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ESTRADOT 37.5 MICROGRAMS/24 HOURS TRANSDERMAL PATCH

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PACKAGE LEAFLET: INFORMATION FOR THE USER

ESTRADOT® / ESTRADIOL
37.5, 50, 75 and 100 micrograms/24 hours transdermal patch
(Estradiol)

Your medicine is known by one of the above names, but will be
referred to as Estradot throughout this leaflet
Read all of this leaflet carefully before you start using this
medicine.
 Keep this leaflet. You may need to read it again.
 If you have any further questions, ask your doctor or
pharmacist.
 This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if their symptoms are the same
as yours.
 If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or
pharmacist.
In this leaflet:
1. What Estradot is and what it is used for
2. Before you use Estradot
3. How to use Estradot
4. Possible side effects
5. How to store Estradot
6. Further information

1. WHAT ESTRADOT IS AND WHAT IT IS USED
FOR
Estradot is a hormone replacement therapy (HRT) and contains
the hormone oestrogen.
Estradot comes as a patch that is applied to the skin. The patch
releases small amounts of estradiol, which pass directly through
the skin into your bloodstream. Estradiol is identical to the natural
hormone oestrogen that is produced by the ovaries until the
menopause (the time when your menstrual periods stop).
Estradot is used for:
Relief of symptoms of the menopause
During the menopause, the amount of oestrogen produced by a
woman’s body drops. For some women this can cause unpleasant
symptoms such as hot face, neck and chest ("hot flushes"), sleep
problems, irritability and depression. Some women also have
problems with dryness of the vagina, which may cause discomfort
during or after sexual intercourse. Estradot can reduce or stop
these symptoms after the menopause.
Prevention of osteoporosis (for Estradot 50, 75 and 100 only)
Reduced oestrogen can increase the risk of osteoporosis.
Osteoporosis is a thinning of the bones that makes them weaker
and more likely to break. Taking oestrogens after the menopause
slows down bone loss and can help to prevent osteoporosis.
Estradot may be used to prevent osteoporosis after the menopause
in women who are at an increased risk of fractures but who are
unable to use other drugs approved for the prevention of
osteoporosis. Your doctor should discuss all the available options
with you.
The experience treating women older than 65 years is limited.

2. BEFORE YOU USE ESTRADOT
Do not use Estradot

 if you have, or have ever had breast cancer, or think you might
have it;
 if you have or have ever had any cancer which is sensitive to
oestrogens, such as cancer of the lining of the womb
(endometrium), or think you might have it;
 if you have vaginal bleeding of unknown cause;
 if you have abnormal growth of the womb lining
(endometrial hyperplasia) and you have not been treated for
this yet;
 if you have or have ever had a blood clot in your veins. This
may cause blockage of a blood vessel in the legs (deep vein







thrombosis) leading to thromboembolism, e.g. in the lungs
(pulmonary embolism) or other organs;
if you have thrombophilic disorders (e.g. protein C, protein S or
antithrombin deficiency);
if you have or have ever had a heart attack, stroke or severe
chest pain due to angina (angina pectoris);
if you have or have ever had a liver disease and your liver
function has not returned to normal;
if you have porphyria (red blood pigment in your urine);
if you are allergic to estradiol or any of the other ingredients of
Estradot;

Tell your doctor if any of these applies to you. You should not
receive Estradot.

