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
CombiPatch Patient, Information, Instructions - Estradiol/norethindrone Acetate
CombiPatch Patient, Information, Instructions - Estradiol/norethindrone Acetate
PATIENT
INFORMATION
CombiPatch®
(estradiol/norethindrone acetate transdermal system)
Read this PATIENT INFORMATION
before you start taking CombiPatch® (estradiol/norethindrone
acetate transdermal system) and read all the information that you get each time
you refill CombiPatch. There may be new information. This information does not
take the place of talking to your health care provider about your medical condition
or your treatment.
What is the most important information I should know about CombiPatch
(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 attacks, strokes, breast cancer, and blood clots. You
and your health care provider should talk regularly about whether you still
need treatment with Combi-Patch and whether you are taking the lowest dose that
works for you.
What is CombiPatch?
CombiPatch® is a medicine that contains two
kinds of hormones, estrogen and progestin CombiPatch, when applied to the skin
on your lower abdomen, releases small amounts of these two hormones every day.
These hormones travel through your skin into your bloodstream. The first hormone,
estradiol is an estrogen, the same hormone that your ovaries produced before
menopause. The second hormone is norethindrone acetate (abbreviated as NETA),
a progestin similar to the progesterone hormones your body used to produce naturally.
CombiPatch is available in two round sizes:
|
System Size
|
Amount of Each Drug in Each System Estradiol / NETA (mg)
|
Amount of Each Drug Released Every Day Estradiol / NETA
(mg per day)
|
|
9 sq cm
|
0.62 / 2.7
|
0.05 / 0.14
|
|
16 sq cm
|
0.51 / 4.8
|
0.05 / 0.25
|
What is CombiPatch used for?
CombiPatch is used after the menopause to:
reduce moderate to severe hot flashes.
Estrogens are hormones made by a womans ovaries. The ovaries
normally stop making estrogens when a woman is between 45 and 55 years old.
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 the estrogen levels begin dropping, some women develop
very uncomfortable symptoms, such as feelings of warmth in the face, neck, and
chest or sudden strong feelings of heat and sweating ("hot flashes"
or "hot flushes"). In some women the symptoms are mild, and they will
not need estrogens. In other women, symptoms can be more severe. You and your
health care provider should talk regularly about whether you still need treatment
with CombiPatch.
treat moderate to severe dryness, itching and burning
in or around the vagina. You and your health care provider should talk regularly
about whether you still need treatment with CombiPatch to control these problems.
treat certain conditions in which a young womans ovaries
do not produce enough estrogens naturally.
Who should not take CombiPatch?
Do not take CombiPatch if you have had your uterus removed
(hysterectomy). CombiPatch contains a progestin to decrease the chances
of getting cancer of the uterus. If you do not have a uterus, you do not need
a progestin and you should not take CombiPatch.
Do not start taking CombiPatch if you:
have unusual vaginal bleeding
currently have or have had certain cancers.
Estrogens may increase the chances of getting certain types
of cancers, including cancer of the breast or uterus. If you have or had cancer,
talk with your health care provider about whether you should take CombiPatch.
had a stroke or heart attack in the recent past (for example
in the past year).
currently have or have had blood clots.
are allergic to CombiPatch or any of its ingredients.
See the end of this leaflet for a list of ingredients in CombiPatch.
think you may be, or know that you are, pregnant.
Tell your health care provider:
if you are breastfeeding. The hormones in CombiPatch
can pass into your milk.
about all of your medical problems: Your health care
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 CombiPatch works. CombiPatch may also affect how other medicines
work.
if you are going to have surgery or will be on bed rest.
You may need to stop taking estrogens.
How should I use CombiPatch?
Estrogens should be used only as long as needed and at the
lowest possible dose that works. You and your health care provider should talk
regularly (for example every 3 to 6 months) about whether you still need treatment
with CombiPatch.
CombiPatch is a thin, opaque, plastic patch that sticks to
the skin. Each patch is sealed in a pouch that protects it until you are ready
to put it on. Do not open the pouch or remove a patch until just before you
apply it.
How often should you apply CombiPatch®?
Put on a new CombiPatch every 3 to 4 days, according to your
healthcare provider's instructions
Wear the patch all the time until it is time to replace it
with a new patch
Change the patch on the same two days each week. Your
CombiPatch package contains a calendar checklist to help you remember a schedule.
Mark the schedule you plan to follow.
Only one CombiPatch should be worn at any one time
Where do you apply CombiPatch®?
CombiPatch® (estradiol/norethindrone acetate
transdermal system) should be placed on the lower abdomen (below the panty line).
For best results, choose:
A smooth (fold free), clean, dry area of skin
An area that has been freshly washed and dried well (free
of oils, lotions or powders that could keep the patch from sticking well to
your skin)
An area that has no cuts, rashes, or other skin problems
Every time you put on a new CombiPatch, move to a different
area on your lower abdomen than used before. The same area should not be used
again for at least 1 week.
Do not put CombiPatch on or near your breasts. You should
not put CombiPatch on the waistline, since tight clothing may rub off the patch.
To avoid disturbing the patch it may help to choose an area where your underwear
will cover it all the time.
How do you apply CombiPatch®?
Each CombiPatch is sealed in its own protective pouch. Tear
open this pouch at the slit (do not use scissors) and remove the patch. The
pouch should not be opened until you are ready to put the patch on
A protective liner covers the adhesive side of the patch.
