Ortho-Novum 1/50 (mestranol + norethindrone) is a progestin/estrogen combined oral contraceptive indicated for use by females to prevent unwanted pregnancy.
Contents:
Indications for use
Ortho-Novum 1/50 is used as contraception to prevent pregnancy.
Mechanism of action
The medicine prevents ovulation (the release of an egg from an ovary). It also causes changes in your cervical mucus and uterine lining, making it difficult for sperm to reach the uterus and difficult for a fertilized egg to attach to the uterus.
Dosage and mode of application
Follow all directions given by your doctor and also those given on your prescription label. Do not exceed the dose of the medicine.
Start taking the pills on the first day of your period or on the first Sunday following the onset of your period. You may need to use an additional non-hormonal method of birth control when you first start using this contraceptive.
Take 1 pill daily, at intervals not exceeding 24 hours. When the pack is finished, start a new pack the next day. You may get pregnant if you miss doses.
The pack contains seven inert “reminder” pills that help you keep on your regular cycle. Your period should occur while you are using these inert pills.
You may have breakthrough bleeding or spotting, especially during the first there months of use. Consult your doctor if this bleeding continues or is very abundant.
Use an additional non-hormonal method of birth control if you have severe vomiting or diarrhea.
If you are expecting surgery or a prolonged bed rest, stop using this contraceptive for a short time. Any doctor or surgeon who treats you should know that you are using Ortho-Novum 1/50.
While taking this medicine, you will need to visit your doctor regularly for check-ups.
Side effects
Stop taking these pills and consult your doctor right away if you have:
- a breast lump;
- vision changes;
- sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with balance;
- chest pain, sudden cough, wheezing, coughing up blood, swelling or warmth in one or both legs;
- sleep problems, weakness, tired feeling, mood changes;
- a change in the pattern or severity of migraine headaches;
- chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;
- swelling in your hands, ankles, or feet.
Common side effects of Ortho-Novum 1/50 are:
- nausea;
- vomiting;
- spotting;
- breakthrough bleeding;
- temporary infertility after discontinuation of treatment;
- change in menstrual flow;
- melasma which may persist;
- breast changes: tenderness, enlargement, secretion;
- gastrointestinal symptoms (such as abdominal cramps and bloating);
- change in weight (increase or decrease);
- amenorrhea;
- reduced tolerance to carbohydrates;
- change in cervical erosion and secretion;
- migraine;
- change in corneal curvature (steepening);
- intolerance to contact lenses;
- edema;
- allergic reaction, including rash, urticaria, angioedema;
- mental depression;
- vaginal candidiasis;
- diminution in lactation when given immediately postpartum;
- cholestatic jaundice.
Get emergency medical help if you have signs difficult breathing; swelling of your face, lips, tongue, or throat.
Contraindications
You should not take Ortho-Novum 1/50 if you have:
- liver disease or liver cancer;
- untreated or uncontrolled high blood pressure;
- problems with your eyes, kidneys or circulation caused by diabetes;
- heart disease (coronary artery disease, uncontrolled heart valve disorder, history of heart attack, stroke, or blood clot);
- a history of hormone-related cancer such as breast or uterine cancer;
- unusual vaginal bleeding that has not been checked by a doctor;
- a history of jaundice caused by pregnancy or birth control pills;
- severe migraine headaches (with aura, numbness, weakness, or vision changes), especially if you are older than 35;
- a blood-clotting disorder or circulation problems;
- if you smoke and are over 35 years old.
To make sure this medicine is safe for you, tell your doctor if you have:
- high cholesterol or triglycerides, or if you are overweight;
- underactive thyroid;
- tuberculosis;
- high blood pressure, varicose veins;
- a history of depression;
- abnormal mammogram.
- gallbladder disease;
- a history of irregular menstrual cycles;
- a history of fibrocystic breast disease, lumps, nodules,
- diabetes;
- seizures or epilepsy;
Interactions
Some medicine can make reduce the efficiency of this contraceptive. Other medicines may be affected by mestranol + norethindrone. This includes prescription and OTC drugs, vitamins, and herbal supplements. Tell your doctor about all drugs you are using, and those you are going to use soon. Give a list of all your drugs to any doctor who treats you.
Pregnancy and breastfeeding
Do not use Ortho-Novum 1/50 if you are pregnant. Mestranol and norethindrone can get into breast milk and harm a nursing baby. The contra-ceptive may also slow breast milk production. Do not use this product during breastfeeding.
What if I miss a pill?
Missing an active pill increases your risk of becoming pregnant.
- If you miss one active pill, take two pills on the day that you realize your mistake. Then return to your usual schedule;
- If you miss two active pills in a row in Week 1 or 2, take two pills per day for two days in a row. Then return to your usual schedule. an additional non-hormonal method of birth control for the next 7 days each time you have sex;
- If you miss two active pills in a row in Week 3, discard the remaining pills and start a new pack the same day if you are a Day 1 starter. If you are a Sunday starter, continue to take one pill daily until Sunday. On Sunday, discard the remaining pills and start a new pack that day;
- If you miss three active pills in a row in Week 1, 2, or 3, discard the remaining pills and start a new pack the same day if you are a Day 1 starter. If you are a Sunday starter, continue to take one pill daily until Sunday. On Sunday, discard the remaining pills and start a new pack that day.
If you miss two or more active pills, you may not get your period during the month. If you get no period for two months in a row, contact your doctor because you might be pregnant.
If you miss an inert pill, discard it and keep taking one inert pill each day until the pack is finished. You do not need an additional non-hormonal method of birth control if you miss an inert pill.
Precautions
Smoking can increase your risk of blood clot, stroke, or heart attack while taking Ortho-Novum 1/50. You should not take birth control pills if you smoke and are over the age of 35 years.
Taking oral contraceptives can increase your risk of blood clots, stroke, or heart attack, especially if you are overweight.
This product will not protect you from sexually transmitted diseases, including HIV and AIDS.
If you have taken too much of this contraceptive, seek emergency medical attention or call the Poison Help line at 1-800-222-1222.