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Ethinyl estradiol and norgestrel is used as contraception to prevent pregnancy.
Ethinyl estradiol and norgestrel may also be used for other purposes not listed in this medication guide.
Common uses

This medicine is progesterone and estrogen combination contraceptive pill used to prevent pregnancy. It may also be used to treat other conditions as determined by your doctor.

Before using

Smoking cigarettes while using this medicine increases your chance of having heart problems. Do not smoke while using this medicine. Women greater than 35 years of age and women who smoke 15 or more cigarettes per day are at a greater risk for heart problems. Some medicines or medical conditions may interact with this medicine. INFORM YOUR DOCTOR OR PHARMACIST of all prescription and over-the-counter medicine that you are taking. DO NOT TAKE THIS MEDICINE if you are also taking azole antifungal medicines such as ketoconazole or itraconazole, acitretin, aprepitant, bosetan, barbiturates, griseofulvin, carbamazepine, topiramate, tetracycline antibiotics, hydantoins such as phenytoin, St. John's wort, or rifampin without talking with your doctor. An increased risk of pregnancy has been identified when taking these medicines with birth-control pills. Check with your doctor or pharmacist for more information. ADDITIONAL MONITORING OF YOUR DOSE OR CONDITION may be needed if you are taking benzodiazepines, corticosteroids, felbamate, HIV protease inhibitors, nevirapine, modafinil, beta-blockers such as metoprolol or carvedilol, lamotrigine, pioglitazone, penicillin antibiotics, theophylline, troglitazone, troleandomycin, or medicine for seizures. DO NOT START OR STOP any medicine without doctor or pharmacist approval. Inform your doctor of any other medical conditions including cancer, diabetes, headaches or migraines, high triglyceride level in the blood, high blood pressure, recent surgery, allergies, pregnancy, or breast-feeding. USE OF THIS MEDICINE IS NOT RECOMMENDED if you have a history of problems with the blood vessels in the brain or heart, heart valve problems, heart attack, uncontrolled high blood pressure, abnormal or undiagnosed vaginal bleeding, certain cancers including breast cancer, serious liver problems, blood clots, certain blood disorders such as porphyria, stroke, or smoking. Contact your doctor or pharmacist if you have any questions or concerns about taking this medicine.

Directions

Take this medication exactly as it was prescribed for you. Do not take larger amounts, or take it for longer than recommended by your doctor. You will take your first pill on the first day of your period or on the first Sunday after your period begins (follow your doctor's instructions).
You may need to use back-up birth control, such as condoms or a spermicide, when you first start using this medication. Follow your doctor's instructions.
The 28-day birth control pack contains seven 'reminder' pills to keep you on your regular cycle. Your period will usually begin while you are using these reminder pills.
You may have breakthrough bleeding, especially during the first 3 months. Tell your doctor if this bleeding continues or is very heavy.
Take one pill every day, no more than 24 hours apart. When the pills run out, start a new pack the following day. Get your prescription refilled before you run out of pills completely.
If you need to have any type of medical tests or surgery, or if you will be on bed rest, you may need to stop using this medication for a short time. Any doctor or surgeon who treats you should know that you are using birth control pills.
Your doctor will need to see you on a regular basis while you are using this medication. Do not miss any appointments.
Store this medication at room temperature away from moisture and heat.

Cautions

Do not use Ovral if you are pregnant or if you have recently had a baby. Do not use Ovral if you have any of the following conditions: a history of stroke or blood clot, circulation problems (especially if caused by diabetes), a hormone-related cancer such as breast or uterine cancer, abnormal vaginal bleeding, liver disease or liver cancer, severe high blood pressure, migraine headaches, a heart valve disorder, or a history of jaundice caused by birth control pills.
You may need to use back-up birth control, such as condoms or a spermicide, when you first start using Ovral. Follow your doctor's instructions.
Taking hormones can increase your risk of blood clots, stroke, or heart attack, especially if you smoke and are older than 35.
Some drugs can make Ovral less effective, which may result in pregnancy. Tell your doctor about all the prescription and over-the-counter medications you use, including vitamins, minerals and herbal products. Do not start using a new medication without telling your doctor.

Possible side effects

Ovral presents a reasonable risk of side effects. Some may be severe, although a low percentage of patients experience allergic reactions or severe side effects. Allergic reactions and severe side effects require prompt medical assessment. An allergic reaction may present with symptoms including hives, facial swelling, swelling of the lips, mouth, tongue, or throat, and difficulty breathing. Other serious side effects are likely to include lumps in the breast, swelling in the hands, ankles, or feet, depression, insomnia, loss of appetite, or other depression related symptoms, heaviness in the chest or chest pain usually including the sensation which travels down the arm along with difficulty breathing and a general feeling of illness, sudden headache with pain behind the eye, confusion, and difficulty with speech, balance, or vision, sudden numbness or weakness that usually dominates one side of the body, dark urine, pale stools, loss of appetite, increased thirst, jaundice, stomach pain, low fever, or changes in either the pattern or the severity of migraine headaches. Less serious side effects are much more common while taking Ovral and should simply be reported to the prescribing physician if uncomfortable. Common side effects include fatigue, nervousness, dizziness, loss of interest in sexual activity, sexual dysfunction, difficulty with contact lenses, vaginal itching or discharge, changes in the menstrual cycle, variances in weight or appetite, pain, tenderness, or swelling of the breasts, thinning scalp hair, increased facial hair growth, darkening of the skin, freckles, mild nausea, vomiting, bloating, or stomach cramps.

If you take too much

Seek emergency medical attention if you think you have used too much of this medicine. Overdose symptoms may include nausea, vomiting, and vaginal bleeding.

Additional information

The dose of hormone(s) in emergency contraception is safe - there are no long-term effects.• Emergency contraception does not bring on your period right away. • Your period may come early or late, but it should come in the next 21 to 28 days. If you do not get your period you should have a pregnancy test. A pregnancy test can be done by your health-care provider or at a birth control clinic

Drug interactions

Some drugs can make birth control pills less effective, which may result in pregnancy. Before using birth control pills, tell your doctor if you are using any of the following drugs:
• acetaminophen (Tylenol) or ascorbic acid (vitamin C);
• phenylbutazone (Azolid, Butazolidin);
• modafinil (Provigil);
• dexamethasone (Decadron, Hexadrol);
• an antibiotic;
• seizure medicines such as phenytoin (Dilantin), carbamazepine (Tegretol), oxcarbazepine (Trileptal), topiramate (Topamax), and others;
• a barbiturate such as amobarbital (Amytal), butabarbital (Butisol), mephobarbital (Mebaral), secobarbital (Seconal), or phenobarbital (Luminal, Solfoton); or
• HIV medicines such as amprenavir (Agenerase), atazanavir (Reyataz), indinavir (Crixivan), saquinavir (Invirase), fosamprenavir (Lexiva), ritonavir (Norvir), and others.
This list is not complete and there may be other drugs that can affect birth control pills. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

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