Peel off one side of the protective liner. Do not touch the sticky part of the
patch with your fingers
Put the sticky side of the patch on an area of skin on your
lower abdomen. Peel off the second side of the protective liner
Press the patch firmly in place with your hand for about
10 seconds. Make sure there is good contact, especially around the edges
When changing CombiPatch, peel off the used patch slowly. Fold
the used patch in half (sticky sides together) and throw it in the trash.
Please remember to keep CombiPatch out of the reach of children.
If any adhesive remains on your skin after removal of the patch,
let the area dry for 15 minutes. Then gently rub the area with an oil-based
cream or lotion to remove the adhesive from your skin.
What if you forget to put on a new CombiPatch®?
If you are currently wearing a patch, remove it and put on
a new patch in a different area of your lower abdomen. Then go back to changing
the patch on the same days each week.
Can you wear CombiPatch when bathing, swimming, or in the sun?
Bathing, swimming, or showering should not affect the patch.
Make sure that the patch does not loosen during these activities
The patch should not be exposed to the sun for long periods
of time. Once in place, make sure that the patch is covered by your clothing
(but remember not to apply CombiPatch on or near your breasts)
What should I do if CombiPatch® comes
off?
Most women find that CombiPatch seldom comes off. But if a
patch should fall off, the same patch may be put on a different area of the
lower abdomen (make sure you are choosing a clean, dry, lotion-free area of
skin). If the patch will not stick completely to your skin, put a new CombiPatch
on a different area of the lower abdomen. No matter what day this happens, go
back to changing the patch on the same days each week.
What are the possible side effects of estrogens?
Less common but serious side effects include:
¾ Breast cancer
¾ Cancer of the uterus
¾ Stroke
¾ Heart attack
¾ Blood clots
¾ Gallbladder disease
¾ Ovarian cancer
These are some of the warning signs of serious side effects:
¾ Breast lumps
¾ Unusual vaginal bleeding
¾ Dizziness and faintness
¾ Changes in speech
¾ Severe headaches
¾ Chest pain
¾ Shortness of breath
¾ Pains in your legs
¾ Changes in vision
¾ Vomiting
Call your health care provider right away if you get any of
these warning signs, or any other unusual symptom that concerns you
Common side effects include:
¾ Headache
¾ Breast pain
¾ Irregular vaginal bleeding or spotting
¾ Stomach/abdominal cramps, bloating
¾ Nausea and vomiting
¾ Hair loss
Other side effects include:
¾ High blood pressure.
¾ Liver problems
¾ High blood sugar. Taking oral medicines
that have an estrogen and/or progestin in them may have effects on blood sugar
levels. This may make a diabetic condition worse. Similar blood sugar effects
have not been reported in women who used estradiol/NETA skin patches, such
as CombiPatch.
¾ Fluid retention
¾ Enlargement of benign tumors of the uterus
("fibroids")
¾ Vaginal yeast infection Other side effects
of CombiPatch are possible. For more information, ask your health care provider
or pharmacist.
What can I do to lower my chances of a serious side effect
with CombiPatch?
Talk with your health care provider regularly about whether you should
continue taking CombiPatch.
See your health care provider right away if you get vaginal bleeding while
taking CombiPatch.
Have a breast exam and mammogram (breast X-ray) every year unless your
health care 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,
you may need to have breast exams more often.
If you have high blood pressure, high cholesterol (fat in the blood), diabetes,
are overweight, or if you use tobacco, you may have higher chances for getting
heart disease. Ask your health care provider for ways to lower your chances
for getting heart disease.
General information about the safe and effective use of CombiPatch
Medicines are sometimes prescribed for conditions that are
not mentioned in patient information leaflets. Do not take CombiPatch for conditions
for which it was not prescribed. Do not give CombiPatch to other people, even
if they have the same symptoms you have. It may harm them. Keep CombiPatch
out of the reach of children.
This leaflet provides a summary of the most important information
about CombiPatch. If you would like more information, talk with your health
care provider or pharmacist. You can ask for information about CombiPatch that
is written for health professionals. You can get more information by calling
the toll free number (888-NOW-NOVA (888-669-6682)
What are the ingredients in CombiPatch?
CombiPatch transdermal systems are comprised of three layers.
Proceeding from the visible surface toward the surface attached to the skin,
these layers are (1) a translucent polyolefin film backing, (2) an adhesive
layer containing estradiol, norethindrone acetate, acrylic adhesive, silicone
adhesive, oleyl alcohol, oleic acid NF, povidone USP and dipropylene glycol,
and (3) a polyester release protective liner, which is attached to the adhesive
surface and must be removed before the system can be used. The active components
of the system are estradiol USP and norethindrone acetate USP. The remaining
components of the system are pharmacologically inactive.
Where should you store CombiPatch?
Each CombiPatch is sealed in its own pouch. To protect the
medication, store the patch in the pouch until you are ready to use it.
Before CombiPatch was sold to you, the pharmacist stored the
package in the refrigerator. You can store CombiPatch at room temperature,
below 77ΊF (25ΊC). The patch sticks best to your skin when
stored at room temperature. For best results, DO NOT store CombiPatch patches
in the refrigerator or in areas where the temperature can become extreme (very
high or very low), such as in DIRECT SUNLIGHT or in a car.
Keep this and all medicines out of the reach of children.
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