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
Climara Patient, Information, Instructions - Estradiol transdermal
Climara Patient, Information, Instructions - Estradiol transdermal
PATIENT INFORMATION
The CIimara® patch that your healthcare provider
has prescribed for you releases small amounts of an estrogen hormone through
the skin. This leaflet describes the risks and benefits of treatment with Climara®.
Climara® is not for everyone. Talk to your healthcare
provider if you have any questions or concerns about this medicine.
WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT
CLIMARA®?
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ESTROGENS INCREASE THE RISK OF CANCER OF THE UTERUS
If you use any drug that contains estrogen, it is important
to visit your doctor or healthcare provider regularly and report any unusual
vaginal bleeding right away. Vaginal bleeding after menopause may be a
warning sign of uterine cancer. Your doctor or healthcare provider should
evaluate any unusual vaginal bleeding to find out the cause. Women who
do not have a uterus have no risk of endometrial cancer.
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What is Climara®?
Climara® (pronounced Cly-MARE-a) is a patch
that contains an estrogen hormone called 17b-estradiol.
When applied to the skin as directed below, the Climara® patch
releases estrogen through the skin into the bloodstream.
CLIMARA® IS APPROVED FOR USE IN THE
FOLLOWING WAYS:
To reduce moderate or severe menopausal symptoms.
Estrogens are hormones made by a womans ovaries. 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). If both ovaries are removed during an
operation before natural menopause takes place, the sudden drop in estrogen
levels causes "surgical menopause." When the 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 and in others they can be severe. Using estrogen drugs
can help the body adjust to lower estrogen levels and reduce these symptoms.
Most women have only mild menopausal symptoms or none at all and do not need
to use estrogen drugs for these symptoms. Others may need to take estrogens
for a few months while their bodies adjust to lower estrogen levels. The majority
of women do not need estrogen replacement for longer than six months for these
symptoms.
To treat itching, burning and dryness in and
around the vagina associated with menopause.
To treat certain conditions in which a young
womans ovaries do not produce enough estrogen naturally.
To help reduce your chances of getting osteoporosis
(thin weak bones).
Osteoporosis is a thinning of the bones that makes them weaker
and allows them to break more easily. Climara® may be
used as part of a program of weight-bearing exercise like walking and running
and calcium supplements to reduce your chances of getting osteoporosis. Before
you change your calcium intake or exercise habits, it is important to discuss
these lifestyle changes with your doctor to find out if they are safe for you.
Women who are more likely to develop osteoporosis often have one or more of
the following characteristics: white or Asian race, slim body frame, 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 USE CLIMARA®
Climara® should not be used in the following
situations:
During pregnancy.
If you think you may be pregnant, do not use Climara®.
Using Climara® while you are pregnant may harm your unborn
child. Do not use Climara® to prevent miscarriage.
If you have unusual vaginal bleeding that has
not been checked by your healthcare provider.
Unusual vaginal bleeding can be a warning sign of serious conditions
including cancer of the uterus, especially if it happens after menopause. Your
healthcare provider must find out the cause of the bleeding so that he or she
can recommend the proper treatment.
If you have had cancer.
Estrogens increase the risk of certain types of cancer, including
cancer of the breast or uterus. If you have had cancer, talk to your healthcare
provider about the use of Climara®.
If you have any circulation problems.
Talk with your doctor about your condition. Do not take Climara®
if you have blood clots or have had them in the past.
After childbirth or when breastfeedlng a baby.
Do not use Climara® to stop the breasts
from filling with milk after a baby is born.
If you are allergic to Climara® or
any of the ingredients in it.
How and Where to Apply the Climara® Patch
Each Climara® patch is individually sealed
in a protective pouch. To open the pouch, hold it vertically with the Climara®
name facing you. Tear off the top of the pouch using the top tear
notch. Tear off the side of the pouch using the side tear notch. Pull the pouch
open. The Climara® patch is the see-through plastic film
attached to the clear thicker plastic backing. There is a silver foil-sticker
attached to the inside of the pouch. Do not remove it from the pouch. The
sticker contains a moisture protectant (desiccant). Lift out the Climara®
patch. Notice that the patch is attached to a thicker, hard-plastic
backing and that the patch itself is oval and see-through.
Apply the sticky side of the Climara® patch
to a clean, dry area of the lower stomach below your belly button or the top
of the buttocks. Do not apply the Climara® patch
to your breasts. The sites of application on the lower stomach and buttocks
must be rotated, allowing at least 1 week between applications to the same site.
The site selected should not be oily, damaged, or irritated. Avoid the waistline,
since tight clothing may rub and remove the patch. Also, do not put the patch
on areas where sitting would rub it off or loosen it. Apply the patch right
after opening the pouch and removing the protective liner. Press the patch firmly
in place with your fingers for about 10 seconds. Make sure that it sticks all
over, especially around the edges.
The Climara® patch should be worn continuously
for one week. You may wish to try different sites when putting on a new patch,
to find ones that are most comfortable for you and where clothing will not rub
on the patch or loosen it.
When to Apply the Climara® System?
The Climara® patch should be changed
once a week.
When changing the patch, peel off the used Climara®
patch and throw it away. Any sticky material that might stay on your
skin can be easily rubbed off. Then place a new Climara® patch
on a different skin site. (Do not use the same skin site for at least 1 week.)
Tub bathing or swimming could loosen the patch. In the event that a patch should
fall off, a new patch should be put on for the rest of the 7-day period.
WHAT ARE THE POSSIBLE RISKS AND SIDE EFFECTS OF CLIMARA®?
Common side effects include:
Nausea and vomiting.
Breast tenderness or enlargement.
Enlargement of benign tumors ("fibroids") of the uterus.
Retention of excess fluid. This may make some conditions worsen, such as
asthma, epilepsy, migraine, heart disease, or kidney disease.
A spotty darkening of the skin, particularly on the face. Less common but
serious effects include:
Cancer of the uterus.
Cancer of the breast.
Gallbladder disease.
Abnormal blood clotting.
If any of the following warning signals (or any other unusual
symptoms) happen while you are using Climara®, call your
healthcare provider right away:
Abnormal bleeding from the vagina (possible uterine cancer).
Pains in the calves or chest, sudden shortness of breath, or coughing blood
(possible clot in the legs, heart, or lungs).
Severe headache or vomiting, dizziness, faintness, changes in vision or
speech, weakness or numbness of an arm or leg (possible clot In the brain
or eye).
Breast lumps (possible breast cancer). Check your breasts every month.
Ask your doctor or health professional to show you how to examine
your breasts.
Yellowing of the skin or whites of the eyes (possible liver problem).
Pain, swelling, or tenderness in the abdomen (stomach area; possible gallbladder
problem).
What can I do to lower my chances of getting a serious side
effect with Climara®?
If you use Climara®, you can reduce your
risks by doing these things:
See your healthcare provider regularly.
While you are using Climara®, it is important
to visit your healthcare provider at least once a year for a check-up. If you
develop vaginal bleeding while taking Climara®, you may
need further evaluation. 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 to have more frequent breast examinations.
Do not store above 86°F (30°C). Do not store unpouched. Apply
immediately upon removal from the protective pouch.
Medicines are sometimes prescribed for conditions that are
not mentioned in patient information leaflets. Do not use Climara®
for a condition for which it was not prescribed. Do not give Climara®
to other people, even if they have the same symptoms you have. It
may harm them.
This leaflet summarizes the most important information about
Climara®. If you would like more information, talk with
your healthcare provider. You can ask for information about Climara®
that is written for health professionals.
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