Nora-BE Oral

In the U.S.

• Aygestin
• Camila
• Errin
• Jolivette
• Lyza
• Nora-BE
• Nor-QD
• Ortho Micronor

Available Dosage Forms:

• Tablet

Therapeutic Class: Endocrine-Metabolic Agent

Pharmacologic Class: Progestin

This section provides information on the proper use of a number of products that contain norethindrone. It may not be specific to Nora-BE. Please read with care.

To make using hormonal contraceptives as safe and reliable as possible, you should understand how and when to use them and what effects may be expected.

This medicine comes with patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

If you are using Ortho Micronor®:

• This medicine is available in a blister card with a tablet dispenser. Each blister card contains 28 tablets.
• Take this medicine at the same time each day. You may take this medicine with or without food.
• Start the next pack the day after the last pack is finished. There is no break between packs.
• Your doctor may ask you to begin your dose on the first day of your menstrual period (called Day 1 Start). When you begin on another day, you need to use another form of birth control (eg, condom, spermicide) for the first 48 hours. If you have a miscarriage or an abortion, you may start the taking the pill on the next day.
• You may have light bleeding or spotting when you first take the pill.
• If you are switching from the a combination hormonal method to Ortho Micronor®, take the medicine the day after you finish the last active combined pill.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  • For contraception (to prevent pregnancy):
    • Adults and teenagers—One tablet taken at the same time each day for 28 days.
    • Children—Use and dose must be determined by your doctor.
  • For treatment of secondary amenorrhea or abnormal vaginal bleeding:
    • Adults—2.5 to 10 milligrams (mg) once a day for 5 to 10 days.
    • Children—Use is not recommended.
  • For treatment of endometriosis:
    • Adults—At first, 5 milligrams (mg) once a day for 2 weeks. Your doctor may increase your dose by 2.5 mg per day every 2 weeks up to 15 mg per day for 6 to 9 months.
    • Children—Use is not recommended.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you take a pill more than 3 hours late, use another form of birth control for the next 48 hours.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Frequent and irregular bleeding
• menstrual changes

• Abdominal or stomach pain
• blindness
• blue-yellow color blindness
• blurred vision
• breast pain
• changes in menstrual period
• changes in vision
• chills
• clay-colored stools
• confusion
• cough
• dark urine
• decreased vision
• diarrhea
• difficulty with swallowing
• discouragement
• dizziness
• double vision
• eye pain
• fast heartbeat
• feeling sad or empty
• fever
• general tiredness and weakness
• headache
• heavy non-menstrual vaginal bleeding
• hives, itching, or rash
• irritability
• lack of appetite
• light-colored stools
• light vaginal bleeding between regular menstrual periods
• loss of interest or pleasure
• migraine headache
• nausea and vomiting
• numbness of the hands
• pain, redness, or swelling in the arm or leg
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• swelling
• tightness in the chest
• trouble concentrating
• trouble sleeping
• unpleasant breath odor
• unusual tiredness or weakness
• upper right abdominal or stomach pain
• vomiting of blood
• yellow eyes and skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Breast tenderness
• increased hair growth, especially on the face
• pimples
• weight gain

• Brown, blotchy spots on exposed skin
• enlarged breasts
• hair loss or thinning of the hair
• mood swings
• nervousness
• weight changes

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

Nausea, vomiting, headache, bloating, breast tenderness, or weight gain may occur. Vaginal bleeding between periods (spotting) or missed/irregular periods may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly. If you miss 2 periods in a row (or 1 period if the pill has not been used properly), contact your doctor for a pregnancy test.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high.

Tell your doctor right away if you have any serious side effects, including: lumps in the breast, mental/mood changes (such as new/worsening depression), severe stomach/abdominal pain, unusual changes in vaginal bleeding (such as continuous spotting, sudden heavy bleeding, missed periods), dark urine, yellowing eyes/skin.

This medication may rarely cause serious (sometimes fatal) problems from blood clots (such as deep vein thrombosis, heart attack, pulmonary embolism, stroke). Get medical help right away if any of these side effects occur: chest/jaw/left arm pain, confusion, sudden dizziness/fainting, pain/swelling/warmth in the groin/calf, slurred speech, sudden shortness of breath/rapid breathing, unusual headaches (including headaches with vision changes/lack of coordination, worsening of migraines, sudden/very severe headaches), unusual sweating, weakness on one side of the body, vision problems/changes (such as double vision, partial/complete blindness).

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some drugs may cause hormonal birth control to work less well by decreasing the amount of birth control hormones in your body. This effect can result in pregnancy. Examples include griseofulvin, modafinil, rifamycins (such as rifampin, rifabutin), St. John's wort, drugs used to treat seizures (such as barbiturates, carbamazepine, felbamate, phenytoin, primidone, topiramate), HIV drugs (such as nelfinavir, nevirapine, ritonavir), among others.

Tell your doctor when you start any new drug, and discuss if you should use additional reliable birth control. Also tell your doctor if you have any new spotting or breakthrough bleeding, because these may be signs that your birth control is not working well.

This medication may interfere with certain laboratory tests (such as sex hormone-binding globulin, thyroid), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this medication.