NUVELLE CONTINUOUS

Active substance: NORETHISTERONE ACETATE

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Estradiol and norethisterone acetate
PACKAGE BOOKLET: INFORMATION FOR THE USER

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PACKAGE BOOKLET: INFORMATION FOR THE USER

Nuvelle Continuous™
Estradiol and norethisterone acetate

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Read all of this booklet carefully before you start
taking this medicine.
R Keep this booklet. You may need to read it again.
R If you have any further questions, ask your doctor
or pharmacist.
R 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.
R If any of the side effects get serious, or if you notice
any side effects not listed in this booklet, please tell
your doctor or pharmacist.

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In this booklet
1. WHAT NUVELLE CONTINUOUS IS AND
WHAT IT IS USED FOR
2. BEFORE YOU TAKE NUVELLE CONTINUOUS
Medical history and regular check-ups
Do not take Nuvelle Continuous
When you need to take special care with
Nuvelle Continuous
HRT and cancer

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Effect of HRT on heart or circulation
Blood clots in a vein (thrombosis)
Heart disease (heart attack)
Stroke
Other conditions
Using other medicines
Laboratory tests
Pregnancy and breast-feeding
Driving or using machines
Important information about some of
the ingredients of Nuvelle Continuous

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3. HOW TO TAKE NUVELLE CONTINUOUS
About the pack
When to start
If you take more Nuvelle Continuous than
you should
If you forget to take Nuvelle Continuous
If you stop taking Nuvelle Continuous
If you need to have surgery
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE NUVELLE CONTINUOUS
6. FURTHER INFORMATION

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1. WHAT NUVELLE CONTINUOUS IS AND WHAT IT
IS USED FOR
What Nuvelle Continuous is
Nuvelle Continuous is a Hormone Replacement
Therapy (HRT). It contains two types of female
hormone, an oestrogen and a progestogen. Your
ovaries no longer make these hormones after
the menopause. Nuvelle Continuous is used in
postmenopausal women with at least 12 months
(1 year) since their last natural period.

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What Nuvelle Continuous 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”). Nuvelle Continuous alleviates these
symptoms after menopause. You will only be
prescribed Nuvelle Continuous if your symptoms
seriously hinder your daily life.

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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 Nuvelle Continuous to prevent
osteoporosis after menopause.

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2. BEFORE YOU TAKE NUVELLE CONTINUOUS
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 an internal examination, if necessary.
Once you have started on Nuvelle Continuous, 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
Nuvelle Continuous.
 Go for regular breast screening, as recommended
by your doctor.
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Do not take Nuvelle Continuous
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 Nuvelle Continuous,
Do not take Nuvelle Continuous
R If you have or have ever had breast cancer, or if
you are suspected of having it
R 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
R If you have any unexplained vaginal bleeding

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R If you have excessive thickening of the womb
lining (endometrial hyperplasia) that is not being
treated
R If you have or have ever had a blood clot in a
vein (thrombosis) such as in the legs (deep vein
thrombosis) or the lungs (pulmonary embolism)
R If you have a blood clotting disorder (such as
protein C, protein S, or antithrombin deficiency)
R If you have or recently have had a disease caused
by blood clots in the arteries, such as a heart
attack, stroke or angina

[12)

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R If you have or have ever had a liver disease and
your liver function tests have not returned to
normal
R If you have a rare blood problem called “porphyria”
which is passed down in families (inherited)
R If you are allergic (hypersensitive) to estradiol
and norethisterone acetate or any of the other
ingredients of Nuvelle Continuous (listed in
section 6 “Further information”)

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R If you have been told to avoid lactose, that
you have a rare hereditary condition called
Lapp lactase deficiency or glucose-galactose
malabsorption
 If any of the above conditions appear for the first
time while taking Nuvelle Continuous, stop taking
it at once and consult your doctor immediately.

