Elleste Duet 1mg tablets

Main information

  • Trade name:
  • Elleste Duet 1mg tablets
  • Pharmaceutical form:
  • Not applicable
  • Class:
  • No Controlled Drug Status
  • Prescription type:
  • Never Valid To Prescribe As A VMP
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Elleste Duet 1mg tablets
    United Kingdom
  • Language:
  • English

Therapeutic information

  • Product summary:
  • BNF: 06040101; GTIN: 5012882007478

Status

  • Source:
  • eMC
  • Authorization number:
  • PL 15142/0063
  • Last update:
  • 11-07-2019

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

Mock ups

replace 20716049)

Pia Salonen/Ingvar Jonasson

Leaflet Elleste Duet 1 mg

and 2 mg Tablets

160x600 mm

2017-02-07

Pharma code

Prepared by

Country

Project Number

Product

Date

Size/Template

Black

EAN code

Art Works team

Solna, Sweden

10%Black

Package leaflet: Information for the user

Elleste Duet

TM

1 mg Tablets

1 mg + 1 mg/1 mg film-coated tablets

(estradiol + estradiol/norethisterone acetate)

Elleste Duet

TM

2 mg Tablets

2 mg + 2 mg/1 mg film-coated tablets

(estradiol + 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, please ask your

doctor or pharmacist.

This medicine has been prescribed for you only.

Do not pass it on to others. It may harm them, even

if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor or

pharmacist.

This includes any possible side effects

not listed in this leaflet. See section 4.

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 occurring after menopause

During the menopause, the amount of the oestrogen

produced by a woman’s body drops. This can cause

symptoms such as hot face, neck and chest ("hot

flushes"). Elleste Duet alleviates these symptoms

after menopause. You will only be prescribed Elleste

Duet if your symptoms seriously hinder your daily

life.

Prevention of osteoporosis

After the menopause some women may develop

fragile bones (osteoporosis). You should discuss all

available options with your doctor.

If you are at an increased risk of fractures due to

osteoporosis and other medicines are not suitable for

you, you can use Elleste Duet 2 mg to prevent

osteoporosis after menopause.

2. WHAT YOU NEED TO KNOW BEFORE

YOU TAKE ELLESTE DUET

Medical history and regular check-ups

The use of HRT carries risks which need to be

considered when deciding whether to start taking it,

or whether to carry on taking it.

The experience in treating women with a premature

menopause (due to ovarian failure or surgery) is

limited. If you have a premature menopause the

risks of using HRT may be different. Please talk to

your doctor.

Before you start (or restart) HRT, your doctor will

ask about your own and your family’s medical

history. Your doctor may decide to perform a physical

examination. This may include an examination of

your breasts and/or an internal examination, if

necessary.

Once you have started on Elleste Duet you should

see your doctor for regular check-ups (at least once

a year). At these check-ups, discuss with your doctor

the benefits and risks of continuing with Elleste Duet.

Go for regular breast screening, as recommended by

your doctor.

Do not take Elleste Duet

if any of the following applies to you. If you are not

sure about any of the points below, talk to your

doctor before taking Elleste Duet.

Do not take Elleste Duet

If you have or have ever had breast cancer, or if

you are suspected of having it

If you have cancer which is sensitive to

oestrogens, such as cancer of the womb lining

(endometrium), or if you are suspected of having it

If you have any unexplained vaginal bleeding

If you have excessive thickening of the womb

lining (endometrial hyperplasia) that is not being

treated

If you have or have ever had a blood clot in a vein

(thrombosis), such as in the legs (deep venous

thrombosis) or the lungs (pulmonary embolism)

If you have a blood clotting disorder (such as

protein C, protein S, or antithrombin deficiency)

If you have or recently have had a disease caused

by blood clots in the arteries, such as a heart

attack, stroke or angina

If you have or have ever had a liver disease and

your liver function tests have not returned to

normal

If you have a rare blood problem called “porphyria”

which is passed down in families (inherited)

If you are allergic to estradiol hemihydrate or

norethisterone acetate or any of the other

ingredients of this medicine (listed in section 6)

If any of the above conditions appear for the first

time while taking Elleste Duet, stop taking it at once

and consult your doctor immediately.

