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EPIESTROL-SEPTEM 50 MICROGRAMS/24HOURS TRANSDERMAL PATCH

Active substance(s): ESTRADIOL HEMIHYDRATE

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Package Leaflet: Information for the user

UK/H/0303/001-003/ IA IN /025

EPIESTROL-Septem 25 micrograms/24hours
EPIESTROL-Septem 50 micrograms/24hours
EPIESTROL-Septem 75 micrograms/24hours
Estradiol
PATIENT INFORMATION 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 further questions, please ask your doctor or your 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 EPIESTROL-Septem is and what it is used for
2. Before you take EPIESTROL-Septem
3. How to use EPIESTROL-Septem
4. Possible side effects
5. How to store EPIESTROL-Septem
6. Further information
1. What EPIESTROL-Septem is and what it is used for
EPIESTROL-Septem is a Hormone Replacement Therapy (HRT). It contains 17- estradiol.
EPIESTROL-Septem is used in postmenopausal women with at least 6 months since their last
natural period.
EPIESTROL-Septem 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”). EPIESTROL-Septem alleviates
these symptoms after menopause. You will only be prescribed EPIESTROL-Septem if your
symptoms seriously hinder your daily life.
2. Before you take EPIESTROL-Septem
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.

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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 internal examination, if necessary.
Once you have started on EPIESTROL-Septem 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 EPIESTROL-Septem.
Go for regular breast screening, as recommended by your doctor.

Do not take EPIESTROL-Septem
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 EPIESTROL-Septem,

Do not take EPIESTROL-Septem












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
EPIESTROL-Septem (listed in section 6 Further information)

If any of the above conditions appear for the first time while taking EPIESTROL-Septem, stop
taking it at once and consult your doctor immediately.
When to take special care with EPIESTROL-Septem
Tell your doctor if you have ever had any of the following problems, before you start treatment, as
these may return or become worse during treatment with EPIESTROL-Septem. 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)”)
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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

Stop taking EPIESTROL-Septem 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 EPIESTROL-Septem’ 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: EPIESTROL-Septem 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 thickness 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.

-3-

Compare
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.
EPIESTROL-Septem 75 contains a higher dose of oestrogens than other oestrogen-only HRT
products. The risk of endometrium cancer when using EPIESTROL-Septem 75 together with a
progestogen is not known.
Unexpected bleeding
You will have a bleed once a month (so-called withdrawal bleed) while taking EPIESTROLSeptem. 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 taking EPIESTROL-Septem more than 6 months
 carries on after you have stopped taking EPIESTROL-Septem
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 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.
Compare
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).

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Effects 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 EPIESTROL-Septem 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 oestrogen-only 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.

-5-

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.

Using other medicines

Some medicines may interfere with the effect of EPIESTROL-Septem. This might lead to irregular
bleeding. This applies to the following medicines:
 Medicines for epilepsy (such as phenobarbital, phenytoin and carbamazepin)
 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).
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 taking EPIESTROLSeptem, because this medicine can affect the results of some tests.

Pregnancy and breast-feeding

EPIESTROL-Septem is for use in postmenopausal women only. If you become pregnant, stop
taking EPIESTROL-Septem and contact your doctor.

Driving and using machines

EPIESTROL-Septem is not expected to influence the ability to drive or to use machines.

3. How to use EPIESTROL-Septem
Always use EPIESTROL-Septem exactly as your doctor has told you. You should check with your
doctor or pharmacist if you are not sure.
Three strengths of EPIESTROL-Septem are available, EPIESTROL-Septem 25, 50, 75. The choice
of which EPIESTROL-Septem patch will suit you best will be made by your doctor, although most
women start with the EPIESTROL-Septem 25 patch. During treatment your doctor will adjust the
dose of patch to your individual need and this will depend on how effective the treatment is and if
you are suffering from side effects. For initiation and continuation of therapy, your doctor will aim
to prescribe the lowest dose of patch to treat your symptoms for as short as necessary. Speak to
your doctor if you think this dose is too strong or not strong enough.

How to apply the patch

You should apply the patch to clean, dry skin, but not on top of cuts, spots or blemishes or to an
area where you have just applied cream, moisturiser or talc.
You MUST NOT apply EPIESTROL-Septem patches on or near the breasts.
-6-

Your EPIESTROL-Septem patch should be applied to the hip, buttock or abdomen (see Figure 1).

Figure 1
Shaded areas are the correct
places to apply your patch.

