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NOLVADEX
NOLVADEX ONLINE
Before Using This Medicine
In deciding to use a medicine, the risks of taking the medicine
must be weighed against the good it will do. This is a decision
you and your doctor will make. For tamoxifen, the following should
be considered:
Allergies—Tell your doctor if you have ever
had any unusual or allergic reaction to tamoxifen.
Pregnancy—Tell your doctor if you are
pregnant or if you intend to become pregnant. Tamoxifen should not
be used to reduce the risk of breast cancer if you are pregnant of
if you intend to become pregnant. Tamoxifen use in women has been
shown to cause miscarriages, birth defects, death of the fetus,
and vaginal bleeding. Studies in rats and rabbits have shown that
tamoxifen causes miscarriages, death of the fetus, and slowed
learning. Studies in animals also have shown that tamoxifen may
cause some of the same problems as those caused by an estrogen
called diethylstilbestrol (DES). DES causes genital tract problems
and, rarely, an increased risk of cancer of the cervix or vagina
in daughters of women who took it during their pregnancy. It is
not known whether tamoxifen causes these same problems.
Be sure that you have discussed this with your doctor before
taking this medicine. It is best to use some kind of birth control
while you are taking tamoxifen and for about 2 months after you
stop taking it. However, do not use oral contraceptives (“the
Pill”) since they may interfere with this medicine. Tell your
doctor right away if you think you have become pregnant while
taking tamoxifen.
Breast-feeding—Because this medicine may
cause serious side effects, breast-feeding is generally not
recommended while you are taking it.
Older adults—Many medicines have not been
studied specifically in older people. Therefore, it may not be
known whether they work exactly the same way they do in younger
adults. Although there is no specific information comparing use of
tamoxifen in the elderly with use in other age groups, this
medicine is not expected to cause different side effects or
problems in older people than it does in younger adults.
Other medicines—Although certain medicines
should not be used together at all, in other cases two different
medicines may be used together even if an interaction might occur.
In these cases, your doctor may want to change the dose, or other
precautions may be necessary. Tell your health care professional
if you are taking any other prescription or nonprescription
(over-the-counter [OTC]) medicine. If you are taking tamoxifen to
reduce the risk of breast cancer, it is especially important that
your health care professional know if you are taking the
following:
 | Anticoagulant, coumarin-type (blood thinners)—Blood
thinners (e.g., warfarin [Coumadin]) should not be used with
tamoxifen when used to reduce the risk of developing breast
cancer in women who have a high risk of developing breast
cancer. If you need to take blood thinners, your blood
clotting times should be monitored by your doctor. |
| Cytotoxic medicines—These are medicines that damage cells.
If you take these medicines with tamoxifen, you may have an
increased risk of blood clots. |
Proper Use of This Medicine
Use this medicine only as directed by your doctor. Do
not use more or less of it, and do not use it more often than your
doctor ordered. The exact amount of medicine you need has been
carefully worked out. Taking too much may increase the chance of
side effects, while taking too little may not improve your
condition.
Tamoxifen sometimes causes mild nausea and vomiting. However,
it may have to be taken for several weeks or months to be
effective. Even if you begin to feel ill, do not stop using
this medicine without first checking with your doctor. Ask
your health care professional for ways to lessen these effects.
Swallow the tablets whole with a drink of water. You can take
the tablets with or without food.
If you vomit shortly after taking a dose of tamoxifen, check
with your doctor. You will be told whether to take the dose again
or to wait until the next scheduled dose.
Dosing—
The dose of tamoxifen will be different for different patients.
Follow your doctor's orders or the directions on the label.
The following information includes only the average doses of
tamoxifen. If your dose is different, do not change it
unless your doctor tells you to do so.
| For oral dosage form (tablets)
| For breast cancer in women or men:
| Adults—20 to 40 milligrams (mg) daily. |
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| For reducing the risk of developing breast cancer in
high-risk women:
| Adults—20 milligrams (mg) a day, for five years |
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| For reducing the risk of developing invasive breast
cancer in women with ductal carcinoma in situ:
| Adults—20 milligrams (mg) a day, for five years |
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Missed dose—
If you miss a dose of this medicine, do not take the missed
dose at all and do not double the next one. Instead, go back to
your regular dosing schedule and check with your doctor.
Storage—
To store this medicine:
| Keep out of the reach of children.
| Store away from heat and direct light.
| Do not store in the bathroom, near the kitchen sink, or in
other damp places. Heat or moisture may cause the medicine to
break down.
| Do not keep outdated medicine or medicine no longer needed.
