ESTRADOT 25 MICROGRAMS/24 HOURS TRANSDERMAL PATCH

Active substance: ESTRADIOL

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PATIENT INFORMATION LEAFLET
Estradot® 25 micrograms / 24 hours
transdermal patch
(estradiol)
Your medicine is known by the above name but will be referred to as
Estradot throughout the remainder of this leaflet.
Your medicine is available in higher strengths.
Read all of this leaflet carefully before you start using this medicine
because it contains important information for you.
• 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 only. Do not pass it on to
others. It may harm them, even if their signs of illness are the same as
yours.
• If you get any of the side effects talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet.
What is in this leaflet:
1. What Estradot is and what it is used for
2. What you need to know before you use Estradot
3. How to use Estradot
4. Possible side effects
5. How to store Estradot
6. Contents of the pack and other information

1. What Estradot is and what it is used for
Estradot is a Hormone Replacement Therapy (HRT). It contains the
female hormone oestrogen. Estradot is used in postmenopausal women
with at least 12 months since their last natural period.
Estradot comes as a patch that is applied to the skin.
Estradot is used for:
Relief of symptoms occurring after menopause
During the menopause, the amount of oestrogen produced by a woman‟s
body drops. This can cause symptoms such as hot face, neck and chest
("hot flushes"). Estradot alleviates these symptoms after menopause.
You will only be prescribed Estradot if your symptoms seriously hinder
your daily life.
Prevention of osteoporosis (for Estradot 50, 75 and 100 only)
After the menopause some women may develop fragile bones
(osteoporosis). You should discuss all available options with your doctor.
If you are at an increased risk of fractures due to osteoporosis and other
medicines are not suitable for you, you can use Estradot to prevent
osteoporosis after menopause.

2. What you need to know before you use Estradot
Medical history and regular check-ups
The use of HRT carries risks which need to be considered when deciding
whether to start using it, or whether to carry on using it.
The experience in treating women with a premature menopause (due to
ovarian failure or surgery) is limited. If you have a premature menopause
the risks of using HRT may be different. Please talk to your doctor.
Before you start (or restart) HRT, your doctor will ask about your own and
your family's medical history. Your doctor may decide to perform a
physical examination. This may include an examination of your breasts
and/or an internal examination, if necessary.
Once you have started on Estradot, you should see your doctor for
regular check-ups (at least once a year). At these check-ups, discuss
with your doctor the benefits and risks of continuing with Estradot.
Go for regular breast screening, as recommended by your doctor.

Do not use Estradot
If any of the following applies to you. If you are not sure about any of the
points below, talk to your doctor before using Estradot,
Do not use Estradot:
• if you have or have ever had breast cancer, or if you are suspected of
having it;
• if you have cancer which is sensitive to oestrogens, such as cancer
of the womb lining (endometrium), or if you are suspected of having it;
• if you have any unexplained vaginal bleeding;
• if you have excessive thickening of the womb lining (endometrial
hyperplasia) that is not being treated;
• if you have or have ever had a blood clot in a vein (thrombosis), such
as in the legs (deep venous thrombosis) or the lungs (pulmonary
embolism);
• if you have a blood clotting disorder (such as protein C, protein S or
antithrombin deficiency);
• if you have or recently have had a disease caused by blood clots in the
arteries, such as a heart attack, stroke or angina;
• if you have or have ever had a liver disease and your liver function
tests have not returned to normal;
• if you have a rare blood problem called “porphyria” which is passed
down in families (inherited);
• if you are allergic (hypersensitive) to estradiol or any of the other
ingredients of this medicine (listed in section 6);
If any of the above conditions appear for the first time while using
Estradot, stop using it at once and consult your doctor immediately.

