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, Safyral (Drospirenone; ethinyl estradiol; levomefolate calcium) must be taken as directed. Single missed pills should be taken as soon as remembered.

Safyral (Drospirenone; ethinyl estradiol; levomefolate calcium) (drospirenone/ethinyl estradiol/levomefolate calcium tablets and levomefolate calcium tablets) is available in blister packs.

Each blister pack contains 28 film-coated, round, bi-convex tablets in the following order:

Do not prescribe Safyral (Drospirenone; ethinyl estradiol; levomefolate calcium) to women who are known to have the following:

Stop Safyral (Drospirenone; ethinyl estradiol; levomefolate calcium) if an arterial or deep venous thrombotic (VTE) event occurs. Although the use of COCs increases the risk of venous thromboembolism, pregnancy increases the risk of venous thromboembolism as much or more than the use of COCs. The risk of venous thromboembolism in women using COCs is 3 to 9 per 10,000 woman-years. The risk is highest during the first year of use of a COC. Use of COCs also increases the risk of arterial thromboses such as strokes and myocardial infarctions, especially in women with other risk factors for these events. The risk of thromboembolic disease due to oral contraceptives gradually disappears after COC use is discontinued.

If feasible, stop Safyral (Drospirenone; ethinyl estradiol; levomefolate calcium) at least 4 weeks before and through 2 weeks after major surgery or other surgeries known to have an elevated risk of thromboembolism.

Start Safyral (Drospirenone; ethinyl estradiol; levomefolate calcium) no earlier than 4 weeks after delivery, in women who are not breastfeeding. The risk of postpartum thromboembolism decreases after the third postpartum week, whereas the risk of ovulation increases after the third postpartum week.

COCs have been shown to increase both the relative and attributable risks of cerebrovascular events (thrombotic and hemorrhagic strokes), although, in general, the risk is greatest among older (>35 years of age), hypertensive women who also smoke. COCs also increase the risk for stroke in women with other underlying risk factors.

Oral contraceptives must be used with caution in women with cardiovascular disease risk factors.

Stop Safyral (Drospirenone; ethinyl estradiol; levomefolate calcium) if there is unexplained loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions. Evaluate for retinal vein thrombosis immediately.  

Women who currently have or have had breast cancer should not use Safyral (Drospirenone; ethinyl estradiol; levomefolate calcium) because breast cancer is a hormonally-sensitive tumor.

There is substantial evidence that COCs do not increase the incidence of breast cancer. Although some past studies have suggested that COCs might increase the incidence of breast cancer, more recent studies have not confirmed such findings.

Some studies suggest that COCs are associated with an increase in the risk of cervical cancer or intraepithelial neoplasia. However, there is controversy about the extent to which these findings may be due to differences in sexual behavior and other factors.

Discontinue Safyral (Drospirenone; ethinyl estradiol; levomefolate calcium) if jaundice develops. Steroid hormones may be poorly metabolized in patients with impaired liver function. Acute or chronic disturbances of liver function may necessitate the discontinuation of COC use until markers of liver function return to normal and COC causation has been excluded.

Hepatic adenomas are associated with COC use. An estimate of the attributable risk is 3.3 cases/100,000 COC users. Rupture of hepatic adenomas may cause death through intra-abdominal hemorrhage.

Studies have shown an increased risk of developing hepatocellular carcinoma in long-term (> 8 years) COC users. However, the attributable risk of liver cancers in COC users is less than one case per million users.

Oral contraceptive-related cholestasis may occur in women with a history of pregnancy-related cholestasis. Women with a history of COC-related cholestasis may have the condition recur with subsequent COC use.

For women with well-controlled hypertension, monitor blood pressure and stop Safyral (Drospirenone; ethinyl estradiol; levomefolate calcium) if blood pressure rises significantly. Women with uncontrolled hypertension or hypertension with vascular disease should not use COCs.

An increase in blood pressure has been reported in women taking COCs, and this increase is more likely in older women and with extended duration of use. The incidence of hypertension increases with increasing concentration of progestin.

