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MICROGESTIN FE
NORETHINDRONE ACETATE/ETHINYL ESTRADIOL W/ FERROUS FUMARATE ORAL

Important Note

The following information is intended to supplement, not substitute for, the expertise and judgment of your physician, pharmacist or other healthcare professional. It should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. Consult your healthcare professional before using this drug.

NORETHINDRONE ACETATE/ETHINYL ESTRADIOL W/ FERROUS FUMARATE ORAL

(nor-ETH-in-drone/ETH-in-ill ess-truh-DYE-ohl FAIR-us SULL-fate)

COMMON BRAND NAME(S): Estrostep Fe, Loestrin Fe

WARNING: Smoking cigarettes while using this medication increases your chance of having heart problems. Do not smoke while using this medication. The risk of heart problems increases with age (in women greater than 35 years of age) and with frequent smoking (15 cigarettes per day or greater). Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6 years of age. Keep this product out of reach of children. If an accidental overdose does occur, seek immediate medical attention or call a poison control center.

Uses

This medication is used to prevent pregnancy or to regulate your menstrual cycle. It may also be used to treat acne vulgaris.

How To Use

Take this medication with food or immediately after a meal to prevent stomach upset. Try to take this medication at the same time each day. This may help you to remember to take it. This medication is available in a cycle of one tablet a day for 21 days with no medication for 7 days, or in a package of 28 days where 7 of the tablets may not contain any hormone. Follow your dosing schedule carefully. Be sure to ask your doctor if you have any questions. Use a supplemental form of birth control during the first week of taking this medication since it takes a while to be effective.

Side Effects

This medication may cause dizziness, headache, lightheadedness, stomach upset, bloating, or nausea. If these effects persist or worsen, contact your doctor. Notify your doctor if you experience: severe depression, pain in groin or calf, sudden severe headache, chest pain, shortness of breath, lumps in the breast, weakness or tingling in the arms or legs, yellowing of the eyes or skin. If you notice other effects not listed above, contact your doctor or pharmacist.

Precautions

Before you take this medication, tell your doctor your medical history, including: family medical history, (especially if you have asthma), high blood pressure, kidney, or liver problems, heart disease, a history of jaundice (yellowing of skin or eyes), high blood pressure during pregnancy, excessive weight gain or fluid retention during menstrual cycle, strokes, blood clots, seizures, migraine headaches, breast cancer, high blood level of cholesterol or lipids (fats), diabetes, depression. It may take a long time for you to become pregnant after you stop taking birth control pills. Consult your doctor. Do not smoke cigarettes. Birth-control pills slightly increase your risk of strokes, blood clots, high blood pressure, heart attacks, gallbladder disease, vision problems, and liver tumors. Cigarette smoking (especially 15 or more cigarettes daily) and age (women older than 35/smokers or 40/nonsmokers years of age) further increase the risk of stroke, blood clots, high blood pressure and heart attacks. Ask your pharmacist or doctor for a copy of the patient labeling which explains these risks in more detail. Consult your doctor for any questions, including possible use in nonsmokers over 40 years of age. If you are near-sighted or wear contact lenses, you may develop vision problems. Also, your tolerance of the lenses may decrease. Contact your eye doctor if these problems occur. Before having surgery, including dental surgery, tell the doctor that you take birth control pills. Depending on strength, this drug may cause a patchy, darkening of the skin on the face (melasma). Higher strengths are more likely to cause melasma. Sunlight may intensify this darkening and you may need to avoid prolonged sun exposure and sunlamps. Consult your doctor regarding use of sunscreens and protective clothing. Accidental overdose of iron-containing products can be very dangerous and even fatal. Keep this medication out of the reach of children. If overdose occurs, call a doctor or poison control center immediately. This medication must not be used during pregnancy. If you become pregnant or think you may be pregnant, inform your doctor immediately. This medication is excreted into breast milk and has had undesirable effects on nursing infants. Using this drug while breast-feeding is not recommended. Consult your doctor about using alternative birth control methods.

Drug Interactions

Tell your doctor what prescription and nonprescription drugs you are taking. Drugs that may decrease the effectiveness of the pill include: griseofulvin, many antibiotics (e.g., penicillins, macrolides, tetracyclines, sulfa, quinolones, cephalosporins), chloramphenicol, many seizure medications (e.g., phenytoin, barbiturates, primidone, carbamazepine), dapsone, rifamycins (e.g., rifampin), modafinil, nevirapine, nelfinavir, ritonavir, St John's wort, troglitazone. Ask your doctor if you should use additional birth control methods while taking any of these drugs while taking these birth control pills. Also mention use of: thyroid hormone drugs, theophylline, certain benzodiazepines (e.g., diazepam, chlordiazepoxide), prednisone-like drugs, certain antidepressants (e.g., tricyclics), beta-blockers (e.g., metoprolol), "blood thinners" (anticoagulants such as warfarin), insulin, magnesium trisilicate, levodopa, penicillamine. This product can affect the results of certain lab tests. Make sure laboratory personnel and your doctors know you use this drug. Birth control pills may significantly intensify the effects of alcohol. Consult your doctor or pharmacist about this. Do not start or stop any medicine without doctor or pharmacist approval.

Overdose

If overdose is suspected, contact your local poison control center or emergency room immediately. Symptoms of overdose may include nausea and vomiting. Females may experience vaginal bleeding.

Notes

Do not allow anyone else to take this medication. Keep all appointments with your doctor and the laboratory. You should have a complete physical examination, including blood pressure measurements, breast and pelvic examinations, and a PAP test (for vaginal cancer), at least once a year. Follow your doctor's instructions for examining your own breasts, and report any lumps immediately. An information sheet about this medication should be dispensed with each prescription. Read the information carefully. Ask your doctor or pharmacist any questions you may have.

Missed Dose

If you forget to take a dose, take as soon as you remember. If you do not remember until the next day, take the missed tablet and the tablet for that day. If you miss 2 days in a row, take 2 tablets each day for 2 days, then return to your regular schedule. If you miss three days in a row, stop taking this drug and use another method of birth control until your next period. Begin the next cycle of pills at the prescribed time even if you do not begin to menstruate on schedule at the end of a pill cycle.

Storage

Store at room temperature between 59 and 86 degrees F (between 15 and 30 degrees C) away from moisture and sunlight. Do not store in the bathroom. Keep out of the reach of children.