Progestin-Only (norgestrel) Oral Contraceptives

Progestin-only (norgestrel) 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 (norgestrel) 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 (norgestrel) oral contraceptives should not be used as an emergency contraceptive or as a backup in case regular birth control fails or is used incorrectly.

Progestin-only (norgestrel) oral contraceptives comes in packets of 28 tablets to take by mouth once a day, at the same time every day. Take 1 tablet daily for 28 days in a row in the order specified in your packet. Start a new packet the day after you take your 28th tablet. Follow the directions on your package label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take progestin-only (norgestrel) oral contraceptives exactly as directed. Do not take more or less of it or take it more often than recommended.

You can start taking your progestin-only (norgestrel) oral contraceptive on any day. If you are switching from another type of contraception (other birth control pills, vaginal ring, transdermal patch), you should start taking progestin-only (norgestrel) oral contraceptive the day after you stop taking the other type of contraception.

If you are just starting to take progestin-only (norgestrel) oral contraceptives, you should use a backup method of birth control (such as a condom and/or a spermicide) for the first 2 days (48 hours) after you start taking progestin-only (norgestrel) oral contraceptives. If you vomit or have diarrhea within 4 hours after taking progestin-only (norgestrel) oral contraceptives, you should use a backup method of birth control for the next 48 hours. Be sure to ask your doctor or pharmacist if you have any questions about taking your oral contraceptive so that you can prepare a backup method of birth control in case it is needed.

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.

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

Before taking progestin-only (norgestrel) oral contraceptives,

• tell your doctor or pharmacist if you are allergic to norgestrel, aspirin, any other medications, tartrazine (a yellow dye in some processed foods and medications), or any of the ingredients in progestin-only (norgestrel) oral contraceptives. Ask your pharmacist for a list of the ingredients.
• tell your doctor or pharmacist if you are using any other type of hormonal birth control, such as other birth control pills, vaginal ring, transdermal patch, injection, implant, or a intrauterine device [IUD]. Ask your doctor or pharrmacist how and when you should stop using the other type of birth control and start taking progestin-only (norgestrel) oral contraceptive. Do not use any other type of hormonal birth control while you are taking progestin-only (norgestrel) oral contraceptive. Also, tell your doctor or pharmacist if you have used an emergency contraceptive within the last 5 days before starting progestin-only (norgestrel) oral contraceptives. You should know that taking progestin-only (norgestrel) oral contraceptives within 5 days of emergency contraceptives, may cause either medication to not work as well.
• tell your doctor or pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. 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 progestin-only (norgestrel) oral contraceptive: St. John's Wort. Be sure to let your doctor or pharmacist know that you are taking these medications before you start taking progestin-only (norgestrel) oral contraceptive. Do not start this medication while taking progestin-only (norgestrel) oral contraceptive without discussing with your healthcare provider.
• tell your doctor if you have or ever had breast cancer. You should not to take progestin-only (norgestrel) oral contraceptives if you have or have ever had breast cancer.
• tell your doctor if you have unexplained abnormal vaginal bleeding or if you have or ever have had cancer, liver tumors or other types of liver problems, migraines, or any other medical condition.
• do not take oral contraceptives if you are pregnant or plan to become pregnant. If you become pregnant while taking progestin-only (norgestrel) contraceptives, call your doctor.
• tell your doctor if you are breast-feeding or plan to breast feed.
• 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 have not had a period for 2 months, 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.
• you should know that progestin-only (norgestrel) contraceptives should not be used in men.

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 (norgestrel) oral 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 (norgestrel) contraceptives and use a backup method of birth control until you speak to your doctor or pharmacist.

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

• irregular menstrual periods
• bleeding or spotting between menstrual periods
• headache
• increased appetite
• nausea
• dizziness
• stomach pain, cramps, or bloating
• breast tenderness
• acne

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

• unusual vaginal bleeding or menstrual bleeding that is unusually heavy or that lasts a long time
• sudden, severe, or persistent lower abdominal pain
• new or worsening migraine headache
• yellowing of the skin or eyes, fever, tiredness, loss of appetite, or dark colored urine
• rash; hives; itching; swelling of the face, eyes, or mouth; wheezing; or shortness of breath

Progestin-only oral (norgestrel) 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 (http://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).

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. You should continue to have a Pap smear (a test to detect cancer of the cervix) and breast screening (mammogram) regularly while you are taking progestin-only (norgestrel) oral contraceptives.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking progestin-only (norgestrel) oral contraceptives.

Rarely, women can become pregnant even if they are taking oral contraceptives. You should get a pregnancy test if it has been more than 2 months 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 (norgestrel) contraceptives. Progestin-only (norgestrel) contraceptives should not delay your ability to get pregnant.

Do not let anyone else take your medication.

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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