Carefully monitor prediabetic and diabetic women who are taking Safyral (Drospirenone; ethinyl estradiol; levomefolate calcium) . COCs may decrease glucose tolerance in a dose-related fashion.

Consider alternative contraception for women with uncontrolled dyslipidemia. A small proportion of women will have adverse lipid changes while on COCs.

Women with hypertriglyceridemia, or a family history thereof, may be at an increased risk of pancreatitis when using COCs.

If a woman taking Safyral (Drospirenone; ethinyl estradiol; levomefolate calcium) develops new headaches that are recurrent, persistent, or severe, evaluate the cause and discontinue Safyral (Drospirenone; ethinyl estradiol; levomefolate calcium) if indicated.

An increase in frequency or severity of migraine during COC use (which may be prodromal of a cerebrovascular event) may be a reason for immediate discontinuation of the COC. 

Unscheduled (breakthrough or intracyclic) bleeding and spotting sometimes occur in patients on COCs, especially during the first three months of use. If bleeding persists or occurs after previously regular cycles, check for causes such as pregnancy or malignancy. If pathology and pregnancy are excluded, bleeding irregularities may resolve over time or with a change to a different COC.

Data from ten Yasmin contraceptive efficacy clinical trials (N=2,467) show that the percent of women who took Yasmin and experienced unscheduled bleeding decreased over time from 12% at cycle 2 to 6% (cycle 13). A total of 25 subjects out of 3,009 in the Yasmin and Safyral (Drospirenone; ethinyl estradiol; levomefolate calcium) trials (
The average duration of scheduled bleeding episodes in the majority of subjects (86%-88%) was 4-7 days. Women who use Safyral (Drospirenone; ethinyl estradiol; levomefolate calcium) may experience absence of withdrawal bleeding, even if they are not pregnant. Based on subject diaries from Yasmin contraceptive efficacy trials, during cycles 2 –13, 1 - 11% of women per cycle experienced no withdrawal bleeding. Some women may encounter post-pill amenorrhea or oligomenorrhea, especially when such a condition was pre-existent.

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.

Extensive epidemiological studies have revealed no increased risk of birth defects in women who have used oral contraceptives prior to pregnancy. Studies also do not suggest a teratogenic effect when COCs are taken inadvertently during early pregnancy, particularly in so far as cardiac anomalies and limb-reduction defects are concerned. Discontinue Safyral (Drospirenone; ethinyl estradiol; levomefolate calcium) if pregnancy is confirmed and initiate a prenatal vitamin containing folate supplementation.

The administration of oral contraceptives to induce withdrawal bleeding should not be used as a test for pregnancy

The use of COCs may change the results of some laboratory tests, such as coagulation factors, lipids, glucose tolerance, and binding proteins. Women on thyroid hormone replacement therapy may need increased doses of thyroid hormone because serum concentrations of thyroid-binding globulin increase with use of COCs. DRSP causes an increase in plasma renin activity and plasma aldosterone induced by its mild antimineralocorticoid activity.

Folates may mask vitamin B12 deficiency.

The following serious adverse reactions with the use of COCs are discussed elsewhere in the labeling:

Adverse reactions commonly reported by COC users are:

Consult the labeling of all concurrently-used drugs to obtain further information about interactions with hormonal contraceptives or the potential for enzyme alterations

COCs containing EE may inhibit the metabolism of other compounds. COCs have been shown to significantly decrease plasma concentrations of lamotrigine, likely due to induction of lamotrigine glucuronidation. This may reduce seizure control; therefore, dosage adjustments of lamotrigine may be necessary. Consult the labeling of the concurrently-used drug to obtain further information about interactions with COCs or the potential for enzyme alterations.

There is little or no increased risk of birth defects in women who inadvertently use COCs during early pregnancy. Epidemiologic studies and meta-analyses have not found an increased risk of genital or non-genital birth defects (including cardiac anomalies and limb-reduction defects) following exposure to low dose COCs prior to conception or during early pregnancy.

The administration of COCs to induce withdrawal bleeding should not be used as a test for pregnancy. COCs should not be used during pregnancy to treat threatened or habitual abortion.

