Estradiol; Norgestimate tablets

What are estradiol; norgestimate tablets?

ESTRADIOL; NORGESTIMATE (Ortho-Prefest®) tablets are a mixture of a estrogen female hormone and a progestin. Estradiol is essential for maintaining normal female functions and is normally produced by the ovaries. After menopause, the ovaries decrease their production of this hormone. Estradiol can help relieve symptoms of the menopause (hot flashes, night sweats, mood changes, and vaginal dryness and irritation), and may also help to prevent the onset of osteoporosis (a loss of bone mass, so that bones become brittle and easily broken). Norgestimate is a progestin that is helpful in reducing overgrowth of the lining of the uterus (the endometrium), which may help reduce your risk of endometrial cancer. Generic estradiol-norgestimate tablets are available.

What should my health care professional know before I use estradiol-norgestimate?

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

• blood vessel disease, blood clotting disorder, or suffered a stroke

• breast, cervical, endometrial, or uterine cancer

• diabetes

• fibroids in the womb, or endometriosis

• heart, kidney or liver disease

• high blood lipids or cholesterol

• high blood pressure

• high level of calcium in the blood

• hysterectomy

• mental depression

• migraine

• porphyria

• systemic lupus erythematosus (SLE)

• tobacco smoker

• vaginal bleeding

• an unusual or allergic reaction to estrogens, other hormones, medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

Take estradiol; norgestimate tablets by mouth. Follow the directions on the prescription label. You will take one tablet daily, in the order indicated on the package. Take 1 pink tablet once daily for 3 days followed by 1 white tablet once daily for 3 days. Take in this order until package is complete, then start a new package. Try to take your dose at the same time each day. Swallow the tablet with a drink of water. You may take the tablets with food. Do not take your medicine more often than directed.

• For all uses of this medicine:

Before starting this medication, read the paper on your prescription provided by your pharmacist or health care professional. This paper will tell you about the product you are taking. Make certain you understand the instructions.

Contact your pediatrician or health care professional regarding the use of this medicine in children. Special care may be needed.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What drug(s) may interact with estradiol-norgestimate?

• anastrozole

• barbiturates or benzodiazepines used for inducing sleep or treating seizures (convulsions)

• bosentan

• bromocriptine

• carbamazepine

• cimetidine

• cyclosporine

• dantrolene

• exemestane

• medications for diabetes

• grapefruit juice

• griseofulvin

• hydrocortisone, cortisone, or prednisolone

• isoniazid (INH)

• letrozole

• methotrexate

• mineral oil

• phenytoin

• raloxifene or tamoxifen

• rifabutin, rifampin, or rifapentine

• testolactone

• thyroid hormones

• topiramate

• tricyclic antidepressants

• 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 estradiol-norgestimate?

Visit your prescriber for regular checks on your progress. You should have a complete check-up every 6 months. You will need a regular breast and pelvic exam and "Pap" smear while on estradiol-norgestimate. Regular breast examinations by a health professional and monthly self-examination are recommended for all women. You should also discuss the need for regular mammograms with you health care prescriber.

Estradiol; norgestimate tablets can make your body retain fluid, making your fingers, hands, or ankles swell. Your blood pressure can go up. Contact your prescriber if you feel you are retaining fluid.

If you have any reason to think you are pregnant; stop taking estradiol-norgestimate at once and contact your prescriber.

Tobacco smoking increases the risk of getting a blood clot or having a stroke while you are taking estradiol-norgestimate, especially if you are more than 35 years old. You are strongly advised not to smoke.

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

If you are going to have elective surgery, you may need to stop taking your estrogens one month beforehand. Consult your health care professional for advice prior to scheduling the surgery.

In women who still have their uterus, taking a progestin with your estrogens lowers the risk of developing overgrowth of the uterine lining. You should know, however, that taking estrogens with progestins may have additional health risks. You should discuss the use of estrogens and progestins with your health care professional to determine the benefits and risks for you. This product contains both an estrogen and a progestin.

What side effects may I notice from using estradiol-norgestimate?

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

• breakthrough bleeding and spotting

• breast lumps or unusual discharge

• chest pain

• coughing up blood

• dizziness, fainting, or weakness

• leg, arm or groin pain

• nausea, vomiting

• severe headaches

• stomach or abdominal pain (severe), tenderness or swelling

• sudden loss of coordination, especially on one side of the body

• sudden shortness of breath

• swelling of the hands, feet or ankles, or rapid weight gain

• vision or speech problems

• yellowing of the eyes or skin

• weakness or numbness in the arms or legs, especially on one side of the body

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

• breast tenderness

• change in sexual desire

• increased or decreased appetite

• mild stomach upset

• mood changes, anxiety, depression, frustration, anger, or emotional outbursts

• skin rash, acne, or brown spots on the face

• tiredness

• vaginal yeast infection (irritation and white discharge)

• weight gain

Where can I keep my medicine?

Keep out of the reach of children in a container that small children cannot open.

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