When to take special care with Estradot
Tell your doctor if you have ever had any of the following problems,
before you start the treatment, as these may return or become worse
during treatment with Estradot. If so, you should see your doctor more
often for check-ups:
• fibroids inside your womb
• growth of womb lining outside your womb (endometriosis) or a history of
excessive growth of the womb lining (endometrial hyperplasia)
• increased risk of developing blood clots (see “Blood clots in a vein
(thrombosis)”)
• increased risk of getting an oestrogen-sensitive cancer (such as having
a mother, sister or grandmother who has had breast cancer)
• high blood pressure
a liver disorder, such as a benign liver tumour
• diabetes
• gallstones
• migraine or severe headaches
• a disease of the immune system that affects many organs of the body
(systemic lupus erythematosus, SLE)
• epilepsy
• asthma
• a disease affecting the eardrum and hearing (otosclerosis)
• a very high level of fat in your blood (triglycerides)
• fluid retention due to cardiac or kidney problems
• products containing oestrogens may cause or worsen the symptoms of
hereditary angioedema. You should see your doctor immediately if you
experience symptoms of angioedema such as swollen face, tongue
and/or throat and/or difficulty swallowing, or hives together with difficulty
breathing.
Stop using Estradot and see a doctor immediately.
If you notice any of the following when using HRT:
- any of the conditions mentioned in the „Do Not use Estradot‟ section
- yellowing of your skin or the whites of your eyes (jaundice). These may
be signs of a liver disease
- a large rise in your blood pressure (symptoms may be headache,
tiredness, dizziness)
- migraine-like headaches which happen for the first time
- if you become pregnant
- if you notice signs of a blood clot, such as:
• painful swelling and redness of the legs
• sudden chest pain
• difficulty in breathing
For more information, see „Blood clots in a vein (thrombosis)‟.
Note: Estrdot is not a contraceptive. If it is less than 12 months since your
last menstrual period or you are under 50 years old, you may still need to
use additional contraception to prevent pregnancy. Speak to your doctor
for advice.
HRT and cancer
Excessive thickening of the lining of the womb (endometrial
hyperplasia) and cancer of the lining of the womb (endometrial
cancer)

Taking oestrogen-only HRT will increase the risk of excessive thickening
of the lining of the womb (endometrial hyperplasia) and cancer of the
womb lining (endometrial cancer).
Taking a progestogen in addition to the oestrogen for at least 12 days of
each 28 day cycle protects you from this extra risk. So your doctor will
prescribe a progestogen separately if you still have your womb. If you
have had your womb removed (a hysterectomy), discuss with your doctor
whether you can safely take this product without a progestogen.
In women who still have a womb and who are not taking HRT, on
average, 5 in 1000 will be diagnosed with endometrial cancer between
the ages of 50 and 65.
For women aged 50 to 65 who still have a womb and who take
oestrogen-only HRT, between 10 and 60 women in 1000 will be
diagnosed with endometrial cancer (i.e. between 5 and 55 extra cases),
depending on the dose and for how long it is taken.
Estradot 75 and 100 contain a higher dose of oestrogens than other
oestrogen-only HRT products. The risk of endometrium cancer when
using Estradot 75 or 100 together with a progestogen is not known.
Unexpected bleeding
You will have a bleed once a month (so-called withdrawal bleed) while
using Estradot in combination with a progestagen. But, if you have
unexpected bleeding or drops of blood (spotting) besides your monthly
bleeding, which:
- carries on for more than the first 6 months
- starts after you have been using Estradot for more than 6 months
- carries on after you have stopped using Estradot
See your doctor as soon as possible.
Breast cancer
Evidence suggests that taking combined oestrogen-progestogen and
possibly also oestrogen-only HRT increases the risk of breast cancer.
The extra risk depends on how long you take HRT. The additional risk
becomes clear within a few years. However, it returns to normal within a
few years (at most 5) after stopping treatment.
For women who have had their womb removed and who are using
oestrogen-only HRT for 5 years, little or no increase in breast cancer risk
is shown.
Compare
Women aged 50 to 79 who are not taking HRT, on average, 9 to 14 in
1000 will be diagnosed with breast cancer over a 5-year period. For
women aged 50 to 79 who are taking oestrogen-progestogen HRT over 5
years, there will be 13 to 20 cases in 1000 users (i.e. an extra 4 to 6
cases).
• Regularly check your breasts. See your doctor if you notice any
changes such as:
• dimpling of the skin
• changes in the nipple
• any lumps you can see or feel
Ovarian cancer
Ovarian cancer is rare. A slightly increased risk of ovarian cancer has
been reported in women taking HRT for at least 5 to 10 years.
Women aged 50 to 69 who are not taking HRT, on average about 2
women in 1000 will be diagnosed with ovarian cancer over a 5-year
period. For women who have been taking HRT for 5 years, there will be
between 2 and 3 cases per 1000 users (i.e. up to 1 extra case).
Effect of HRT on heart and circulation
Blood clots in a vein (thrombosis)
The risk of blood clots in the veins is about 1.3 to 3- times higher in
HRT users than in non-users, especially during the first year of taking it.
Blood clots can be serious, and if one travels to the lungs, it can cause
chest pain, breathlessness, fainting or even death.
You are more likely to get a blood clot in your veins as you get older and
if any of the following applies to you. Inform your doctor if any of these
situations applies to you:
• you are unable to walk for a long time because of major surgery, injury
or illness (see also section 3, If you need to have surgery)
• you are seriously overweight (BMI >30 kg/m2)
• you have any blood clotting problem that needs long-term treatment
with a medicine used to prevent blood clots
• if any of your close relatives has ever had a blood clot in the leg, lung or
an other organ
• you have systemic lupus erythematosus (SLE)
• you have cancer.
For signs of a blood clot, see “Stop using Estradot and see a doctor
immediately”.
Compare
Looking at women in their 50s who are not taking HRT, on average, over
a 5-year period, 4 to 7 in 1000 would be expected to get a blood clot in a
vein.
For women in their 50s who have been taking oestrogen-progestogen
HRT for over 5 years, there will be 9 to 12 cases in 1000 users (i.e. an
extra 5 cases).
For women in their 50s who have had their womb removed and have
been taking oestrogen-only HRT for over 5 years, there will be 5 to 8
cases in 1000 users (i.e. 1 extra case).
Heart disease (heart attack)
There is no evidence that HRT will prevent a heart attack.
Women over the age of 60 years who use oestrogen-progestogen HRT
are slightly more likely to develop heart disease than those not taking any
HRT.
For women who have had their womb removed and are taking oestrogenonly therapy there is no increased risk of developing a heart disease.
Stroke
The risk of getting stroke is about 1.5-times higher in HRT users than in
non-users. The number of extra cases of stroke due to use of HRT will
increase with age.
Compare
Looking at women in their 50s who are not taking HRT, on average, 8 in
1000 would be expected to have a stroke over a 5-year period. For
women in their 50s who are taking HRT, there will be 11 cases in 1000
users, over 5 years (i.e. an extra 3 cases).
Other conditions
• HRT will not prevent memory loss. There is some evidence of a
higher risk of memory loss in women who start using HRT after the
age of 65. Speak to your doctor for advice.

