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DERMESTRIL SEPTEM 25 MICROGRAMS/24 HOURS

Active substance(s): ESTRADIOL HEMIHYDRATE

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UK/H/0302/001-003/IAIN/024-25/G

Package Leaflet: Information for the user
DERMESTRIL-Septem 25 micrograms/24hours
DERMESTRIL-Septem 50 micrograms/24hours
DERMESTRIL-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 DERMESTRIL-Septem is and what it is used for
2. Before you take DERMESTRIL-Septem
3. How to use DERMESTRIL-Septem
4. Possible side effects
5. How to store DERMESTRIL-Septem
6. Further information
1. What DERMESTRIL-Septem is and what it is used for
DERMESTRIL-Septem is a Hormone Replacement Therapy (HRT). It contains
17- estradiol.
DERMESTRIL-Septem is used in postmenopausal women with at least 6 months since their last natural
period.
DERMESTRIL-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”). DERMESTRIL-Septem alleviates these
symptoms after menopause. You will only be prescribed DERMESTRIL-Septem if your symptoms seriously
hinder your daily life.
2. Before you take DERMESTRIL-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.
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.

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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 DERMESTRIL-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
DERMESTRIL-Septem.
Go for regular breast screening, as recommended by your doctor.
Do not take DERMESTRIL-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 DERMESTRIL-Septem,
Do not take DERMESTRIL-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 DERMESTRILSeptem (listed in section 6 Further information)
If any of the above conditions appear for the first time while taking DERMESTRIL-Septem, stop taking it at
once and consult your doctor immediately.
When to take special care with DERMESTRIL-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 DERMESTRIL-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)”)
 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)

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a very high level of fat in your blood (triglycerides)
fluid retention due to cardiac or kidney problems

Stop taking DERMESTRIL-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 DERMESTRIL-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: DERMESTRIL-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.
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.
DERMESTRIL-Septem 75 contains a higher dose of oestrogens than other oestrogen-only HRT products.
The risk of endometrium cancer when using DERMESTRIL-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
DERMESTRIL-Septem.
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 DERMESTRIL-Septem more than 6 months

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 carries on after you have stopped taking DERMESTRIL-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).
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 DERMESTRIL-Septem and see a doctor immediately”.
Compare

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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.
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 DERMESTRIL-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 DERMESTRIL-Septem,
because this medicine can affect the results of some tests.
Pregnancy and breast-feeding
DERMESTRIL-Septem is for use in postmenopausal women only. If you become pregnant, stop taking
DERMESTRIL-Septem and contact your doctor.
Driving and using machines
DERMESTRIL-Septem is not expected to influence the ability to drive or to use machines.

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3. How to use DERMESTRIL-Septem
Always use DERMESTRIL-Septem exactly as your doctor has told you. You should check with your doctor
or pharmacist if you are not sure.
Three strengths of DERMESTRIL-Septem are available, DERMESTRIL-Septem 25, 50, 75. The choice of
which DERMESTRIL-Septem patch will suit you best will be made by your doctor, although most women
start with the DERMESTRIL-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 DERMESTRIL-Septem patches on or near the breasts.
Your DERMESTRIL-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 DERMESTRIL-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).

Figure 2

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(ii)

(iii)

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

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.

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 DERMESTRIL-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 DERMESTRIL-Septem at any convenient time if you are not currently
on any estrogen therapy.

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If you are currently using cyclic or sequential estrogen-progestogen therapy, you should complete the ongoing treatment cycle before beginning treatment with DERMESTRIL-Septem; the appropriate time to begin
treatment with DERMESTRIL-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
DERMESTRIL-Septem directly.
How to take progestogen with DERMESTRIL-Septem
If you have a uterus i.e. have not had a hysterectomy, your doctor may prescribe a progestogen for you with
DERMESTRIL-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:

1. Cyclic treatment
DERMESTRIL-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
DERMESTRIL-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 DERMESTRIL-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 DERMESTRIL-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 DERMESTRIL-Septem
When stopping the treatment with DERMESTRIL-Septem, you may experience a
postmenopausal symptoms.

recurrence of

If you need to have surgery
If you are going to have surgery, tell the surgeon that you are taking DERMESTRIL-Septem. You may
need to stop taking DERMESTRIL-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
DERMESTRIL-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, DERMESTRIL-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)

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heart disease
stroke
probable memory loss if HRT is started over the age of 65

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)

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- 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 DERMESTRIL-Septem
Keep DERMESTRIL-Septem out of the reach and sight of children.
Do not store DERMESTRIL-Septem above 25°C.
DERMESTRIL-Septem should be stored in its sachet intact.
Do not use DERMESTRIL-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 DERMESTRIL-Septem contains
DERMESTRIL-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.
DERMESTRIL-Septem patches are for external use only.
DERMESTRIL-Septem patches are available in three strengths:
DERMESTRIL-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).

DERMESTRIL-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).

DERMESTRIL-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.

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What DERMESTRIL-Septem looks like and content of the pack
DERMESTRIL-Septem are transparent transdermal patches individually sealed in a protective sachet.
DERMESTRIL-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
Benzstraße 1
61352 Bad Homburg
GERMANY
This medicinal product is authorised in the Member States of EEA under the following names:
Country
Belgium
France
Germany
Ireland
Italy
Luxembourg
Portugal
United Kingdom

Name
DERMESTRIL-Septem
DERMESTRIL-Septem
DERMESTRIL-Septem
DERMESTRIL-Septem
DERMESTRIL-Septem
DERMESTRIL-Septem
DERMESTRIL-Septem
DERMESTRIL-Septem

This leaflet was last approved in April 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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