Elleste Duet Conti tablets

Main information

  • Trade name:
  • Elleste Duet Conti tablets
  • Dosage:
  • 2mg ; 1mg
  • Pharmaceutical form:
  • Tablet
  • Administration route:
  • Oral
  • Class:
  • No Controlled Drug Status
  • Prescription type:
  • Valid as a prescribable product
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Elleste Duet Conti tablets
    United Kingdom
  • Language:
  • English

Therapeutic information

  • Product summary:
  • BNF: 06040101; GTIN: 5012882007485

Status

  • Source:
  • eMC
  • Authorization number:
  • PL 15142/0065
  • Last update:
  • 11-07-2019

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

Package leaflet: Information for the user

Elleste Duet

TM

Conti Tablets

2 mg/1 mg film-coated tablets

(estradiol/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. See section 4.

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 Replace-

ment Therapy (HRT). They contain two types of

female hormones, an oestrogen (estradiol hemihy-

drate) 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 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 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

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 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 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 grand-

mother 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 contracep-

tive. 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 oestro-

gen-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

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-pro-

gestagen 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 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 oestro-

gen-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.

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)

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 Conti

Tablets, because this medicine can affect the results of

some tests.

Pregnancy and breast-feeding

Elleste Duet Conti Tablets 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 instruc-

tions. If you have any doubts you should contact your

doctor.

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 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.

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 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

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 and 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, muscle cramps, breast cancer,

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)

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 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 medicinal product is authorised in the Member

States of the EEA under the following names:

Austria

Parapanol kombi

Germany

Clionara

Elleste Duet Conti Tablets

This leaflet was last revised in 02/2016.

XXXXXXXX

Package leaflet: Information for the user

Elleste Duet

TM

Conti Tablets

2 mg/1 mg film-coated tablets

(estradiol/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. See section 4.

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 Replace-

ment Therapy (HRT). They contain two types of

female hormones, an oestrogen (estradiol hemihy-

drate) 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 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 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

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 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 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 grand-

mother 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 contracep-

tive. 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 oestro-

gen-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

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-pro-

gestagen 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 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 oestro-

gen-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.

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)

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 Conti

Tablets, because this medicine can affect the results of

some tests.

Pregnancy and breast-feeding

Elleste Duet Conti Tablets 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 instruc-

tions. If you have any doubts you should contact your

doctor.

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 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.

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 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

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 and 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, muscle cramps, breast cancer,

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)

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 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 medicinal product is authorised in the Member

States of the EEA under the following names:

Austria

Parapanol kombi

Germany

Clionara

Elleste Duet Conti Tablets

This leaflet was last revised in 02/2016.