Other medicines and Estradot
Some medicines may interfere with the effect of Estradot. This might lead
to irregular bleeding. This applies to the following medicines:
• medicines for epilepsy (such as phenobarbital, phenytoin,
carbamazepine),
• medicines for tuberculosis (such as rifampicin, rifabutin),
• medicines for HIV infection (such as nevirapine, efavirenz, ritonavir,
nelfinavir),
• herbal remedies containing St John's Wort (Hypericum perforatum).
Please tell your doctor or pharmacist if you are taking or have recently
taken any other medicines, including medicines obtained without a
prescription, herbal medicines or other natural products.

Laboratory tests
If you need a blood test, tell your doctor or the laboratory staff that you
are using Estradot, because this medicine can affect the results of some
tests.

Pregnancy and breast-feeding
Estradot is for use in postmenopausal women only. If you become
pregnant, stop using Estradot and contact your doctor. You should not
use Estradot if you are pregnant or while you are breast-feeding.

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

3. How to use Estradot
Always use this medicine exactly as your doctor has told you. Check with
your doctor or pharmacist if you are not sure.
Your doctor will aim to prescribe the lowest dose to treat your symptom
for as short as necessary. Speak to your doctor if you think this dose is
too strong or not strong enough.
S0405-GE-PIL-11.06.2013

How long to use Estradot

If you forget 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.

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.

When to start treatment

If you stop using Estradot

• 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.

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 medicine, ask your
doctor or pharmacist.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not
everybody gets them.

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.

The following diseases are reported more often in women using HRT
compared to women not using HRT:
• breast cancer
• abnormal growth or cancer of the lining of the womb (endometrial
hyperplasia or cancer)
• ovarian cancer
• blood clots in the veins of the legs or lungs (venous thromboembolism)
• heart disease
• stroke
• probable memory loss if HRT is started over the age of 65

Women without a uterus

For more information about these side effects, see Section 2.

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, When to take special care with Estradot.

