Progestin-Only (norethindrone) Oral Contraceptives

Progestin-only (norethindrone) 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 (norethindrone) oral contraceptives are a very effective method of birth control, but they do not prevent the spread of AIDS and other sexually transmitted diseases.

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

Progestin-only (norethindrone) oral contraceptives come in packs of 28 tablets. Begin the next pack the day after the last pack is finished.

Your doctor will tell you when you should start taking your progestin-only (norethindrone) 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 soon after taking a progestin-only (norethindrone) oral contraceptives, you may have to use a backup method of birth control for the next 48 hours. 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.

Before taking progestin-only oral contraceptives, ask your pharmacist or doctor for a copy of the manufacturer's information for the patient and read it carefully.

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

Before taking progestin-only (norethindrone) oral contraceptives,

• tell your doctor and pharmacist if you are allergic to norethindrone, other progestins, any other medications, or any of the ingredients in progestin-only (norethindrone) oral contraceptives.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while taking progestin-only (norethindrone) oral contraceptives. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• the following nonprescription or herbal products may interact with progrestin-only (norethindrone) oral contraceptives: St. John's wort. Be sure to let your doctor and pharmacist know that you are taking these medications before you start taking progestin-only (norethindrone) oral contraceptives. Do not start any of these medications while taking progestin-only (norethindrone) oral contraceptives without discussing with your healthcare provider.
• tell your doctor if you have unexplained abnormal vaginal bleeding; liver cancer, liver tumors, or other types of liver disease. Also tell your doctor if you have or have ever had breast cancer. Your doctor will probably tell you not to take progestin-only (norethindrone) oral contraceptives.
• tell your doctor if you have or have ever had diabetes.
• tell your doctor if you are pregnant or plan to become pregnant or are breast-feeding. If you become pregnant while taking progestin-only (norethindrone) 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.
• tell your doctor if you use tobacco products. Cigarette smoking may increase the risk of heart attacks and strokes. You should not smoke while taking this medication.

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

Take the missed dose as soon as you remember it, and go back to taking progestin-only (norethindrone) contraceptives at your regular time. If you take a dose more than 3 hours late, be sure to use a backup method of birth control for the next 48 hours. If you are not sure what to do about the pills you have missed, keep taking progestin-only (norethindrone) contraceptives and use a backup method of birth control until you speak to your doctor.

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

• irregular menstrual periods
• headache
• breast tenderness
• nausea
• dizziness
• acne
• weight gain
• increased hair growth

Some side effects can be serious. The following symptoms are uncommon, but if you experience any of them, call your doctor immediately:

• menstrual bleeding that is unusually heavy or that lasts a long time
• lack of menstrual periods
• severe stomach pain

Combined estrogen and progestin oral contraceptives may increase the risk of getting breast cancer, endometrial cancer, and liver tumors. It is not known whether progestin-only (norethindrone) oral contraceptives also increase the risks of these conditions. Talk to your doctor about the risks of taking this medication.

Progestin-only oral (norethindrone) contraceptives 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 (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container 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).

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 (https://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

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. https://www.upandaway.org

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.

Keep all appointments with your doctor.

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

Rarely, women can become pregnant even if they are taking oral contraceptives. You should get a pregnancy test if it has been more than 45 days since your last period or if your period is late and you missed one or more doses or took them late and had sex without a backup method of birth control.

If you want to become pregnant, stop taking progestin-only (norethindrone) contraceptives. Progestin-only (norethindrone) 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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