Take special care with Estradot
Estradot is not a transdermal contraceptive nor a fertility
treatment. If you are still capable of becoming pregnant you must
not use any hormone replacement therapy.
Estradot is a hormone replacement therapy. You need to be aware
of the general risks when using HRT.
If you have or have ever had any of the following conditions,
you need to let your doctor know. They may come back or get
worse during treatment with Estradot:
 Benign tumours of the womb (e.g. myoma), endometrial
hyperplasia (abnormal growth of the womb lining) or
endometriosis (endometrial growths outside the uterus): Using
HRT products containing only oestrogens (such as Estradot) for
a long period can increase the risk of abnormal growth of the
womb lining (the endometrium) and endometrial cancer.
Adding a progestogen for at least 12 days every month/28 day
cycle greatly decreases this risk. During the first months of
treatment, irregular bleeding may occur.
Contact your doctor immediately:
 if unexpected bleeding or spotting (breakthrough bleeding)
occurs after having used Estradot for some time or if this
continues after you stop treatment
 if you have painful menstrual periods.
Your doctor should examine what the cause is.
 If your womb has not been removed, you should also use the
hormone progestogen for 12–14 days a month/28 day cycle, in
addition to Estradot, as directed by your doctor.
 Blood clots (thrombosis, lung embolism): You should not use
Estradot if you have ever had a blood clot in your veins.
HRT may increase the risk of blood clots, especially during the
first year of treatment.
Stop using Estradot and contact your doctor immediately if
you get:
 painful swelling and redness of the legs
 sudden chest pain
 difficulty in breathing.
These symptoms may be signs of a blood clot.
Tell your doctor if any of the following applies to you:
 if you are extremely overweight (BMI>30)
 if you have had a blood clot before or if you or someone in
your close family has had blood clots
 if you have any blood-clotting problem needing treatment
with a medicine (anticoagulant)
 if you have had more than one miscarriage
 if you are off your feet for a long time because of surgery,
injury or illness
 if you are about to have an operation; it is best to stop
treatment 4 to 6 weeks before surgery.
Any of these will make your risk of a blood clot higher.
 High blood pressure: Stop using Estradot and contact your
doctor immediately,
 if an increase in blood pressure occurs while using Estradot.

 Liver problems: You need to let your doctor know if you have
ever had liver problems, such as a benign tumour in the liver
(liver adenoma).
Stop using Estradot and contact your doctor immediately,
 if you get yellowing of the eyes and face (jaundice); this
could be a sign of liver problems.
 Migraine or severe headache: Some studies with HRT have
shown a slightly increased risk of ischaemic stroke.
Stop using Estradot and contact your doctor immediately
 if you get unexplained migraine-like headaches, with or
without disturbed vision. Headaches like these can be an
early sign of a stroke. If you have already had a stroke, talk
with your doctor about whether the benefits of the treatment
outweigh the possibly increased risk.
 Breast cancer: You should not use Estradot if you have ever
had breast cancer. There is an increased risk of breast cancer
related to HRT. The risk increases the longer the treatment lasts
and decreases when treatment is stopped. Five years after
stopping treatment, the risk returns to that of women who have
never used HRT. The risk of breast cancer seems to be higher
for women using oestrogen in combination with progestogen
than for women who use products containing only oestrogen
(such as Estradot).
Contact your doctor if you notice any changes to your breasts,
such as:
 dimpling of the breast skin
 changes in the nipple
 lumps that you can see or feel.
Your doctor may advise you to have regular breast check-ups,
including mammography. You need to let your doctor know if
you have a history of breast cancer or other oestrogen-sensitive
cancers in your immediate family (mother, sister or daughter).
 Heart disease: You should not use Estradot if you have ever
had a heart attack or chest pain (angina pectoris). Studies
with HRT tablets have shown that women may be slightly more
likely to get heart disease during the first year of treatment. For
Estradot, it is not certain whether the risk is similar.
Stop using Estradot and contact a doctor immediately,
 if you get pain in your chest that spreads to your arm or neck.
This pain may be a sign of heart disease.
 Ischaemic Stroke: You should not use Estradot if you have
ever had an ischaemic stroke. See “migraine or severe
headache”. These can be warning signs of an ischaemic stroke.
 Cancer of the ovaries: Some studies have shown that using
hormone therapy with oestrogens alone (such as Estradot) for
5–10 years may lead to a slightly increased risk of cancer of the
ovaries compared to women never treated with HRT. It is
suggested that long-term use of combined HRTs may confer a
similar, or slightly smaller risk.
 Hypothyroidism: A condition in which your thyroid gland fails
to produce enough thyroid hormone and for which you are
treated with thyroid hormone replacement therapy.
 Angioedema: Oestrogens may induce or exacerbate symptoms
of angioedema (episodes of rapid swelling of hands, feet, face,
lips, eyes, tongue, throat or digestive tract), in particular in
women with hereditary angioedema.
 High fat levels in your blood which in rare cases may cause
inflammation of the pancreas.
 Diabetes
 Gallstones
 Systemic lupus erythematosus (SLE), an autoimmune disorder
 Epilepsy
 Asthma
 Hearing loss due to otosclerosis (a problem with the bones in
your ear)
 Kidney problems
Tell your doctor before taking Estradot if you have ever had
any of the conditions above.