Do not apply a patch to a part of the body that folds during movement or where your clothing (eg.
elasticated waistbands) may make the patch fall off.
Do not apply patches one after the other to the same place.
A EPIESTROL-Septem patch should be applied to the skin as soon as it is removed from its sachet,
as follows:
(i)

Tear open the sachet at the indentation.
Do not use scissors (see Figure 2).

(ii)

Figure 2
Hold the patch between your thumb and
index finger at the pull-off tag (see Figure 3).

(iii)

Figure 3
Peel off the protective liner with your other
hand (see Figure 4). Do not touch the
sticky side of the patch or it will not stick properly.

-7-

Figure 4
(iv)

Apply the open part of the patch to your skin
and remove the remaining part of the protective
liner. Press firmly for about 10 seconds on the
whole surface of the patch. Run your finger along
the edges to make sure it is firmly stuck down.

How often you should change the patch

There is enough hormone in each patch to last for several days. In order to ensure a steady supply of
hormone, the patch must be changed at one-week intervals; thus each used patch has to be removed
after seven days and replaced by a new one. The patch may be applied at any time of the day.

What to do if a patch comes off
If EPIESTROL-Septem is applied correctly, it is most unlikely that the patch will fall off. However
if the patch does fall off, replace it with a new one and then change the patch again as usual on your
next regular day.
Your patch should stay on in the shower or bath, but may fall off if you have a sauna or a
particularly hot bath.

How to remove the patch
To remove a patch, just peel away at the edge and pull the patch smoothly until it comes off. After
use, fold the patch in half, sticky side inwards and throw in a dustbin where children cannot reach it.

When to start the treatment

You can initiate the treatment with EPIESTROL-Septem at any convenient time if you are not
currently on any estrogen therapy.
If you are currently using cyclic or sequential estrogen-progestogen therapy, you should complete
the on-going treatment cycle before beginning treatment with EPIESTROL-Septem; the appropriate
time to begin treatment with EPIESTROL-Septem would be the first day of a withdrawal bleeding.
If you are already using a continuous combined estrogen/progestogen therapy you may switch to
EPIESTROL-Septem directly.

How to take progestogen with EPIESTROL-Septem

If you have a uterus i.e. have not had a hysterectomy, your doctor may prescribe a progestogen for
you with EPIESTROL-Septem patch to prevent any problems due to a build up of the lining of the
womb, i.e. endometrial hyperplasia (see special warning on endometrial cancer). There are two
ways of doing this:

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1. Cyclic treatment
EPIESTROL-Septem is given usually for 21 days followed by a treatment-free interval of 7 days.
Your doctor will prescribe the progestogen usually for 12-14 days of the cycle. You may experience
a “withdrawal bleed” (like a period) during the last few days of, or after stopping, the progestogen
treatment.
2. Continuous sequential treatment
EPIESTROL-Septem is given all the time with no treatment-free interval, and the progestogen is
prescribed usually for 12-14 days (or more) of every 28 day cycle. Your doctor will recommend this
form of treatment if you experience menopausal symptoms during the treatment-free interval. You
may experience a “withdrawal bleed” (like a period) during the last few days of, or after stopping,
the progestogen treatment.

If you use more EPIESTROL-Septem patches than you should

If you accidentally put too many patches on, you may find that you suffer from breast tenderness
and/or vaginal bleeding, irritability, anxiety, nausea, vomiting, swelling of the abdomen or
pelvis, flatulence, fluid retention and a feeling of heaviness in the legs. The effects of using too
many patches may be reversed simply by removing them.

If you forget to change EPIESTROL-Septem patch

If you forget to change the patch at the right time, you should replace it as soon as possible, and
then follow your original regular schedule for applying the next patch. If you forget a dose you
may increase the likelihood of break-through bleeding and spotting.

If you stop using EPIESTROL-Septem

When stopping the treatment with EPIESTROL-Septem, you may experience a recurrence of
postmenopausal symptoms.

If you need to have surgery
If you are going to have surgery, tell the surgeon that you are taking EPIESTROL-Septem. You
may need to stop taking EPIESTROL-Septem 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 EPIESTROL-Septem 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, EPIESTROL-Septem 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
 stroke
 probable memory loss if HRT is started over the age of 65
-9-

For more information about these side effects, see Section 2.
The following side-effects may occur with HRT:

Common side effects (occur in more than 1 and less than 10 patients out of 100):
-

headache
nausea
abdominal pain
uterine/vaginal bleeding including spotting
weight changes
rash (red and inflammed skin)
pruritus (itching).