When to take special care with Elleste Duet

Tell your doctor if you have ever had any of the

following problems, before you start the treatment,

as these may return or become worse during

treatment with Elleste Duet. If so, you should see

your doctor more often for check-ups:

fibroids inside your womb

growth of womb lining outside your womb

(endometriosis) or a history of excessive growth

of the womb lining (endometrial hyperplasia)

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 and see a doctor

immediately

If you notice any of the following when taking HRT:

any of the conditions mentioned in the ‘DO NOT

take Elleste Duet’ section

yellowing of your skin or the whites of your eyes

(jaundice). These may be signs of a liver disease

a large rise in your blood pressure (symptoms may

be headache, tiredness, dizziness)

migraine-like headaches which happen for the first

time

if you become pregnant

if you notice signs of a blood clot, such as:

painful swelling and redness of the legs

sudden chest pain

difficulty in breathing

For more information, see ‘Blood clots in a vein

(thrombosis)’

Note: Elleste Duet is not a contraceptive. If it is less

than 12 months since your last menstrual period or

you are under 50 years old, you may still need to use

additional contraception to prevent pregnancy.

Speak to your doctor for advice.

HRT and cancer

Excessive thickening of the lining of the womb

(endometrial hyperplasia) and cancer of the

lining of the womb (endometrial cancer)

Taking oestrogen-only HRT will increase the risk of

excessive thickening of the lining of the womb

(endometrial

hyperplasia) and cancer of the womb

lining (endometrial cancer).

The progestogen in Elleste Duet protects you from

this extra risk.

Unexpected bleeding

You will have a bleed once a month (so-called

withdrawal bleed) while taking Elleste Duet. But, if

you have unexpected bleeding or drops of blood

(spotting) besides your monthly bleeding, which:

carries on for more than the first 6 months

starts after you have been taking Elleste Duet more

than 6 months

carries on after you have stopped taking Elleste

Duet

see your doctor as soon as possible

Breast cancer

Evidence suggests that taking combined oestrogen-

progestogen and possibly also oestrogen-only HRT

increases the risk of breast cancer. The extra risk

depends on how long you take HRT. The additional

risk becomes clear within a few years. However, it

returns to normal within a few years (at most 5)

after stopping treatment.

Compare

Women aged 50 to 79 who are not taking HRT, on

average, 9 to 17 in 1000 will be diagnosed with

breast cancer over a 5-year period. For women aged

50 to 79 who are taking oestrogen-progestogen HRT

over 5 years, there will be 13 to 23 cases in 1000

users (i.e. an extra 4 to 6 cases).

Regularly check your breasts. See your doctor

if you notice any changes such as:

dimpling of the skin

changes in the nipple

any lumps you can see or feel

Additionally, you are advised to join mammography

screening programs when offered to you. For

mammogram screening, it is important that you

inform the nurse/healthcare professional who is

actually taking the x-ray that you use HRT, as this

medication may increase the density of your breasts

which may affect the outcome of the mammogram.

Where the density of the breast is increased,

mammography may not detect all lumps.

Ovarian cancer

Ovarian cancer is rare - much rarer than breast

cancer. The use of oestrogen-only or combined

oestrogen-progestagen HRT has been associated

with a slightly increased risk of ovarian cancer.

The risk of ovarian cancer varies with age. For

example, in women aged 50 to 54 who are not

taking HRT, about 2 women in 2000 will be

diagnosed with ovarian cancer over a 5-year period.

For women who have been taking HRT for 5 years,

there will be about 3 cases per 2000 users (i.e. about

1 extra case).

Effect of HRT on heart and circulation

Blood clots in a vein (thrombosis)

The risk of blood clots in the veins is about 1.3 to

3- times higher in

HRT users than in non-users,

especially during the first year of taking it.