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When you need to take special care with Nuvelle
Continuous
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 Nuvelle continuous. If so, you should see your
doctor more often for check-ups:
R fibroids inside your womb
R growth of womb lining outside your womb
(endometriosis) or a history of excessive growth of
the womb lining (endometrial hyperplasia)
R increased risk of developing blood clots (see "Blood
clots in a vein (thrombosis)")

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R increased risk of getting an oestrogen-sensitive
cancer (such as a mother, sister or grandmother
who has had breast cancer)
R high blood pressure
R a liver disorder, such as a benign liver tumour
R diabetes
R gallstones
R migraine or severe headaches
R a disease of the immune system that affects many
organs of the body (systemic lupus erythematosus,
SLE)
R epilepsy
[16)

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R asthma
R a disease affecting the eardrum and hearing
(otosclerosis)
R a very high level of fat in your blood (triglycerides)
R fluid retention due to cardiac or kidney problems
R hereditary angioedema (episodes of swelling of
body parts)
Stop taking Nuvelle Continuous and see a doctor
immediately
If you notice any of the following when taking HRT:
R any of the conditions mentioned in the ‘DO NOT
take Nuvelle Continuous’ section

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R yellowing of your skin or the whites of your eyes
(jaundice). These may be signs of a liver disease
R a large rise in your blood pressure (symptoms may
be headache, tiredness, dizziness)
R migraine-like headaches which happen for the first
time
R if you become pregnant
R if you notice signs of a blood clot, such as:
P painful swelling and redness of the legs
P sudden chest pain
P difficulty in breathing

for more information, see ‘Blood clots in a vein
(thrombosis)’
[18)

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Note: Nuvelle Continuous 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

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lining (endometrial cancer).
The progestogen in Nuvelle Continuous protects you
from this extra risk.
Irregular bleeding
You may have irregular bleeding or drops of blood
(spotting) during the first 3–6 months of taking
Nuvelle Continuous. However, if the irregular
bleeding:
R Carries on for more than the first 6 months
R Starts after you have been taking Nuvelle
Continuous for more than 6 months
[20)

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R Carries on after you have stopped taking Nuvelle
Continuous
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.

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Compare
Women aged 50 to 79 who are not taking HRT, on
average, 9 to 14 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 20 cases in 1000
users (i.e. an extra 4 to 6 cases).
Regularly check your breasts. See your doctor if
you notice any changes in your breast, such as:
R dimpling of the skin
R changes in the nipple
R any lumps you can see or feel
[22)

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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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Effect of HRT on heart or 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 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 if these situations apply
to you:
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R 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”)
R you are seriously overweight (BMI >30 kg/m2)
R you have any blood clotting problem that needs
long-term treatment with a medicine used to
prevent blood clots
R if any of your close relatives has ever had a blood
clot in the leg, lung or another organ
R you have systemic lupus erythematosus (SLE)
R you have cancer
For signs of a blood clot, see “Stop taking Nuvelle
Continuous 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 are taking oestrogen-progestogen HRT for over
5 years, there will be 9 – 12 cases in 1000 (i.e. an extra
5 cases).

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Heart disease (heart attack)
There is no evidence that HRT will prevent a heart
attack.
Women over the age of 60 years who use oestrogenprogestogen HRT are slightly more likely to develop
heart disease than those not taking any HRT.
Stroke
The risk of getting a stroke is about 1.5–times higher in
HRT users than in non–users. The number of extra cases
of stroke due to HRT use will increase with age.

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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
R 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.
[28)

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R If you have a tendency to develop blotchy brown
patches (chloasma) on the face you should avoid
exposure to the sun or ultraviolet light whilst using
Nuvelle Continuous
Using other medicines
Some medicines may interfere with the effect of
Nuvelle Continuous. This might lead to irregular
bleeding. This applies to the following medicines

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R medicines for epilepsy (such as phenobarbital,
phenytoin, carbamazepine)
R medicines for tuberculosis (such as rifampicin,
rifabutin)
R medicines for HIV infection (such as nevirapine,
efavirenz, ritonavir and nelfinavir)
R 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.
[30)

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Laboratory tests
If you need a blood test, tell your doctor or the
laboratory staff that you are taking Nuvelle
Continuous, because this medicine can affect the
results of some tests.
Pregnancy and breast-feeding
Nuvelle Continuous is for use in post menopausal
women only. If you become pregnant, stop taking
Nuvelle Continuous and contact your doctor.

