ELLESTE DUET 2MG

Active substance: NORETHISTERONE ACETATE

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Package leaflet: Information for the user

Elleste Duet

TM

1 mg and 2 mg Tablets

(estradiol hemihydrate and norethisterone acetate)
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.
What is in this leaflet:
1. What Elleste Duet is and what it is used for
2. What you need to know before you take Elleste Duet
3. How to take Elleste Duet
4. Possible side effects
5. How to store Elleste Duet
6. Contents of the pack and other information
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) and a progestogen
(norethisterone acetate).
Elleste Duet 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"). 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.






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 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 oestrogenprogestogen 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
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 3times 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
Do not take Elleste Duet
or even death.
if any of the following applies to you. If you are not
sure about any of the points below, talk to your doctor You are more likely to get a blood clot in your veins as
you get older and if any of the following applies to
before taking Elleste Duet.
you. Inform your doctor if any of these situations
Do not take Elleste Duet
applies to you:
• If you have or have ever had breast cancer, or if
• you are unable to walk for a long time because of
you are suspected of having it
major surgery, injury or illness (see also section 3,
• If you have cancer which is sensitive to oestrogens,
If you need to have surgery)
such as cancer of the womb lining (endometrium),
• you are seriously overweight (BMI >30 kg/m2)
or if you are suspected of having it
• you have any blood clotting problem that needs
• If you have any unexplained vaginal bleeding
long-term treatment with a medicine used to prevent
• If you have excessive thickening of the womb lining
blood clots
(endometrial hyperplasia) that is not being treated.
• if any of your close relatives has ever had a blood
• If you have or have ever had a blood clot in a vein
clot in the leg, lung or another organ
(thrombosis), such as in the legs (deep venous
• you have systemic lupus erythematosus (SLE)
thrombosis) or the lungs (pulmonary embolism)
• you have cancer
• If you have a blood clotting disorder (such as
For signs of a blood clot, see “Stop taking Elleste Duet
protein C, protein S, or antithrombin deficiency)
• If you have or recently have had a disease caused by and see a doctor immediately”.
blood clots in the arteries, such as a heart attack,
Compare
stroke or angina
Looking at women in their 50s who are not taking
• If you have or have ever had a liver disease and your
HRT, on average, over a 5-year period, 4 to 7 in 1000
liver function tests have not returned to normal
would be expected to get a blood clot in a vein.
• If you have a rare blood problem called “porphyria”
For women in their 50s who have been taking
which is passed down in families (inherited)
oestrogen-progestogen HRT for over 5 years, there will
• If you are allergic (hypersensitive) to estradiol
be 9 to 12 cases in 1000 users (i.e. an extra 5 cases).
hemihydrate or norethisterone acetate or any of
the other ingredients of Elleste Duet (listed in
Heart disease (heart attack)
section 6 Contents of the pack and other information). There is no evidence that HRT will prevent a heart
If any of the above conditions appear for the first time attack.
while taking Elleste Duet, stop taking it at once and
Women over the age of 60 years who use oestrogenconsult your doctor immediately.
progestogen HRT are slightly more likely to develop
heart disease than those not taking any HRT.
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)
• 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

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.
Children
Do not give this medicine to children.
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 and nelfinavir)
• Herbal remedies containing St John’s Wort
(Hypericum perforatum)
• Diabetic drugs, as this product may affect your
blood glucose level. If you are being treated for
diabetes please let your doctor or pharmacist know
that you take Elleste Duet
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 1mg pack contains 16 white tablets
and 12 pale green tablets.
• You must start with the white tablets.
The Elleste Duet 2mg 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 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.

Rare: loss of hair from the scalp, increase in body and
facial hair, itchiness, rashes.
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)
- painful reddish skin nodules (erythema nodosum)
- rash with target-shaped reddening or sores
(erythema multiforme)
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 any side
effects via the internet at www.mhra.gov.uk/yellowcard
or alternatively you can call Freephone 0808 100 3352
(available between 10am-2pm Monday-Friday), or fill
in a paper form available from your local pharmacy.
By reporting side effects, you can help make sure
medicines remain as safe as possible.
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.
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)
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 leaflet was last approved in 09/2012.
If you have any comments on the way this leaflet is
written, please write to Medical Information at Meda
Pharmaceuticals Ltd, Skyway House, Parsonage Road,
Takeley, Bishop’s Stortford, CM22 6PU, UK.

If you take more Elleste Duet than you should
There should be no problems, but you may feel sick or
actually be sick. If you are worried, contact your
doctor. Take the usual tablet the following day.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Elleste Duet 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
Common: feeling sick, stomach cramps, headache, an
increase in size of fibroids in the womb, breakthrough
bleeding, changes in weight, oedema (swelling) of
legs, breast tenderness and enlargement, mood
changes, changes in sex drive.
Uncommon: indigestion, being sick, flatulence,
gallstones and gallbladder disease, feeling dizzy,
migraine, vaginal thrush, increase in blood pressure,
leg cramps.
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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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