Blood clots can be serious, and if one travels to the

lungs, it can cause chest pain, breathlessness,

fainting or even death.

You are more likely to get a blood clot in your veins

as you get older 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/m

you have any blood clotting problem that needs

long-term treatment with a medicine used to

prevent blood clots

if any of your close relatives has ever had a blood

clot in the leg, lung or another organ

you have systemic lupus erythematosus (SLE)

you have cancer

For signs of a blood clot, see “Stop taking Elleste

Duet and see a doctor immediately”.

Compare

Looking at women in their 50s who are not taking

HRT, on average, over a 5-year period, 4 to 7 in

1000 would be expected to get a blood clot in a vein.

For women in their 50s who have been taking

oestrogen-progestogen HRT for over 5 years, there

will be 9 to 12 cases in 1000 users (i.e. an extra 5

cases).

Heart disease (heart attack)

There is no evidence that HRT will prevent a heart

attack.

Women over the age of 60 years who use oestrogen-

progestogen HRT are slightly more likely to develop

heart disease than those not taking any HRT.

Stroke

The risk of getting stroke is about 1.5 times higher

in HRT users than in non-users. The number of extra

cases of stroke due to use of HRT will increase with

age.

Compare

Looking at women in their 50s who are not taking

HRT, on average, 8 in 1000 would be expected to

have a stroke over a 5-year period. For women in

their 50s who are taking HRT, there will be 11 cases

in 1000 users, over 5 years (i.e. an extra 3 cases).

Underactive thyroid gland

If you are having medicine for treatment of an

underactive thyroid gland, your doctor will carry out

tests while you are taking HRT, to ensure that your

thyroid hormone levels remain acceptable.

Angioedema

If you have angioedema (a serious allergic reaction

often involving

swelling of the face, mouth and

throat), oestrogens may make this worse.

Other conditions

HRT will not prevent memory loss. There is some

evidence of a higher risk of memory loss in

women who start using HRT after the age of 65.

Speak to your doctor for advice.

Children

Do not give this medicine to children.

Other medicines and Elleste Duet

Some medicines may interfere with the effect of

Elleste Duet. This might lead to irregular bleeding.

This applies to the following medicines:

Medicines for epilepsy (such as phenobarbital,

phenytoin and carbamazepin)

Medicines for tuberculosis (such as rifampicin,

rifabutin)

Medicines for HIV infection (such as nevirapine,

efavirenz, ritonavir, telaprevir and nelfinavir)

Herbal remedies containing St John’s Wort

(Hypericum perforatum)

Please tell your doctor or pharmacist if you are

taking or have recently taken any other medicines

including medicines obtained without a prescription,

herbal medicines or other natural products.

Laboratory tests

If you need a blood test, tell your doctor or the

laboratory staff that you are taking Elleste Duet,

because this medicine can affect the results of some

tests.

Pregnancy and breast-feeding

Elleste Duet is for use in postmenopausal women

only. If you become pregnant, stop taking Elleste

Duet and contact your doctor.

Driving and using machines

No effects on driving or using machinery have been

observed for Elleste Duet.

Elleste Duet 2 mg contains Sunset yellow colouring

which can cause allergic-type reactions, including

asthma. This allergy is more common in people who

are allergic to aspirin.

Elleste Duet contains lactose.

If you have been told by your doctor that you have

an intolerance to

some sugars, contact your doctor

before taking this medicinal product.

3. HOW TO TAKE ELLESTE DUET

Always take this medicine exactly as your doctor or

pharmacist has told you. Check with your doctor or

pharmacist if you are not sure.

Your doctor will aim to prescribe the lowest possible

dose to treat your symptoms for as short a time as

necessary. Speak to your doctor if you think the

dose is too strong or not strong enough.

The Elleste Duet 1 mg pack contains 16 white

tablets and 12 pale green tablets.

You must start with the white tablets.

The Elleste Duet 2 mg pack contains 16 orange

tablets and 12 grey tablets.

You must start with the orange tablets.

If you are still having regular periods, start on the

first day of bleeding.

If you are not having regular periods you can start

straight away.

