Norethindrone Acetate, Oral

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KEY POINTS

• This medicine is taken by mouth to treat secondary amenorrhea, endometriosis, or abnormal uterine bleeding. Take it exactly as directed.
• You should take hormones only when you need them, at the lowest effective dosage, and only for as long as you need them. Estrogen increases the risk of stroke, blood clots in the lungs and legs, heart disease, breast cancer, and possibly dementia.
• Keep all appointments for tests to see how this medicine affects you.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: progestin hormone

Generic and brand names: norethindrone acetate, oral; Aygestin

What is this medicine used for?

This medicine is taken by mouth to treat:

• Secondary amenorrhea (when monthly periods stop before menopause)
• Endometriosis (changes in the tissue of the uterus that may cause cysts)
• Abnormal bleeding from the uterus due to a hormone imbalance

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• A stroke or transient ischemic attack (TIA)
• An incomplete miscarriage or ectopic (tubal) pregnancy
• Asthma
• Blood clots in your legs, lungs, brain, or eyes
• Breast cancer or cancer of the lining of the uterus, cervix, or vagina
• Depression
• Diabetes
• Heart disease or a heart attack
• High blood pressure or high cholesterol
• Kidney disease
• Liver disease
• Lupus
• Migraine headaches or headaches along with vomiting, double vision, unsteadiness, weakness, or personality changes
• Seizures
• Unexplained vaginal bleeding

Tell your healthcare provider if you have recently had a long period of bed rest after major surgery or a broken bone in a cast. Tell your provider if you have a family history of heart disease, heart attack, blood clots, strokes, breast cancer, or other conditions.

Tell your healthcare provider if you smoke. Smoking while you are using this medicine increases the risk of serious side effects such as heart attack, stroke, and blood clots. The risk increases with age and the number of cigarettes smoked a day. Talk to your healthcare provider about ways to quit smoking.

Females of childbearing age: Do not take this medicine if you are pregnant. This medicine has been reported to cause birth defects. Stop taking this medicine at the first sign that you may be pregnant and contact your healthcare provider right away. Do not breast-feed while taking this medicine.

How do I use it?

Check the label on the medicine for directions about your specific dose. Take this medicine exactly as your healthcare provider prescribes. Take it on a regular schedule for as long as prescribed. Do not take more or for longer than directed.

You may take this medicine with or without food. Taking it with meals may lessen the chance the drug will upset your stomach.

Check with your healthcare provider before using this medicine in girls who have not reached puberty.

If you are not sure how to take this medicine, ask your healthcare provider or pharmacist to explain.

This medicine may make you dizzy or drowsy. Take the medicine at bedtime to reduce side effects.

What if I miss a dose?

If you miss a dose, take it as soon as you remember unless it is almost time for the next scheduled dose. In that case, skip the missed dose and take the next one as directed. Do not take double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

Symptoms of an acute overdose have not been reported.

What should I watch out for?

This medicine does not protect you against HIV (AIDS) or other sexually transmitted diseases. Use condoms if you are at risk of getting or giving someone HIV (AIDS) or any other STD.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine. You may need to stop taking hormones at least 4 to 6 weeks before the surgery and bedrest. If you need lab tests, tell the healthcare provider you are taking this medicine. Hormones may change some blood test results.

Hormone therapy offers both benefits and risks. This medicine may increase your risk of strokes, blood clots, high blood pressure, heart attacks, vision problems, cancer, and possibly dementia. Talk with your healthcare provider about these risks.

Most experts now recommend short-term use if hormone therapy is needed. You should take hormones only when you need them, at the lowest effective dosage, and only for as long as you need them. The risk of medical problems such as stroke or blood clots increases further with higher doses and longer treatments. Talk with your healthcare provider about this.

You need to see your provider regularly (every 6 months) for checkups to find out if this medicine is still needed and if you are having any side effects. Do not take this medicine for longer than 1 year without a complete physical exam.

If you notice a change in your vision or wear contacts and it becomes difficult to wear your lenses, contact your healthcare provider.

This medicine may make you dizzy or drowsy. Do not drive or operate machinery unless you are fully alert.

If you have diabetes: This medicine may affect your blood sugar level. If you are taking insulin or another medicine for diabetes, talk to your healthcare provider because your dosage of diabetes medicine may need to be changed.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; chest pain or tightness in your chest; swelling of your lips, tongue, and throat); numbness, weakness, or tingling in the arms or legs (especially on one side); problems with your speech or balance; trouble breathing; pain, swelling, or warmth in one or both legs.

Serious (Report these to your healthcare provider right away.): Vision changes; yellowing of your skin or eyes; dark urine; light colored bowel movements; irregular vaginal bleeding or spotting that happens in more than 1 menstrual cycle or lasts for more than a few days; severe stomach pain.

Other: Spotting, weight gain or loss, change in appetite, nervousness, headache, dizziness, tiredness, nausea, acne, breast tenderness, mood swings, depression, trouble sleeping, increase in body or facial hair, change in sexual ability or desire, darkening of skin on your face.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Antifungal medicines such as fluconazole (Diflucan), griseofulvin (Grifulvin V, Gris-PEG), itraconazole (Sporanox), ketoconazole (Nizoral), posaconazole (Noxafil), and voriconazole (Vfend)
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), ethotoin (Peganone), felbamate (Felbatol), fosphenytoin (Cerebyx), gabapentin (Neurontin), lamotrigine (Lamictal), levetiracetam (Keppra), oxcarbazepine (Trileptal), phenytoin (Dilantin, Phenytek), primidone (Mysoline), tiagabine (Gabitril), topiramate (Qudexy, Topamax, Trokendi), and valproic acid (Depacon, Depakene, Depakote)
• Aprepitant (Emend)
• Barbiturates such as butabarbital (Butisol), pentobarbital (Nembutal), phenobarbital, and secobarbital (Seconal)
• Bosentan (Tracleer)
• Cancer medicines such as bosutinib (Bosulif), dabrafenib (Tafinlar), osimertinib (Tagrisso) and vincristine (Marqibo)
• Diabetes medicines such as acarbose (Precose), glimepiride (Amaryl), glipizide (Glucotrol), glyburide (Glynase), insulin, metformin (Fortamet, Glucophage, Riomet), miglitol (Glyset), nateglinide (Starlix), pioglitazone (Actos), repaglinide (Prandin), rosiglitazone (Avandia), and sitagliptin (Januvia)
• HIV medicines such as atazanavir (Reyataz), delavirdine (Rescriptor), fosamprenavir (Lexiva), indinavir (Crixivan), lopinavir/ritonavir (Kaletra), nelfinavir (Viracept), nevirapine (Viramune), ritonavir (Norvir), and saquinavir (Invirase)
• Natural remedies such as black cohosh, bloodroot, chasteberry, damiana, dong quai, red clover, saw palmetto, St. John's wort, and yucca
• Rifabutin (Mycobutin) and rifampin (Rifadin)
• Tranexamic acid (Cyklokapron, Lysteda)
• Ulipristal (ella)
• Warfarin (Coumadin)

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicines in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.