablets, she should still be protected against pregnancy provided she begins taking a new cycle of pink tablets on the proper day.

For postpartum women who do not breastfeed or after a second trimester abortion, start Vestura no earlier than 4 weeks postpartum due to the increased risk of thromboembolism. If the patient starts on Vestura postpartum and has not yet had a period, evaluate for possible pregnancy, and instruct her to use an additional method of contraception until she has taken Vestura for 7 consecutive days.

2.3 Advice in Case of Gastrointestinal Disturbances

In case of severe vomiting or diarrhea, absorption may not be complete and additional contraceptive measures should be taken. If vomiting occurs within 3 to 4 hours after tablet-taking, this can be regarded as a missed tablet.

There have been no reports of serious ill effects from overdose, including ingestion by children. Overdosage may cause withdrawal bleeding in females and nausea.

DRSP is a spironolactone analogue which has anti-mineralocorticoid properties. Serum concentration of potassium and sodium, and evidence of metabolic acidosis, should be monitored in cases of overdose.

14.1 Oral Contraceptive Clinical Trial

In the primary contraceptive efficacy study of Vestura (3 mg DRSP/0.02 mg EE) of up to 1 year duration, 1,027 subjects were enrolled and completed 11,480 28-day cycles of use. The age range was 17 to 36 years. The racial demographic was: 87.8% Caucasian, 4.6% Hispanic, 4.3% Black, 1.2% Asian, and 2.1% other. Women with a BMI greater than 35 were excluded from the trial. The pregnancy rate (Pearl Index) was 1.41 (95% CI [0.73, 2.47]) per 100 woman-years of use based on 12 pregnancies that occurred after the onset of treatment and within 14 days after the last dose of Vestura in women 35 years of age or younger during cycles in which no other form of contraception was used.

14.3 Acne Clinical Trials

In two multicenter, double-blind, randomized, placebo-controlled studies, 889 subjects, ages 14 to 45 years, with moderate acne received Vestura or placebo for six 28-day cycles. The primary efficacy endpoints were the percent change in inflammatory lesions, non-inflammatory lesions, total lesions, and the percentage of subjects with a "clear" or "almost clear" rating on the Investigator's Static Global Assessment (ISGA) scale on day 15 of cycle 6, as presented in Table 3:

Table 3: Efficacy Results for Acne Trials*

* Evaluated at day 15 of cycle 6, last observation carried forward for the Intent to treat population

See “FDA-approved patient labeling (Patient Information).”

• Counsel patients that cigarette smoking increases the risk of serious cardiovascular events from COC use, and that women who are over 35 years old and smoke should not use COCs.
  
• Counsel patients that the increased risk of VTE compared to non-users of COCs is greatest after initially starting a COC or restarting (following a 4-week or greater pill-free interval) the same or a different COC.
  
• Counsel patients about the information regarding the risk of VTE with DRSP-containing COCs compared to COCs that contain levonorgestrel or some other progestins.
  
• Counsel  patients  that  Vestura  does  not  protect  against  HIV-infection  (AIDS)  and  other  sexually  transmitted diseases.
  
• Counsel patients on Warnings and Precautions associated with COCs.
  
• Counsel patients that Vestura contains DRSP. Drospirenone may increase potassium. Patients should be advised to inform their healthcare provider if they have kidney, liver or adrenal disease because the use of Vestura in the presence  of  these  conditions  could  cause  serious  heart  and  health  problems.  They should  also  inform their healthcare provider if they are currently on daily, long-term treatment (NSAIDs, potassium-sparing diuretics, potassium supplementation, ACE inhibitors, angiotensin-II receptor antagonists, heparin or aldosterone antagonists) for a chronic condition or taking strong CYP3A4 inhibitors.
  
• Inform patients that Vestura is not indicated during pregnancy. If pregnancy occurs during treatment with Vestura, instruct the patient to stop further intake.
  
• Counsel patients to take one tablet daily by mouth at the same time every day. Instruct patients what to do in the event pills are missed. See “What to Do if You Miss Pills” section in FDA-Approved Patient Labeling.
  