Take one tablet each day. You can take the tablet at

a time of the day that suits you but it is best to take

it at about the same time each day.

Swallow the tablets whole, with some water.

Follow the direction of the arrows on the pack and

take a tablet each day until the pack is empty.

When you finish your first foil strip, start a new

strip on the next day. Remember to put a fresh

sticker on your new foil strip.

To help you remember to take your tablets, we have

included stickers in the pack with the days of the

week marked on them. For example, if you are

starting the tablets on a Friday, use the sticker which

starts with 'Fri'. Stick this at the top of the foil strip

on the side where you can see the tablets.

If you are taking

Elleste Duet 1 mg, the first day should be above

the white tablet which has the start arrow next to it.

Elleste Duet 2 mg, the first day should be above

the orange tablet which has the start arrow next to it.

Changing from another type of HRT

If you are changing from another type of HRT, start

taking Elleste Duet when you finish the pack of

HRT you are taking at the moment.

If your doctor gives you instructions on changing

from another type of HRT you should follow these

instructions. If you have any doubts you should

contact your doctor.

Will I have periods?

You will probably have a monthly bleed. This may

start any time 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 experien-

ce some breakthrough bleeding or spotting.

If you take more Elleste Duet than you should

There should be no problems, but you may

experience breast tenderness, feel sick or actually be

sick, have irregular periods, feel down, feel tired,

develop acne or experience an increase in body and

facial hair. If you are worried, contact your doctor.

Take the usual tablet

the following day.

If you have any further questions on the use of this

medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side

effects, although not everybody gets them.

The following diseases are reported more often in

women using HRT compared to women not using

HRT:

breast cancer

abnormal growth or cancer of the lining of the

womb (endometrial hyperplasia or cancer)

ovarian cancer

blood clots in the veins of the legs or lungs (venous

thromboembolism)

heart disease

stroke

probable memory loss if HRT is started over the

age of 65

For more information about these side effects, see

section 2.

The following side effects have been associated with

Elleste Duet:

Frequencies are defined as follows:

Very common: may affect more than 1 in 10 people

Common: may affect up to 1 in 10 people

Uncommon: may affect up to 1 in 100 people

Rare: may affect up to 1 in 1,000 people

Very rare: may affect up to 1 in 10,000 people

Not known: frequency cannot be estimated from the

available data

Very common: headache, breast pain, breast

tenderness, painful periods, problems with your

menstrual cycle.

Common: feeling down, feeling anxious, mood

changes, changes in sex drive, feeling dizzy,

difficulty sleeping, feeling sick, bloating, diarrhoea,

indigestion, stomach cramps, acne, rashes, itchiness,

dry skin, back pain, pain in the extremities, breast

enlargement, heavy periods, vaginal discharge,

break-through bleeding, spasms (contractions) of

the womb, vaginal infection, excessive thickening of

the lining of the womb, pain, feeling of weakness,

swelling of the ankles, feet or fingers, increase in

weight.

Uncommon: migraine, a feeling of dizziness or

“spinning”, high blood pressure, varicose veins,

being sick, gallstones and gallbladder disease,

change in colour of the skin, breast cancer, muscle

cramps,

increased levels of chemicals in the blood

which may indicate disease.

Rare: hypersensitivity, tingling or numbness, blood

clot in a vein, inflammation of a vein, muscle

weakness, growths in the womb (myoma, cysts,

polyps).

Very rare: increase in body and facial hair,

yellowing of the skin.

Not known: loss of hair from the scalp.

The following side effects have been reported with

other HRTs:

various skin disorders

- discolouration of the skin especially of the face

or neck known as “pregnancy patches”

(chloasma)

- painful reddish skin nodules (erythema

nodosum)

- rash with target-shaped reddening or sores

(erythema multiforme)

dry eyes

tear film changes

Reporting of side effects

If you get any side effects, talk to your doctor,

pharmacist or nurse. This includes any possible side

effects not listed in this leaflet.

