Ethinyl estradiol/norethindrone acetate (By mouth)

Introduction

Ethinyl Estradiol (ETH-i-nil es-tra-DYE-ol), Norethindrone Acetate (nor-ETH-in-drone AS-e-tate)

Treats feelings of warmth or redness that can happen during menopause ("hot flashes" or "hot flushes"). Also helps to prevent osteoporosis after menopause. This medicine is a combination of two female hormones.

Brand Name(s)

Microgestin Fe 1/20, Microgestin Fe 1.5/30, Junel Fe 1.5/30, Junel Fe 1/20, Loestrin 24 Fe, Microgestin 1.5/30, Microgestin 1/20, Junel 1/20, Junel 1.5/30, Jinteli, Femhrt 1/5, Jevantique, Femhrt Lo, Estrostep Fe, Tri-Legest Fe 28

There may be other brand names for this medicine.

When This Medicine Should Not Be Used

You should not use this medicine if you have had an allergic reaction to ethinyl estradiol (estrogen) or norethindrone (a progestin). Do not use this medicine if you might be pregnant. You should not use this medicine if you have breast cancer or certain other kinds of cancer, or if you have blood clotting problems. Do not use this medicine if you have unusual vaginal bleeding that has not been checked by your doctor. You should not use this medicine if you have had a heart attack or stroke within the past 12 months.

How to Use This Medicine

Tablet

• Your doctor will tell you how much of this medicine to use and how often. Do not use more medicine or use it more often than your doctor tells you to.
• Carefully follow your doctor's instructions about any special diet. You might need to use daily calcium and vitamin D supplements (pills).

If a dose is missed:

• If you miss a dose or forget to use your medicine, use it as soon as you can. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up for a missed dose.

How to Store and Dispose of This Medicine

• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any outdated medicine or medicine no longer needed.
• Keep all medicine away from children and never share your medicine with anyone.

Drugs and Foods to Avoid

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Make sure your doctor knows if you are also using atorvastatin (Lipitor®), cyclosporine (Neoral®, Sandimmune®), or rifampin (Rifadin®, Rifamate®, Rifater®). Your doctor will need to know if you are using prednisolone (Pediapred®, Orapred®), or temazepam (Restoril®). Tell your doctor if you are using acetaminophen, aspirin, clofibrate, morphine (MS Contin®), or theophylline (Theo-Dur®). Tell your doctor if you are also using any other medicine that contains hormones, such as birth control pills or other treatments for menopause.
• Make sure your doctor knows if you are also using medicine for seizures. Some medicines used for seizures are carbamazepine (Tegretol®), phenobarbital (Luminal®), and phenytoin (Dilantin®). Tell your doctor if you are using thyroid medicine such as levothyroxine, Levoxyl®, or Unithroid®. Also tell your doctor if you are using a medicine to treat an infection such as erythromycin, clarithromycin (Biaxin®), itraconazole, ketoconazole, or ritonavir. Ask your doctor before you take any supplements that contain St. John's wort.
• Do not eat grapefruit or drink grapefruit juice while you are using this medicine.

Warnings While Using This Medicine

• Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.
• Make sure your doctor knows if you are breast feeding. Also make sure your doctor knows if you have gallbladder problems, cancer, high blood pressure, or liver disease. Tell your doctor if you have breast lumps, other breast problems, diabetes, or a history of depression. Tell your doctor if anyone in your family has had breast cancer or problems with too much fat in the blood, such as high cholesterol or high triglycerides.
• This medicine might make your body keep more fluid than normal ("retain water"). Retaining water can make asthma, epilepsy, migraine headaches, heart disease, or kidney disease worse. Tell your doctor if you have any of these problems.
• This medicine may increase your risk for heart attack, stroke, blood clots, and some kinds of cancer. This is much more likely if you use a high dose of medicine or use the medicine for a long time. Talk to your doctor about this risk. Your doctor will help you decide the best way to use this medicine in your personal situation.
• Your doctor will need to check your progress at regular visits while you are using this medicine. Be sure to keep all appointments. During these check-ups, your doctor will also make sure you are not starting to have serious side effects.
• Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain medical tests.
• Only women who have a uterus (womb) should use this medicine, unless your doctor tells you otherwise. Make sure your doctor knows if you have had a hysterectomy (had your uterus removed).

Possible Side Effects While Using This Medicine

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Abdominal (stomach) pain, especially with nausea or vomiting.
• Chest pain, or coughing up blood.
• Numbness or weakness in your arm or leg, or on one side of your body.
• Pain in your lower leg (calf).
• Sudden or severe headache, trouble walking or talking.
• Trouble seeing, or other problems with your eyes.
• Unusual vaginal bleeding.

If you notice these less serious side effects, talk with your doctor:

• Breast pain or tenderness.
• Mild headache.
• Mild nausea, vomiting, stomach pain.
• Nervousness or sadness.
• Trouble wearing contact lenses.

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088