Norgestrel

Norgestrel is used by women as a way to prevent pregnancy.

Norgestrel should not be used as emergency birth control (morning after pill) and will not protect you from sexually transmitted diseases including HIV and AIDS.

Norgestrel may also be used for other reasons that are not mentioned in this medication guide.

Use exactly as directed on the label, or as prescribed by your doctor. Read and carefully follow the instruction guide provided with the medicine.

Take the medicine at the same time each day.

Do not use norgestrel as an emergency contraceptive (morning after pill) or if you are already pregnant. Norgestrel will not prevent a pregnancy when used after unprotected sex and this medicine will not terminate a pregnancy.

If you are switching from another oral contraceptive, vaginal ring, or patch, start taking norgestrel the day after you stop the other method. Follow your doctor's dosing instructions very carefully.

Make sure you use a barrier form of birth control (condom or diaphragm with spermicide) for the first 2 days (48 hours) when you first start taking norgestrel or if you vomit or have severe diarrhea within 4 hours of taking norgestrel.

Do not stop the medicine without your doctor's advice.

You may have changes in your menstrual period, or your period may stop while taking this medicine. Call your doctor if you have unusual menstrual symptoms, abnormal bleeding, miss your period for 2 months, or you think you may be pregnant.

You may need to take a pregnancy test if you miss any doses or your menstrual period is late.

Your doctor should check your progress on a regular basis. Continue to have regular cervical (Pap smears) and mammograms while taking norgestrel.

Do not keep or flush unused medicine down the toilet. Ask your pharmacist about a drug take-back program.

Store at room temperature away from moisture and heat.

Take the medicine every day at the same time.

Do not use norgestrel if you are pregnant or think you might be pregnant.

You should not use norgestrel if you are allergic to it and its ingredients, or if you have or ever had:

• an allergy to aspirin or certain food dyes like tartrazine;
• unprotected sex and want to prevent a pregnancy right after;
• breast cancer; or
• if you are male.

Some drugs should not be used with norgestrel. Talk to a doctor or pharmacist if you also use:

• an emergency contraceptive (morning after pill) such as ulipristal in the last 5 days; or
• other birth control methods including birth control pills, injections, implants, intra-uterine device (IUD), skin patches, and vaginal rings.

Tell your doctor if you have or ever had:

• cancer;
• migraines, stroke;
• unusual vaginal bleeding that has not been checked by a doctor; or
• liver problems.

Do not use norgestrel if you are pregnant. Tell your doctor right away if you become pregnant or think you may be pregnant.

Tell your doctor if you are breastfeeding.

Get emergency medical help if you notice signs of an allergic reaction: hives, trouble breathing, swelling of your face, lips, tongue, or throat.

Call your doctor right away or seek emergency medical help if you have severe pain in your lower stomach (especially on just one side). This could be a sign of an ectopic pregnancy.

Norgestrel may cause serious side effects. Call your doctor immediately if you experience:

• unusual or unexpected vaginal bleeding;
• unusual changes in your menstrual periods such as heavy bleeding or a period lasting more than 8 days;
• changes in the pattern or severity of migraine headaches; or
• liver problems, which may include loss of appetite, nausea, vomiting, upper right stomach pain, tiredness, itching, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes).

Common side effects of norgestrel may include:

• stomach pain, bloating, or cramps;
• increased appetite;
• nausea;
• dizziness;
• headache; or
• menstrual bleeding.

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You can report side effects to the FDA at 1-800-FDA-1088.

Usual Adult Dose for Contraception:

Maintenance dose: 0.075 mg orally once dailyComments:-The dose must be taken at the same time each day and can be started any day of the month.-This drug takes two days to start working, therefore a condom (or other barrier method) should be used for the first two days after starting on the first pack of this drug.-Take exactly as directed. Never skip a dose. Use: Prevention of pregnancy

If you are less than 3 hours late for your dose, take the medicine as soon as possible and then return to your regular schedule the next day.

If you are more than 3 hours late for your dose, take the medicine as soon as you remember and then take your next dose at your regular time. You may need to take 2 doses in 1 day. Be sure to use a barrier form of birth control for the next 2 days (48 hours).

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Avoid taking an herbal supplement that contains St. John's wort.

Norgestrel will not protect you from sexually transmitted diseases (STD), including HIV and AIDS. Ask your doctor about barrier methods like condoms to help protect you from these diseases.

Avoid missing a dose because this increases your risk of becoming pregnant. Continue taking norgestrel daily without breaks, even if you do not have sex often.

Ask a doctor or pharmacist before taking norgestrel if you regularly use medication for seizures, tuberculosis, pulmonary hypertension, or HIV/AIDS. Some medications can make norgestrel less effective as a birth control method.

Tell your doctor about all your other medicines, especially:

• birth control and other hormones; or
• ulipristal (an emergency contraceptive).