You can also report side effects directly via the

Yellow Card Scheme at:

www.mhra.gov.uk/yellowcard

By reporting side effects, you can help provide more

information on the safety of this medicine.

5. HOW TO STORE ELLESTE DUET

Keep this medicine out of the sight and reach of

children.

Do not store Elleste Duet 1 mg Tablets above 30

Do not store Elleste Duet 2 mg Tablets above 25

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,

Manufacturer

Piramal Healthcare (UK) Ltd.

Whalton Road, Morpeth, Northumberland,

NE61 3YA,

This medicinal product is authorised in the Member

States of the EEA under the following names:

Austria Parapanol duo and Parapanol duo mite

Elleste Duet 1 mg Tablets and Elleste Duet

2 mg Tablets

This leaflet was last revised in 02/2016.

Mock ups PIL Elleste Duet 1mg and 2mg tabl UK 2017-02.pdf 1 2017-02-07 14:30:22

XXXXXXXX

Package leaflet: Information for the user

Elleste Duet

TM

1 mg Tablets

1 mg + 1 mg/1 mg film-coated tablets

(estradiol + estradiol/norethisterone acetate)

Elleste Duet

TM

2 mg Tablets

2 mg + 2 mg/1 mg film-coated tablets

(estradiol + 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, please ask your

doctor or pharmacist.

This medicine has been prescribed for you only.

Do not pass it on to others. It may harm them, even

if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor or

pharmacist.

This includes any possible side effects

not listed in this leaflet. See section 4.

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 occurring after menopause

During the menopause, the amount of the oestrogen

produced by a woman’s body drops. This can cause

symptoms such as hot face, neck and chest ("hot

flushes"). Elleste Duet alleviates these symptoms

after menopause. You will only be prescribed Elleste

Duet if your symptoms seriously hinder your daily

life.

Prevention of osteoporosis

After the menopause some women may develop

fragile bones (osteoporosis). You should discuss all

available options with your doctor.

If you are at an increased risk of fractures due to

osteoporosis and other medicines are not suitable for

you, you can use Elleste Duet 2 mg to prevent

osteoporosis after menopause.

2. WHAT YOU NEED TO KNOW BEFORE

YOU TAKE ELLESTE DUET

Medical history and regular check-ups

The use of HRT carries risks which need to be

considered when deciding whether to start taking it,

or whether to carry on taking it.

The experience in treating women with a premature

menopause (due to ovarian failure or surgery) is

limited. If you have a premature menopause the

risks of using HRT may be different. Please talk to

your doctor.

Before you start (or restart) HRT, your doctor will

ask about your own and your family’s medical

history. Your doctor may decide to perform a physical

examination. This may include an examination of

your breasts and/or an internal examination, if

necessary.

Once you have started on Elleste Duet you should

see your doctor for regular check-ups (at least once

a year). At these check-ups, discuss with your doctor

the benefits and risks of continuing with Elleste Duet.

Go for regular breast screening, as recommended by

your doctor.

Do not take Elleste Duet

if any of the following applies to you. If you are not

sure about any of the points below, talk to your

doctor before taking Elleste Duet.

Do not take Elleste Duet

If you have or have ever had breast cancer, or if

you are suspected of having it

If you have cancer which is sensitive to

oestrogens, such as cancer of the womb lining

(endometrium), or if you are suspected of having it

If you have any unexplained vaginal bleeding

If you have excessive thickening of the womb

lining (endometrial hyperplasia) that is not being

treated

If you have or have ever had a blood clot in a vein

(thrombosis), such as in the legs (deep venous

thrombosis) or the lungs (pulmonary embolism)

If you have a blood clotting disorder (such as

protein C, protein S, or antithrombin deficiency)

If you have or recently have had a disease caused

by blood clots in the arteries, such as a heart

attack, stroke or angina

If you have or have ever had a liver disease and

your liver function tests have not returned to

normal

If you have a rare blood problem called “porphyria”

which is passed down in families (inherited)

If you are allergic to estradiol hemihydrate or

norethisterone acetate or any of the other

ingredients of this medicine (listed in section 6)

If any of the above conditions appear for the first

time while taking Elleste Duet, stop taking it at once

and consult your doctor immediately.

