Ethinyl Estradiol Oral tablet, Ferrous Fumarate Oral tablet, Norethindrone Acetate, Ethinyl Estradiol Chewable tablet

What is this medicine?

ETHINYL ESTRADIOL; NORETHINDRONE ACETATE (ETH in il es tra DYE ole; nor eth IN drone AS e tate) and FERROUS FUMARATE (FER us FUE ma rate) 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.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider 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 use this medicine?

Take one tablet by mouth daily. Take this medicine at the same time each day and in the order directed on the package. The package contains some chewable and some tablets that should be swallowed whole. The first 24 tablets in the package should be chewed completely then swallowed. After swallowing the chewed tablet, drink a full glass of water. The last 4 tablets in the package should be swallowed whole. Do not chew or crush these tablets. To reduce nausea, this medicine may be taken with food. Do not take your medicine more often than directed.

A patient package insert for the product will be given with each prescription and refill. Read this sheet carefully each time. The sheet may change frequently.

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've 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, refer to the patient information sheet you received with your medicine for direction. 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 ortetracyclines

• 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 list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using 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 receiving 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 these 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. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should 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.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

Ethinyl Estradiol Oral tablet, Ferrous Fumarate Oral tablet, Norethindrone Acetate, Ethinyl Estradiol Oral tablet

What is this medicine?

ETHINYL ESTRADIOL; NORETHINDRONE ACETATE; FERROUS FUMARATE (ETH in il es tra DYE ole; nor eth IN drone AS e tate; FER us FUE ma rate) 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. Some products are also used to treat acne in females.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

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

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

• abnormal vaginal bleeding

• blood vessel disease

• breast, cervical, endometrial, ovarian, liver, or uterine cancer

• diabetes

• gallbladder disease

• heart disease or recent heart attack

• high blood pressure

• high cholesterol

• history of blood clots

• kidney disease

• liver disease

• migraine headaches

• smoke tobacco

• stroke

• systemic lupus erythematosus (SLE)

• 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 use this medicine?

Take this medicine by mouth. To reduce nausea, this medicine may be taken with food. Follow the directions on the prescription label. 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.

A patient package insert for the product will be given with each prescription and refill. Read this sheet carefully each time. The sheet may change frequently.

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've 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, refer to the patient information sheet you received with your medicine for direction. 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

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using 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 receiving this medicine?

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 vaginal bleeding during your period or between your periods

• changes in vision

• chest pain

• confusion

• coughing up blood

• dizziness

• feeling faint or lightheaded

• headaches or migraines

• leg, arm or groin pain

• loss of balance or coordination

• severe or sudden headaches

• stomach pain (severe)

• sudden shortness of breath

• sudden numbness or weakness of the face, arm or leg

• symptoms of vaginal infection like itching, irritation or unusual discharge

• tenderness in the upper abdomen

• trouble speaking or understanding

• vomiting

• yellowing of the eyes or skin

Side effects that usually do not require medical attention (Report these 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. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should 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.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

Ferrous Fumarate Chewable tablet, Norethindrone Acetate, Ethinyl Estradiol Chewable tablet

What is this medicine?

ETHINYL ESTRADIOL; NORETHINDRONE ACETATE; FERROUS FUMARATE (ETH in il es tra DYE ole; nor eth IN drone AS e tate; FER us FUE ma rate) 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.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider 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 use this medicine?

Take this medicine by mouth. Take tablet whole or chew it completely before swallowing. If you chew this medicine, drink a full glass of water after. Follow the directions on the prescription label. 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.

A patient package insert for the product will be given with each prescription and refill. Read this sheet carefully each time. The sheet may change frequently.

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've 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, refer to the patient information sheet you received with your medicine for direction. 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

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using 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 receiving 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 these 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. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should 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.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

Ferrous Fumarate Oral tablet, Norethindrone Acetate, Ethinyl Estradiol Oral tablet

What is this medicine?

ETHINYL ESTRADIOL; NORETHINDRONE ACETATE; FERROUS FUMARATE (ETH in il es tra DYE ole; nor eth IN drone AS e tate; FER us FUE ma rate) 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. Some products are also used to treat acne in females.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

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

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

• abnormal vaginal bleeding

• blood vessel disease

• breast, cervical, endometrial, ovarian, liver, or uterine cancer

• diabetes

• gallbladder disease

• heart disease or recent heart attack

• high blood pressure

• high cholesterol

• history of blood clots

• kidney disease

• liver disease

• migraine headaches

• smoke tobacco

• stroke

• systemic lupus erythematosus (SLE)

• 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 use this medicine?

Take this medicine by mouth. To reduce nausea, this medicine may be taken with food. Follow the directions on the prescription label. 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.

A patient package insert for the product will be given with each prescription and refill. Read this sheet carefully each time. The sheet may change frequently.

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've 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, refer to the patient information sheet you received with your medicine for direction. 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

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using 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 receiving this medicine?

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 vaginal bleeding during your period or between your periods

• changes in vision

• chest pain

• confusion

• coughing up blood

• dizziness

• feeling faint or lightheaded

• headaches or migraines

• leg, arm or groin pain

• loss of balance or coordination

• severe or sudden headaches

• stomach pain (severe)

• sudden shortness of breath

• sudden numbness or weakness of the face, arm or leg

• symptoms of vaginal infection like itching, irritation or unusual discharge

• tenderness in the upper abdomen

• trouble speaking or understanding

• vomiting

• yellowing of the eyes or skin

Side effects that usually do not require medical attention (Report these 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. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should 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.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

Ferrous Fumarate Oral tablet, Norethindrone Acetate, Ethinyl Estradiol Oral tablet, Norethindrone Acetate, Ethinyl Estradiol Oral tablet, Norethindrone Acetate, Ethinyl Estradiol Oral tablet

What is this medicine?

