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ELLESTE DUET 1MG

Active substance(s): ESTRADIOL HEMIHYDRATE / NORETHISTERONE ACETATE

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Outside Cover
Package leaflet: Information for the user

Elleste Duet 1 mg Tablets
TM

1 mg + 1 mg/1 mg film-coated tablets
(estradiol + estradiol/norethisterone acetate)
and

Elleste Duet 2 mg Tablets
TM

2 mg + 2 mg/1 mg film-coated tablets
(estradiol + estradiol/norethisterone acetate)

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Read all of this leaflet carefully before you start taking 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, please 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 side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet.
See section 4.
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What is in this leaflet:
1. What Elleste Duet is and what it is used for
page 3
2. What you need to know before you take Elleste Duet
page 5
3. How to take Elleste Duet
page 24
4. Possible side effects
page 30
5. How to store Elleste Duet
page 35
6. Contents of the pack and other information
page 36
1. WHAT ELLESTE DUET IS AND WHAT IT IS USED FOR
Elleste Duet is a Hormone Replacement Therapy (HRT). It contains
two types of female hormones, an oestrogen (estradiol hemihydrate)
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and a progestogen (norethisterone acetate).
Elleste Duet is used for:
Relief of symptoms occurring 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"). Elleste Duet alleviates these
symptoms after menopause. You will only be prescribed Elleste Duet
if your symptoms seriously hinder your daily life.
Prevention of osteoporosis
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 Elleste
Duet 2 mg to prevent osteoporosis after menopause.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ELLESTE
DUET
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 Elleste Duet 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 Elleste Duet.
Go for regular breast screening, as recommended by your doctor.
Do not take Elleste Duet
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 Elleste Duet.

Do not take Elleste Duet
▮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)

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▮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 to estradiol hemihydrate or norethisterone
acetate 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 taking

Elleste Duet, stop taking it at once and consult your doctor
immediately.
When to take special care with Elleste Duet
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 Elleste Duet. 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)

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▮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
Stop taking Elleste Duet 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 Elleste Duet’
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: Elleste Duet 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).
The progestogen in Elleste Duet protects you from this extra risk.
Unexpected bleeding
You will have a bleed once a month (so-called withdrawal bleed) while
taking Elleste Duet. But, if you have unexpected bleeding or drops of

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blood (spotting) besides your monthly bleeding, which:
▮carries on for more than the first 6 months
▮starts after you have been taking Elleste Duet more than 6 months
▮carries on after you have stopped taking Elleste Duet
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.

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

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Additionally, you are advised to join mammography screening
programs when offered to you. For mammogram screening, it is
important that you inform the nurse/healthcare professional who is
actually taking the x-ray that you use HRT, as this medication may
increase the density of your breasts which may affect the outcome of
the mammogram. Where the density of the breast is increased,
mammography may not detect all lumps.
Ovarian cancer
Ovarian cancer is rare - much rarer than breast cancer. The use of
oestrogen-only or combined oestrogen-progestagen HRT has been
associated with a slightly increased risk of ovarian cancer.
The risk of ovarian cancer varies with age. For example, in women

aged 50 to 54 who are not taking HRT, about 2 women in 2000 will be
diagnosed with ovarian cancer over a 5-year period. For women who
have been taking HRT for 5 years, there will be about 3 cases per
2000 users (i.e. about 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

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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 Elleste Duet and see a
doctor immediately”.
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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).
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.

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).
Underactive thyroid gland
If you are having medicine for treatment of an underactive thyroid

gland, your doctor will carry out tests while you are taking HRT, to
ensure that your thyroid hormone levels remain acceptable.
Angioedema
If you have angioedema (a serious allergic reaction often involving
swelling of the face, mouth and throat), oestrogens may make this worse.
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.
Children
Do not give this medicine to children.

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Inside Cover
Other medicines and Elleste Duet
Some medicines may interfere with the effect of Elleste Duet. 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, telaprevir 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 Elleste Duet, because this medicine can affect the
results of some tests.
Pregnancy and breast-feeding
Elleste Duet is for use in postmenopausal women only. If you become
pregnant, stop taking Elleste Duet and contact your doctor.
Driving and using machines
No effects on driving or using machinery have been observed for
Elleste Duet.

Elleste Duet 2 mg contains Sunset yellow colouring which can
cause allergic-type reactions, including asthma. This allergy is more
common in people who are allergic to aspirin.
Elleste Duet contains lactose.
If you have been told by your doctor that you have an intolerance to
some sugars, contact your doctor before taking this medicinal product.
3. HOW TO TAKE ELLESTE DUET
Always take 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 possible dose to treat your
symptoms for as short a time as necessary. Speak to your doctor if
you think the dose is too strong or not strong enough.

The Elleste Duet 1 mg pack contains 16 white tablets and 12 pale
green tablets.
▮You must start with the white tablets.
The Elleste Duet 2 mg pack contains 16 orange tablets and 12 grey
tablets.
▮You must start with the orange tablets.
If you are still having regular periods, start on the first day of
bleeding.
If you are not having regular periods you can start straight away.
▮Take one tablet each day. You can take the tablet at a time of the
day that suits you but it is best to take it at about the same time
each day.

