Progestin-Only (drospirenone) Oral Contraceptives

Progestin-only (drospirenone) oral contraceptives are used to prevent pregnancy. Progestin is a female hormone. It works by preventing the release of eggs from the ovaries (ovulation) and changing the cervical mucus and the lining of the uterus. Progestin-only oral contraceptives are a very effective method of birth control, but they do not prevent the spread of of human immunodeficiency virus (HIV, the virus that causes acquired immunodeficiency syndrome [AIDS]) and other sexually transmitted diseases.

Progestin-only (drospirenone) oral contraceptives come as tablets to take by mouth once a day. Take oral contraceptives at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take your oral contraceptive exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Progestin-only (drospirenone) oral contraceptives come in packs of 28 tablets that have 2 different colors. Take 1 tablet daily for 28 days in a row in the order specified in your packet. The first 24 tablets are white and contain the active ingredient (drospirenone). The last 4 tablets are green and contain an inactive ingredient. Start a new packet the day after you take your 28th tablet.

Your doctor will tell you when you should start taking your progestin-only (drospirenone) oral contraceptive. Tell your doctor if you are switching from another type of contraception (other birth control pills, vaginal ring, transdermal patch, implant, injection, intrauterine device [IUD]).

If you vomit or have diarrhea within 3 or 4 hours after taking a white tablet (containing the active ingredient), take the next tablet in your packet as soon as possible (preferably within 12 hours of the dose previously taken). Continue your regular dosing schedule and finish your current packet. When you start a new packet, it will be one day earlier than your previous schedule. You may need to use a backup method of birth control if you vomit or have diarrhea for more than 1 day while you are taking the white tablets (containing the active ingredient). Talk to your doctor about this before you begin to take your oral contraceptive so that you can prepare a backup method of birth control in case it is needed. If you vomit or have diarrhea while you are taking an oral contraceptive, call your doctor to find out how long you should use the backup method.

Oral contraceptives will work only as long as they are taken regularly. Continue to take oral contraceptives every day even if you are spotting or bleeding, have an upset stomach, or do not think that you are likely to become pregnant. Do not stop taking oral contraceptives without talking to your doctor.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking progestin-only (drospirenone) oral contraceptive tablets,