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Driving or using machines
There is nothing to suggest that the use of Nuvelle
Continuous affects driving or use of machines.
Important information about some of the
ingredients of Nuvelle Continuous
Nuvelle Continuous contains lactose (a type of sugar).
If you have an intolerance to some sugars, check
with your doctor before taking Nuvelle Continuous.

[32)

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3. HOW TO TAKE NUVELLE CONTINUOUS
Do not take Nuvelle Continuous until at least
12 months after your last natural period.
Your doctor will aim to prescribe the lowest dose to
treat your symptom for as short as necessary. Speak
to your doctor if you think this dose is too strong or
not strong enough.
Nuvelle Continuous is not for use in children or
adolescents.

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About the pack
This pack is designed to help you remember to take your
medicine. Each tablet is placed in a section
marked with the day of the week on which it should
be taken. The arrows between tablets show the order
in which they must be taken. Your doctor may tell
you when to start (see "when to start" for further
information).
On the day you start, take your first pink tablet from
the top row of tablets marked with the correct day.
For instance, if you start on a Tuesday, press out the
tablet from the blister marked 'TUE'.
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Take one tablet each day, following the directions of
the arrows, until you have finished all 28 tablets in
the memo strip. It is best to take your tablet at the
same time each day. You can take Nuvelle Continuous
with or without food. The tablet should be swallowed
whole with a glass of water or milk.
When you have finished each memo strip, start the
next memo strip on the following day. Do not leave
a break between memo strips. Tablet taking should
be continuous and each memo strip will therefore be
started on the same day of the week.

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When to start
If you are not currently using an HRT preparation:
start taking Nuvelle Continuous on any day.
If you have been taking other HRT preparations:
carry on until you have finished your current pack
and have taken all the tablets for that month. Take
your first Nuvelle Continuous tablet the next day. Do
not leave a break between your old tablets and the
Nuvelle Continuous tablets.

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If you take more Nuvelle Continuous than you
should
If you have taken too many Nuvelle Continuous
tablets by mistake, you may feel sick, vomit or
have some menstruation-like bleeding. No specific
treatment is necessary but you should consult your
doctor or pharmacist if you are worried.
If you forget to take Nuvelle Continuous
If you forget to take a tablet at your usual time and
you are less than 12 hours late, take it as soon as
possible. Take the next tablet at the usual time.

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If you are more than 12 hours late, leave the forgotten
tablet in the pack. Continue to take the rest of
the tablets at the usual time every day. You may
experience irregular bleeding.
If you stop taking Nuvelle Continuous
You may begin to feel the usual symptoms of
menopause again, which may include hot flushes,
trouble sleeping, nervousness, dizziness or vaginal
dryness. Consult your doctor or pharmacist if you
want to stop taking Nuvelle Continuous tablets.

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If you need to have surgery
If you are going to have surgery, tell the surgeon that
you are taking Nuvelle Continuous. You may need to
stop taking Nuvelle Continuous about 4 to 6 weeks
before the operation to reduce the risk of a blood clot
(see section 2, “Blood clots in a vein (thrombosis)”).
Ask your doctor when you can start taking Nuvelle
Continuous again.

