Safyral

Name: Safyral

What is the most important information i should know about this medication (beyaz, safyral)?

Do not use birth control pills if you are pregnant or if you have recently had a baby.

You should not take birth control pills if you have any of the following conditions: uncontrolled high blood pressure, heart disease, a blood-clotting disorder, circulation problems, diabetic problems with your eyes or kidneys, unusual vaginal bleeding, liver disease or liver cancer, severe migraine headaches, if you smoke and are over 35, or if you have ever had breast or uterine cancer, jaundice caused by birth control pills, a heart attack, a stroke, or a blood clot.

Smoking can increase your risk of blood clots, stroke, or heart attack caused by birth control pills, especially if you are older than 35. Drospirenone may be more likely to cause blood clots than other types of birth control pills.

You may need to use back up birth control, such as condoms or a spermicide, when you first start using this medication or if you miss a dose. Follow your doctor's instructions.

Missing a pill increases your risk of becoming pregnant. Carefully follow the "missed dose" instructions if you forget to take your birth control pills.

What happens if i miss a dose (beyaz, safyral)?

Follow the patient instructions provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions. Missing a pill increases your risk of becoming pregnant. If you miss one active pill, take two pills on the day that you remember. Then take one pill per day for the rest of the pack.

If you miss two active pills in a row in Week 1 or 2, take two pills per day for two days in a row. Then take one pill per day for the rest of the pack. Use back-up birth control for at least 7 days following the missed pills.

If you miss two active pills in a row in Week 3, throw out the rest of the pack and start a new pack the same day if you are a Day 1 starter. If you are a Sunday starter, keep taking a pill every day until Sunday. On Sunday, throw out the rest of the pack and start a new pack that day.

If you miss three active pills in a row in Week 1, 2, or 3, throw out the rest of the pack and start a new pack on the same day if you are a Day 1 starter. If you are a Sunday starter, keep taking a pill every day until Sunday. On Sunday, throw out the rest of the pack and start a new pack that day.

If you miss two or more pills, you may not have a period during the month. If you miss a period for two months in a row, call your doctor because you might be pregnant. If you miss a reminder pill, throw it away and keep taking one reminder pill per day until the pack is empty. You do not need back-up birth control if you miss a reminder pill.

Safyral Overview

Safyral is a brand name medication included in a group of medications called Combination Progesterone and Estrogen Contraceptives. For more information about Safyral see its generic Drospirenone & Ethinyl Estradiol & Levomefolate calcium

What is drospirenone, ethinyl estradiol, and levomefolate?

Drospirenone and ethinyl estradiol prevent ovulation (the release of an egg from an ovary) and also cause changes in your cervical and uterine lining, making it harder for sperm to reach the uterus and harder for a fertilized egg to attach to the uterus. Levomefolate is a type of B vitamin that helps prevent a rare birth defect that could occur in a baby if pregnancy occurs while taking birth control pills or shortly after stopping them.

Drospirenone, ethinyl estradiol, and levomefolate is a combination medicine used as contraception to prevent pregnancy. The Beyaz brand of this medicine is also used to treat moderate acne in women who are at least 14 years old and have started having menstrual periods, and who wish to use birth control pills.

Beyaz is also used to treat the symptoms of premenstrual dysphoric disorder (PMDD), such as anxiety, depression, irritability, trouble concentrating, lack of energy, sleep or appetite changes, breast tenderness, joint or muscle pain, headache, and weight gain.

Drospirenone, ethinyl estradiol, and levomefolate may also be used for purposes not listed in this medication guide.

Uses For Safyral

Drospirenone, ethinyl estradiol, and levomefolate combination is used to prevent pregnancy. It is a birth control pill that contains two types of hormones, ethinyl estradiol and drospirenone, and when taken properly, prevents pregnancy. It works by stopping a woman's egg from fully developing each month. The egg can no longer accept a sperm and fertilization is prevented.

This medicine is also used to treat premenstrual dysphoric disorder (PMDD) and acne in women at least 14 years of age. PMDD is a severe form of premenstrual syndrome (PMS). Patients with PMDD may have severe emotional and physical symptoms a few days before their menstrual flow starts.

This medicine also contains levomefolate, which is a form of folic acid. Folic acid is one of the B vitamins that pregnant women need to help prevent neural tube defects in a baby.

No contraceptive method is 100 percent effective. Birth control methods such as having surgery to become sterile or not having sex are more effective than birth control pills. Discuss your options for birth control with your doctor.