▮Swallow the tablets whole, with some water.
▮Follow the direction of the arrows on the pack and take a tablet
each day until the pack is empty.
▮When you finish your first foil strip, start a new strip on the next day.
Remember to put a fresh sticker on your new foil strip.
To help you remember to take your tablets, we have included stickers
in the pack with the days of the week marked on them. For example,
if you are starting the tablets on a Friday, use the sticker which starts
with 'Fri'. Stick this at the top of the foil strip on the side where you
can see the tablets.
If you are taking
▮Elleste Duet 1 mg, the first day should be above the white tablet

which has the start arrow next to it.
▮Elleste Duet 2 mg, the first day should be above the orange tablet
which has the start arrow next to it.
Changing from another type of HRT
If you are changing from another type of HRT, start taking Elleste
Duet when you finish the pack of HRT you are taking at the moment.
If your doctor gives you instructions on changing from another type of
HRT you should follow these instructions. If you have any doubts you
should contact your doctor.
Will I have periods?
You will probably have a monthly bleed. This may start any time

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between day 21 of the pack to day 5 of the next pack. This pattern will
usually be the same from month to month. Some women may have
no bleeds.
In the first few months you may get irregular bleeding. However, if this
carries on you should tell your doctor.
If you need to have surgery
If you are going to have surgery, tell the surgeon that you are taking
Elleste Duet. You may need to stop taking Elleste Duet 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 Elleste Duet again.

If you forget to take Elleste Duet
Take the tablet as soon as you remember, and take the next one at
the normal time.
If you have missed your tablet by more than 12 hours, dispose of this
tablet safely and take the next one at the normal time. Do not take a
double dose to make up for the forgotten tablet. You may experience
some breakthrough bleeding or spotting.
If you take more Elleste Duet than you should
There should be no problems, but you may experience breast
tenderness, feel sick or actually be sick, have irregular periods, feel
down, feel tired, develop acne or experience an increase in body and
facial hair. If you are worried, contact your doctor. Take the usual tablet
the following day.
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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.
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
For more information about these side effects, see section 2.
The following side effects have been associated with Elleste Duet:
Frequencies are defined as follows:
Very common: may affect more than 1 in 10 people
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people
Rare: may affect up to 1 in 1,000 people
Very rare: may affect up to 1 in 10,000 people
Not known: frequency cannot be estimated from the available data

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Very common: headache, breast pain, breast tenderness, painful
periods, problems with your menstrual cycle.
Common: feeling down, feeling anxious, mood changes, changes in
sex drive, feeling dizzy, difficulty sleeping, feeling sick, bloating,
diarrhoea, indigestion, stomach cramps, acne, rashes, itchiness, dry
skin, back pain, pain in the extremities, breast enlargement, heavy
periods, vaginal discharge, break-through bleeding, spasms
(contractions) of the womb, vaginal infection, excessive thickening of
the lining of the womb, pain, feeling of weakness, swelling of the
ankles, feet or fingers, increase in weight.
Uncommon: migraine, a feeling of dizziness or “spinning”, high blood
pressure, varicose veins, being sick, gallstones and gallbladder

disease, change in colour of the skin, breast cancer, muscle cramps,
increased levels of chemicals in the blood which may indicate disease.
Rare: hypersensitivity, tingling or numbness, blood clot in a vein,
inflammation of a vein, muscle weakness, growths in the womb
(myoma, cysts, polyps).
Very rare: increase in body and facial hair, yellowing of the skin.
Not known: loss of hair from the scalp.
The following side effects have been reported with other HRTs:
▮various skin disorders
- discolouration of the skin especially of the face or neck known as
“pregnancy patches” (chloasma)

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- painful reddish skin nodules (erythema nodosum)
- rash with target-shaped reddening or sores (erythema multiforme)
▮dry eyes
▮tear film changes
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse.
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 ELLESTE DUET
Keep this medicine out of the sight and reach of children.
Do not store Elleste Duet 1 mg Tablets above 30°C.
Do not store Elleste Duet 2 mg Tablets above 25°C.
Store in the original package.
Do not use this medicine after the 'expiry date' which is stated on the
carton after “EXP”. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste.
Ask your pharmacist to throw away medicines you no longer use.
These measures will help protect the environment.

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6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Elleste Duet contains
Each strip of Elleste Duet 1 mg Tablets contains the active
substances:
▮16 white tablets containing 1 milligram estradiol (as hemihydrate)
▮12 pale green tablets containing 1 milligram estradiol (as
hemihydrate) and 1 milligram norethisterone acetate.
Each strip of Elleste Duet 2 mg Tablets contains the active
substances:
▮16 orange tablets containing 2 milligrams estradiol (as
hemihydrate).

▮12 grey tablets containing 2 milligrams estradiol (as hemihydrate)
and 1 milligram norethisterone acetate
(The estradiol hemihydrate used to make Elleste Duet does not come
from animals).
The tablets also contain: lactose monohydrate, maize starch,
povidone, talc, magnesium stearate, macrogol 400 and hypromellose
(E464).
▮Elleste Duet 1 mg contains the colours indigo carmine (E132),
quinoline yellow (E104) and titanium dioxide (E171).
▮Elleste Duet 2 mg contains the colours sunset yellow (E110),
titanium dioxide (E171) and black iron oxide (E172). (see also the
warning at the end of section 2)

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What Elleste Duet looks like and contents of the pack
One pack of Elleste Duet 1 mg Tablets contains white and pale green
film-coated tablets with an embossing.
One pack of Elleste Duet 2 mg Tablets contains orange and grey
film-coated tablets with an embossing.
They are supplied in packs containing blister strips of 28 or 84 tablets.
Not all packs sizes may be marketed.
Marketing Authorisation Holder
Meda Pharmaceuticals Ltd, Skyway House,
Parsonage Road, Takeley, Bishop’s Stortford,
CM22 6PU,
UK

Manufacturer
Piramal Healthcare (UK) Ltd.
Whalton Road, Morpeth, Northumberland,
NE61 3YA,
UK
This medicinal product is authorised in the Member States of the EEA
under the following names:
Austria Parapanol duo and Parapanol duo mite
UK
Elleste Duet 1 mg Tablets and Elleste Duet 2 mg Tablets
This leaflet was last revised in 02/2016.

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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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