Ortho-Novum 1/35

Generic Name: Norethindrone

  • What is Ortho-Novum 1/35?

    Ortho-Novum 1/35 tablets are oral contraceptives, or birth control pills, used to prevent pregnancy.

  • What is the most important information I should know about Ortho-Novum 1/35?

    Cigarette smoking increases the risk of serious cardiovascular side effects such as blood clots, stroke, and heart attack from oral contraceptive use such as Ortho-Novum 1/35. This risk increases with age, especially if you are >35 years old and smoke ≥15 cigarettes per day). You should not smoke while you are taking oral contraceptives.

    Oral contraceptive use is associated with increased risk of heart attack, clotting disorders, stroke, liver tumors, and gallbladder disease. These risks increase in people with a history of high blood pressure, high cholesterol, obesity, diabetes, clotting disorders, heart attack, stroke, chest pain, cancer of the breast or sex organs, or malignant or benign liver tumors.

    Oral contraceptives may increase cholesterol levels. Women with high cholesterol should be monitored closely.

    Ortho-Novum 1/35 does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

    You may experience breakthrough bleeding or spotting while taking oral contraceptives, especially during the first 3 months of use. You may also have irregular periods. If you have missed more than two periods in a row, take a pregnancy test to determine if you are pregnant. Ortho-Novum 1/35 should not be used in women who are pregnant.

  • Who should not take Ortho-Novum 1/35?

    Do not use Ortho-Novum 1/35 if you are >35 years old and smoke ≥15 cigarettes a day.

    Do not use Ortho-Novum 1/35 if you have a history of heart attack or stroke; heart disease; blood clots in the legs, lungs, or deep veins of your legs; chest pain (angina pectoris); diabetes (including associated circulation problems); known or suspected breast cancer; cancer of the lining of the uterus, cervix, or vagina; unexplained vaginal bleeding; yellowing of the skin or whites of the eyes (jaundice) during pregnancy or during previous use of oral contraceptives; liver tumors; very high blood pressure; certain types of headaches; are allergic to any of the ingredients in Ortho-Novum 1/35; or if you plan to have surgery with prolonged bed rest.

    Do not use Ortho-Novum 1/35 if you think you may be pregnant.

    Ortho-Novum 1/35 should not be used in women who have not had their first period or in women >65 years of age.

  • What should I tell my doctor before I take the first dose of Ortho-Novum 1/35?

    Tell your doctor if you have ever had any of the health conditions listed above, and also about all prescription, over-the-counter, and herbal medication you are taking before beginning treatment with Ortho-Novum 1/35. Also, talk to your doctor about your complete medical history, especially if you have or have had breast nodules, fibrocystic disease of the breast, an abnormal breast x-ray or mammogram, high triglycerides, water retention, depression, migraines or other headaches, epilepsy, history of irregular menstrual bleeding or periods, gallbladder disease, liver or kidney disease, wear contact lenses, smoke, will undergo surgery with prolonged bed rest, or if you are pregnant or planning to become pregnant, or are breastfeeding.

  • What is the usual dosage?

    The information below is based on the dosage guidelines your doctor uses. Depending on your condition and medical history, your doctor may prescribe a different regimen. Do not change the dosage or stop taking your medication without your doctor's approval.

    Adults: Each peach "active" tablet contains 1 milligram (mg) of norethindrone and 0.035 mg of ethinyl estradiol. Each green "reminder" tablet contains inactive ingredients.

    Sunday Start: When taking Ortho-Novum 1/35, take the first peach "active" tablet on the Sunday after your period begins, even if you are still bleeding. Take one light peach tablet daily for 21 days followed by one green "reminder" tablet daily for 7 days. After all 28 tablets have been taken, start a new course the next day (Sunday).

    Day 1 Start: Take the first peach "active" pill of the first pack during the first 24 hours of your period. Take one peach "active" tablet daily from the 1st day through the 21st day of the menstrual cycle (counting the day your period starts as Day 1) followed by one green "reminder" tablet daily for 7 days. Take the tablets without interruption for 28 days. After all 28 tablets have been taken, start a new course the next day.

  • How should I take Ortho-Novum 1/35?

    Before you start taking Ortho-Novum 1/35, be sure to read the directions. You should take Ortho-Novum 1/35 once daily at the same time every day until the pack is empty.

    When you finish a pack or switch your brand of pills, start the next pack on the day after your last green "reminder" pill. Do not wait any days between packs.

    For the first cycle of a Sunday Start regimen, use another method of birth control (such as condoms or spermicide) as a back-up method if you have sex any time from the Sunday you start your first pack until you have been taking the pills for 7 days. You will not need to use a back-up method of birth control for the first cycle of a Day 1 regimen, since you are starting the pill at the beginning of your period.

  • What should I avoid while taking Ortho-Novum 1/35?

    Avoid smoking while taking Ortho-Novum 1/35. Also avoid becoming pregnant.

    Do not skip pills even if you are spotting or bleeding between monthly periods or feel sick to your stomach (nausea). Do not skip pills even if you do not have sex very often.

  • What are possible food and drug interactions associated with Ortho-Novum 1/35?

    If Ortho-Novum 1/35 is taken with certain other drugs, the effects of either could be increased, decreased, or altered. It is especially important to check with your doctor before combining Ortho-Novum 1/35 with the following: acetaminophen, antibiotics, anticonvulsants (such as carbamazepine, lamotrigine, phenytoin, and topiramate), phenylbutazone, barbiturates, bosentan, clofibric acid, cyclosporine, felbamate, griseofulvin, certain medicines used in the treatment of HIV or AIDS such as protease inhibitors, itraconazole, ketoconazole, morphine, oxcarbazepine, prednisolone, rifampin, salicylic acid, St. John's wort, temazepam, theophylline, and vitamin C.

  • What are the possible side effects of Ortho-Novum 1/35?

    Side effects cannot be anticipated. If any develop or change in intensity, tell your doctor as soon as possible. Only your doctor can determine if it is safe for you to continue taking this drug.

    Side effects may include: high blood pressure, gallbladder disease, irregular vaginal bleeding, breakthrough bleeding or spotting, change in vision or inability to wear your contact lenses, depression, breast tenderness, allergic reactions, vaginal infections, spotty darkening of the skin (especially on the face), nausea, vomiting, abdominal cramps and bloating, change in appetite, headache, nervousness, dizziness, loss of scalp hair, rash, water retention causing swelling of the fingers or ankles, weight change

  • Can I receive Ortho-Novum 1/35 if I am pregnant or breastfeeding?

    Oral contraceptives should not be used if you are pregnant or breastfeeding.

  • What should I do if I miss a dose of Ortho-Novum 1/35?

    If you miss one peach "active" pill, take it as soon as you remember. Take the next pill at your regular time. This means you can take two pills in the same day. You do not need a back-up birth control method if you have sex.

    If you miss two pills or more, consult the patient information that accompanied your prescription or call your pharmacist for advice.

  • How should I store Ortho-Novum 1/35?

    Store Ortho-Novum 1/35 at room temperature.

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