ELLESTE DUET CONTI TABLETS

Active substance: NORETHISTERONE ACETATE

View full screen / Print PDF » Download PDF ⇩

Transcript
Elleste DuetTM Conti 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, 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 of the 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 Conti Tablets are and what they
are used for
2. What you need to know before you take Elleste
Duet Conti Tablets
3. How to take Elleste Duet Conti Tablets
4. Possible side effects
5. How to store Elleste Duet Conti Tablets
6. Contents of the pack and other information
1. WHAT ELLESTE DUET CONTI TABLETS
ARE AND WHAT THEY ARE USED FOR
Elleste Duet Conti Tablets are a Hormone Replacement Therapy (HRT). They contain two types of
female hormones, an oestrogen (estradiol hemihydrate) and a progestogen (norethisterone acetate).
Elleste Duet Conti Tablets are used in postmenopausal
women with at least one year since their last natural
period.
Elleste Duet Conti Tablets are 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 Conti Tablets alleviate these
symptoms after menopause. You will only be prescribed
Elleste Duet Conti Tablets 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 Conti Tablets to prevent
osteoporosis after menopause.
2. WHAT YOU NEED TO KNOW BEFORE YOU
TAKE ELLESTE DUET CONTI TABLETS

80mm

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 Conti Tablets
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 Conti Tablets.
Go for regular breast screening, as recommended by
your doctor.
Do not take Elleste Duet Conti Tablets
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 Conti Tablets,
Do not take Elleste Duet Conti Tablets
• 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
hemihydrate or norethisterone acetate or any of
the other ingredients of Elleste Duet Conti Tablets
(listed in section 6 Contents of the pack and other
information).
If any of the above conditions appear for the first time
while taking Elleste Duet Conti Tablets, stop taking
them at once and consult your doctor immediately.
When to take special care with Elleste Duet Conti
Tablets
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 Conti Tablets. 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 Conti Tablets 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 Conti Tablets’ 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 Conti Tablets are 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 Conti Tablets 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 Elleste
Duet Conti Tablets. However, if the irregular bleeding:
• carries on for more than the first 6 months
• starts after you have been taking Elleste Duet Conti
Tablets for more than 6 months
• carries on after you have stopped taking Elleste
Duet Conti Tablets
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.

2mm

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

80mm

Package leaflet: Information for the user

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
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 Elleste Duet
Conti Tablets and see a doctor immediately”.
Compare
Looking at women in their 50s who are not taking
HRT, on average, over a 5-year period, 4 to 7 in 1000
would be expected to get a blood clot in a vein.
For women in their 50s who have been taking
oestrogen-progestogen HRT for over 5 years, there will
be 9 to 12 cases in 1000 users (i.e. an extra 5 cases).
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 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 Conti Tablets
Some medicines may interfere with the effect of
Elleste Duet Conti Tablets. 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)

160mm

Appendix i.d

• 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 Conti Tablets
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 Conti
Tablets, because this medicine can affect the results of
some tests.
Pregnancy and breast-feeding
Elleste Duet Conti Tablest are for use in postmenopausal women only. If you become pregnant, stop taking
Elleste Duet Conti Tablets and contact your doctor.
Driving and using machines
No effects on driving or using machinery have been
observed for Elleste Duet Conti Tablets.
Elleste Duet Conti Tablets contain 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 CONTI
TABLETS
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.
If you are not taking any HRT
If you are not taking any HRT, you can start taking
Elleste Duet Conti Tablets straightaway.
• Take one tablet each day. You can take the tablets at
a time of the day that suits you, but it is best to take
them at about the same time each day.
• Swallow the tablets whole, with some water. All the
tablets are the same.
• The days are marked on the strip to help you to
remember to take one each day.
• Follow the direction of the arrows on the pack and
take a tablet every day until the pack is empty.
• When you finish a foil strip, start a new strip the
next day.
Changing from another type of HRT
If you are changing from another type of HRT, and
you usually have a monthly bleed, start taking Elleste
Duet Conti Tablets on the first day of bleeding.
If you do not have a monthly bleed, start taking Elleste
Duet Conti Tablets on any convenient day.
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.

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 CONTI
TABLETS
Keep this medicine out of the sight and reach of
children.
Do not store 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 Conti Tablets contains
• Each tablet contains the active substances:
2 milligrams estradiol (as hemihydrate) and
1 milligram norethisterone acetate.
(The estradiol used to make Elleste Duet Conti
Tablets does not come from animals).
• The tablets also contain: lactose monohydrate,
maize starch, povidone, talc, magnesium stearate,
macrogol 400, titanium dioxide (E171), black iron
oxide (E172), and hypromellose (E464) (see also
the warning at the end of section 2).
What Elleste Duet Conti Tablets look like and
contents of the pack
Elleste Duet Conti Tablets are 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 need to have surgery
If you are going to have surgery, tell the surgeon that
you are taking Elleste Duet Conti Tablets. You may
need to stop taking Elleste Duet Conti Tablets 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
Conti Tablets again.
If you forget to take Elleste Duet Conti
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 Conti 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

300mm

Like all medicines, Elleste Duet Conti Tablets 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 Conti Tablets:
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.
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)

xxxxxxxx

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.

Hide
(web2)