A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Femhrt Patient, Information, Instructions - Norethindrone acetate and ethinyl estradiol
Femhrt Patient, Information, Instructions - Norethindrone acetate and ethinyl estradiol
PATIENT INFORMATION
Please read this PATIENT INFORMATION before you start taking
femhrt 1/5 and each time you refill femhrt. There may be new information.
This information does not take the place of talking to your healthcare provider
about your medical condition or your treatment.
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What is the most important information I should know
about femhrt 1/5 (a combination of estrogen and progestin hormones)?
· Do not use estrogens and
progestins to prevent heart disease, heart attacks, or strokes.
Using estrogens and progestins may increase your chances
of getting heart attack, strokes, breast cancer, and blood clots. You
and your healthcare provider should talk regularly about whether you still
need treatment with femhrt 1/5.
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What is femhrtÒ
1/5?
Your healthcare provider has prescribed femhrt 1/5,
a combination of two hormones, a progestin (1 mg norethindrone acetate) and
an estrogen (5 mcg ethinyl estradiol) intended for use once a day. This insert
describes the major benefits and risks of your treatment, as well as how and
when treatment may be taken. If you have any questions, please contact your
physician, nurse or pharmacist. femhrt 1/5 is approved for use in
the following ways:
· To reduce moderate to severe
hot flashes Estrogens are hormones produced by the ovaries of menstruating
women. When a woman is between the ages of 45 and 55, the ovaries normally stop
making estrogens. This drop in body estrogen levels causes the "change
of life" or menopause, the end of monthly menstrual periods. Sometimes
both ovaries are removed during an operation before natural menopause takes
place. The sudden drop in estrogen levels causes "surgical menopause."
When estrogen levels begin dropping, some women develop very
uncomfortable symptoms, such as feelings of warmth in the face, neck, and chest,
or sudden intense episodes of heat and sweating ("hot flashes" or
"hot flushes"). In some women the symptoms are mild; in others they
can be severe.You and your healthcare provider should talk regularly about whether
you still need treatment with femhrt 1/5.
· To prevent thinning bones
(osteoporosis). Osteoporosis is a thinning of the bones that makes them
weaker and allows them to break more easily. The bones of the spine, wrists,
and hips may be affected by osteoporosis. If you use femhrt 1/5 only
to prevent osteoporosis from menopause, talk with your healthcare provider about
whether a different treatment or medicine without estrogens may be better for
you. You and your healthcare provider should talk regularly about whether you
should continue taking femhrt 1/5.
Weight-bearing exercise, like walking or running, and taking
calcium and vitamin D supplements may also lower your chances of getting postmenopausal
osteoporosis. It is important to talk about exercise and supplements with your
healthcare provider before starting them.
Women likely to develop osteoporosis often have the following
characteristics: white or Asian race, slim, cigarette smokers, and a family
history of osteoporosis in a mother, sister or aunt. Women who have menopause
at an earlier age, either naturally or because their ovaries were removed during
an operation, are more likely to develop osteoporosis than women whose menopause
happens later in life.
Who should not take femhrt 1/5? femhrt
1/5 should not be taken in the following situations:
· During pregnancy. If
you think you may be pregnant, do not take femhrt 1/5.
· If you have unusual vaginal
bleeding that has not been checked by your healthcare provider. Unusual
vaginal bleeding can be a warning sign of a serious condition, including cancer
of the uterus, especially if bleeding happens after menopause. Your doctor must
find out the cause of the bleeding to recommend the right treatment.
· If you currently have or
have had certain cancers. Estrogens increase the risk of certain types of
cancers, including cancer of the breast and uterus. If you have or had cancer,
talk with your doctor about whether you should take femhrt 1/5.
· If you currently have or
have had blood clots. (see "What are the possible risks and side effects
of femhrt 1/5?").
· If you have had a stroke
or heart attack in the past year.
· After childbirth or when
breast-feeding a baby. femhrt 1/5 should not be taken to try to stop
the breasts from filling with milk after a baby is born.
· If you have had a hysterectomy
(uterus removed). femhrt 1/5 contains a progestin to decrease the
risk of developing endometrial hyperplasia (an overgrowth of the lining of the
uterus that may lead to cancer). If you do not have a uterus, you do not need
a progestin, and you should not take femhrt 1/5.
· If you are allergic to femhrt
1/5 or any of its ingredients. See the end of this leaflet for a list
of ingredients in femhrt 1/5.
Tell your healthcare provider:
· About all of your medical
problems. Your healthcare provider may need to check you more carefully
if you have certain conditions, such as asthma (wheezing), epilepsy (seizures),
migraine, endometriosis, or problems with your heart, liver, thyroid, kidneys,
or have high calcium levels in your blood.
· About all the medicines
you take, including prescription and nonprescription medicines, vitamins,
and herbal supplements. Some medicines may affect how femhrt 1/5 works.
femhrt 1/5 may also affect how your other medicines work.
· If you are going to have
surgery or will be on bed rest. You may need to stop taking estrogens and
progestins.
How should I take femhrt 1/5?
Take your femhrt 1/5 pill once a day at about the same
time each day. If you miss a dose, take it as soon as you remember. If it is
almost time for your next dose, skip the missed dose and take only your next
regularly scheduled dose. Do not take two doses at the same time. Estrogens
should only be used as long as needed. You and your healthcare provider should
reevaluate every 3 to 6 months whether or not you still need treatment with
femhrt 1/5.
What are the possible risks and side effects of femhrt 1/5?
· Heart Disease. femhrt
1/5 should not be used to treat or prevent heart disease. Studies show that
taking estrogen/progestin therapy may increase your risk of heart disease.
