Uses

This medication is used to prevent pregnancy. It contains the hormone drospirenone (a progestin).

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

Using this product does not protect you or your partner against sexually transmitted diseases (such as HIV, hepatitis B, gonorrhea, syphilis). To decrease your risk of infection, always use an effective barrier method (latex or polyurethane condom/dental dams) during all sexual activity.

How To Use

Read the Patient Information Leaflet provided by your pharmacist before you start using this product and each time you get a refill. The leaflet contains very important information on 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 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.

Begin taking this medication on the first day of your menstrual period. Continue taking one tablet every day. 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.

If you have vomiting or diarrhea within 3 to 4 hours after taking your tablet, follow the directions in the Patient Information Leaflet for what to do if you miss a dose. Vomiting or diarrhea can prevent your birth control pills from working well. If vomiting or diarrhea continues, use a back-up birth control method (such as condoms, spermicide) and check with your doctor or pharmacist for more details.

Taking this medication after your evening meal or at bedtime may help if you have stomach upset or nausea with the medication. You may choose to take this medication at another time of day that is easier for you to remember. No matter what dosing schedule you use, it is very important that you take this medication at the same time each day, 24 hours apart.

Your pill pack contains 24 pills with active medication. It also contains 4 reminder pills with no medication. Take one active pill (with hormones) once daily for 24 days in a row. Take an inactive pill once daily for 4 days in a row after you have taken the last active pill unless otherwise directed by your doctor. After you have taken the last inactive tablet in the pack or gone 4 days without taking an active tablet, 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.

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

Side Effects

Nausea, vomiting, headache, bloating, breast tenderness, acne, or weight gain 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.

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)
• severe stomach/abdominal pain
• symptoms of a high potassium blood level (such as muscle weakness, slow/irregular heartbeat)
• unusual changes in vaginal bleeding (such as continuous spotting, sudden heavy bleeding, missed periods)
• dark urine
• yellowing eyes/skin

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.

Precautions

Before taking drospirenone, tell your doctor or pharmacist if you are allergic to it; or to any progestins (such as norethindrone, desogestrel); 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 medication, tell your doctor or pharmacist your medical history, especially of:

• adrenal gland problems
• abnormal breast exam
• cancer (especially endometrial or breast cancer)
• depression
• diabetes
• severe headaches/migraines
• history of yellowing eyes/skin (jaundice) during pregnancy or while using hormonal birth control (such as pills, patch)
• kidney disease
• liver disease (including tumors)
• swelling (edema)
• 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.

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 skin (melasma). Sunlight may worsen this effect. Avoid prolonged sun exposure, sunlamps, and tanning booths. Use a sunscreen, and wear protective clothing when outdoors.

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 or 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.

This medication passes into breast milk in very small amounts but is unlikely to harm a nursing infant. Consult your doctor before breast-feeding.

Drug Interactions

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:

• atazanavir/cobicistat
• fezolinetant

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 enalapril/lisinopril, angiotensin receptor blockers such as losartan/valsartan, heparin, NSAIDs such as ibuprofen/naproxen, potassium-sparing "water pills"/diuretics such as eplerenone/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 many lab tests, possibly causing false test results. Make sure lab personnel and all your doctors know you use this medication.

Overdose

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 their local poison control center at 1-800-222-1222. Alberta residents can call PADIS (Poison and Drug Information Service) 24 hours a day at 1-800-332-1414. Canada residents can call a provincial poison control center. Symptoms of overdose may include: severe nausea, vomiting, sudden/unusual vaginal bleeding.

Notes

Do not share this medication with others.

Keep all regular medical and lab appointments. You should have regular complete physical exams including potassium blood level, blood pressure, breast exam, pelvic exam, pap smear. Follow your doctor's instructions for examining your breasts, and report any lumps right away. Consult your doctor for more details.

Missed Dose

Missed dose advice is different depending on the number of doses missed. 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.

If you have questions about missing a dose or you don't have more medication, contact your healthcare provider or pharmacist.

Storage

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.