Frequently Asked Questions

What is Generess® Fe?

Generess Fe is a low-dose birth control pill that contains 2 types of female hormones, an estrogen called ethinyl estradiol and a progestin called norethindrone. When taken as directed, birth control pills help to lower the chances of becoming pregnant. They do not protect against HIV infection (AIDS) and other sexually transmitted diseases.1

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How well does Generess Fe work?

Generess Fe is highly effective at preventing pregnancy. Your chance of getting pregnant depends on how well you follow the directions for taking your birth control pills. The more carefully you follow the directions, the less chance you have of getting pregnant.1

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How do I take Generess Fe?

Chew and swallow 1 pill without water at the same time every day. Take the pills in the order as directed on the blister pack. Do not skip pills or take at intervals exceeding 24 hours. If you miss any pills or if you vomit or have diarrhea within 3 to 4 hours of taking your pill, follow the instructions for “What should I do if I miss any pills?”1

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When can I start taking Generess Fe?

Talk to your doctor about which day is best for you to start taking Generess Fe. It is important to take your birth control pill at the same time every day and in the order as directed on the blister pack.1

If you are starting a hormonal birth control pill for the first time1:

  1. Take the first light green pill of the first pack during the first 24 hours of your period
  2. You will not need to use a backup method of birth control because you are starting the pill at the beginning of your period. However, if you start on a day other than the first day of your period, use a backup method of birth control, such as condoms or spermicides, until you have taken a light green pill for 7 days in a row
  3. After taking the last brown pill (Day 28) of the blister pack, start taking the first light green pill from a new blister pack the very next day whether or not you have your period

Learn more about starting or switching to Generess Fe.

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What should I expect when I start taking Generess Fe?

You may have spotting or light bleeding when you first take Generess Fe. Spotting or light bleeding is normal at first. You may feel sick to your stomach (nauseated), especially during the first few months that you take Generess Fe. If you feel sick to your stomach, do not stop taking the pill. The problem will usually go away, but if it doesn’t, call your doctor.1

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What should I do if I miss any pills?

Your birth control pills may not be as effective if you miss any light green pills, and particularly if you miss the first few or the last few light green pills in a pack.1

If you MISS 1 light green pill1:

  • Take it as soon as you remember. Take the next pill at your regular time. This means you may take 2 pills in 1 day
  • You do not need to use a backup birth control method if you have sex

If you MISS 2 light green pills in a row in WEEK 1 or WEEK 2 of your pack1:

  • Take 2 pills on the day you remember and 2 pills the next day
  • Then take 1 pill a day until you finish the pack
  • You could become pregnant if you have sex during the 7 days after you restart your pills. You must use a non-hormonal birth control method, such as condoms or spermicides, as a backup for those 7 days after you restart your pills

If you MISS 2 light green pills in a row in WEEK 3 or WEEK 4 of your pack1:

  • Throw out the rest of the pill pack and start a new pack that same day
  • You could become pregnant if you have sex during the 7 days after you restart your pills. You must use a non-hormonal birth control method, such as condoms or spermicides, as a backup for those 7 days after you restart your pills

If you MISS 3 OR MORE light green pills in a row at any time1:

  • Throw out the rest of the pill pack and start a new pack that same day
  • You could become pregnant if you have sex on the days when you missed pills or during the first 7 days after restarting your pills. You must use a non-hormonal birth control method, such as condoms or spermicides, as a backup method the next time you have sex and for the first 7 days after you restart your pills

If you are not sure of what to do about the pills you have missed, you should call your doctor. Use a backup method of birth control, such as condoms or spermicides, anytime you have sex and keep taking 1 pill each day. You should call your doctor if you are unsure whether you are already pregnant.1

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Who should not take Generess Fe?

You should not take birth control pills if you smoke cigarettes and are over 35 years old. Smoking increases your risk of serious cardiovascular side effects (heart and blood vessel problems) from birth control pills, including death from heart attack, blood clots, or stroke. This risk increases with age and the number of cigarettes you smoke.1

Birth control pills should not be taken during pregnancy.1

If you are breastfeeding, consider another birth control method until you are ready to stop breastfeeding. Birth control pills that contain estrogen, like Generess Fe, may decrease the amount of breast milk your body makes. A small amount of the pill’s hormones pass into breast milk.1

Your doctor will not give you Generess Fe if you have ever had breast cancer or any cancer that is sensitive to female hormones, liver disease including liver tumors, blood clots in your arms, legs, or lungs, a stroke, heart attack, certain heart valve problems or heart rhythm abnormalities that can cause blood clots to form in the heart, an inherited problem with your blood that makes it clot more than normal, high blood pressure that medicine can’t control, diabetes with kidney, eye, or blood vessel damage, certain kinds of severe migraines with aura, numbness, weakness, or changes in vision. Birth control pills may not be a good choice for you if you have ever had jaundice (yellowing of the skin or eyes) caused by pregnancy (also called cholestasis of pregnancy).1

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Can I take Generess Fe with my other medications?