When to take special care with Elleste Duet

Tell your doctor if you have ever had any of the

following problems, before you start the treatment,

as these may return or become worse during

treatment with Elleste Duet. If so, you should see

your doctor more often for check-ups:

fibroids inside your womb

growth of womb lining outside your womb

(endometriosis) or a history of excessive growth

of the womb lining (endometrial hyperplasia)

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 and see a doctor

immediately

If you notice any of the following when taking HRT:

any of the conditions mentioned in the ‘DO NOT

take Elleste Duet’ section

yellowing of your skin or the whites of your eyes

(jaundice). These may be signs of a liver disease

a large rise in your blood pressure (symptoms may

be headache, tiredness, dizziness)

migraine-like headaches which happen for the first

time

if you become pregnant

if you notice signs of a blood clot, such as:

painful swelling and redness of the legs

sudden chest pain

difficulty in breathing

For more information, see ‘Blood clots in a vein

(thrombosis)’

Note: Elleste Duet is not a contraceptive. If it is less

than 12 months since your last menstrual period or

you are under 50 years old, you may still need to use

additional contraception to prevent pregnancy.

Speak to your doctor for advice.

HRT and cancer

Excessive thickening of the lining of the womb

(endometrial hyperplasia) and cancer of the

lining of the womb (endometrial cancer)

Taking oestrogen-only HRT will increase the risk of

excessive thickening of the lining of the womb

(endometrial

hyperplasia) and cancer of the womb

lining (endometrial cancer).

The progestogen in Elleste Duet protects you from

this extra risk.

Unexpected bleeding

You will have a bleed once a month (so-called

withdrawal bleed) while taking Elleste Duet. But, if

you have unexpected bleeding or drops of blood

(spotting) besides your monthly bleeding, which:

carries on for more than the first 6 months

starts after you have been taking Elleste Duet more

than 6 months

carries on after you have stopped taking Elleste

Duet

see your doctor as soon as possible

Breast cancer

Evidence suggests that taking combined oestrogen-

progestogen and possibly also oestrogen-only HRT

increases the risk of breast cancer. The extra risk

depends on how long you take HRT. The additional

risk becomes clear within a few years. However, it

returns to normal within a few years (at most 5)

after stopping treatment.

Compare

Women aged 50 to 79 who are not taking HRT, on

average, 9 to 17 in 1000 will be diagnosed with

breast cancer over a 5-year period. For women aged

50 to 79 who are taking oestrogen-progestogen HRT

over 5 years, there will be 13 to 23 cases in 1000

users (i.e. an extra 4 to 6 cases).

Regularly check your breasts. See your doctor

if you notice any changes such as:

dimpling of the skin

changes in the nipple

any lumps you can see or feel

Additionally, you are advised to join mammography

screening programs when offered to you. For

mammogram screening, it is important that you

inform the nurse/healthcare professional who is

actually taking the x-ray that you use HRT, as this

medication may increase the density of your breasts

which may affect the outcome of the mammogram.

Where the density of the breast is increased,

mammography may not detect all lumps.

Ovarian cancer

Ovarian cancer is rare - much rarer than breast

cancer. The use of oestrogen-only or combined

oestrogen-progestagen HRT has been associated

with a slightly increased risk of ovarian cancer.

The risk of ovarian cancer varies with age. For

example, in women aged 50 to 54 who are not

taking HRT, about 2 women in 2000 will be

diagnosed with ovarian cancer over a 5-year period.

For women who have been taking HRT for 5 years,

there will be about 3 cases per 2000 users (i.e. about

1 extra case).

Effect of HRT on heart and circulation

Blood clots in a vein (thrombosis)

The risk of blood clots in the veins is about 1.3 to

3- times higher in

HRT users than in non-users,

especially during the first year of taking it.

Blood clots can be serious, and if one travels to the

lungs, it can cause chest pain, breathlessness,

fainting or even death.

