NORETHINDRONE/ETHINYL ESTRADIOL W/ FERROUS FUMARATE 24/4 - ORAL
HOW TO PRONOUNCE
(nor-ETH-in-drone/ETH-in-ill ess-truh-DYE-ohl with FAIR-us FEW-ma-rate)
COMMON BRAND NAMES
Loestrin 24 Fe
WARNINGS
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.
USES This medication is used to prevent pregnancy. It contains 2
hormones (norethindrone, a progestin, and ethinyl estradiol, an
estrogen). These hormones prevent pregnancy by preventing the release of
an egg (ovulation). They also change the womb and cervical mucus, making
it more difficult for an egg to meet sperm (fertilization) or for the
fertilized egg to attach to the wall of the womb (implantation). There
is a small amount of iron (ferrous fumarate) in each of the 4 inactive
tablets taken during the fourth week. (The inactive pills do not contain
any hormones). These tablets are meant to keep you in the habit of
taking 1 tablet each day and do not have enough iron to treat iron
deficiency. Besides preventing pregnancy, birth control pills have been
shown to help make your periods more regular, decrease blood loss and
painful periods (dysmenorrhea), and decrease ovarian cysts. Use of this
medication does not protect you or your partner against sexually
transmitted diseases (e.g., HIV, gonorrhea, chlamydia).
HOW TO TAKE
Read the Patient Information Leaflet provided by your
pharmacist before you start using this product and each time you get a
refill. The leaflet contains very important information on when to take
your pills and what to do if you miss a dose. If you have any questions,
consult your doctor or pharmacist. Take this medication by mouth with or
without food, once daily or as directed by your doctor. Pick a time of
day that is easy for you to remember, and take your pill at the same
time each day. It is very important to continue taking this medication
exactly as prescribed by your doctor. Follow the package instructions to
find the first tablet, start with the first tablet in the pack, and take
them in the correct order. Do not skip any doses. Pregnancy is more
likely if you miss pills, start a new pack late, or take your pill at a
different time of the day than usual. Taking this medication after your
evening meal or at bedtime may help if you have any stomach upset or
nausea with the medication. You may choose to take this medication at
another time of day that is easier for you to remember. No matter what
dosing schedule you use, it is very important that you take this
medication at the same time each day, 24 hours apart. Ask your doctor or
pharmacist if you have any questions. Your pill pack contains 24 pills
with active medication. It also contains 4 reminder pills with iron.
Take one active pill (with hormones) once daily for 24 days in a row.
Take one inactive pill (with iron) once daily for 4 days in a row after
you have taken the last active pill unless otherwise directed by your
doctor. You should have your period within 3 days after the last active
pill during the fourth week of the pack. After you have taken the last
iron tablet in the pack, start a new pack the next day even if your
period is continuing or if you do not have your period. If you do not
get your period, consult your doctor. If you are taking certain
medications (e.g., cefdinir, levodopa, penicillamine, quinolones such as
ciprofloxacin, tetracyclines) that can interact with iron, ask your
doctor whether you should throw away the reminder pills (iron tablets)
each day rather than taking them. Iron can react with these medications,
preventing their full absorption. If this is the first time you are
using this medication and you are not switching from another form of
hormonal birth control (e.g., patch, other birth control pills), take
the first tablet in the pack on the first Sunday following the beginning
of your period (menstruation) or on the first day of your period. If
your period begins on a Sunday, begin taking this medication on that
day. For the first cycle of use only, use an additional form of
non-hormonal birth control (e.g., condoms, spermicide) for the first 7
days to prevent pregnancy until the medication has enough time to work.
If you start on the first day of your period, you do not need to use
back-up birth control the first week. Ask your doctor or pharmacist for
information about how to switch from other forms of hormonal birth
control (e.g., patch, other birth control pills) to this product. If any
of this information is unclear, consult the Patient Information Leaflet
or your doctor or pharmacist.
SIDE EFFECTS
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 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, confusion, 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: rash, itching,
swelling, severe dizziness, trouble breathing. If you notice other
effects not listed above, contact your doctor or pharmacist.
PRECAUTIONS
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
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, depression, diabetes,
swelling (edema), gallbladder problems, kidney disease, migraine,
obesity, 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 should not be used during pregnancy. If you become
pregnant or think you may be pregnant, inform your doctor immediately.
If you have just given birth and are not breast-feeding, or if you have
had a pregnancy loss or abortion after the first trimester, wait at
least 4 weeks before starting this medication. Talk with your doctor
about other forms of birth control and to find out when it is safe to
start using hormonal birth control. This medication passes into breast
milk. This may affect milk production and may have harmful effects on a
nursing infant. Breast-feeding is not recommended while using this
product. Consult your doctor before breast-feeding.
DRUG INTERACTIONS
Your healthcare professionals (e.g., doctor or
pharmacist) may already be aware of any possible drug interactions and
may be monitoring you for them. Do not start, stop or change the dosage
of any medicine before checking with them first. This drug should not be
used with the following medications because very serious interactions
may occur: aromatase inhibitors (e.g., anastrazole, exemestane), sodium
tetradecyl sulfate, troleandomycin. If you are currently using any of
these medications listed above, tell your doctor or pharmacist before
starting this medication. Before taking this medication, tell your
doctor of all prescription and nonprescription medications you may use,
especially of: raloxifene, tamoxifen, medication for underactive thyroid
(hypothyroidism), drugs that may increase blood levels of this drug
(e.g., acetaminophen, ascorbic acid/vitamin C, atorvastatin, azole
antifungals such as itraconazole/ketoconazole/vaginal miconazole).
Certain drugs can decrease the effectiveness of combination-type birth
control by decreasing the amount of birth control hormones in your
system. This can result in pregnancy. These drugs include: many
antibiotics (e.g., cephalosporins, chloramphenicol, macrolides such as
erythromycin, penicillins, sulfas), aprepitant, bexarotene, bosentan,
dapsone, griseofulvin, certain HIV protease inhibitors (e.g.,
amprenavir, nelfinavir, ritonavir), modafinil, nevirapine,
phenylbutazone, rifamycins (e.g., rifampin), many seizure medications
(e.g., barbiturates, carbamazepine, felbamate, phenytoin, lamotrigine,
topiramate), St. John's wort. Consult your doctor or pharmacist for
details, and ask if you should use additional reliable birth control
methods while taking any of the drugs listed above. This drug can speed
up or slow down the removal of other drugs from your body by affecting
certain liver enzymes. These affected drugs include acetaminophen,
aspirin, certain beta blockers (e.g., metoprolol), clofibrate,
cyclosporine, morphine, corticosteroids such as prednisolone, certain
benzodiazepines such as lorazepam/temazepam, and theophylline, among
others. If you are currently using any of these medications listed
above, tell your doctor or pharmacist before starting this medication.
This medication can affect the results of certain lab tests (e.g., blood
tests for clotting factors, thyroid). Make sure laboratory personnel and
all your doctors know you use this medication.
For more information, please visit www.loestrin24.com
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