· Cancer of the breast.
Studies show that taking estrogen/progestin therapy may increase your risk for
getting breast cancer. You should have regular breast examinations by a health
professional and examine your own breasts monthly. Ask your healthcare provider
to show you how to do a breast exam yourself. If you are over 50 years of age,
you should have a mammogram every year.
· Cancer of the uterus.
femhrt 1/5 has estrogen and progestin in it. If you take any drug that
contains estrogen, including femhrt, you should see your doctor for regular
check-ups and report any unusual vaginal bleeding right away. Vaginal bleeding
after menopause may be a warning sign of a serious condition, including cancer
of the uterus. Your doctor should identify the cause of any unusual vaginal
bleeding. The risk of cancer of the uterus increases when estrogens are used
without a progestin. The risk also increases the longer estrogens are taken
and the larger the doses. You are more likely to get cancer of the uterus if
you are overweight, diabetic, or have high blood pressure. femhrt 1/5,
which contains a progestin, reduces the estrogen-related risk of getting a condition
of the uterine lining called endometrial hyperplasia. This condition may lead
to cancer of the uterus (see "Other Information").
· Gallbladder disease. Women
who use estrogens after menopause are more likely to develop gallbladder disease
that leads to surgery than women who do not use estrogens.
· Abnormal blood clotting.
Taking estrogens may cause changes in your blood clotting system that allow
the blood to clot more easily. If blood clots form in your bloodstream, they
can cut off the blood supply to vital organs, causing serious problems. These
problems may include a stroke (by cutting off blood to the brain), a heart attack
(by cutting of blood to the heart), or a pulmonary embolus (by cutting off blood
supply to the lungs). Any of these conditions may cause death or serious long-term
disability.
· Vaginal bleeding. With
femhrt 1/5, menstrual-like vaginal bleeding may occur. If bleeding occurs, it
is frequently light spotting or bleeding, but it may be moderate or heavy. If
you experience vaginal bleeding while taking femhrt 1/5, discuss your bleeding
pattern with your healthcare provider.
In addition to the risks and side effects just listed, patients
taking estrogen or progestin have reported the following side effects:
· nausea and vomiting
· breast tenderness or enlargement
· headache
· retention of extra fluid (edema),
which may make some conditions worse, such as asthma, epilepsy, migraine, heart
disease, or kidney disease
· runny nose
· abdominal pain
· enlargement of non-cancerous
tumors (fibroids) of the uterus
· spotty darkening of the skin,
particularly on the face; reddening of the skin; skin rashes These are not all
the possible side effects of femhrt 1/5. For more information, ask your healthcare
provider or pharmacist.
How can I reduce the risks associated with taking femhrt 1/5?
If you take femhrt 1/5, you can reduce your risks by carefully
monitoring your treatment.
· See your healthcare provider
regularly. Talk with your healthcare provider regularly (every 3-6 months)
about whether you should continue taking femhrt 1/5.
· See your healthcare provider
right away if you develop vaginal bleeding while taking femhrt 1/5.
· Have a breast exam and mammogram
(breast x-ray) every year unless your healthcare provider tells you something
else. If members of your family have had breast cancer or if you have ever
had breast lumps or an abnormal mammogram (breast x-ray), you may need more
frequent breast examinations.
· If you have high blood pressure,
high cholesterol (fat in the blood), diabetes, are overweight, or use tobacco,
you may have higher chances for getting heart disease. Ask your healthcare
provider for ways of lowering your chances for getting heart disease.
· Be alert for signs of trouble.
If any of the following warning signs (or any other unusual symptoms) happen
while you are taking femhrt 1/5, call your doctor right away:
· pains in the calves or chest,
sudden shortness of breath, or coughing blood (possible clots in the legs, heart,
or lungs)
· severe headache or vomiting, dizziness,
faintness, or changes in vision or speech, weakness or numbness of an arm or
leg (possible clots in the brain or eye)
· breast lumps (possible breast
cancer)
· yellowing of the skin or whites
of the eyes (possible liver problem)
· pain, swelling, or tenderness
in the abdomen (possible gallbladder problem)
Other Information
· Discuss carefully with your
doctor or healthcare provider all the possible risks and benefits of estrogen
and progestin treatment as they affect you personally.
· If you take calcium supplements
as part of your treatment to help prevent osteoporosis, ask your doctor about
the amounts recommended. A daily intake of 1500 mg of calcium is often recommended
for postmenopausal women. Vitamin D (400 IU daily) may help your body use more
of the calcium.
· Taking estrogens with progestins
may have unhealthy effects on blood sugar, which might make a diabetic condition
worse.
· Your doctor has prescribed
this drug for you and you alone. Do not give your femhrt 1/5 to anyone else.
Do not take femhrt 1/5 for conditions for which it was not prescribed.
· Keep all drugs out of the reach
of children. In case of overdose, call you doctor, hospital, or poison control
center right away. What are the ingredients in femhrt 1/5? Each white D-shaped
tablet contains 1 mg norethindrone acetate [19-Norpregn-4-en-20-yn-3-one, 17-(acetyloxy)-,
(17a)-] and 5 mcg ethinyl estradiol [19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol,
(17a)-]. Each tablet also contains calcium stearate,
lactose monohydrate, microcrystalline cellulose, and cornstarch. This leaflet
provides the most important information about femhrt 1/5. If you want more information,
ask your doctor or pharmacist for the professional labeling. The professional
labeling is published in a book called "The Physicians’ Desk Reference"
or PDR, available in bookstores and public libraries. Manufactured by: Duramed
Pharmaceuticals, Inc. Cincinnati, OH 45213
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