• tell your doctor and pharmacist if you are allergic to drospirenone, other progestins, or any other medications.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, and nutritional supplements you are taking. Be sure to mention any of the following: angiotensin-converting enzyme (ACE) inhibitors such as benazepril (Lotensin, in Lotrel), captopril, enalapril (Epaned, Vasotec, in Vaseretic), fosinopril, lisinopril (in Zestoretic), moexipril, perindopril (in Prestalia), quinapril (Accupril, in Accuretic, in Quinaretic), ramipril (Altace) and trandolapril (in Tarka); angiotensin receptor blockers such as azilsartan (Edarbi, in Edarbyclor), candesartan (Atacand, in Atacand HCT), eprosartan, irbesartan (Avapro, in Avalide), losartan (Cozaar, in Hyzaar), olmesartan (Benicar, in Azor, in Benicar HCT, in Tribenzor), telmisartan (Micardis, in Micardis HCT, in Twynsta) and valsartan (Diovan, in Entresto, in Diovan HCT, in Exforge, in Exforge HCT); antifungal medications such as itraconazole (Onmel, Sporanox), ketoconazole, and voriconazole (Vfend); aprepitant (Emend); aspirin and other nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen (Advil, Motrin) and naproxen (Aleve, Naprosyn); bosentan (Tracleer); boceprevir (Victrelis); carbamazepine (Carbatrol, Epitol, Equetro, Tegretol, others); clarithromycin; certain medications for HIV including efavirenz (Sustiva, in Atripla, in Symfi) and indinavir (Crixivan); diuretics ('water pills') such as amiloride (Midamor), spironolactone (Aldactone, Carospir, in Aldactzide), and triamterene (Dyrenium, in Dyazide, in Maxzide); eplerenone (Inspra); felbamate (Felbatol); griseofulvin (Gris-Peg); heparin; phenobarbital; phenytoin (Dilantin, Phenytek); potassium supplements; oxcarbazepine (Trileptal); rifabutin (Mycobutin); rifampin (Rifadin, Rimactane, in Rifamate, in Rifater); and rufinamide (Banzel). Your doctor may need to change the doses of your medications or monitor you carefully for side effects
• tell your doctor what herbal products you are taking, especially St. John's wort.
• tell your doctor if you have adrenal insufficiency (condition in which the body does not produce enough of certain natural substances needed for important functions such as blood pressure); unexplained abnormal vaginal bleeding; liver cancer, liver tumors, or other types of liver disease; or kidney disease. Also tell your doctor if you have or have ever had breast cancer or cancer of the lining of the uterus, cervix, or vagina. Your doctor will probably tell you not to take progestin-only (drospirenone) oral contraceptives.
• tell your doctor if you have or have ever had blood clots in your legs, lungs, or eyes; stroke or mini-stroke; a heart attack; osteoporosis; diabetes; high levels of potassium in the blood; or depression.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking progestin-only (drospirenone) oral contraceptives, call your doctor.
• if you miss periods while you are taking oral contraceptives, you may be pregnant. If you have taken your tablets according to the directions and you miss one period, you may continue to take your tablets. However, if you have not taken your tablets as directed and you miss one period or if you have taken your tablets as directed and you miss two periods, call your doctor and use another method of birth control until you have a pregnancy test. Also, call your doctor if you experience symptoms of pregnancy such as nausea, vomiting, and breast tenderness, or if you suspect you may be pregnant.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking progestin-only (drospirenone) oral contraceptives.

Unless your doctor tells you otherwise, continue your normal diet.

If you miss 2 or more doses of the white tablets (containing the active ingredient), you may not be protected from pregnancy. You may need to use a backup method of birth control for 7 days. If you miss doses of the green tablets (containing inactive ingredients), skip the missed dose and continue your regular dosing schedule. Progestin-only (drospirenone) oral contraceptive tablets come with specific directions to follow if you miss one or more doses. Carefully read the directions in the manufacturer's information for the patient that came with your oral contraceptive. If you have any questions, call your doctor or pharmacist. Continue to take your tablets as scheduled and use a backup method of birth control until your questions are answered.

Progestin-only (drospirenone) oral contraceptive may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• nausea
• vomiting
• acne
• irregular menstrual periods
• bleeding or spotting between menstrual periods
• painful periods
• headache
• breast tenderness
• weight gain
• decreased sexual desire

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:

• severe headache
• severe vomiting
• speech problems
• weakness or numbness of an arm or leg
• chest pain or chest heaviness
• irregular or rapid heartbeat
• shortness of breath
• leg pain
• partial or complete loss of vision or vision changes
• severe stomach pain
• yellowing of the skin or eyes
• pain in the upper right part of the stomach
• depression, especially if you also have trouble sleeping, tiredness, loss of energy, other mood changes, or if you are thinking of harming yourself
• menstrual bleeding that is unusually heavy or that lasts a long time
• lack of menstrual periods

Oral contraceptives may increase the risk of getting cervical cancer and liver tumors. It is not known whether progestin-only (drospirenone) oral contraceptives also increase the risks of these conditions. Talk to your doctor about the risks of taking this medication.

Progestin-only (drospirenone) oral contraceptive may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the packet it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include:

• nausea
• vomiting
• vaginal bleeding

Keep all appointments with your doctor.

Before you have any laboratory tests, tell the laboratory personnel that you take progestin-only (drospirenone) oral contraceptive, as this medication may interfere with some laboratory tests.

If you want to become pregnant, stop taking progestin-only (drospirenone) contraceptive. Progestin-only contraceptives should not delay your ability to get pregnant.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

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