Be sure that any discarded medicine is out of the reach of
children. |
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Precautions While Using This Medicine
Side Effects of This Medicine
Along with its needed effects, a medicine may cause some
unwanted effects. Some side effects will have signs or symptoms
that you can see or feel. Your doctor will watch for others by
doing certain tests.
Also, because of the way this medicine acts on the body, there
is a chance that it might cause other unwanted effects that may
not occur until months or years after the medicine is used.
Tamoxifen increases the chance of cancer of the uterus (womb) in
some women taking it. Tamoxifen may cause blockages to form in a
vein, lung, or brain. In women, tamoxifen may cause cancer or
other problems of the uterus (womb). It also causes liver cancer
in rats. In addition, tamoxifen has been reported to cause
cataracts and other eye problems. Discuss these possible effects
with your doctor.
Check with your doctor as soon as possible if any of the
following side effects occur:
| For both females and males
| Less common or rare
| Anxiety; blistering, peeling, or loosening of
skin and mucous membranes; blurred vision;
chest pain; confusion; cough;
dizziness; fainting; fast heartbeat;
lightheadedness; pain or swelling in legs;
shortness of breath or trouble breathing;
weakness or sleepiness; yellow eyes or skin |
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| For females only
| Less common or rare
| Change in vaginal discharge; chills ;
fever; hoarseness; lower back or side
pain; pain or feeling of pressure in pelvis;
pain, redness, or swelling in your arm or leg;
painful or difficult urination ; rapid shallow
breathing; skin rash or itching over the entire
body; sweating ; vaginal bleeding;
wheezing |
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| For females and males
| Frequency not determined
| Bloating; constipation; darkened urine;
diarrhea; difficult breathing;
indigestion; itching; joint or muscle
pain; large, hard skin blisters; large
hive-like swelling on face, eyelids, lips, tongue,
throat, hands, legs, feet, and sex organs; loss
of appetite; nausea; pain in stomach or
side, possibly radiating to the back; red,
irritated eyes; red skin lesions, often with a
purple center; sore throat; sores, ulcers
or white spots in mouth or on lips; unusual
tiredness or weakness; vomiting |
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This medicine may also cause the following side effect that
your doctor will watch for:
| For both females and males
| Less common or rare
| Cataracts in the eyes or other eye problems;
liver problems |
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Other side effects may occur that usually do not need medical
attention. These side effects may go away during treatment as your
body adjusts to the medicine. Also, your health care professional
may be able to tell you about ways to prevent or reduce some of
these side effects. Check with your health care professional if
any of the following side effects continue or are bothersome or if
you have any questions about them:
| For both females and males
| Less common
| Bone pain; headache; nausea and/or
vomiting (mild); skin rash or dryness |
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| For females only
| More common
| Absent, missed, or irregular periods;
confusion; decrease in amount of urine;
feeling of warmth redness of the face, neck, arms and
occasionally, upper chest; lower back or side
pain; menstrual changes; nausea;
noisy, rattling breathing; painful or difficult
urination; rapid, shallow breathing; skin
changes; stopping of menstrual bleeding;
swelling of fingers, hands, feet, or lower legs;
troubled breathing at rest; vaginal bleeding;
weight gain; weight loss; white or
brownish vaginal discharge |
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| Less common or rare
| Abdominal cramps; black, tarry stools ;
bleeding gums; blood in urine or stools;
Bluish color changes in skin color ;
discouragement; feeling sad or empty;
irritability; itching in genital area;
lack of appetite; loss of interest or pleasure;
pain; pinpoint red spots on skin; stomach
or pelvic discomfort, aching or heaviness;
swelling ; trouble concentrating; trouble
sleeping; unusual bleeding or bruising |
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| For males only
| Less common
| decreased interest in sexual intercourse;
inability to have or keep an erection; loss in
sexual ability, desire, drive, or performance |
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This medicine may infrequently cause hair thinning or partial
loss of hair.
Other side effects not listed above may also occur in some
patients. If you notice any other effects, check with your doctor.
Additional Information
Once a medicine has been approved for marketing for a certain
use, experience may show that it is also useful for other medical
problems. Although these uses are not included in product
labeling, tamoxifen is used in certain patients with the following
medical conditions:
| Malignant melanoma (a certain type of skin cancer)
| Cancer of the endometrium (lining of the uterus) |
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Other than the above information, there is no additional
information relating to proper use, precautions, or side effects
for these uses.
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