drospiren-e.estrad-l.mefol 3 mg-0.03 mg-0.451 mg(21)/0.451 mg(7)tablet

Generic name:
Drospirenone/ethinyl estradiol/folate supplement 21/7 - oral

Pronunciation
(droe-SPYE-re-none/ETH-i-nil ES-tra-DYE-ol/FOE-late)

Brand name(s)
Safyral

Do not use this medication if you smoke cigarettes/use tobacco and are over 35 years old. Smoking raises your risk of stroke, heart attack, blood clots, and high blood pressure from hormonal birth control (such as the pill, patch, ring). The risk of these serious problems increases with age and with the number of cigarettes you smoke. Do not smoke or use tobacco.

This combination hormone medication is used to prevent pregnancy. It contains 2 hormones: an estrogen (ethinyl estradiol) and a progestin (drospirenone).

This product also contains a folate supplement (such as l-methylfolate, levomefolate). Folate is a B-vitamin that women of childbearing age use to help prevent spinal cord defects in an unborn baby. The folate supplement in this medication, along with a diet rich in folate, lowers this risk if you become pregnant while taking this drug or soon after you stop taking it.

Besides preventing pregnancy, birth control pills may make your periods more regular, and may decrease blood loss, painful periods, and the risk of ovarian cysts.

Using this medication does not protect you or your partner against sexually transmitted diseases (such as HIV, gonorrhea, chlamydia).

This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

Birth control pills may also be used for premenstrual dysphoric disorder (PMDD) or moderate acne if you have chosen to use birth control pills as your method of pregnancy prevention.

Read the Patient Information Leaflet provided by your pharmacist before you start taking this product and each time you get a refill. The leaflet contains very important advice about when to take your pills and what to do if you miss a dose. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth with or without food as directed by your doctor, usually once daily. Pick a time of day that is easy for you to remember, and take your pill at the same time each day. Taking this medication after your evening meal or at bedtime may help decrease stomach upset and nausea.

It is very important to keep taking this medication exactly as prescribed by your doctor. Follow the package instructions to find the first tablet, start with the first tablet in the pack, and take them in the correct order. Do not skip any doses. Pregnancy is more likely if you miss pills, start a new pack late, or take your pill at a different time of the day than usual.

Vomiting or diarrhea can prevent your birth control pills from working well. If you have vomiting or diarrhea, you may need to use a backup birth control method (such as condoms, spermicide). Follow the directions in the Patient Information Leaflet and check with your doctor or pharmacist for more details.

Your pill pack contains 21 pills with active medication (hormones and folate). It also contains 7 reminder pills (without hormones, but with folate) at the end of the pack. Take one active pill (with hormones) once daily for 21 days in a row. After you have taken the last active pill, take one reminder pill (without hormones) once daily for 7 days in a row unless otherwise directed by your doctor. You should have your period during the fourth week of the cycle. After you have taken the last reminder tablet in the pack, start a new pack the next day even if your period is continuing or if you do not have your period. If you do not get your period, consult your doctor.

If this is the first time you are using this medication and you are not switching from another form of hormonal birth control (such as patch, other birth control pills), take the first tablet in the pack on the first Sunday following the beginning of your menstrual period or on the first day of your period. If your period begins on a Sunday, begin taking this medication on that day. For the first cycle of use only, use a backup form of non-hormonal birth control (such as condoms, spermicide) for the first 7 days to prevent pregnancy until the medication has enough time to work. If you start on the first day of your period, you do not need to use backup birth control the first week.

Ask your doctor or pharmacist for information about how to switch from other forms of hormonal birth control (such as patch, vaginal ring, other birth control pills) to this product. If any information is unclear, consult the Patient Information Leaflet or your doctor or pharmacist.

See also Precautions section.

Nausea, vomiting, headache, abdominal cramps, bloating, breast tenderness, swelling of the ankles/feet (retaining fluid), or weight change may occur. Vaginal bleeding between periods (spotting) or missed/irregular periods may occur, especially during the first few months of use. If any of these effects last or get worse, tell your doctor or pharmacist promptly. If you miss 2 periods in a row (or 1 period if the pill has not been used properly), contact your doctor for a pregnancy test.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high.

Tell your doctor right away if you have any serious side effects, including:

• lumps in the breast
• mental/mood changes (such as new/worsening depression)
• unusual changes in vaginal bleeding (such as continuous spotting, sudden heavy bleeding)
• severe stomach/abdominal pain
• symptoms of a high potassium blood level (such as muscle weakness, slow/irregular heartbeat)
• dark urine
• yellowing eyes/skin

This medication may rarely cause serious (sometimes fatal) problems from blood clots (such as heart attack, stroke, blood clots in the lungs or legs). Get medical help right away if you have:

• pain/swelling/warmth in the groin/calf
• shortness of breath/rapid breathing
• chest/jaw/left arm pain
• unusual sweating
• sudden dizziness/fainting
• confusion
• trouble speaking
• weakness on one side of the body
• sudden vision changes
• sudden/severe headaches

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

See also Warning section.