You are more likely to get a blood clot in your veins

as you get older 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/m

you have any blood clotting problem that needs

long-term treatment with a medicine used to

prevent blood clots

if any of your close relatives has ever had a blood

clot in the leg, lung or another organ

you have systemic lupus erythematosus (SLE)

you have cancer

For signs of a blood clot, see “Stop taking Elleste

Duet and see a doctor immediately”.

Compare

Looking at women in their 50s who are not taking

HRT, on average, over a 5-year period, 4 to 7 in

1000 would be expected to get a blood clot in a vein.

For women in their 50s who have been taking

oestrogen-progestogen HRT for over 5 years, there

will be 9 to 12 cases in 1000 users (i.e. an extra 5

cases).

Heart disease (heart attack)

There is no evidence that HRT will prevent a heart

attack.

Women over the age of 60 years who use oestrogen-

progestogen HRT are slightly more likely to develop

heart disease than those not taking any HRT.

Stroke

The risk of getting stroke is about 1.5 times higher

in HRT users than in non-users. The number of extra

cases of stroke due to use of HRT will increase with

age.

Compare

Looking at women in their 50s who are not taking

HRT, on average, 8 in 1000 would be expected to

have a stroke over a 5-year period. For women in

their 50s who are taking HRT, there will be 11 cases

in 1000 users, over 5 years (i.e. an extra 3 cases).

Underactive thyroid gland

If you are having medicine for treatment of an

underactive thyroid gland, your doctor will carry out

tests while you are taking HRT, to ensure that your

thyroid hormone levels remain acceptable.

Angioedema

If you have angioedema (a serious allergic reaction

often involving

swelling of the face, mouth and

throat), oestrogens may make this worse.

Other conditions

HRT will not prevent memory loss. There is some

evidence of a higher risk of memory loss in

women who start using HRT after the age of 65.

Speak to your doctor for advice.

Children

Do not give this medicine to children.

Other medicines and Elleste Duet

Some medicines may interfere with the effect of

Elleste Duet. This might lead to irregular bleeding.

This applies to the following medicines:

Medicines for epilepsy (such as phenobarbital,

phenytoin and carbamazepin)

Medicines for tuberculosis (such as rifampicin,

rifabutin)

Medicines for HIV infection (such as nevirapine,

efavirenz, ritonavir, telaprevir and nelfinavir)

Herbal remedies containing St John’s Wort

(Hypericum perforatum)

Please tell your doctor or pharmacist if you are

taking or have recently taken any other medicines

including medicines obtained without a prescription,

herbal medicines or other natural products.

Laboratory tests

If you need a blood test, tell your doctor or the

laboratory staff that you are taking Elleste Duet,

because this medicine can affect the results of some

tests.

Pregnancy and breast-feeding

Elleste Duet is for use in postmenopausal women

only. If you become pregnant, stop taking Elleste

Duet and contact your doctor.

Driving and using machines

No effects on driving or using machinery have been

observed for Elleste Duet.

Elleste Duet 2 mg contains Sunset yellow colouring

which can cause allergic-type reactions, including

asthma. This allergy is more common in people who

are allergic to aspirin.

Elleste Duet contains lactose.

If you have been told by your doctor that you have

an intolerance to

some sugars, contact your doctor

before taking this medicinal product.

3. HOW TO TAKE ELLESTE DUET

Always take this medicine exactly as your doctor or

pharmacist has told you. Check with your doctor or

pharmacist if you are not sure.

Your doctor will aim to prescribe the lowest possible

dose to treat your symptoms for as short a time as

necessary. Speak to your doctor if you think the

dose is too strong or not strong enough.

The Elleste Duet 1 mg pack contains 16 white

tablets and 12 pale green tablets.

You must start with the white tablets.

The Elleste Duet 2 mg pack contains 16 orange

tablets and 12 grey tablets.

You must start with the orange tablets.

If you are still having regular periods, start on the

first day of bleeding.

If you are not having regular periods you can start

straight away.