Women who do not breastfeed may start COCs no earlier than four weeks postpartum.

When possible, advise the nursing mother to use other forms of contraception until she has weaned her child. Estrogen-containing OCs can reduce milk production in breastfeeding mothers. This is less likely to occur once breastfeeding is well-established; however, it can occur at any time in some women. Small amounts of oral contraceptive steroids and/or metabolites are present in breast milk.

After oral administration of 3 mg DRSP/0.03 mg EE tablets (Yasmin), about 0.02% of the DRSP dose was excreted into the breast milk of postpartum women within 24 hours. This results in a maximal daily dose of about 0.003 mg DRSP in an infant.

Studies to date indicate there is no adverse effect of folate on nursing infants.

Safyral (Drospirenone; ethinyl estradiol; levomefolate calcium) is contraindicated in patients with renal impairment .

Following administration of DRSP 3 mg daily for 14 days, the serum DRSP levels in subjects with mild renal impairment (creatinine clearance CLcr, 50-80 mL/min) were comparable to those in subjects with normal renal function (CLcr, >80 mL/min). The serum DRSP levels were on average 37% higher in the group with moderate renal impairment (CLcr, 30-50 mL/min) compared to those in the group with normal renal function. DRSP treatment did not show any clinically significant effect on serum potassium concentration. Although hyperkalemia was not observed in the study, in five of the seven subjects who continued use of potassium sparing drugs during the study, mean serum potassium levels increased by up to 0.33 mEq/L. Therefore, potential exists for hyperkalemia to occur in subjects with renal impairment whose serum potassium is in the upper reference range, and who are concomitantly using potassium sparing drugs .

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

Levomefolate calcium doses of 17 mg/day (37-fold higher than the levomefolate calcium dose of Safyral (Drospirenone; ethinyl estradiol; levomefolate calcium) ) were well tolerated after long-term treatment up to 12 weeks.

Safyral (Drospirenone; ethinyl estradiol; levomefolate calcium) (drospirenone/ethinyl estradiol/levomefolate calcium tablets and levomefolate calcium tablets) provides an oral contraceptive regimen consisting of 28 film-coated tablets that contain the active ingredients specified for each tablet below:

The inactive ingredients in the orange tablets are lactose monohydrate NF, microcrystalline cellulose NF, croscarmellose sodium NF, hydroxypropyl cellulose USP, magnesium stearate NF, hypromellose USP, titanium dioxide USP, talc USP, polyethylene glycol NF, ferric oxide pigment, yellow NF, and ferric oxide pigment, red NF. The light orange film-coated tablets contain 0.451 mg of levomefolate calcium. The inactive ingredients in the light orange tablets are lactose monohydrate NF, microcrystalline cellulose NF, croscarmellose sodium NF, hydroxypropyl cellulose NF, magnesium stearate NF, hypromellose USP, titanium dioxide USP, talc USP, polyethylene glycol NF and ferric oxide pigment, yellow NF, and ferric oxide pigment, red NF.

Drospirenone (6R,7R,8R,9S,10R,13S,14S,15S,16S,17S)-1,3',4',6,6a,7,8,9,10,11,12,13, 14,15,15a,16-hexadecahydro-10,13-dimethylspiro-[17H-dicyclopropa-6,7:15,16] cyclo-penta[a]phenanthrene-17,2'(5H)-furan]-3,5'(2H)-dione) is a synthetic progestational compound and has a molecular weight of 366.5 and a molecular formula of CHO.

Ethinyl estradiol (19-nor-17α-pregna 1,3,5(10)-triene-20-yne-3,17-diol) is a synthetic estrogenic compound and has a molecular weight of 296.4 and a molecular formula of CHO.

Levomefolate calcium (N-[4-[[(2-amino-1,4,5,6,7,8-hexahydro-5-methyl-4-oxo-(6S)-pteridinyl)methyl]amino]benzoyl]-L-glutamic acid, calcium salt) is a synthetic calcium salt of L-5-methyltetrahydrofolate (L-5-methyl-THF), which is a metabolite of vitamin B and has a molecular weight of 497.5 and a molecular formula of CHCaNO

The structural formulas are as follows:

The development program for Safyral (Drospirenone; ethinyl estradiol; levomefolate calcium) (Yasmin + levomefolate calcium) consisted of two clinical trials.