Medical check-ups
Before you start using Estradot your doctor should ask you about
your own and your family's medical history. Your doctor should
examine your breasts and your abdomen and may do an internal
examination. He/she should tell you what kind of changes in the
breast you should report to the doctor and may advise you to have
a breast X-ray (a mammogram). Once you have started Estradot,
you should see your doctor for regular check-ups (at least once a
year). At these check-ups your doctor should discuss with you the
benefits and risks of continuing to take Estradot.

Effects on laboratory tests
Using oestrogens may influence the results of certain laboratory
results.
Tell your doctor that you use Estradot before undergoing a blood
test.

Taking other medicines
Tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including medicines obtained
without a prescription. Some medicines may increase or decrease
the effect of Estradot, such as medicines containing:
 phenobarbital, phenytoin or carbamazepine (used to treat
epilepsy),
 rifampicin, rifabutin (used to treat tuberculosis),
 nevirapine, efavirenz, ritonavir, nelfinavir (used to treat HIV
infection),
 St John's Wort (herbal medicine used to treat depression).

Pregnancy and breast-feeding
You should not use Estradot if you are pregnant or can still
become pregnant or while you are breast-feeding.
Stop using Estradot and contact your doctor immediately if
you become pregnant during Estradot treatment. Ask your doctor
or pharmacist for advice before taking any medicine.

Driving and using machines
Estradot has no known effect on the ability to drive and use
machines.

3. HOW TO USE ESTRADOT
Always use Estradot exactly as your doctor has told you. You
should check with your doctor or pharmacist if you are not sure.
During the treatment your doctor may adjust the dose according to
your individual needs.

How long to use Estradot
It is important that you use the lowest possible effective dose and
only as long as needed.
From time to time, you should discuss with your doctor whether
you still need the treatment.
When to start treatment
 If you are currently not using any form of HRT (patches or
tablets), or if you have been using a continuous combined
HRT product (where oestrogen and the progestogen are given
every day without interruption), you can start to use Estradot on
any convenient day.
 If you are changing from a cyclic or sequential HRT
treatment (where the progestogen is added for 12-14 days of
the cycle), you should start to use Estradot on the day after you
complete your previous cycle.

When to apply Estradot

 An Estradot patch should be replaced twice weekly (every 3 to
4 days). It is best to always replace it on the same two days of
the week (e.g. Monday and Thursday). Your Estradot pack
contains a calendar checklist on the back to help you remember
your schedule. Mark the twice-a-week schedule that you plan to
follow. Always change the patch on the two days of the week
you have marked.
 Estradot should be worn continuously until it is time to replace
it with a new patch.

Any adhesive that might remain on your skin can be easily rubbed
off. Then place the new Estradot patch onto a different area of
skin.

Make sure that the patch
sticks properly to your skin
and go over the edges with
your finger to ensure good
contact between the patch and
skin.

Women without a uterus
The Estradot patch is applied continuously without a break.
Additional use of another type of hormone called progestogen is
not required, unless you have a condition where the lining of the
uterus also grows outside the uterus (endometriosis). Check the
risks to be aware of with HRT in general in section 2, Take
special care with Estradot.

When changing the patch,
peel it off, fold it with the
sticky side inside, and
discard it with normal
household waste.

Your doctor should give you another hormone called progestogen
in addition to Estradot to reduce the risk of cancer of the uterus.
While Estradot is applied continuously without a break, the
progestogen tablet should be taken for at least 12–14 days every
month/28 day cycle. Check the risks to be aware of with HRT in
general in section 2, Take special care with Estradot.

Further useful information

Where to apply Estradot
Apply the patch to the lower abdomen, below the waistline. Avoid
the waistline itself, since clothing may cause the patch to rub off.
Do not apply the patch to the breasts or any area near to the
breasts.