• Counsel patients to use a back-up or alternative method of contraception when enzyme inducers are used with COCs.
  
• Counsel patients who are breastfeeding or who desire to breastfeed that COCs may reduce breast milk production. This is less likely to occur if breastfeeding is well established.
  
• Counsel any patient who starts COCs postpartum, and who has not yet had a period, to use an additional method of contraception until she has taken a pink tablet for 7 consecutive days.
  
• Counsel patients that amenorrhea may occur. Rule out pregnancy in the event of amenorrhea in two or more consecutive cycles.

Manufactured by:
Warner Chilcott Company, LLC Fajardo, Puerto Rico 00738

Distributed by:
Actavis Pharma, Inc. Parsippany, NJ 07054 USA

*Brands listed are trademarks of their respective owners.

FDA Approved Patient Labeling

Guide for Using VesturaTM

(Drospirenone/Ethinyl Estradiol Tablets, 3 mg/0.02 mg)

28 Day regimen

Rx Only

Birth control pills help to lower the chances of becoming pregnant when taken as directed. They do not protect against HIV infection (AIDS) and other sexually transmitted diseases.

What is Vestura?

Vestura is a birth control pill. It contains two female hormones, a synthetic estrogen called ethinyl estradiol and a progestin called drospirenone.

The progestin drospirenone may increase potassium. Therefore, you should not take Vestura 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 Vestura is right for you, and during the first month that you take Vestura, you should have a blood test to check your potassium level.

• NSAIDs (ibuprofen [Motrin*, Advil*], naproxen [Aleve* and others] when taken long-term and daily 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
  
• Aldosterone antagonists

Vestura may also be taken to treat moderate acne if all of the following are true:

• Your healthcare provider says it is safe for you to use Vestura.
  
• You are at least 14 years old.
  
• You have started having menstrual periods.
  
• You want to use a birth control pill to prevent pregnancy.

How Well Does Vestura Work?

Your chance of getting pregnant depends on how well you follow the directions for taking your birth control pills. The better you follow the directions, the less chance you have of getting pregnant.

Based on the results of one clinical study, 1 to 2 women out of 100 women, may get pregnant during the first year they use Vestura.

The following chart shows the chance of getting pregnant for women who use different methods of birth control. Each box on the chart contains a list of birth control methods that are similar in effectiveness. The most effective methods are at the top of the chart. The box on the bottom of the chart shows the chance of getting pregnant for women who do not use birth control and are trying to get pregnant.

How Do I Take Vestura?

1.  Be sure to read these directions before you start taking your pills or 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 in the order directed on the package.

Preferably, take the pill after the evening meal or at bedtime, with some liquid, as needed. Vestura 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 at unexpected times, or may feel sick to their stomach during the first 1 to 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 and 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.  If you have any questions or are unsure about the information 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 Vestura in the order directed on the package at the same time every day, preferably after the evening meal or at bedtime, with some liquid, as needed. Vestura can be taken without regard to meals.

2. Look at Your Pill Pack – It has 28 Pills

The Vestura-pill pack has 24 pink pills (with hormones) to be taken for 24 days, followed by 4 peach pills (without hormones) to be taken for the next four days.

3. Also look for:

a) Where on the pack to start taking pills,

b) In what order to take the pills (follow the arrows)

4.  Be sure you have ready at all times (a) another kind of birth control (such as condoms and spermicides) to use as a back- up in case you miss pills, and (b) 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 pink pill of the 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. However, if you start Vestura later than the first day of your period, you should use another method of birth control (such as a condom and spermicide) as a back-up method until you have taken 7 pink pills.

Sunday Start:

1.  Take the first pink pill of the 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 a condom and spermicide) as a back-up method if you have sex anytime from the Sunday you start your first pack until the next Sunday (7 days). This also applies if you start Vestura after having been pregnant, and you have not had a period since your pregnancy.

When You Switch From a Different Birth Control Pill

When switching from another birth control pill, Vestura should be started on the same day that a new pack of the previous birth control pill would have been started.

