Mestranol/Norethindrone, Oral

What are other names for this medicine?

Type of medicine: contraceptive (birth control)

Generic and brand names: mestranol and norethindrone, oral; Necon 1/50; Norinyl 1+50 21-Day; Norinyl 1+50 28-Day; Ortho-Novum 1/50 28

What is this medicine used for?

This medicine (commonly called birth control pills) is used to prevent pregnancy. It may be used for other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• an allergic reaction to any medicine
• blood clots in your legs, lungs, brain, or eyes
• breast cancer or cancer of the lining of the uterus, cervix, or vagina
• depression
• diabetes
• disease of the heart valves
• gallbladder or kidney disease
• headaches along with symptoms such as vomiting, double vision, unsteadiness, weakness, or personality changes
• heart attack, heart disease, or stroke
• high blood pressure
• high cholesterol or high triglycerides
• liver disease or liver tumor
• porphyria (nerve pain or sensitivity to sunlight)
• seizures
• thyroid disease
• unexplained vaginal bleeding
• yellowing of the eyes or skin (jaundice) during pregnancy or during past use of birth control pills

Tell your healthcare provider if you have a history of irregular periods.

Tell your healthcare provider if you have recently had a long period of bed rest after major surgery or a broken bone in a cast.

Tell your provider if you have a family history of heart disease, heart attack, blood clots, strokes, breast cancer, or other conditions.

Tell your healthcare provider if you smoke. Smoking while you are using this medicine increases the risk of serious side effects such as heart attack, stroke, and blood clots. The risk increases with age and the number of cigarettes smoked a day. Talk to your healthcare provider about ways to quit smoking.

Females of childbearing age: DO NOT use this product if you are pregnant or breast-feeding because it may harm the baby. Stop taking this medicine at the first sign you may be pregnant and contact your healthcare provider right away.

How do I take it?

Check the label on the medicine for directions about your specific dose. Take this medicine exactly as prescribed by your healthcare provider on the schedule prescribed. Take it with a full glass (8 ounces) of water. Take it at the same time each day. Use the special packaging to keep track of doses. Read the information sheet that comes in the medicine package for more information.

What if I miss a dose?

If you miss a dose at your normal time, take it as soon as you remember. If you do not remember until the next day, take 2 tablets that day. If you miss 2 or more doses in a row, see the information sheet that comes in the medicine package or ask your healthcare provider what to do. You may need to use another method of birth control (such as a condom or spermicide) as a back-up method for 7 days.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: nausea, vomiting.

What should I watch out for?

You need to see your provider at least once a year for checkups while you are taking this medicine. Do not take this medicine for longer than 1 year without a complete physical exam.

Depending on the type of pill prescribed for you, your healthcare provider may recommend that you use a second method of birth control when you first start taking this medicine.

This medicine only prevents pregnancy. It does not prevent sexually transmitted diseases (STDs) such as HIV or herpes.

If you need surgery or dental work, tell the healthcare provider or dentist you are using this medicine.

If you need any lab tests, tell your healthcare provider you are using this medicine. Birth control hormones may change some blood test results.

If you have spotting or light bleeding or feel sick to your stomach, do not stop taking the pill. The symptoms will usually go away. If symptoms continue, check with your healthcare provider.

Severe vomiting or diarrhea and certain other medicines may make this medicine less effective. Tell all healthcare providers who treat you that you are taking this medicine. You may need to use another method of birth control if the healthcare provider prescribes a medicine that might reduce the effectiveness of the birth control pills.

If you notice a change in your vision or wear contacts and it becomes difficult to wear your lenses, contact your healthcare provider.

Diabetics: If you are taking insulin or another medicine for diabetes, talk to your healthcare provider because your dosage of diabetes medicine may need to be changed.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you are unable to reach your healthcare provider right away, get emergency medical care or call 911 for help):

• allergic reaction (hives, itching, rash, tightness in your chest, trouble breathing)
• severe chest pain, coughing blood, or sudden shortness of breath
• sudden severe headache or vomiting, dizziness or fainting, problems with vision or speech, weakness, or numbness in an arm or leg
• sudden partial or complete loss of vision.

