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ESTRADERM MATRIX 25

Active substance(s): ESTRADIOL

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Estraderm® Matrix 25/
Estraderm® MX 25
(oestradiol)
This product is available using the above names but will be referred to as
Estraderm MX throughout this leaflet:
Estraderm MX is available in other strengths.
Patient Information Leaflet
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. See
section 4.
What is in this leaflet:
1) What Estraderm MX is, and what it is used for
2) What you need to know before you use Estraderm MX
3) How to use Estraderm MX
4) Possible side effects
5) How to store Estraderm MX
6) Content of the pack and other information

1) What Estraderm MX is and what it is used for
Estraderm MX is a Hormone Replacement Therapy (HRT). It contains the
female hormone oestrogen. Estraderm MX is used in postmenopausal
women with at least 12 months since their last natural period.
Estraderm MX is a patch that is applied to the skin. The patch contains a
supply of oestradiol which is released from the patch and absorbed through
the skin into your blood stream. This is called a transdermal patch.
Estraderm MX is used for:
Relief of symptoms occuring after menopause
During the menopause, the amount of the oestrogen produced by a
woman’s body drops. This can cause symptoms such as hot face, neck and
chest (hot flushes). Estraderm MX alleviates these symptoms after
menopause. You will only be prescribed Estraderm MX if your symptoms
seriously hinder your daily life.
Prevention of osteoporosis (for Estraderm MX 50 and 75 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 Estraderm MX to prevent
osteoporosis after menopause.

2) What you need to know before you use Estraderm MX
Medical history and regular check-ups
The use of HRT carries risks which need to be considered when deciding
whether to start taking it, or whether to carry on taking 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 Estraderm MX 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 Estraderm MX.
Go for regular breast screening, as recommended by your doctor.
Do not take Estraderm MX
If any of the following applies to you. If you are not sure about any of the
points below, talk to your doctor before taking Estraderm MX,
Do not take Estraderm MX
• 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 oestradiol or any of the other
ingredients of this medicine (listed in section 6)
• You are pregnant or breastfeeding.
If any of the above conditions appear for the first time while taking
Estraderm MX, stop taking it at once and consult your doctor immediately.
When to take special care with Estraderm MX
Take special care with Estraderm MX If you experience:
• difficulty breathing or swallowing, tightness of the chest, hives, general
rash, swelling, itching, dizziness, vomiting, abdominal pain (possible
signs of a severe allergic reaction) or
• swelling of the face, lips, tongue, throat, and/or extremities (possible
signs of angioedema)
Stop using Estraderm MX and tell your doctor immediately.
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 Estraderm MX. 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 a 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
• Do you have 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)?
• Do you have hereditary angioedema or if you have had episodes of
rapid swelling of the hands, feet, face, lips, eyes, tongue, throat (airway
blockage) or digestive tract?
Stop taking Estraderm MX and see a doctor immediately
If you notice any of the following when taking HRT:
− any of the conditions mentioned in the ‘DO NOT take Estraderm MX’
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: Estraderm MX 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 oestrogenonly 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.
Estraderm MX 75 and Estraderm MX 100 contains a higher dose of
oestrogens than other oestrogen-only HRT products. The risk of
endometrium cancer when using Estraderm MX together with a
progestogen is not known.
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 17 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 23 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
another organ
• you have systemic lupus erythematosus (SLE)
• you have cancer.
For signs of a blood clot, see ‘Stop taking Estraderm MX 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 Estraderm MX
Some medicines may interfere with the effect of Estraderm MX. This might
lead to irregular bleeding. This applies to the following medicines:
• Medicines for epilepsy (such as phenobarbital, phenytoin and
carbamazepine)
• Medicines for tuberculosis (such as rifampicin, rifabutin)
• Medicines for HIV infection (such as nevirapine, efavirenz, ritonavir
and nelfinavir)
• Herbal remedies containing St John’s Wort (Hypericum perforatum).
• Other anti-infective medicines (such as ketoconazole, erythromycin).
Tell your doctor or pharmacist if you are taking, have recently taken or
might take 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
taking Estraderm MX, because this medicine can affect the results of some
tests. Some laboratory tests, such as tests for glucose tolerance or thyroid
function, may be affected by Estraderm MX therapy.
Pregnancy and breast-feeding
Estraderm MX is for use in postmenopausal women only. If you become
pregnant, stop taking Estraderm MX and contact your doctor.
Driving and using machines
Estraderm MX has no known effect on the ability to drive and use
machines.

3) How to use Estraderm MX
Always use this medicine exactly as your doctor or pharmacist 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.

