Ethinyl Estradiol; Norethindrone Acetate tablets

What are ethinyl estradiol; norethindrone acetate tablets?

ETHINYL ESTRADIOL/NORETHINDRONE ACETATE products are usually used as oral contraceptives (birth control pills or 'the pill'). These products combine natural or synthetic estrogens and progestins, similar to the natural sex hormones (estrogen and progesterone) produced in a woman's body. Ethinyl estradiol is an estrogen and norethindrone acetate is a progestin. These products can prevent ovulation and pregnancy. In general, a combination of estrogen and progestin works better than a single-ingredient product. Ethinyl estradiol/norethindrone acetate tablets can also help regulate menstrual flow, treat acne, or may be used for other hormone related problems in females. The type and amount of estrogen and/or progestin may be different from one birth control product to another. Generic ethinyl estradiol; norethindrone tablets for birth control are available.

One ethinyl estradiol; norethindrone acetate product (femhrt®1/5) is used as hormone replacement in women who still have their uterus and who are experiencing menopause. FEMHRT® 1/5 DOES NOT PREVENT PREGNANCY. When prescribed, this product helps to treat hot flashes, maintain healthy bones and prevent osteoporosis. Generic ethinyl estradiol; norethindrone tablets for hormone replacement are available.

What should my health care professional know before I use ethinyl estradiol; norethindrone acetate?

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

• blood clots

• blood sugar problems, like diabetes

• cancer of the breast, cervix, ovary, uterus, vagina, or unusual vaginal bleeding that has not been evaluated by a health care professional

• depression

• fibroids

• gallbladder disease

• heart or circulation problems

• high blood pressure

• jaundice

• liver disease

• menstrual problems

• migraine headaches

• stroke

• systemic lupus erythematosus (SLE)

• tobacco smoker

• an unusual or allergic reaction to estrogen/progestin, other hormones, medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

Take ethinyl estradiol/norethindrone acetate pills by mouth. Before you start taking these pills decide what is a suitable time of day and always take them at the same time of day and in the order directed. Swallow the pills with a drink of water. Take with food to reduce stomach upset. Do not take more often than directed.

Before starting this medication, read the paper on your prescription provided by your pharmacist. This paper will tell you about the specific 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.

If you are taking this product for birth control (all products except Femhrt®), you will most likely start taking your pills on the first Sunday after you start your period or on the first day of your period. You may need to ask your health care provider which day you should start your packet.

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

What if I miss a dose?

If you are taking this product for hormone replacement: 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.

For Products taken for birth control (all products except femhrt®):

Try not to miss a dose. If you do, it may be necessary to consult your prescriber or health care professional, especially if you take Estrostep® tablets. The following information describes only some of the ways that missed doses can be handled.

For all products (except Estrostep®):

21-day schedule:

If you miss one dose, take it as soon as you remember and then take the next pill at the regular time as usual. You may take 2 tablets in one day. If you miss two doses (days) in a row, take 2 tablets for the next 2 days, then, continue with your regular schedule. Whenever 1 or 2 doses are missed, you should use a second method of contraception for the next 7 days in addition to taking the pills. If you miss three doses in a row, you should notify your physician or other health care professional for instructions. You will probably need to throw away the rest of the tablets in that cycle pack and start over. Another method of contraception should be used until at least 7 doses have been taken in the new cycle. Missing a pill can cause spotting or light bleeding. Make sure that no more than 7 days pass at the end of the 21 day cycle, before you start your next pack of pills.

28-day schedule:

Follow the same directions as above for the first 21 days of the schedule. If you miss 1 of the last 7 pills, you can either double the dose or skip it, but it is important to start the next month's cycle on the scheduled day.

For Estrostep®: You will need to contact your health care provider for specific instructions based on which tablets have been missed, for how many days they have been missed, and based on what week of your current cycle you are currently taking tablets.

What drug(s) may interact with ethinyl estradiol; norethindrone acetate?

• anastrozole

• antibiotics or medicines for infections, especially rifampin, rifabutin, rifapentine, and griseofulvin

• aprepitant

• barbiturate medicines for producing sleep or treating seizures (convulsions)

• bosentan

• carbamazepine

• caffeine

• clofibrate

• cyclosporine

• dantrolene

• doxercalciferol

• exemestane

• grapefruit juice

• hydrocortisone

• letrozole

• medicines for anxiety or sleeping problems, such as diazepam or temazepam

• medicines for mental depression

• medicines for diabetes, including troglitazone and pioglitazone

• mineral oil

• modafinil

• mycophenolate

• nefazodone

• oxcarbazepine

• phenytoin

• prednisolone

• ritonavir or other medicines for the treatment of the HIV virus or AIDS

• selegiline

• soy isoflavones supplements

• St. John's wort

• tamoxifen or raloxifene

• testolactone

• theophylline

• 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 before stopping or starting any of your medicines.

What should I watch for while taking ethinyl estradiol; norethindrone acetate?

Visit your prescriber or health care provider for regular checks on your progress. You should have a complete check-up every 6 to 12 months. If you have any unusual vaginal bleeding contact your doctor or health care provider for advice.

Use an additional method of contraception during the first cycle that you take these tablets. If you miss a period, the possibility of pregnancy must be considered. See your prescriber or health care professional as soon as you can.

If you stop taking these tablets and want to get pregnant, a return to normal ovulation can take some time. You may not return to normal ovulation and fertility for 3 to 6 months. Discuss your pregnancy plans with your health care provider.

If you are taking oral contraceptives for the treatment of acne, hirsutism (male-like hair growth), endometriosis or other hormone related problems, it may take several months of continued treatment to notice improvement in your symptoms or condition.

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

Oral contraceptives can increase your sensitivity to the sun and you may burn more easily. Use sunscreen and protective clothing during long periods outdoors. Tanning booths should be used with caution.

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.

You may get a vaginal yeast infection. If you have never had a yeast infection before, see your prescriber or other health care provider to confirm the problem. If you have had yeast infections in the past and are comfortable with self-medicating the problem, get and use a nonprescription medication to treat the yeast infection.

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

Taking contraceptive pills does not protect you against HIV infection (AIDS) or any other sexually transmitted diseases.

What side effects may I notice from taking ethinyl estradiol; norethindrone acetate?

Severe side effects are uncommon in women taking this combination in the low doses prescribed for hormone replacement during and after menopause. Many of the side effects listed below are for the use of this medicine in dosages used for birth control. However, if you notice any of these side effects while taking femhrt®, you should report them.

Severe side effects are relatively rare in women who are healthy and do not smoke while they are taking oral contraceptives (birth control pills). 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.

The following symptoms or side effects may be related to blood clots and require immediate medical or emergency help:

• chest pain

• coughing up blood

• dizziness or fainting spells

• 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

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

• vision or speech problems

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

Other serious side effects are rare. Contact your health care provider as soon as you can if the following side effects occur:

• breast tissue changes or discharge

• changes in vaginal bleeding during your period or between your periods

• headaches or migraines

• increases in blood sugar, especially if you have diabetes

• increases in blood pressure, especially if you are known to have high blood pressure

• symptoms of vaginal infection (itching, irritation or unusual discharge)

• tenderness in the upper abdomen

• vomiting

• yellowing of the eyes or skin

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

• breakthrough bleeding and spotting that continues beyond the 3 initial cycles of pills

• breast tenderness

• mild stomach upset

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

• increased or decreased appetite

• increased sensitivity to sun or ultraviolet light

• nausea

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

• tiredness

• weight gain

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.