Before taking this medication, tell your doctor or pharmacist if you are allergic to drospirenone, ethinyl estradiol, or folate supplements; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this product, tell your doctor or pharmacist your medical history, especially of:

• adrenal gland problems
• blood clots (for example, in the legs, eyes, lungs)
• blood clotting disorders (such as protein C or protein S deficiency)
• high blood pressure
• high cholesterol or triglyceride (blood fat) levels
• abnormal breast exam
• cancer (especially endometrial or breast cancer)
• depression
• diabetes
• family or personal history of a certain swelling disorder (angioedema)
• gallbladder problems
• severe headaches/migraines
• heart problems (such as heart valve disease, irregular heartbeat, previous heart attack)
• kidney disease
• liver disease (including tumors)
• obesity
• history of yellowing eyes/skin (jaundice) during pregnancy or while using hormonal birth control (such as pills, patch)
• swelling (edema)
• stroke
• thyroid problems
• unexplained vaginal bleeding

If you have diabetes, this medication may affect your blood sugar. Check your blood sugar regularly as directed and share the results with your doctor. Tell your doctor right away if you have symptoms of high blood sugar such as increased thirst/urination. Your doctor may need to adjust your diabetes medication, exercise program, or diet.

Tell your doctor if you just had or will be having surgery or if you will be confined to a chair or bed for a long time (such as on a long plane flight). These conditions increase your risk of getting blood clots, especially if you are using hormonal birth control. You may need to stop this medication for a time or take special precautions.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This product may increase your potassium levels. Before using potassium supplements or salt substitutes that contain potassium, consult your doctor or pharmacist.

This medication may cause blotchy, dark areas on your face and skin (melasma). Sunlight may worsen this effect. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors.

If you are nearsighted or wear contact lenses, you may develop vision problems or trouble wearing your contact lenses. Contact your eye doctor if these problems occur.

It may take longer for you to become pregnant after you stop taking birth control pills. Consult your doctor.

This medication should not be used during pregnancy. If you become pregnant or think you may be pregnant, tell your doctor right away. If you have just given birth or had a pregnancy loss/abortion after the first 3 months, talk with your doctor about reliable forms of birth control, and find out when it is safe to start using birth control that contains a form of estrogen, such as this medication.

A small amount of this medication passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breastfeeding.

See also Precautions section.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include:

• aromatase inhibitors (such as anastrozole, exemestane, letrozole)
• atazanavir/cobicistat
• fezolinetant
• ospemifene
• tamoxifen
• tranexamic acid
• certain combination products used to treat chronic hepatitis C (ombitasvir/paritaprevir/ritonavir with or without dasabuvir)

Drospirenone may raise your potassium blood level. Tell your doctor if you are regularly taking other drugs/products that can also raise your potassium level (including aliskiren, ACE inhibitors such as benazepril/lisinopril, angiotensin receptor blockers such as losartan/valsartan, heparin, NSAIDs such as ibuprofen/naproxen, potassium-sparing "water pills"/diuretics such as spironolactone/triamterene).

Some drugs may cause hormonal birth control to work less well by decreasing the amount of birth control hormones in your body. This effect can result in pregnancy. Examples include griseofulvin, modafinil, rifamycins (such as rifampin, rifabutin), ritonavir, St. John's wort, drugs used to treat seizures (such as barbiturates, carbamazepine, felbamate, phenytoin, primidone, topiramate), HIV drugs (such as nelfinavir, nevirapine), among others.

Tell your doctor when you start any new drug, and discuss if you should use reliable backup birth control. Also tell your doctor if you have any new spotting or breakthrough bleeding, because these may be signs that your birth control is not working well.

This medication may interfere with certain lab tests (such as blood clotting factors, thyroid), possibly causing false test results. Make sure lab personnel and all your doctors know you use this drug.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669. Symptoms of overdose may include: severe nausea and vomiting, sudden/unusual vaginal bleeding.

Do not share this medication with others.

Regular complete physical exams which include lab and/or medical tests (such as potassium blood level, blood pressure, breast exam, pelvic exam, Pap smear) should be done while you are taking this medication. Follow your doctor's instructions for examining your breasts, and report any lumps right away. Keep all medical and lab appointments. Consult your doctor for more details.

Refer to the product package information for advice on missed doses. You may need to use backup birth control (such as condoms, spermicide) to prevent pregnancy. Ask your doctor or pharmacist if you have any questions.

If you often forget to take your pills as directed, contact your doctor to discuss switching to another form of birth control.

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.