If you have not had a hysterectomy, your doctor will give you tablets
containing another hormone called progestogen to offset the effects of
oestrogens on the lining of the womb. (See the section above on ovarian
cancer.) Your doctor will explain to you how to take these tablets.
Withdrawal bleeding may occur at the end of the progestogen treatment
period. Tell your doctor if you get irregular and/or heavy bleeding (see
ovarian cancer).
When to start treatment
• If you are not currently using any form of HRT (patch or tablets), if you
have had a hysterectomy 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 Estraderm
MX 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), start to use
Estraderm MX the day after you complete the cycle.
• If you are still having periods you should start to use Estraderm MX
within 5 days of starting your period, irrespective of how long you bleed.
How long to use Estraderm MX
It is important that you use the lowest possible effective dose and only as
long as needed. You should apply a new patch twice a week i.e. every 3 or
4 days.
From time to time, you should discuss with your doctor whether you still
need the treatment
Where to apply Estraderm MX
• Estraderm MX patches are applied to the skin. You wear them all the
time.
Stick the patch on to a hairless area of skin below the waist. Most patients
find that the buttock is the best place. Choose an area of the buttock where
the skin is not inflamed, broken, or irritated.
You could also try the lower back, hip or abdomen.
Never put a patch on or near the breasts.
Choose a clean, dry area of skin. To help the patch stick, the skin should be
clean, dry, and free of creams, lotions, oil, or powder. You should use a
different area of skin each time. Wait a week before using the same area
again. Avoid skin which is red or irritated. Do not expose the patch to direct
sunlight.
How to apply Estraderm MX
Each Estraderm MX patch is sealed in an airtight sachet. Tear open one of
the sachets at the notch (do not use scissors) and take out the patch. Don’t
take the patch out of the sachet until immediately before you intend to use
it.

• stroke
• probable memory loss if HRT is started over the age of 65
For more information about these side effects, see Section 2.
Stop using Estraderm MX immediately and tell your doctor if you
develop any of the following:
• Signs of a severe allergic reaction may include rash, itching, hives,
breathlessness or difficulty in breathing, wheezing or coughing, lightheadedness, dizziness, changes in levels of consciousness,
hypotension, with or without mild generalised itching, skin reddening,
swelling of the face, throat, lips, tongue, skin and periorbital edema
• Migraine or unusually severe headaches, or signs of stroke
• You become pregnant
• Signs of jaundice (yellowing of your skin or eyes).
The side effects listed below have also been reported:
Very common, may affect more than 1 in 10 people:
• Redness, pain and itching where the patch has been applied (signs of
application site reaction includes bleeding, bruising, burning, discomfort,
dryness, skin boils, edema, erythema, inflammation, irritation, pain, tiny
solid skin bumps, rash, skin discolouration, skin pigmentation, swelling,
hives, and blisters)
• Tender, painful or swollen breasts
• Breakthrough bleeding
Common, may affect up to 1 in 10 people:
• Headache
• Feeling sick or bloated, stomach ache
Uncommon, may affect up to 1 in 100 people:
• Breast cancer.
Rare, may affect up to 1 in 1,000 people:
• Unusual weight changes, fluid retention (swelling or accumulation of
fluid in the lower legs or ankles), leg pain.
• Dizziness
Very rare, may affect up to 1 in 10,000 people:
• Blood clots, bruising, worsening varicose veins, raised blood pressure
• Abnormal liver function test results, jaundice
• Rash and itching over large areas of the skin. This sensitivity reaction
may become severe if you carry on using the patches without talking to
your doctor.
• Changes in the pigmentation in your skin (lightening or darkening of
your skin colour)
Other side effects include:
• Dry eyes.
• Contact lens discomfort.

Removing the lining
A stiff, transparent protective lining covers the sticky side of the patch, i.e.
the side that will be placed against your skin. First remove the smaller piece
of the transparent liner. Then peel off the larger piece. Try to avoid touching
the adhesive and remember not to allow the patch to become folded so that
the sticky surfaces come in contact with each other. Now apply the patch.

Applying the patch
With the palm of your hand press the sticky side of the patch firmly onto the
spot you have chosen. Hold it there for about 10-20 seconds. Make sure
that it sticks well, especially around the edges, but once the patch is in
place do not pull at it to test that it is sticking properly.

