Ethinyl Estradiol, Norethindrone Chewable tablet, Ferrous Fumarate Chewable tablet
What is this medicine?
ETHINYL ESTRADIOL; NORETHINDRONE; FERROUS FUMARATE (ETH in il es tra DYE ole; nor eth IN drone; 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
breast, cervical, endometrial, ovarian, liver, or uterine cancer
heart disease or recent heart attack
high blood pressure
history of blood clots
systemic lupus erythematosus (SLE)
an unusual or allergic reaction to estrogens, progestins, other medicines, foods, dyes, or preservatives
pregnant or trying to get pregnant
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?
antibiotics or medicines for infections, especially rifampin, rifabutin, rifapentine, and griseofulvin, and possibly penicillins or tetracyclines
ascorbic acid (vitamin C)
barbiturate medicines, such as phenobarbital
medicines for anxiety or sleeping problems, such as diazepam or temazepam
medicines for diabetes, including pioglitazone
ritonavir or other medicines for HIV infection or AIDS
soy isoflavones supplements
St. John's wort
tamoxifen or raloxifene
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 exams and Pap smears while on this medicine.
Use an additional method of contraception during the first cycle that you take this medicine.
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
coughing up blood
feeling faint or lightheaded
headaches or migraines
leg, arm or groin pain
loss of balance or coordination
severe or sudden headaches
severe stomach pain
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
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.):
mood changes, anxiety, depression, frustration, anger, or emotional outbursts
increased sensitivity to sun or ultraviolet light
skin 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.
March 21, 2017
U.S. FDA-approved Package Insert