This medicine does not prevent AIDS or other sexually transmitted diseases. It will not help as emergency contraception, such as after unprotected sexual contact.

This medicine is available only with your doctor's prescription.

Safyral Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common
  • Breast pain or tenderness
  • headache, severe and throbbing
  • heavy non-menstrual vaginal bleeding
  • irregular menstrual periods
  • nausea
  • normal menstrual bleeding occurring earlier, possibly lasting longer than expected
Less common
  • Longer or heavier menstrual periods
  • unusual tiredness or weakness
  • vomiting
Incidence not known
  • Abdominal or stomach pain
  • chills
  • clay-colored stools
  • dark urine
  • difficulty with breathing
  • dizziness
  • fever
  • headache
  • itching
  • loss of appetite
  • pain in the chest, groin, or legs, especially the calves
  • rash
  • slurred speech
  • sudden loss of coordination
  • sudden, severe weakness or numbness in the arm or leg
  • sudden, unexplained shortness of breath
  • unpleasant breath odor
  • unusual tiredness or weakness
  • vision changes
  • vomiting of blood
  • yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common
  • Crying
  • decreased interest in sexual intercourse
  • delusions of persecution, mistrust, suspiciousness, and/or combativeness
  • false or unusual sense of well-being
  • inability to have or keep an erection
  • irritability
  • loss in sexual ability, desire, drive, or performance
  • mental depression
  • quick to react or overreact emotionally
  • rapidly changing moods
  • weight gain

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

What do I need to tell my doctor BEFORE I take Safyral?

  • If you have an allergy to ethinyl estradiol, drospirenone, levomefolate, or any other part of Safyral.
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you have had any of these health problems: Blood clots, blood clotting problem, breast cancer, diseased arteries in the brain, disease of a heart valve with problems, heart disease, chest pain caused by angina, heart attack, stroke, high blood pressure, high cholesterol, a pancreas problem (pancreatitis) due to high blood triglycerides, liver disease, liver tumor, very bad headache or migraine, diabetes that affects blood flow, or tumor where estrogen makes it grow.
  • If you have kidney disease.
  • If you have adrenal gland problems.
  • If you have had any of these health problems: Endometrial cancer, cancer of the cervix or vagina, or vaginal bleeding where the cause is not known.
  • If you have surgery and need bedrest.
  • If you turned yellow during pregnancy or with estrogen-based or hormone contraceptive use.
  • If you are pregnant or may be pregnant. Do not take this medicine if you are pregnant.
  • If you are taking ombitasvir, paritaprevir, and ritonavir (with or without dasabuvir).

This is not a list of all drugs or health problems that interact with Safyral.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

If OVERDOSE is suspected

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.

FDA Approved Patient Labeling

Guide for Using Safyral

WARNING TO WOMEN WHO SMOKE

Do not use Safyral if you smoke cigarettes and are over 35 years old. Smoking increases your risk of serious cardiovascular side effects (heart and blood vessel problems) from birth control pills, including death from heart attack, blood clots or stroke. This risk increases with age and the number of cigarettes you smoke.

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 Safyral?

Safyral is a birth control pill. It contains two female hormones, a synthetic estrogen called ethinyl estradiol and a progestin called drospirenone. Safyral also contains levomefolate calcium, which is a B vitamin.

The progestin drospirenone may increase potassium. Therefore, you should not take Safyral 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 Safyral is right for you, and during the first month that you take Safyral, 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

Safyral may also be taken by women who elect to use an oral contraceptive, to provide folate supplementation. It is recommended that women of reproductive age supplement their diet with 0.4 mg (400 mcg) of folic acid daily to lower their risk of having a pregnancy with a rare type of birth defect (known as a neural tube defect). The amount of folate contained in Safyral supplements folate in the diet to lower this risk should you become pregnant while taking the drug or shortly after stopping it.

How Well Does Safyral 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 two clinical studies, about1 woman out of 100 women, may get pregnant during the first year they use Safyral.

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 Safyral?

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. Safyral 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 1-3 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 Safyral 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. Safyral can be taken without regard to meals.

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

The Safyral pill pack has 21 orange pills (with hormones and folate) to be taken for three weeks, followed by 7 light orange pills (without hormones, containing folate) to be taken for one week. It is important to take the light orange pills because they contain folate.

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 orange 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, because you are starting the Pill at the beginning of your period. However, if you start Safyral 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 orange pills.