When and how to remove the patch
The patches should be changed twice a week on the same two days of the
week, e.g. Mondays and Thursdays. Choose two days which you are likely
to remember. You will find a table at the end of this leaflet for you to fill in to
jog your memory. Tick the day of the week on which you are starting the
treatment and keep this leaflet somewhere safe so that you can refer back
to it if you need to.
When the time comes to change the patch, peel it off and fold it in half with
the sticky side inside. Dispose of the patch carefully (see Section 5), making
sure that it is kept out of the reach of children because it will still contain
some medication. Stick a new patch onto a different area of skin.
What to do if a patch comes off
If a patch falls off it will not stick to your skin again. Use another patch on a
different area of your skin (see Where to apply the patch). Make sure you
choose a clean, dry, lotion-free area of the skin. No matter what day this
happens, go back to changing the patch on the same days as usual.
Further useful information
• Bathing, swimming, showering or exercising should not affect the patch
if it has been correctly applied. You may wear the patch under your
swimming costume.
• Never apply a patch on a sweaty area or after a hot bath or shower.
Wait until the skin is completely cool and dry.
• Do not remove the patch and try to put it somewhere else, it will not
stick to your skin again. Instead apply a new patch in the usual way.
Remember to apply your next patch at the normal time. If you have run
out of patches, please contact your doctor straight away. (See also
advice on ‘What to do if a patch comes off’.)
• Sunbathing: always make sure your patch is covered by clothing.
• Using a sunbed: cover up the patch
• The drug in your patch is contained in the adhesive and not in a special
reservoir.
• The drug in your patch is a gel which is colourless. This does not mean
that the patch does not contain any medication.
If you use more Estraderm MX than you should
Remove the patch if you have used too much Estraderm MX. Symptoms of
overdose are usually tenderness of the breasts and/or vaginal bleeding.
Acute overdose is unlikely due to the way Estraderm is used (patch). If
symptoms persist contact your doctor.

Not known: frequency cannot be estimated from the available data
• Rapid changes in mood (e.g. depression, nervousness, etc.)
• Changes in sex drive
• Migraine
• Diarrhoea
• Vomiting
• Gallbladder disorder (tendency to form gallstones)
• Hair loss
• Darkening of the skin particularly on the face or abdomen (chloasma)
• Irregular heavy vaginal bleeding or constant spotting (possible signs of
endometrial hyperplasia)
• Fibroids (benign growths in the uterus)
• Hives
• Menstrual cramps
• Breast discharge
• Lumps in the breast (non cancerous)
If any of these apply to you and are severe, tell your doctor.
The following side effects have been reported with other HRTs:
• gall bladder 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)
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes
any possible side effects not listed in this leaflet. You can also report side
effects directly via the internet at www.mhra.gov.uk/yellowcard. Alternatively
you can call Freephone 0808 100 3352 (available from 10 a.m. to 2 p.m.
Mondays to Fridays) or fill in a paper form available from your local
pharmacy. By reporting side effects, you can help provide more information
on the safety of this medicine.

5) How to store the patches
• Keep out of the sight and reach of children.
• Do not store above 25°C.
• Do not use this medicine after the expiry date which is stated on the
carton and patch after ‘EXP’. The expiry date refers to the last day of that
month.
• Do not use a new Estraderm MX pack that is damaged or shows signs of
tampering.
• If your doctor tells you to stop using Estraderm MX, please take any
patches left back to your pharmacist to be destroyed. Only keep them if
the doctor tells you to.
• Do not throw away any medicines via wastewater or household waste.
Ask your pharmacist how to throw away medicines you no longer use.
These measures will help to protect the environment.

6) Further information
What Estraderm MX contains
The active substance in Estraderm MX is oestradiol. The oestradiol is
derived from plants and is produced synthetically.
Each Estraderm MX transdermal patch contains a total of 0.75 mg
oestradiol releasing about 25 micrograms of oestradiol a day.
The other ingredients in Estraderm MX are isopropyl palmitate, acrylic
copolymer adhesive solution, polyethylene terephthalate mixture and ethyl
vinyl acetate copolymer. The estradiol is released gradually while you are
wearing the patch.
Estraderm MX is available as a one month calendar pack containing 8
patches.
Marketing Authorisation Holder and Manufacturer
PL 10383/1854

Estraderm Matrix 25/Estraderm MX 25

POM

If you forget to use Estraderm MX
If you forget to apply a patch, apply a new patch as soon as you remember.
No matter what day that happens, go back to changing this patch on the
same day as you usually do. There is an increased chance of breakthrough
bleeding or spotting if there is a break in treatment. Do not use a double
dose to make up for the forgotten patch.

Your medicine is manufactured by Novartis Farmaceutica, S.A., Ronda
Santa Maria, 158, Barbera del Valles, 08210 Spain. Procured from within
the EU and repackaged by the Product Licence holder: Primecrown Ltd.,
4/5 Northolt Trading Estate, Belvue Road, Northolt, Middlesex, UB5 5QS.

If you stop using Estraderm MX
Stopping use of Estraderm MX 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.
If you need to have surgery
If you are going to have surgery, tell the surgeon that you are taking
Estraderm MX. You may need to stop taking Estraderm MX 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 taking Estraderm
MX again

Fill this in to remind you when to change your patch. Please tick the box for
the days of the week when you should change your patch.

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

Leaflet Date: 24.04.2015

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Estraderm MX is a registered trademark 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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