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4. POSSIBLE SIDE EFFECTS
Like all medicines, Nuvelle Continuous can cause side
effects, although not everybody gets them.
If any of the side effects gets serious, or if you notice
any side effects not listed in this booklet, please tell
your doctor or pharmacist.
The following diseases are reported more often in
women using HRT compared to women not using HRT:

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Serious side effects
R breast cancer
R abnormal growth or cancer of the lining of the
womb (endometrial hyperplasia or cancer)
R ovarian cancer
R blood clots in the veins of the legs or lungs (venous
thromboembolism)
R heart disease
R stroke
R probable memory loss if HRT is started over the
age of 65

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For more information about these side effects see
Section 2.
Other side effects that have been linked to the
use of Nuvelle Continuous and other oral hormone
replacement therapies:
R During the first few months of treatment you may
experience some vaginal bleeding at unexpected
times (breakthrough bleeding and spotting).
These symptoms normally lessen with continued
treatment. If they don’t, contact your doctor (see
section 2 ‘HRT and cancer/ Excessive thickening of
the lining of the womb (endometrial hyperplasia)
and cancer of the lining of the womb (endometrial
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cancer)’ for more information).
R breast pain, tenderness or enlargement, breast
discharge
R painful periods, changes in vaginal secretions,
pre-menstrual symptoms, increased size of fibroids
in the womb, thrush, changes to the neck of the
womb
R indigestion, a feeling of being bloated, passing
wind, feeling or being sick, abdominal pain, gall
bladder disease
R skin rashes or discolouration, itching, eczema, acne,
unusual hair loss or hair growth, increased skin
pigment especially on the face (chloasma – see

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section 2 ‘other conditions’ for more information),
some rare skin problems
R headache, migraine, dizziness, anxiety or depressive
symptoms, fatigue
R fast or irregular heartbeat (palpitations), high
blood pressure, inflammation of veins usually in
the legs
R fluid retention leading to swelling of parts of the
body
R changes in body weight and sex drive, increased
appetite
R muscle cramps, leg pains
[44)

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R nose bleeds, visual disturbances (such as blurred
vision), discomfort with contact lenses, allergictype reactions, a worsening of glucose tolerance,
bladder inflammation, rare disorders (porphyria,
chorea).
R worsening of hereditary angioedema, with rapid
swelling of the skin and/or mucous membranes
such as swollen hands, face (eyes, lips, nose),
tongue and/or pharynx. Swollen tongue/pharynx
may lead to difficulty swallowing. Possible hives
together with difficulty breathing.

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The following side effects have been reported with
other HRTs:
R various skin disorders:
P painful reddish skin nodules (erythema
nodosum)
P rash with target-shaped reddening or sores
(erythema multiforme)

[46)

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5. HOW TO STORE NUVELLE CONTINUOUS
Keep out of the reach and sight of children.
Do not use Nuvelle Continuous after the expiry date
which is printed on the label after "EXP". The expiry
date refers to the last day of the month stated.
Do not dispose of medicines down the drain or in
the household rubbish. Ask your pharmacist how
to dispose of medicines no longer required. These
measures will help to protect the environment.

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6. FURTHER INFORMATION
What Nuvelle Continuous contains
The active substances are estradiol (as hemihydrate)
and norethisterone acetate.
The other ingredients are lactose monohydrate,
maize starch, pre-gelatinized maize starch,
povidone 25 000, talc, magnesium stearate (E572),
methylhydroxypropyl cellulose, macrogol 6000,
titanium dioxide (E171) and red ferric oxide pigments
(E172).

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What Nuvelle Continuous looks like and contents
of the pack
Nuvelle Continuous tablets are pink film-coated
tablets.
They are supplied in a blister pack (memo strip)
containing 28 tablets with the days of the week
printed on the blister.
Boxes containing three blister packs are available

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Marketing Authorisation Holder
Bayer PLC
Bayer House
Strawberry Hill
Newbury
Berkshire
RG14 1JA
Manufacturer
Bayer Pharma AG, Berlin, Germany or Bayer Weimar
GmbH und Co. KG, 99427 Weimar, Germany.

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Date of the last revision of this booklet
December 2012.

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81497435

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Expand view ⇕

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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