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Ethinyl Estradiol and Drospirenone tablet

What is this medicine?

DROSPIRENONE; ETHINYL ESTRADIOL is an oral contraceptive (birth control pill). This medicine combines two types of female hormones, estrogen and progestin. It is used to prevent ovulation and pregnancy.

What should I tell my health care provider before I take this medicine?

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

• abnormal vaginal bleeding
• adrenal gland disease
• 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
• high potassium level
• kidney disease
• liver disease
• migraine headaches
• stroke
• systemic lupus erythematosus (SLE)
• tobacco smoker
• an unusual or allergic reaction to estrogens, progestins, or other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medicine?

For routine prevention of pregnancy.

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.

Keep an extra month’s supply of your pills available to ensure that you will not miss the first day of the next cycle.

Talk to 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, don’t share it with others.

What if I miss a dose?

Missing a pill increases your risk of becoming pregnant.

If you miss one "active" pill, take the dose as soon as you remember or take two pills at the time of your next regularly scheduled dose. You do not need to use backup birth control.

If you miss two"active" tablets in a row in week one or two, take two tablets each for the next two regularly scheduled doses (one missed tablet plus one regularly scheduled tablet for 2 days in a row). Use another form of birth control for at least 7 days following the missed tablets.

If you miss two "active" tablets in a row in week three, or if you miss three tablets in a row during any of the first 3 weeks, throw out the rest of the pack and start a new package on the same day if you are a Day 1 starter. If you are a Sunday starter, keep taking a pill every day until Sunday.

On Sunday, throw out the rest of the pack and start a new pack of pills that same day. You may not have a period that month, but this is expected. However, if you miss your period 2 months in a row, call your doctor because you might be pregnant.

If you miss one of the reminder pills in week four, skip that dose and take the next one as directed.

If you miss a pill, you may become pregnant if you have sex in the 7 days after your missed pill. You MUST use another birth control method (such as condoms or spermicides) as a back-up for those 7 days.

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

This product is different from other birth control pills because it contains the progestin drospirenone. Drospirenone may increase potassium levels. Interactions with other drugs may increase the chance of an elevated potassium level. You may need blood tests to check your potassium level. Drugs that can increase the potassium level include:

• certain medications for high blood pressure or heart conditions (examples include ACE-inhibitors and also Angiotensin-II receptor blockers, and Eplerenone
• dietary salt substitutes (these may contain potassium)
• heparin
• NSAIDs (antiinflammatory drugs), if they are taken long-term and daily, like for arthritis
• potassium supplements
• some 'water pills' (diuretics like amiloride, spironolactone or triamterene)

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 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?

Severe side effects are relatively rare in women who are healthy and do not smoke while they are taking oral contraceptives. On average, more women have problems due to complications from getting pregnant than have problems with oral contraceptives. Many of the minor side effects may go away as your body adjusts to the medicine. However, the potential for severe side effects does exist and you may want to discuss these with your health care provider.

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

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• breast tissue changes or discharge
• changes in vision
• chest pain
• confusion, trouble speaking or understanding
• dark urine
• general ill feeling or flu-like symptoms
• light-colored stools
• nausea, vomiting
• pain, swelling, warmth in the leg
• right upper belly pain
• severe headaches
• shortness of breath
• sudden numbness or weakness of the face, arm or leg
• trouble walking, dizziness, loss of balance or coordination
• unusual vaginal bleeding
• 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):

• acne
• brown spots on the face
• change in appetite
• change in sexual desire
• depressed mood or mood swings
• fluid retention and swelling
• stomach cramps or bloating
• unusually weak or tired
• weight gain

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). Keep container tightly closed. Throw away any unused medicine after the expiration date.