When You Switch From Another Type of Birth Control Method

When switching from a transdermal patch or vaginal ring, Vestura should be started when the next application would have been due. When switching from an injection, Vestura should be started when the next dose would have been due. When switching from an intrauterine contraceptive or an implant, Vestura should be started on the day of removal.

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 peach pill. Do not wait any days between packs.

What to Do if You Miss Pills

If you miss 1 pink pill 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 control method if you have sex.

If you miss 2 pink 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 a condom and spermicide) as a back-up for those 7 days.

If you miss 2 pink 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 a condom and spermicide) 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 pink 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 and spermicides) as a back-up for those 7 days.

3.  Call your healthcare provider if you miss your period, because you might be pregnant.

If you miss any of the 4 peach 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 and spermicides) anytime you have sex.

Contact your healthcare provider and continue taking one active pink pill each day until otherwise directed.

WHO SHOULD NOT TAKE VESTURA?

Your healthcare provider will not give you Vestura if you:

• Ever had blood clots in your legs (deep vein thrombosis), lungs (pulmonary embolism), or eyes (retinal thrombosis)
  
• Ever had a stroke
  
• Ever had a heart attack
  
• Have certain heart valve problems or heart rhythm abnormalities that can cause blood clots to form in the heart
  
• Have an inherited problem with your blood that makes it clot more than normal
  
• Have high blood pressure that medicine can’t control
  
• Have diabetes with kidney, eye, nerve, or blood vessel damage
  
• Ever had certain kinds of severe migraine headaches with aura, numbness, weakness or changes in vision
  
• Ever had breast cancer or any cancer that is sensitive to female hormones
  
• Have liver disease, including liver tumors
  
• Have kidney disease
  
• Have adrenal disease

Also, do not take birth control pills if you:

• Smoke and are over 35 years old
  
• Are or suspect you are pregnant

Birth control pills may not be a good choice for you if you have ever had jaundice (yellowing of the skin or eyes) caused by pregnancy (also called cholestasis of pregnancy).

Tell your healthcare provider if you have ever had any of the above conditions (your healthcare provider can recommend another method of birth control).

What Else Should I Know about Taking Vestura?

Birth control pills do not protect you against any sexually transmitted disease, including HIV, the virus that causes AIDS.

Do not skip any pills, even if you do not have sex often.

If you miss a period, you could be pregnant. However, some women miss periods or have light periods on birth control pills, even when they are not pregnant. Contact your healthcare provider for advice if you:

• Think you are pregnant
  
• Miss one period and have not taken your birth control pills every day
  
• Miss two periods in a row

Birth control pills should not be taken during pregnancy. However, birth control pills taken by accident during pregnancy are not known to cause birth defects.

You should stop Vestura at least four weeks before you have major surgery and not restart it until at least two weeks after the surgery due to an increased risk of blood clots.

If you are breastfeeding, consider another birth control method until you are ready to stop breastfeeding. Birth control pills that contain estrogen, like Vestura, may decrease the amount of milk you make. A small amount of the pill's hormones pass into breast milk.

If you have vomiting or diarrhea, your birth control pills may not work as well. Use another birth control method, like condoms and a spermicide, until you check with your healthcare provider.

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.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements.

Yasmin* may affect the way other medicines work, and other medicines may affect how well Yasmin* works. Know the medicines you take.

Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

What are the Most Serious Risks of Taking Birth Control Pills?

Like pregnancy, birth control pills increase the risk of serious blood clots (see following graph), especially in women who have other risk factors, such as smoking, obesity, or age greater than 35. This increased risk is highest when you first start taking birth control pills and when you restart the same or different birth control pills after not using them for a month or more. Women who use birth control pills with drospirenone (like Vestura) may have a higher risk of getting a blood clot. Some studies reported that the risk of blood clots was higher for women who use birth control pills that contain drospirenone than for women who use birth control pills that do not contain drospirenone.

Talk with your healthcare provider about your risk of getting a blood clot before deciding which birth control pill is right for you.

