(norethindrone acetate) Tablets USP
Read this PATIENT INFORMATION before you start taking
AYGESTIN and read what you get each time you refill AYGESTIN.
There may be new information. This information does not take the place of
talking to your healthcare provider about your medical condition.
What is the most important information I should know
about AYGESTIN (A Progestin Hormone)?
- Do not use AYGESTIN if you are pregnant, breastfeeding
or are trying to conceive.
- Do not use AYGESTIN if you have had a previous blood
clot, stroke, or heart attack.
- Do not use AYGESTIN if you are postmenopausal.
What is AYGESTIN?
AYGESTIN is similar to the progesterone hormones
naturally produced by the body. Your healthcare provider may provide AYGESTIN
as individual tablets.
What are AYGESTIN used for?
AYGESTIN are used for the treatment of secondary
amenorrhea (absence of menstrual periods in women who have previously had a
menstrual period who are not pregnant), the treatment of endometriosis, and the
treatment of irregular menstrual periods due to hormone imbalance.
Who should not take AYGESTIN?
You should not take AYGESTIN if you are postmenopausal,
pregnant or breastfeeding.
You should not take AYGESTIN if you have the following
- Known or suspected pregnancy. AYGESTIN are not
indicated during pregnancy as it may causefetal harm when administered to
pregnant women. There is an increased risk of minor birth defects in children
whose mothers take AYGESTIN during the first 4 months of pregnancy (mild masculinization
of the external genitalia of the female fetus, as well as hypospadias in the
male fetus). If you take AYGESTIN and later find out you were pregnant, talk
with your healthcare provider right away.
- History of blood clots in the legs , lungs , eyes ,
brain, or elsewhere, or a past history of these conditions
- Liver impairment or disease
- Known or suspected cancer of the breast. If you
have or had cancer of the breast, talk with your healthcare provider about
whether you should take AYGESTIN.
- Undiagnosed vaginal bleeding
- Hypersensitivity to AYGESTIN. See the end of this
leaflet for a list of all of the ingredients in AYGESTIN.
What are the risks associated with AYGESTIN?
- Risk To The Fetus
AYGESTIN should not be used if you are pregnant. AYGESTIN are
contraindicated during pregnancy as it may cause fetal harm when administered
to pregnant women. There is an increased risk of minor birth defects in
children whose mothers take this drug during the first 4 months of pregnancy.
Several reports suggest an association between mothers who take these drugs in
the first trimester of pregnancy and congenital abnormalities in male and
female babies. Although it is not clear that these events were drug related,
you should check with your healthcare provider about the risks to your unborn
child of any medication taken during pregnancy.
You should avoid using AYGESTIN during pregnancy. If you
take AYGESTIN and later find you were pregnant when you took it, be sure to
discuss this with your healthcare provider as soon as possible.
- Abnormal Blood Clotting
Use of progestational drugs, such as AYGESTIN, has been associated with
changes in the bloodclotting system. These changes allow the blood to clot more
easily, possibly allowing clots to form in the bloodstream. If blood clots do
form in your bloodstream, they can cut off the blood supply to vital organs,
causing serious problems. These problems may include a stroke (by cutting off
blood to part of the brain), a heart attack (by cutting off blood to part of
the heart), a pulmonary embolus (by cutting off blood to part of the lungs),
visual loss or blindness (by cutting off blood vessels in the eye), or other problems.
Any of these conditions may cause death or serious long-term disability. Call
your healthcare provider right away if you suspect you have any of these conditions.
He or she may advise you to stop using the drug.
- Eye Abnormalities
Discontinue AYGESTIN tablets and call your healthcare provider right away
if you experience sudden partial or complete loss of vision, blurred vision, or
sudden onset of bulging eyes, double vision, or migraine.
These are some of the warning signs of serious side
effects with progestin therapy
- Breast lumps
- Dizziness and faintness
- Changes in speech
- Severe headaches
- Chest pain
- Shortness of breath
- Pains in your legs
- Changes in vision
Call your healthcare provider right away if you get any
of these warning signs, or any other unusual symptom that concerns you.
Common side effects include
- Breast pain
- Irregular vaginal bleeding or spotting
- Stomach/abdominal cramps/bloating
- Nausea and vomiting
- Hair loss
Other side effects include
- High blood pressure
- Liver problems
- High blood sugar
- Fluid retention
- Enlargements of benign tumors of the uterus (“fibroids”)
- Vaginal yeast infections
- Mental depression
These are not all the possible side effects of progestin
and/or estrogen therapy. For more information, ask your healthcare provider or
What can I do to lower my chances of getting a serious
side effect with AYGESTIN?
- Talk with your healthcare provider regularly about
whether you should continue taking AYGESTIN.
- Have a breast exam and mammogram (breast x-ray) every
year unless your healthcare provider tells you something else. If members of
your family have had breast cancer or if you have ever had breast lumps or an
abnormal mammogram, you may need to have breast exams more often.
- If you have high blood pressure, high cholesterol (fat in
the blood), diabetes, are overweight, or if you use tobacco, you may have
higher chances for getting heart disease. Ask your healthcare provider for ways
to lower your chances of getting heart attacks.
General information about the safe and effective us e
Medicines are sometimes prescribed for conditions that
are not mentioned in patient information leaflets. Do not take AYGESTIN for
conditions for which it was not prescribed. Do not give AYGESTIN tablets to
other people, even if they have the same symptoms you have. It may harm them.
Keep AYGESTIN out of the reach of children.
This leaflet provides a summary of the most important
information about progestin and/or estrogen therapy. If you would like more
information, talk with your healthcare provider or pharmacist. You can ask for
information about AYGESTIN that is written for health professionals.
What are the ingredients in AYGESTIN?
AYGESTIN contain the following inactive ingredients: anhydrous
lactose, magnesium stearate, and microcrystalline cellulose.