Serious (report these to your healthcare provider right away):

• yellowing of the skin or eyes, especially with fever, tiredness, loss of appetite, dark urine, or light-colored bowel movements
• pain in the calf
• severe pain, swelling, or tenderness in the abdomen
• breast lumps or tenderness
• irregular vaginal bleeding or spotting that happens in more than 1 menstrual cycle or lasts for more than 7 days
• swelling of your hands or ankles
• discomfort from contact lenses or vision changes
• trouble sleeping, weakness, lack of energy, fatigue, or depression

Other: Vaginal or urinary infection, vaginal discharge, weight gain, nausea, vomiting, dizziness, nervousness, bloating, darkening of skin on the face, headache, change in sexual desire.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• acetaminophen (Tylenol) and products containing acetaminophen
• antibiotics such as griseofulvin (Fulvicin, Grifulvin V, Gris-Peg), penicillin, ampicillin (Omnipen, Totacillin, Principen, Unasyn), amoxicillin (Amoxil, Trimox, Augmentin), cloxacillin (Cloxapen), dicloxacillin, oxacillin (Bactocill), penicillin VK (Veetids), demeclocycline (Declomycin), doxycycline (Vibramycin, Vibra-Tabs, Doryx, Monodox), minocycline (Minocin, Vectrin), oxytetracycline (Terramycin), tetracycline (Bristacycline, Sumycin, Panmycin, Tetracyn), clarithromycin (Biaxin), erythromycin (Ery-Tabs, E.E.S.), and rifampin (Rifadin, Rimactane)
• antiseizure medicines such as carbamazepine (Tegretol), felbamate (Felbatol), oxcarbazepine (Trileptal), phenytoin (Dilantin), topiramate (Topamax), ethotoin (Peganone), fosphenytoin (Cerebyx), primidone (Mysoline), gabapentin (Neurontin), lamotrigine (Lamictal), levetiracetam (Keppra), valproic acid (Depacon, Depakene, Depakote), and tiagabine (Gabitril)
• antifungals such as itraconazole (Sporanox), fluconazole (Diflucan), voriconazole (Vfend), and ketoconazole (Nizoral)
• aprepitant (Emend)
• barbiturates such as phenobarbital, butabarbital (Butisol), and pentobarbital (Nembutal)
• benzodiazepines such as alprazolam (Xanax), clorazepate (Tranxene, Gen-XENE), chlordiazepoxide (Librium, Libritabs), diazepam (Valium), lorazepam (Ativan), oxazepam (Serax), temazepam (Restoril), and triazolam (Halcion)
• beta blockers such as carvedilol (Coreg), bisoprolol (Zebeta), metoprolol (Lopressor, Toprol XL), propranolol (Inderal), timolol, and labetalol (Normodyne, Trandate)
• bosentan (Tracleer)
• cholesterol-lowering medicines (statins) such as atorvastatin (Lipitor), lovastatin (Mevacor), and simvastatin (Zocor)
• corticosteroids such as betamethasone (Celestone), cortisone (Cortone), dexamethasone (Hexadrol), hydrocortisone (Hydrocortone, Cortef), methylprednisolone (Medrol), prednisone (Liquid Pred, Prednisone Intensol), prednisolone (Pediapred, Prelone), and triamcinolone (Aristocort, Kenacort)
• dantrolene (Dantrium)
• diabetes medicines such as insulin, glyburide (DiaBeta, Micronase), glipizide (Glucotrol), repaglinide (Prandin), metformin (Glucophage), rosiglitazone (Avandia), and pioglitazone (Actos)
• herbal remedies such as alfalfa, chasteberry, bloodroot, hops, yucca, licorice, St. John's wort, dong quai, black cohosh, red clover, ginseng, and saw palmetto
• immunosuppressants such as cyclosporine (Sandimmune, Neoral, Gengraf), tacrolimus (Prograf, Protopic), and mycophenolate (CellCept)
• medicines to treat HIV such as amprenavir (Agenerase), indinavir (Crixivan), nevirapine (Viramune), nelfinavir (Viracept), and ritonavir (Norvir, Kaletra)
• modafinil (Provigil)
• morphine (MS Contin, Oramorph, Kadian, Roxanol, MSIR)
• salicylic acid
• selegiline (Eldepryl)
• theophylline (Theo-24, Elixophyllin, T-Phyl, Uniphyl, Quibron-T, Theolair, Theochron) and aminophylline (Truphylline)
• tricyclic antidepressants such as amitriptyline, nortriptyline (Aventyl, Pamelor), imipramine (Tofranil), and doxepin (Sinequan)
• vitamins A, B, and C, and minerals such as zinc, iron, and magnesium
• warfarin (Coumadin)

Do not eat grapefruit or drink grapefruit juice while taking this medicine. Grapefruit affects the way this medicine works and may increase the risk of side effects.

Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.