One study was a multicenter, randomized, double-blind, active-controlled, parallel group US study. Plasma folate and red blood cell folate levels were investigated during a 24-week treatment with 3 mg DRSP/0.02 mg EE (YAZ) + 0.451 mg levomefolate calcium as compared to YAZ alone in a U.S. population that consumed folate fortified food. A total of 379 healthy women between 18 and 40 years of age with no restrictions on folate supplementation received YAZ + levomefolate calcium (N= 285) or YAZ (N=94). The plasma and RBC folate concentrations at Week 24 were the co-primary endpoints. Figures 1 and 2 display the results for plasma and RBC folate concentrations, respectively, among evaluable subjects in each arm of the study.

In the second study, the pharmacodynamic effect on plasma folate, RBC folate, and the profile of circulating folate metabolites was assessed during 24 weeks of treatment with 0.451 mg levomefolate calcium or with 0.4 mg folic acid (equimolar dose to 0.451 mg levomefolate calcium), both in combination with 3 mg DRSP/0.03 mg EE (Yasmin) followed by 20 weeks of open-label treatment with Yasmin only (elimination phase). One-hundred and seventy-two healthy women between 18 to 40 years of age from a German population that consumed food without folate fortification and without concomitant intake of folate supplements were randomized to one of the two treatments. Figures 3 and 4 display the results for plasma and RBC folate concentrations, respectively, among evaluable subjects in the levomefolate arm of the study.

The potential to reduce the incidence of neural tube defects (NTDs) with folate supplementation is well established based on a body of evidence derived from randomized, controlled trials, nonrandomized intervention trials, and observational studies using folic acid. Therefore, the Centers for Disease Control and Prevention (CDC) and the U.S. Preventive Services Task Force recommend that women of childbearing age consume supplemental folic acid in a dose of at least 0.4 mg (400 mcg) daily . .

1. US Preventive Services Task Force. Folic Acid for the Prevention of Neural Tube Defects: US Preventive Services Task Force Recommendation Statement. Ann Intern Med 2009;150:626-631.

2. 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. 2007;75:344-354.

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

4. 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. 2009;339:b2921.

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

6. Centers for Disease Control. Recommendations for the use of folic acid to reduce the number of cases of spina bifida and other neural tube defects. MMWR 1992;41(No. RR-14):(inclusive page numbers).

Safyral (Drospirenone; ethinyl estradiol; levomefolate calcium)  (drospirenone/ethinyl estradiol/levomefolate calcium tablets and levomefolate calcium tablets) is available in packages of three blister packs (50419-403-03).

The film-coated tablets are rounded with biconvex faces, one side is embossed with a regular hexagon shape with Y+ or M+.

Each blister pack contains 28 film-coated tablets in the following order:

21 round, biconvex, orange, film-coated tablets with embossed “Y+” in a regular hexagon on one side each containing 3 mg drospirenone, 0.03 mg ethinyl estradiol, and 0.451 mg levomefolate calcium

7 round, biconvex, light orange, film-coated tablets with embossed “M+” in a regular hexagon on one side each containing 0.451 mg levomefolate calcium

Manufactured for Bayer HealthCare Pharmaceuticals Inc.

Wayne, NJ 07470

Manufactured in Germany

©2010 Bayer HealthCare Pharmaceuticals Inc. All Rights Reserved

Bayer HealthCare Pharmaceuticals Inc.

Do not use Safyral (Drospirenone; ethinyl estradiol; levomefolate calcium) 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.

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

The progestin drospirenone may increase potassium. Therefore, you should not take Safyral (Drospirenone; ethinyl estradiol; levomefolate calcium) 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 (Drospirenone; ethinyl estradiol; levomefolate calcium) is right for you, and during the first month that you take Safyral (Drospirenone; ethinyl estradiol; levomefolate calcium) , you should have a blood test to check your potassium level.