Uncommon side effects (occur in more than 1 and less than 10 patients out of 1,000):
-

dizziness
hypersensitivity reactions
depressed mood
visual disturbances (disturbed vision)
palpitations (irregular heartbeat)
dyspepsia (difficult or disturbed digestion)
erythma nodosum (painful reddish skin nodules)
urticaria (hives)
breast pain, breast tenderness
edema (abnormally large fluid volume in the circulatory system or in tissues).

Rare side effects (occur in more than 1 and less than 10 patients out of 10,000):
-

changes in libido
eye irritation during contact lenses use
anxiety
migraine
bloating (post-prandial abdominal fullness or swelling)
vomiting (being sick)
hirsutism (excessive growth of facial or body hair)
acne (pimples on the face, chest and back)
muscle cramps
dysmenorrhea (painful cramps during menstruation)
vaginal discharge
premenstrual-like syndrome (physical symptoms that occur between ovulation and the onset
of menstruation, such as breast tenderness, back pain, abdominal cramps, headache, and
changes in appetite, as well as psychological symptoms of anxiety, depression, and unrest)
- breast enlargement
- fatigue (physical and/or mental exhaustion).

Other side effects:

- gall bladder disease
- various skin disorders:
o discoloration of the skin especially of the face or neck known as “pregnancy patches”
(chloasma)
o rash with target-shaped reddening or sores (erythema multiforme)
o painful reddish skin nodules (erythema nodosum)
o vascular purpura (blood vessel inflammation that results in the appearance of purplish
spots or patches on the skin)
- 10 -

- dementia (HRT will not prevent memory loss. In one study of women who started using
combined HRT after the age of 65, a small increase in the risk of dementia was observed).
If any of these side effects gets serious, or if you notice side effects not listed in this leaflet,
please tell your doctor or pharmacist.
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 Yellow Card Scheme at
www.mhra.gov.uk/yellowcard.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store EPIESTROL-Septem
Keep EPIESTROL-Septem out of the reach and sight of children.
Do not store EPIESTROL-Septem above 25°C.
EPIESTROL-Septem should be stored in its sachet intact.
Do not use EPIESTROL-Septem after the expiry date which is stated on the carton or on the sachets
after EXP. The expiry date refers to the last day of that month.
After use, fold the patch in half, sticky side inwards and throw in a dustbin where children cannot
reach it.
The patches left over should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. The measures will help to protect the
environment.
6. Further information

What EPIESTROL-Septem contains
EPIESTROL-Septem patches contain the estrogen hormone 17- estradiol. The adhesive backed
patches are applied to the skin and the hormone will then pass continuously through your skin and
into your body.
EPIESTROL-Septem patches are for external use only.
EPIESTROL-Septem patches are available in three strengths:
EPIESTROL-Septem 25:

contains 2.5 mg of the active ingredient estradiol (as hemihydrate)
and releases about 25 micrograms of estradiol per day (in 24
hours).

EPIESTROL-Septem 50:

contains 5.0 mg of the active ingredient estradiol (as hemihydrate)
and releases about 50 micrograms of estradiol per day (in 24
hours).

- 11 -

EPIESTROL-Septem 75:

contains 7.5 mg of the active ingredient estradiol (as hemihydrate)
and releases about 75 micrograms of estradiol per day (in 24
hours).

The other ingredients are adhesive substances (acrylic copolymers), a backing foil (polyethylene
terephthalate) and a protective liner (siliconised polyethylene terephthalate) which is removed prior
to use.

What EPIESTROL-Septem looks like and content of the pack
EPIESTROL-Septem are transparent transdermal patches individually sealed in a protective sachet.
EPIESTROL-Septem patches come in cartons which contain 4 or 12 patches.
Marketing Authorisation Holder
Rottapharm Ltd.
Damastown, Industrial Park, Mulhuddart
Dublin 15
Ireland.
Manufacturer responsible for batch release:
MEDA Pharma GmbH & Co. KG
Benzstr. 1
61352 Bad Homburg
GERMANY
This medicinal product is authorised in the Member States of EEA under the following names:
Country
France
Greece
Italy
Portugal

Name
THAIS SEPT
DERMESTRIL-Septem
EPIESTROL-Septem
EPIESTROL-Septem

United Kingdom

EPIESTROL-Septem

This leaflet was last approved in May 2016.

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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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