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Ortho-Novum 1/ 50

Generic Name: mestranol/norethindrone (MES-tra-nole/nor-eth-IN-drone)
Brand Name: Examples include Norinyl 1 + 50 and Ortho-Novum 1/50

Cigarette smoking increases the risk of serious heart and blood vessel side effects from birth control pill use. This risk increases with age and with heavy smoking (15 or more cigarettes per day) and is quite significant in women older than 35 years of age. Women who use birth control pills are strongly advised not to smoke.

Ortho-Novum 1/ 50 is used for:

Prevention of pregnancy. It may also be used to regulate the menstrual cycle. It does NOT protect against HIV infection (AIDS) and other sexually transmitted diseases. It may also be used for other conditions as determined by your doctor.

Ortho-Novum 1/50 is a combination of 2 female sex hormones, estrogen and progestin. Ortho-Novum 1/50 works by preventing the ovaries from releasing eggs. When there is no egg to be fertilized, pregnancy cannot occur. It also thickens the cervical mucus, making it difficult for sperm to enter the uterus.

Do NOT use Ortho-Novum 1/ 50 if:

  • you are allergic to any ingredient in Ortho-Novum 1/50
  • you are pregnant or think you may be pregnant
  • you have or have ever had abnormal growth or cancer of the breast, cervical or uterine cancer, or unexplained vaginal bleeding
  • you have or have ever had stoppage or rupture of blood vessels in the brain (stroke); blockage of blood vessels (blood clots) in the legs, lungs, heart (heart attack or angina/chest pain), or other parts of the body; heart valve problems; or severe high blood pressure
  • you have liver disease, liver tumors, or yellowing of the eyes or skin during pregnancy or during previous use of Ortho-Novum 1/50 or a similar medicine
  • you are taking acitretin, aprepitant, barbiturates (eg, phenobarbital), bosentan, carbamazepine, felbamate, griseofulvin, hydantoins (eg, phenytoin), modafinil, nevirapine, penicillins (eg, amoxicillin), protease inhibitors (eg, indinavir), rifamycins (eg, rifampin), St. John's wort, tetracyclines (eg, doxycycline), topiramate, or troglitazone

Contact your doctor or health care provider right away if any of these apply to you.

Before using Ortho-Novum 1/ 50:

Some medical conditions may interact with Ortho-Novum 1/50. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines or other substances
  • if you smoke cigarettes or are 35 years of age or older
  • if you have breast nodules, disease of the breast, an abnormal breast x-ray or mammogram, or a strong family history of breast cancer
  • if you have vision problems, depression, diabetes, epilepsy (seizures), gallbladder or liver disease, heart problems, high blood pressure, kidney disease, or migraine headaches
  • if you have high cholesterol, triglycerides, or calcium in the blood; pancreas disease; obesity; or uterine fibroids or endometriosis
  • if you are going to have surgery or you will be on bed rest

Some MEDICINES MAY INTERACT with Ortho-Novum 1/50. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Acitretin, aprepitant, azole antifungals (eg, ketoconazole), barbiturates (eg, phenobarbital), bosentan, carbamazepine, felbamate, griseofulvin, hydantoins (eg, phenytoin), modafinil, nevirapine, penicillins (eg, amoxicillin), protease inhibitors (eg, indinavir), rifamycins (eg, rifampin), St. John's wort, tetracyclines (eg, doxycycline), topiramate, or troglitazone because they may decrease Ortho-Novum 1/50's effectiveness. While on these medicines, you will need an alternative form of birth control (eg, condoms) until your next period after stopping these medicines.
  • Beta-blockers (eg, metoprolol), cyclosporine, theophyllines, or troleandomycin because the risk of their side effects or toxicity may be increased by Ortho-Novum 1/50
  • Corticosteroids (eg, prednisone) because their side effects, including rounding of the face, weight gain, fluid retention, elevated blood pressure, elevated blood sugar, or skin changes, may be increased by Ortho-Novum 1/50
  • Oral anticoagulants (eg, warfarin) because their side effects, including risk of bleeding, may be increased by Ortho-Novum 1/50; however, it is also possible that the effectiveness may also be decreased by Ortho-Novum 1/50
  • Lamotrigine because its effectiveness may be decreased by Ortho-Novum 1/50; stopping Ortho-Novum 1/50 may lead to severe side effects

This may not be a complete list of all interactions that may occur. Ask your health care provider if Ortho-Novum 1/50 may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Ortho-Novum 1/ 50:

Use Ortho-Novum 1/50 as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • An extra patient leaflet is available with Ortho-Novum 1/50. Talk to your pharmacist if you have questions about this information.
  • Take Ortho-Novum 1/50 by mouth with food.
  • If you have trouble remembering to take Ortho-Novum 1/50, talk to your doctor about how to make pill-taking easier or about using another method of birth control.
  • Always have another kind of birth control (eg, condoms) to use as a backup in case you miss pills. Also, always keep an extra, full pack of pills.
  • Decide what time of day you want to take your medicine. It is important that you take it at about the same time every day.
  • 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.
  • If you miss a dose of Ortho-Novum 1/50, take it as soon as your remember. Take your next dose at the regular time. This means you may take 2 doses on the same day. If you miss more than 1 dose of Ortho-Novum 1/50, refer to the patient information that came with Ortho-Novum 1/50 or contact your doctor or pharmacist.