Safyral (Drospirenone; ethinyl estradiol; levomefolate calcium) 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 (Drospirenone; ethinyl estradiol; levomefolate calcium) supplements folate in the diet to lower this risk should you become pregnant while taking the drug or shortly after stopping it.

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 Safyral (Drospirenone; ethinyl estradiol; levomefolate calcium) .

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.

1. 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 (Drospirenone; ethinyl estradiol; levomefolate calcium) 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.

1. Decide What Time of Day You Want to Take Your Pill

It is important to take Safyral (Drospirenone; ethinyl estradiol; levomefolate calcium) 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 (Drospirenone; ethinyl estradiol; levomefolate calcium) can be taken without regard to meals.

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

The Safyral (Drospirenone; ethinyl estradiol; levomefolate calcium) pill pack has (with hormones and folate) to be taken for three weeks, followed by (without hormones, containing folate) to be taken for one week.

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 or spermicides) to use as a back-up in case you miss pills, and (b) an extra, full pill pack.

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 (Drospirenone; ethinyl estradiol; levomefolate calcium) 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 (Drospirenone; ethinyl estradiol; levomefolate calcium) after having been pregnant and you have not had a period since your pregnancy.

When switching from another birth control pill , Safyral (Drospirenone; ethinyl estradiol; levomefolate calcium) should be started on the same day that a new pack of the previous birth control pill would have been started.

When switching from a transdermal patch or vaginal ring, Safyral (Drospirenone; ethinyl estradiol; levomefolate calcium) should be started when the next application would have been due. When switching from an injection, Safyral (Drospirenone; ethinyl estradiol; levomefolate calcium) should be started when the next dose would have been due. When switching from an intrauterine contraceptive or an implant, Safyral (Drospirenone; ethinyl estradiol; levomefolate calcium) should be started on the day of removal.

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. Do not wait any days between packs.

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.

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. 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.

Throw out the rest of the pill pack and start a new pack that same day.

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.

Throw out the rest of the pill pack and start a new pack that same day.

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.

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.

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.

 Your healthcare provider should not give you Safyral (Drospirenone; ethinyl estradiol; levomefolate calcium) 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 pregnant 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.

Birth control pills do notprotect 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:

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 (Drospirenone; ethinyl estradiol; levomefolate calcium) 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 (Drospirenone; ethinyl estradiol; levomefolate calcium) , may decrease the amount of milk you make. A small amount of the pill's hormones pass into breast milk.

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 Safyral (Drospirenone; ethinyl estradiol; levomefolate calcium) :

Tell your healthcare provider about all medicines and herbal products that you take. Some other medicines and herbal products may make birth control pills less effective, including:

Consider using another birth control method when you take medicines (such as the ones listed above) that may make birth control pills less effective.

Birth control pills may interact with lamotrigine, an anticonvulsant used for epilepsy. This may increase the risk of seizures, so your healthcare provider may need to adjust the dose of lamotrigine.

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.

Like pregnancy, birth control pills increase the risk of serious blood clots, especially in women who have other risk factors, such as smoking, obesity, or age greater than 35. It is possible to die from a problem caused by a blood clot, such as a heart attack or a stroke. Some examples of serious blood clots are in the:

A few women who take birth control pills may get:

The most common side effects of birth control pills are:

These side effects are usually mild and usually disappear with time.

Less common side effects are:

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.

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.

Irregular vaginal bleeding or spotting may occur while you are taking Safyral (Drospirenone; ethinyl estradiol; levomefolate calcium) . 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 regularly on time.

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 (Drospirenone; ethinyl estradiol; levomefolate calcium) if you are 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 (Drospirenone; ethinyl estradiol; levomefolate calcium) , are pregnant, or plan on becoming pregnant.

Your healthcare provider prescribed Safyral (Drospirenone; ethinyl estradiol; levomefolate calcium) for you. Please do not share Safyral (Drospirenone; ethinyl estradiol; levomefolate calcium) with anyone else. Keep Safyral (Drospirenone; ethinyl estradiol; levomefolate calcium) 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.

Bayer HealthCare Pharmaceuticals Inc.