Sunday Start:

1. Take the first orange 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 Safyral 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, Safyral 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, Safyral should be started when the next application would have been due. When switching from an injection, Safyral should be started when the next dose would have been due. When switching from an intrauterine contraceptive or an implant, Safyral 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 light orange pill. It is important to take the light orange pills because they contain folate. Do not wait any days between packs.

What to Do if You Miss Pills

If you miss 1 orange pill in Week 1 of your pack:

1. Take it as soon as you remember. Take the next pill at your regular time. This means you may take two pills in one day.

2. You do not need to use a back-up birth control method if you have sex.

If you miss 2 orange 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 orange 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.

2. 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.

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.

4. 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 orange 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.

2. 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.

3. You could become pregnant if you have sex in the 7 days after you restart your pills. You must use another birth control method (such as condoms and spermicides) as a back-up for those 7 days.

4. You may not have your period this month but this is expected. However, if you miss your period two months in a row, call your healthcare provider because you might be pregnant.

If you miss any of the 7 light orange 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 orange pill each day until otherwise directed.

WHO SHOULD NOT TAKE Safyral?

Your healthcare provider will not give you Safyral 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).

Tell your healthcare provider if you are already taking daily folate supplements.

What Else Should I Know about Taking Safyral?

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 on time 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.

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

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

Folates may make certain drugs, including some used for epilepsy, less effective, so talk to your healthcare provider about any medicines you take.

If you have vomiting or diarrhea, your birth control pills may not work as well. Take another pill if you vomit within 3-4 hours after taking your pill, or 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.

Safyral may affect the way other medicines work, and other medicines may affect how well Safyral 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 Safyral) 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

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 Safyral?

Irregular vaginal bleeding or spotting may occur while you are taking Safyral. 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 as you have taken the pills regularly on time.

What if I Miss My Scheduled Period when Taking Safyral?

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 regularly on time, 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 Safyral 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. See your healthcare provider about appropriate folate supplementation if you stop taking Safyral, are pregnant, or plan on becoming pregnant.

General Advice about Safyral

Your healthcare provider prescribed Safyral for you. Please do not share Safyral with anyone else. Keep Safyral 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 for:
Bayer HealthCare Pharmaceuticals Inc.
Whippany, NJ 07981

Manufactured in Germany

©2015 Bayer HealthCare Pharmaceuticals Inc. All Rights Reserved

Bayer HealthCare Pharmaceuticals Inc

Important information

Do not use Safyral if you are pregnant or if you recently had a baby.

You should not take Safyral if you have any of the following conditions: kidney disease, uncontrolled high blood pressure, heart disease, a blood-clotting disorder, circulation problems, diabetic problems with your eyes, an adrenal gland disorder, unusual vaginal bleeding, liver disease or liver cancer, severe migraine headaches, a history of breast or uterine cancer, or if you ever had a heart attack, stroke, or blood clot.

You should not take Safyral if you smoke and are older than 35 years of age. Smoking can increase your risk of blood clot, stroke, or heart attack while taking Safyral.

You may need to use back up birth control, such as condoms or a spermicide, when you first start using Safyral or if you miss a dose. Follow your doctor's instructions.

Missing a pill increases your risk of becoming pregnant. Carefully follow the "missed dose" instructions if you forget to take your Safyral.

Before taking this medicine

Smoking can increase your risk of blood clots, stroke, or heart attack while taking Safyral, especially if you are older than 35 years of age. Your risk increases the more you smoke. You should not take birth control pills if you smoke and are older than 35 years of age.

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

You should not take Safyral if you have:

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

  • a history of blood clots;

  • untreated or uncontrolled high blood pressure;

  • a blood-clotting disorder or circulation problems;

  • kidney disease;

  • an adrenal gland disorder;

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

  • liver disease or liver cancer;

  • severe migraine headaches (with aura, numbness, weakness, or vision changes);

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

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

To make sure Safyral is safe for you, tell your doctor if you have:

  • high levels of potassium in your blood;

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

  • underactive thyroid, diabetes, gallbladder disease; or

  • a history of jaundice caused by pregnancy or birth control pills.

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

Safyral dosing information

Usual Adult Dose of Safyral for Contraception:

1 tablet orally each day. A patient should begin taking either on the first day of the menstrual period (Day 1 Start) or on the first Sunday after the onset of the menstrual period (Sunday Start). The patient should begin the next and all subsequent 28-day regimens on the same day of the week as she began the first regimen, following the same schedule.

(web3)