Bathing, swimming, showering or exercising should not affect the
patch if it has been correctly applied. If a patch falls off, e.g.
during bathing or showering, shake it to remove the water. After
careful drying and cooling down of the skin, reapply the same
patch on a different area of the lower abdomen (see ‘Where to
apply Estradot’).

When changing your patch, based on your twice-a-week schedule,
apply your new patch to a different site.
Do not apply a new patch to that same area for at least one week.

If the patch does not stick completely to your skin, use a new
patch. No matter what day this happens, go back to changing this
patch on the same days as your original schedule.

Before you apply Estradot, make sure that your skin is:
 clean, dry and cool,
 free of any powder, oil, moisturiser, or lotion,
 free of cuts and/or irritation.

When sunbathing or using a solarium, the patch should be
covered. When swimming, the patch can be worn under your
bathing suit.

If you have used more Estradot than you should
Each patch is individually
sealed in a protective pouch.
Tear open this pouch at the
indentation and remove the
patch (do not use scissors to
open the pouch as this could
damage the patch).

A stiff protective backing covers the sticky side of the patch. This
backing must be removed before the patch is stuck to the skin.
Apply the patch immediately after opening the pouch and
removing the protective backing.
Hold the patch with the
protective backing facing
you. Peel off one side of the
protective backing and
discard it. Try to avoid
touching the sticky side of
the patch with your fingers.
Holding the other half of the backing, apply the sticky side of the
patch to a dry area of your lower abdomen. Press the sticky side to
the skin and smooth down. Fold back the remaining side of the
patch.
Grasp the straight edge of the
protective backing and pull it
off the patch.

Press the sticky remaining
side of the patch to the skin
and smooth down. Press the
patch firmly in place with the
palm of your hand for about
10 seconds.

Remove the patch if you have used too much Estradot. Symptoms
of overdose are usually tenderness of the breasts and/or vaginal
bleeding. Acute overdose is unlikely due to the way Estradot is
used (patch). If symptoms persist contact your doctor.

If you forget to use Estradot
If you forget to change the patch, change the patch as soon as you
remember. No matter what day this happens, go back to changing
the newly applied patch on the same days as your original
schedule.
Do not use a double dose to make up for the forgotten patch.

If you stop using Estradot
Stopping use of Estradot may increase the risk of breakthrough
bleeding or spotting. Talk to your doctor if this occurs. After a
long break in treatment, consult your doctor before starting to use
the patch again.
If you have any further questions on the use of this product, ask
your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Estradot patches can cause side effects,
although not everybody gets them.

Some effects could be serious
These symptoms need immediate medical attention:
 Sudden chest pain
 Pain in your chest that spreads to your arm or neck
 Difficulty in breathing
 Painful swelling and redness of the legs
 Yellowing of the eyes and face (jaundice), darkening of urine,
itchy skin
 Unexpected vaginal bleeding or spotting (breakthrough
bleeding) after using Estradot for some time, or after you stop
treatment
 Breast changes, including dimpling of the breast skin, changes
in the nipple, lumps that you can see or feel.
 Painful menstrual periods
 Unexplained migraine-like headaches

6. FURTHER INFORMATION
What Estradot contains:
Estradot® 37.5:

3.75 cm2 patch. Each patch contains estradiol
hemihydrate corresponding to 0.585 mg
estradiol and releases about 37.5 microgram
estradiol per 24 hours.

Estradot® 50:

5.0 cm2 patch. Each patch contains estradiol
hemihydrate corresponding to 0.78 mg
estradiol and releases about 50 microgram
estradiol per 24 hours.

Estradot® 75:

7.5 cm2 patch. Each patch contains estradiol
hemihydrate corresponding to 1.17 mg
estradiol and releases about 75 microgram
estradiol per 24 hours.

Estradot® 100:

10 cm2 patch. Each patch contains estradiol
hemihydrate corresponding to 1.56 mg
estradiol and releases about 100 microgram
estradiol per 24 hours.

Other side effects
In addition, the following side effects have been reported with
Estradot. If any of these gets severe, tell your doctor or
pharmacist.

