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Ovral (ethinyl estradiol and norgestrel) Product Info

Ethinyl Estradiol and Norgestrel tablet

What is this medicine?

ETHINYL ESTRADIOL; NORGESTREL is an oral contraceptive. The products combine two types of female hormones, an estrogen and a progestin. They are used to prevent ovulation and pregnancy.

What should my health care professional know before I take this medicine?

They need to know if you have any of these conditions:

• abnormal vaginal bleeding
• blood vessel disease or blood clots
• breast, cervical, endometrial, ovarian, liver, or uterine cancer
• diabetes
• gallbladder disease
• heart disease or recent heart attack
• high blood pressure
• high cholesterol
• kidney disease
• liver disease
• migraine headaches
• stroke
• systemic lupus erythematosus (SLE)
• tobacco smoker
• an unusual or allergic reaction to estrogens, progestins, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I take this medicine?

Take this medicine by mouth. To reduce nausea, this medicine may be taken with food. Take this medicine at the same time each day and in the order directed on the package. Do not take your medicine more often than directed.

Contact your pediatrician regarding the use of this medicine in children. Special care may be needed. This medicine has been used in female children who have started having menstrual periods.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soone as possible. If you miss more than one pill, this medicine may not be as effective and you may need to use another form of birth control.

What may interact with this medicine?

• acetaminophen
• antibiotics or medicines for infections, especially rifampin, rifabutin, rifapentine, and griseofulvin, and possibly penicillins or tetracyclines
• aprepitant
• ascorbic acid (vitamin C)
• atorvastatin
• barbiturate medicines, such as phenobarbital
• bosentan
• carbamazepine
• caffeine
• clofibrate
• cyclosporine
• dantrolene
• doxercalciferol
• felbamate
• grapefruit juice
• hydrocortisone
• medicines for anxiety or sleeping problems, such as diazepam or temazepam
• medicines for diabetes, including pioglitazone
• mineral oil
• modafinil
• mycophenolate
• nefazodone
• oxcarbazepine
• phenytoin
• prednisolone
• ritonavir or other medicines for HIV infection or AIDS
• rosuvastatin
• selegiline
• soy isoflavones supplements
• St. John's wort
• tamoxifen or raloxifene
• theophylline
• thyroid hormones
• topiramate
• warfarin

Tell your prescriber or health care professional about all other medicines you are taking, including non-prescription medicines, nutritional supplements, or herbal products. Also tell your prescriber or health care professional if you are a frequent user of drinks with caffeine or alcohol, if you smoke, or if you use illegal drugs. These may affect the way your medicine works. Check with your health care professional before stopping or starting any of your medicines.

What should I watch for while taking this medicine?

Visit your doctor or health care professional for regular checks on your progress. You will need a regular breast and pelvic exam and Pap smear while on this medicine.

Use an additional method of contraception during the first cycle that you take these tablets.

If you have any reason to think you are pregnant, stop taking this medicine right away and contact your doctor or health care professional.

If you are taking this medicine for hormone related problems, it may take several cycles of use to see improvement in your condition.

Smoking increases the risk of getting a blood clot or having a stroke while you are taking birth control pills, especially if you are more than 35 years old. You are strongly advised not to smoke.

This medicine can make your body retain fluid, making your fingers, hands, or ankles swell. Your blood pressure can go up. Contact your doctor or health care professional if you feel you are retaining fluid.

This medicine can make you more sensitive to the sun. Keep out of the sun. If you cannot avoid being in the sun, wear protective clothing and use sunscreen. Do not use sun lamps or tanning beds/booths.

If you wear contact lenses and notice visual changes, or if the lenses begin to feel uncomfortable, consult your eye care specialist.

In some women, tenderness, swelling, or minor bleeding of the gums may occur. Notify your dentist if this happens. Brushing and flossing your teeth regularly may help limit this. See your dentist regularly and inform your dentist of the medicines you are taking.

If you are going to have elective surgery, you may need to stop taking this medicine before the surgery. Consult your health care professional for advice.

This medicine does not protect you against HIV infection (AIDS) or any other sexually transmitted diseases.

What side effects may I notice from this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• breast tissue changes or discharge
• changes in vaginal bleeding during your period or between your periods
• chest pain
• coughing up blood
• dizziness or fainting spells
• headaches or migraines
• leg, arm or groin pain
• severe or sudden headaches
• stomach pain (severe)
• sudden shortness of breath
• sudden loss of coordination, especially on one side of the body
• speech problems
• symptoms of vaginal infection like itching, irritation or unusual discharge
• tenderness in the upper abdomen
• vomiting
• weakness or numbness in the arms or legs, especially on one side of the body
• yellowing of the eyes or skin

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• breakthrough bleeding and spotting that continues beyond the 3 initial cycles of pills
• breast tenderness
• mood changes, anxiety, depression, frustration, anger, or emotional outbursts
• increased sensitivity to sun or ultraviolet light
• nausea
• skin rash, acne, or brown spots on the skin
• weight gain (slight)

This list may not describe all possible side effects.

Where can I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medicine after the expiration date.

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