Ask your health care provider any questions you may have about how to use Ortho-Novum 1/50.

Important safety information:

  • Ortho-Novum 1/50 may increase the risk of stroke, heart attack, blood clots, high blood pressure, or similar problems. The risk may be greater if you smoke.
  • There may be times when you may not have regular menstrual periods after you have taken a pack of Ortho-Novum 1/50 for a cycle. If you have taken Ortho-Novum 1/50 regularly and missed 1 period, keep taking Ortho-Novum 1/50 for the next cycle but be sure to tell your doctor first.
  • If you have not taken Ortho-Novum 1/50 daily as instructed and missed a period, or if you missed 2 consecutive periods, you may be pregnant. You could get pregnant if you have sex in the 7 days after you miss pills. Do not continue to take Ortho-Novum 1/50 until you are sure that you are not pregnant, but continue to use another method of birth control (eg, condoms).
  • Contact your doctor if you miss any menstrual periods so that the cause may be determined.
  • Follow your doctor's instructions to examine your breasts, and report any lumps to your doctor immediately.
  • Tell your doctor or dentist that you take Ortho-Novum 1/50 before you receive any medical or dental care, emergency care, or surgery.
  • If you will be confined to a chair or bed for a long period of time (eg, a long plane flight), notify your doctor 3 to 4 weeks in advance. Special precautions may be needed.
  • Ortho-Novum 1/50 does not stop the spread of HIV or sexually transmitted diseases (STDs) to others through blood or sexual contact. Use barrier methods of birth control (eg, condoms) if you have an HIV infection or an STD. Do not share needles, injection supplies, or items like toothbrushes or razors.
  • Taking certain antibiotics or anticonvulsants while you are using Ortho-Novum 1/50 may decrease the effectiveness of Ortho-Novum 1/50. To prevent pregnancy, use an additional form of birth control (eg, condoms) until your next menstrual period.
  • If you wear contact lenses and you develop problems with them, contact your doctor.
  • Ortho-Novum 1/50 may cause dark skin patches on your face. Avoid the sun, sunlamps, or tanning booths until you know how you react to Ortho-Novum 1/50. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.
  • Diabetes patients - Ortho-Novum 1/50 may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
  • Ortho-Novum 1/50 may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Ortho-Novum 1/50.
  • Lab tests, including PAP tests, may be performed while you use Ortho-Novum 1/50. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Ortho-Novum 1/50 should not be used in CHILDREN or before the child's first menstrual period; safety and effectiveness in children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: Do not use Ortho-Novum 1/50 if you are pregnant. If you think you may be pregnant, contact your doctor right away. Ortho-Novum 1/50 is found in breast milk. Do not breast-feed while taking Ortho-Novum 1/50.

Possible side effects of Ortho-Novum 1/ 50:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Breast tenderness; bleeding between menstrual periods; change in vaginal mucus; headache; nausea; nervousness; rash; spotty darkening of the skin (especially on the face); stomach cramps and bloating; vaginal infection; vomiting; weight or appetite change.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); breast lumps; calf or leg pain or swelling; chest pain; coughing of blood; dark urine or light-colored bowel movements; depression; dizziness or fainting; fever; heaviness in the chest; lack of energy or fatigue; loss of appetite; loss of scalp hair; mood change; numbness in arm or leg; partial or complete loss of vision or other vision changes; sleeping problems; slurred speech; stomach pain or tenderness; sudden severe headache; sudden shortness of breath; swelling of the fingers or ankles; weakness on one side of the body; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include nausea; vaginal bleeding.

Proper storage of Ortho-Novum 1/50:

Store Ortho-Novum 1/50 at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store Ortho-Novum 1/50 in the container it came in, tightly closed, away from heat, moisture, and light. Do not store in the bathroom. Keep Ortho-Novum 1/50 out of the reach of children and away from pets.

General information:

  • If you have any questions about Ortho-Novum 1/50, please talk with your doctor, pharmacist, or other health care provider.
  • Ortho-Novum 1/50 is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take Ortho-Novum 1/50 or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Ortho-Novum 1/50. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Ortho-Novum 1/50. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Ortho-Novum 1/50.

Issue Date: June 3, 2015

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.