ETHINYL ESTRADIOL; NORETHINDRONE ACETATE; FERROUS FUMARATE (ETH in il es tra DYE ole; nor eth IN drone AS e tate; FER us FUE ma rate) 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. Some products are also used to treat acne in females.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

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

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

• abnormal vaginal bleeding

• blood vessel disease

• breast, cervical, endometrial, ovarian, liver, or uterine cancer

• diabetes

• gallbladder disease

• heart disease or recent heart attack

• high blood pressure

• high cholesterol

• history of blood clots

• kidney disease

• liver disease

• migraine headaches

• smoke tobacco

• stroke

• systemic lupus erythematosus (SLE)

• 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 use this medicine?

Take this medicine by mouth. To reduce nausea, this medicine may be taken with food. Follow the directions on the prescription label. 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.

A patient package insert for the product will be given with each prescription and refill. Read this sheet carefully each time. The sheet may change frequently.

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've 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, refer to the patient information sheet you received with your medicine for direction. 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

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using 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 receiving this medicine?

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 vaginal bleeding during your period or between your periods

• changes in vision

• chest pain

• confusion

• coughing up blood

• dizziness

• feeling faint or lightheaded

• headaches or migraines

• leg, arm or groin pain

• loss of balance or coordination

• severe or sudden headaches

• stomach pain (severe)

• sudden shortness of breath

• sudden numbness or weakness of the face, arm or leg

• symptoms of vaginal infection like itching, irritation or unusual discharge

• tenderness in the upper abdomen

• trouble speaking or understanding

• vomiting

• yellowing of the eyes or skin

Side effects that usually do not require medical attention (Report these 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. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should 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.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

Norethindrone Acetate, Ethinyl Estradiol Oral tablet

What is this medicine?

ETHINYL ESTRADIOL; NORETHINDRONE ACETATE (ETH in il es tra DYE ole; nor eth IN drone AS e tate) 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.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

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

• 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 use this medicine?

Take this medicine by mouth. To reduce nausea, this medicine may be taken with food. Follow the directions on the prescription label. 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.

A patient package insert for the product will be given with each prescription and refill. Read this sheet carefully each time. The sheet may change frequently.

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, refer to the patient information sheet you received with your medicine for direction. 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

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using 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 receiving 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. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should 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.

Norethindrone Acetate, Ethinyl Estradiol Oral tablet [Estrogen Replacement/Osteoporosis]

What is this medicine?

ETHINYL ESTRADIOL; NORETHINDRONE ACETATE (ETh in il es tra DYE ole; nor eth IN drone AS e tate) is used as hormone replacement in menopausal women who still have their uterus. This product helps to treat hot flashes and prevent osteoporosis (weak bones).

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

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

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

• blood vessel disease or blood clots

• breast, cervical, endometrial, or uterine cancer

• diabetes

• endometriosis

• fibroids

• gallbladder disease

• heart disease or recent heart attack

• high blood cholesterol

• high blood pressure

• high level of calcium in the blood

• hysterectomy

• kidney disease

• liver disease

• mental depression

• migraine headaches

• porphyria

• systemic lupus erythematosus (SLE)

• tobacco smoker

• stroke

• vaginal bleeding

• 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 use this medicine?

Take this medicine by mouth with a drink of water. You may take this medicine with food. Follow the directions on the prescription label. You will take one tablet daily at roughly the same time each day. Do not take your medicine more often than directed.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

A patient package insert for the product will be given with each prescription and refill. Read this sheet carefully each time. The sheet may change frequently.

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 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 may interact with this medicine?

• barbiturates, such as phenobarbital

• benzodiazepines

• bosentan

• bromocriptine

• carbamazepine

• cimetidine

• cyclosporine

• dantrolene

• grapefruit juice

• griseofulvin

• hydrocortisone, cortisone, or prednisolone

• isoniazid (INH)

• medications for diabetes

• methotrexate

• mineral oil

• phenytoin

• raloxifene

• rifabutin, rifampin, or rifapentine

• tamoxifen

• thyroid hormones

• topiramate

• tricyclic antidepressants

• warfarin

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Visit your health care professional 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. You should also discuss the need for regular mammograms with your health care professional, and follow his or her guidelines.

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.

If you have any reason to think you are pregnant; stop taking this medicine at once and contact your doctor or health care professional.

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

If you wear contact lenses and notice visual changes, 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 this medicine beforehand. Consult your health care professional for advice prior to scheduling the surgery.

What side effects may I notice from receiving this medicine?

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

• breakthrough bleeding and spotting

• breast enlargement, tenderness, or discharge

• chest pain

• leg, arm, or groin pain

• severe headaches

• stomach or abdominal pain (severe)

• sudden shortness of breath

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

• vaginal yeast infection (irritation and white discharge)

• vision or speech problems

• 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):

• change in appetite

• change in sexual desire

• mild stomach upset

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

• nausea

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

• tiredness

• weight gain

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should 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.