Women with a uterus

How to apply Estradot

Stop using Estradot and tell your doctor immediately if you
get any of the effects mentioned above. Check the risks to be
aware of with HRT in general in section 2, Take special care with
Estradot.

Very common (affects more than 1 user in 10):
Headache, skin reactions at the patch application site
(redness, rash, itching), erythema, breast tension and pain,
menstrual pains, menstrual disorder.
Common (affects 1 to 10 users in 100):
Depression, nervousness, mood changes, sleeplessness,
nausea (feeling sick), indigestion, diarrhoea, abdominal pain,
bloated feeling, acne, rash, dry skin, itching, pruritus, breast
enlargement, heavy menstrual periods, a white or yellowish
discharge from the vagina, irregular vaginal bleeding, severe
uterine contractions, inflammation of the vagina, abnormal
growth of the womb lining (endometrial hyperplasia), pain,
back pain, weakness, fluid retention (oedema) in the
extremities (hands and feet), weight changes.
Uncommon (affects 1 to 10 users in 1,000):
Migraine, dizziness, increase in blood pressure, vomiting
(being sick), skin discoloration, impaired liver function tests.
Rare (affects 1 to 10 users in 10,000):
Tingling or numbness of hand and feet, blood clot, gallstones,
hair loss, muscular weakness, benign smooth muscle growth
in uterus, cysts close to uterine tubes, polyps (small growths)
in the uterine cervix (neck of the womb), changes in sexual
desire, hypersensitivity, allergic reactions such as rash.
Very rare (affects less than 1 user in 10,000):
Hives, signs of serious allergic reaction such as sudden
trouble breathing, tightness of the chest, general rash,
swelling or itching, decreased carbohydrate tolerance,
involuntary movements which may affect the eyes, head and
neck, contact lens discomfort, dry eyes, tear film composition
changes, severe skin lesions, excessive hair growth.
Not known (cannot be estimated from the available data):
Breast cancer, embolism, pain in extremity, liver function test
abnormal.
Other side effects that have been linked to HRT:
Hard painful lumps looking like bruises on the legs, skin
eruptions (redness, spots and sometimes blistering, possibly
also affecting the inside of the mouth) and decline in memory
or mental ability (possible dementia), gallbladder disease.
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, tell your doctor or pharmacist.

5. HOW TO STORE ESTRADOT
 Keep Estradot out of the sight and reach of children.
 Store Estradot in the original package in a dry place. Once
opened or once the protective pouch has been removed, the
patch should be applied to the skin immediately. The patch
should not be exposed to direct sunlight.
 Do not refrigerate or freeze Estradot.
 Do not use Estradot after the expiry date shown on the box. The
expiry date refers to the last date of the month.
 Do not use any Estradot that is damaged or shows signs of
tampering.
 Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help to
protect the environment.

 The active substance of Estradot is estradiol (as hemihydrate).
 The other ingredients contained in the adhesive layer of the
patch are: acrylic adhesive, silicone adhesive, oleyl alcohol,
dipropylene glycol, povidone.
 The backing layer is composed of: ethylene/vinyl acetate
copolymer, polyethylene, vinylidene/vinyl chloride copolymer,
polyethylene, ethylene/vinyl acetate copolymer co-extruded
film.
 The release liner (to be removed before application) is a
fluoropolymer-coated polyester film.

What Estradot looks like and contents of the pack
Estradot is available in cartons of 8 patches.
PL 10383/1403

PL 10383/1404
PL 10383/1405
PL 10383/1406

Estradot 37.5
micrograms/24hours Transdermal
Patch
Estradot 50 micrograms/24hours
Transdermal Patch
Estradot 75 micrograms/24hours
Transdermal Patch
Estradot 100 micrograms/24hours
Transdermal Patch

POM

Who makes and repackages your medicine?
Your medicine is manufactured by Norvatis Pharma SAS 26, Rue
De La Chapelle, 68330 Huningue France. Procured from within
the EU and repackaged by Product Licence Holder Primecrown
Ltd., 4/5 Northolt Trading Estate, Belvue Road, Northolt,
Middlesex, UB5 5QS.
Leaflet date: 15.11.2012
Estradot® is a trade mark of Novartis AG, Basle, Switzerland.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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