Some effects could be serious

Women with a uterus
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, When to take
special care with Estradot.
You may have some irregular bleeding or spotting during the first few
months of treatment. If you have heavy bleeding or continue to have
bleeding or spotting after a few months of treatment, tell your doctor so
that the treatment can be re-evaluated if necessary (see section 2,
Unexpected bleeding).

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.
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.
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.

How to apply Estradot
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.

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, darkening of urine, itchy skin (jaundice)
• 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 (breast cancer)
• Painful menstrual periods
• Unexplained migraine-like headaches
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, When to take special care with Estradot.

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.

Very common, may affect more than 1 in 10 people:
Headache, skin reactions at the patch application site (redness, rash,
itching), breast tension and pain, menstrual pains, menstrual
disorder.

Common, may affect up to 1 in 10 people:
Depression, nervousness, mood changes, sleeplessness, nausea
(feeling sick), indigestion, diarrhoea, abdominal pain, bloated feeling,
acne, rash, dry skin, itching, 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 (e.g. back pain, arms, legs, wrists, ankles),
weakness, fluid retention (oedema) in the extremities (hands and
feet), weight changes.

Uncommon, may affect up to 1 in 100 people:
Migraine, dizziness, increase in blood pressure, vomiting (being sick),
skin discoloration, impaired liver function tests.

Rare, may affect up to 1 in 1,000 people:
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, allergic
reactions such as rash.

Very rare, may affect up to 1 in 10,000 people:
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, severe
skin lesions, excessive hair growth.

Not known (can not be estimated from the available data):
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.

Breast cancer, liver function test abnormal.
The following side effects have been reported with other HRTs:
• gallbladder disease
• various skin disorders:
- discoloration of the skin especially of the face or neck known as
“pregnancy patches” (chloasma)
- painful reddish skin nodules (erythema nodosum),
- rash with target-shaped reddening or sores (erythema multiforme),
• decline in memory or mental ability (possible dementia).
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet.

5. How to store Estradot
• Keep Estradot out of the sight and reach of children.
• Store Estradot in the original pouch and carton.
• Store in a cool, dry place. Once opened or once the protective pouch
has been removed, the patch should be applied to the skin immediately.
• Do not refrigerate or freeze Estradot.
• Do not use Estradot after the expiry date which is stated on the
carton and patch after „EXP‟. The expiry date refers to the last date of the
month.
• Do not use any Estradot pack 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.

6. Contents of the pack and other information
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.

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

Further useful information

What Estradot contains

Each patch contains Estradiol (as hemihydrate) 0.39mg/2.5 cm2
(equivalent to 25 micrograms estradiol per 24 hours).
• The active substance is estradiol (as hemihydrate).
• The other ingredients in the adhesive layer of the patch are acrylic
adhesive, silicone adhesive, oleyl alcohol, dipropylene glycol and
povidone.
• The backing layer is composed of: ethylene/vinyl acetate copolymer,
polyethylene, vinylidene/vinyl chloride copolymer, ethylene/vinyl acetate
copolymer co-extruded film and silicon dioxide/titanium dioxide.
• The release liner (to be removed before application) is a
fluoropolymer-coated polyester film.

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‟).

What Estradot looks like and contents of the pack

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.

Estradot is available in cartons of 8 and 26 patches.

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

Procured from within the EU and repackaged by:
Amimed Direct Ltd, Hendon, London, NW9 6AQ.
Product Licence Holder: Sam Pharma Ltd, Unit 20 Garrick Industrial
Estate, Irving Way, Hendon, London, NW9 6AQ.

If you need to have surgery
If you are going to have surgery, tell the surgeon that you are using
Estradot. You may need to stop using Estradot about 4 to 6 weeks before
the operation to reduce the risk of a blood clot (see section 2, Blood clots
in a vein). Ask your doctor when you can start using Estradot again.

If you use more Estradot than you should
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.

Estradot 25 is a 2.5 cm2 rectangular patch with rounded corners,
comprising a pressure-sensitive adhesive layer containing estradiol,
with a translucent polymeric backing on one side and a protective liner
on the other.
Manufacturer:
Novartis Pharma GmbH, 90327 Nürnberg, Germany.

POM

PL No: 33902/0405

This leaflet was last revised: 11/06/2013
Estradot® is a registered trademark of Novartis AG.

S0405-GE-PIL-11.06.2013

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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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