See also Warning section.
Before using this medication, tell your doctor or pharmacist if you are allergic to ethinyl estradiol, norethindrone acetate, or ferrous fumarate; or to other estrogens, progestins or iron products; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
This medication should not be used if you have certain medical conditions. Before using this product, consult your doctor or pharmacist if you have:
- history of stroke or other blood clots (e.g., in the legs, eyes, lungs)
- severe high blood pressure
- abnormal breast exam
- cancer (especially endometrial or breast cancer)
- diabetes that has caused kidney/eye/nerve/blood vessel disease
- severe headaches
- history of heart disease (e.g., heart attack, chest pain)
- heart valve disease
- liver problems (e.g., liver tumor, active liver disease)
- current or suspected pregnancy
- recent major surgery
- long periods of sitting or lying down (e.g., immobility such as being bedridden)
- history of yellowing eyes/skin (jaundice) during pregnancy or while using birth control pills
- unexplained vaginal bleeding
- heavy tobacco use (especially if 35 or over)
Before using this product, tell your doctor your medical history, especially of:
- high blood pressure
- high cholesterol or triglyceride (blood fat) levels
- swelling (edema)
- gallbladder problems
- kidney disease
- irregular/missed/very light periods
- recent pregnancy
- thyroid problems
Do not smoke cigarettes or use tobacco. Hormonal birth control (e.g., pills, injections, devices) combined with smoking significantly increases your risk for stroke, blood clots, high blood pressure, and heart attacks, especially in women older than 35. For more details, ask your doctor or pharmacist, or consult the Patient Information Leaflet that comes with this product.
If you have diabetes, this medication may make it harder to control your blood sugar levels. Monitor your blood sugar regularly as directed by your doctor. Tell your doctor the results and any symptoms such as increased thirst/urination. Your anti-diabetic medication or diet may need to be adjusted.
Notify your doctor beforehand if you will be having surgery or will be confined to a chair/bed for a long time (e.g., a long plane flight). You may need to stop the medication for a time or take special precautions.
This medication may cause blotchy, dark areas on your skin (melasma). Sunlight may worsen this effect. Avoid prolonged sun exposure, sunlamps, and tanning booths. Use a sunscreen, and wear protective clothing when outdoors.
If you are nearsighted or wear contact lenses, you may develop vision problems or trouble wearing your contact lenses. Contact your eye doctor if these problems occur.
It may take longer for you to become pregnant after you stop taking birth control pills. Consult your doctor.
This medication must not be used during pregnancy. If you become pregnant or think you may be pregnant, tell your doctor immediately. If you have just given birth or had a pregnancy loss/abortion after the first 3 months, talk with your doctor about reliable forms of birth control, and find out when it is safe to start using birth control that contains a form of estrogen, such as this medication.
This medication passes into breast milk. This may affect milk production and may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.
Nausea, vomiting, headache, stomach cramping/bloating, dizziness, vaginal discomfort/irritation, increased vaginal fluids, or breast tenderness/enlargement may occur. Acne may improve or get worse. Vaginal bleeding between periods (spotting) or missed/irregular periods may occur, especially during the first few months of use. If any of these effects persist or worsen, notify your doctor promptly. If you miss 2 periods in a row (or 1 period if the pill has not been used properly), contact your doctor for a pregnancy test.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor immediately if any of these serious side effects occur:
- changes in vaginal bleeding (e.g., continuous spotting, sudden heavy bleeding, missed periods)
- problem wearing contact lenses
- dark patches on the skin (melasma)
- unwanted facial/body hair
- swelling of the ankles/feet
- weight changes (gain or loss)
This medication may rarely cause serious (sometimes fatal) problems from blood clots (e.g., pulmonary embolism, stroke, heart attack). Seek immediate medical attention if you experience:
- sudden shortness of breath
- chest/jaw/left arm pain
- coughing up blood
- sudden dizziness/fainting
- pain/swelling/warmth in the groin/calf
- tingling/weakness/numbness in the arms/legs
- headaches that are different from those you may have experienced in the past (e.g., headaches with other symptoms such as vision changes/lack of coordination, existing migraines becoming worse, sudden/very severe headaches)
- slurred speech
- weakness on one side of the body
- vision problems/changes
Tell your doctor immediately if any of these rare but very serious side effects occur:
- lumps in the breast
- severe stomach/abdominal/pelvic pain
- mental/mood changes (e.g., depression, suicidal thoughts, persistent trouble sleeping)
- unusual tiredness
- dark urine
- yellowing eyes/skin
A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include:
- itching/swelling (especially of the face/tongue/throat)
- severe dizziness
- trouble breathing
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Smoking cigarettes/using tobacco while using hormonal birth control (pill/patch/ring) increases your risk of heart problems and stroke. Do not smoke. The risk of heart problems increases with age (especially in women over 35) and with frequent smoking (15 or more cigarettes a day).
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 overdose does occur, seek immediate medical attention or call a poison control center.