It is possible to die or be permanently disabled from a problem caused by a blood clot, such as a heart attack or a stroke. Some examples of serious clots are blood clots in the:

• Legs (deep vein thrombosis or DVT)
  
• Lungs (pulmonary embolus or PE)
  
• Eyes (loss of eyesight)
  
• Heart (heart attack)
  
• Brain (stroke)

To put the risk of developing a blood clot into perspective: If 10,000 women who are not pregnant and do not use birth control pills are followed for one year, between 1 and 5 of these women will develop a blood clot. The figure below shows the likelihood of developing a serious blood clot for women who are not pregnant and do not use birth control pills, for women who use birth control pills, for pregnant women, and for women in the first 12 weeks after delivering a baby.

Likelihood of Developing a Serious Blood Clot

* Pregnancy data based on actual duration of pregnancy in the reference studies. Based on a model assumption that pregnancy d uration is nine months, the rate is 7 to 27 per 10,000 WY.

A few women who take birth control pills may get:

• High blood pressure
  
• Gallbladder problems
  
• Rare cancerous or noncancerous liver tumors

All of these events are uncommon in healthy women.

Call your healthcare provider right away if you have:

• Persistent leg pain
  
• Sudden shortness of breath
  
• Sudden blindness, partial or complete
  
• Severe pain in your chest
  
• Sudden, severe headache unlike your usual headaches
  
• Weakness or numbness in an arm or leg, or trouble speaking
  
• Yellowing of the skin or eyeballs

What are the Common Side Effects of Birth Control Pills?

The most common side effects of birth control pills are:

• Spotting or bleeding between menstrual periods
  
• Nausea
  
• Breast tenderness
  
• Headache

These side effects are usually mild and usually disappear with time. Less common side effects are:

• Acne
  
• Less sexual desire
  
• Bloating or fluid retention
  
• Blotchy darkening of the skin, especially on the face
  
• High blood sugar, especially in women who already have diabetes
  
• High fat (cholesterol; triglyceride) levels in the blood
  
• Depression, especially if you have had depression in the past. Call your healthcare provider immediately if you have any thoughts of harming yourself.
  
• Problems tolerating contact lenses
  
• Weight changes

This is not a complete list of possible side effects. Talk to your healthcare provider if you develop any side effects that concern you. You may report side effects to the FDA at 1-800-FDA-1088.

No serious problems have been reported from a birth control pill overdose, even when accidentally taken by children.

Do Birth Control Pills Cause Cancer?

Birth control pills do not seem to cause breast cancer. However, if you have breast cancer now, or have had it in the past, do not use birth control pills because some breast cancers are sensitive to hormones.

Women who use birth control pills may have a slightly higher chance of getting cervical cancer. However, this may be due to other reasons such as having more sexual partners.

What Should I Know about My Period when Taking Vestura?

Irregular vaginal bleeding or spotting may occur while you are taking Vestura. 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, is unusually heavy, or lasts for more than a few days, call your healthcare provider.

Some women may not have a menstrual period but this should not be cause for alarm as long has you have taken the pills according to direction.

What if I Miss My Scheduled Period when Taking Vestura?

It is not uncommon to miss your period. However, if you miss two periods in a row or miss one period when you have not taken your birth control pills according to directions, call your healthcare provider. Also notify your healthcare provider if you have symptoms of pregnancy such as morning sickness or unusual breast tenderness. It is important that your healthcare provider checks you to find out if you are pregnant. Stop taking Vestura if you are pregnant.

What If I Want to Become Pregnant?

You may stop taking the pill whenever you wish. Consider a visit with your healthcare provider for a pre-pregnancy checkup before you stop taking the pill.

General Advice about Vestura

Your healthcare provider prescribed Vestura for you. Please do not share Vestura with anyone else. Keep Vestura out of the reach of children.

If you have concerns or questions, ask your healthcare provider. You may also ask your healthcare provider for a more detailed label written for medical professionals.

Manufactured by:
Warner Chilcott Company, LLC Fajardo, Puerto Rico 00738

Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA

Revised: February 2016

*Brands listed are trademarks of their respective owners.

PRINCIPAL DISPLAY PANEL
NDC 52544-982-31
Vestura
Drospirenone and Ethinyl Estradiol
3 mg/ 0.02 mg
Rx Only