Tell your doctor about all medicines and herbal products that you take. Some medicines and herbal products may make birth control less effective, including barbiturates, bosentan, carbamazepine, felbamate, griseofulvin, oxcarbazepine, phenytoin, rifampin, St John’s wort, and topiramate.1

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What are the common side effects of birth control pills?

The most common side effects of birth control pills are spotting or bleeding between menstrual periods, nausea, breast tenderness, and headache. These side effects are usually mild and disappear with time. Talk to your doctor if you develop any side effects that concern you.1

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Are there any serious risks of taking birth control pills?

Like pregnancy, birth control pills increase the risk of serious blood clots, especially in women who have other risk factors, such as smoking, obesity, or age greater than 35 years.1

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How will Generess Fe affect my period?

Unscheduled or irregular vaginal bleeding or spotting may occur while you are taking Generess Fe. Unscheduled bleeding may vary from slight staining to breakthrough bleeding, which is a flow much like a regular period but that occurs between menstrual periods. It is important to continue taking your pills on schedule. If the bleeding occurs in more than 1 cycle, is unusually heavy, or lasts for more than a few days, call your doctor.1

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What if I miss my period while taking Generess Fe?

Women who use Generess Fe may not have a period at the end of every 28-day pack of pills. If you miss more than 2 periods in a row or miss 1 period when you have not taken your birth control pills according to directions, call your doctor. Also, tell your doctor if you have symptoms of pregnancy such as morning sickness or unusual breast tenderness. Stop taking Generess Fe if you are pregnant.1

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What if I want to become pregnant?

You may stop taking Generess Fe whenever you wish. Consider a visit with your doctor for a pre-pregnancy checkup and pre-natal care before you stop taking Generess Fe.1

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+-References

  1. 1. Generess® Fe prescribing information. Parsippany, NJ: Watson Pharma, Inc. March 2012.
  2. 2. Data on file. Actavis Pharma, Inc.
  3. 3. Birth control patient education booklet. The American Congress of Obstetricians and Gynecologists. http://www.acog.org/publications/patient_ education/ab020.cfm. Accessed January 28, 2011.
  4. 4. Menstruation patient education booklet. The American Congress of Obstetricians and Gynecologists. http://www.acog.org/publications/patient_ education/bp049.cfm. Accessed April 6, 2011.
  5. 5. Hatcher RA, Trussell J, Stewart F, et al. Contraceptive Technology. 18th ed. New York, NY: Ardent Media; 2004.
  6. 6. Birth control pills. Planned Parenthood Web site. http://www.plannedparenthood.org/health-topics/birth-control/birth-control-pill-4228.htm. Accessed January 18, 2013.

INDICATION AND USAGE for Generess® Fe

Generess Fe is a prescription birth control pill used for the prevention of pregnancy.

IMPORTANT SAFETY INFORMATION about Generess Fe, including Boxed Warning

WARNING TO WOMEN WHO SMOKE

Do not use Generess Fe if you smoke cigarettes and are over 35 years old. Smoking increases your risk of serious cardiovascular side effects (heart and blood vessel problems) from birth control pills, including death from heart attack, blood clots, or stroke. This risk increases with age and the number of cigarettes you smoke.

Do not use Generess Fe if you have kidney, liver, or adrenal disease because this could cause serious heart and health problems, or if you have or have had blood clots, history of heart attack or stroke, high blood pressure that medicine cannot control, breast cancer or any cancer that is sensitive to female hormones, liver disease or liver tumors, unexplained bleeding from the vagina, or if you are or may be pregnant.

Treatment with Generess Fe should be stopped if you have a blood clot, and at least 4 weeks before and through 2 weeks after major surgery. You should not take Generess Fe any earlier than 4 weeks after having a baby or if you are breastfeeding. If you experience yellowing of the skin or eyes due to problems with your liver, you should stop taking Generess Fe. If you are pre-diabetic or diabetic, your doctor should monitor you while using Generess Fe and should evaluate you if you have any significant change in headaches or irregular menstrual bleeding.

Generess Fe increases the risk of serious conditions including blood clots, stroke, and heart attack. These can be life-threatening or lead to permanent disability.

The most common side effects reported by women taking Generess Fe were nausea/vomiting, headaches/migraine, depression/mood complaints, pain with menstrual bleeding, acne, increased weight, breast pain/tenderness, and anxiety.

Birth control pills do not protect you against any sexually transmitted disease, including HIV, the virus that causes AIDS.

Please see the FDA-Approved Patient Information Leaflet for Generess Fe, including Boxed Warning.

To report a side effect from one of our products, please call the Actavis Drug Safety Department at 1-800-272-5525.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.