Take one tablet each day. You can take the tablet at

a time of the day that suits you but it is best to take

it at about the same time each day.

Swallow the tablets whole, with some water.

Follow the direction of the arrows on the pack and

take a tablet each day until the pack is empty.

When you finish your first foil strip, start a new

strip on the next day. Remember to put a fresh

sticker on your new foil strip.

To help you remember to take your tablets, we have

included stickers in the pack with the days of the

week marked on them. For example, if you are

starting the tablets on a Friday, use the sticker which

starts with 'Fri'. Stick this at the top of the foil strip

on the side where you can see the tablets.

If you are taking

Elleste Duet 1 mg, the first day should be above

the white tablet which has the start arrow next to it.

Elleste Duet 2 mg, the first day should be above

the orange tablet which has the start arrow next to it.

Changing from another type of HRT

If you are changing from another type of HRT, start

taking Elleste Duet when you finish the pack of

HRT you are taking at the moment.

If your doctor gives you instructions on changing

from another type of HRT you should follow these

instructions. If you have any doubts you should

contact your doctor.

Will I have periods?

You will probably have a monthly bleed. This may

start any time 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 experien-

ce some breakthrough bleeding or spotting.

If you take more Elleste Duet than you should

There should be no problems, but you may

experience breast tenderness, feel sick or actually be

sick, have irregular periods, feel down, feel tired,

develop acne or experience an increase in body and

facial hair. If you are worried, contact your doctor.

Take the usual tablet

the following day.

If you have any further questions on the use of this

medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side

effects, although not everybody gets them.

The following diseases are reported more often in

women using HRT compared to women not using

HRT:

breast cancer

abnormal growth or cancer of the lining of the

womb (endometrial hyperplasia or cancer)

ovarian cancer

blood clots in the veins of the legs or lungs (venous

thromboembolism)

heart disease

stroke

probable memory loss if HRT is started over the

age of 65

For more information about these side effects, see

section 2.

The following side effects have been associated with

Elleste Duet:

Frequencies are defined as follows:

Very common: may affect more than 1 in 10 people

Common: may affect up to 1 in 10 people

Uncommon: may affect up to 1 in 100 people

Rare: may affect up to 1 in 1,000 people

Very rare: may affect up to 1 in 10,000 people

Not known: frequency cannot be estimated from the

available data

Very common: headache, breast pain, breast

tenderness, painful periods, problems with your

menstrual cycle.

Common: feeling down, feeling anxious, mood

changes, changes in sex drive, feeling dizzy,

difficulty sleeping, feeling sick, bloating, diarrhoea,

indigestion, stomach cramps, acne, rashes, itchiness,

dry skin, back pain, pain in the extremities, breast

enlargement, heavy periods, vaginal discharge,

break-through bleeding, spasms (contractions) of

the womb, vaginal infection, excessive thickening of

the lining of the womb, pain, feeling of weakness,

swelling of the ankles, feet or fingers, increase in

weight.

Uncommon: migraine, a feeling of dizziness or

“spinning”, high blood pressure, varicose veins,

being sick, gallstones and gallbladder disease,

change in colour of the skin, breast cancer, muscle

cramps,

increased levels of chemicals in the blood

which may indicate disease.

Rare: hypersensitivity, tingling or numbness, blood

clot in a vein, inflammation of a vein, muscle

weakness, growths in the womb (myoma, cysts,

polyps).

Very rare: increase in body and facial hair,

yellowing of the skin.

Not known: loss of hair from the scalp.

The following side effects have been reported with

other HRTs:

various skin disorders

- discolouration of the skin especially of the face

or neck known as “pregnancy patches”

(chloasma)

- painful reddish skin nodules (erythema

nodosum)

- rash with target-shaped reddening or sores

(erythema multiforme)

dry eyes

tear film changes

Reporting of side effects

If you get any side effects, talk to your doctor,

pharmacist or nurse. This includes any possible side

effects not listed in this leaflet.

You can also report side effects directly via the

Yellow Card Scheme at:

www.mhra.gov.uk/yellowcard

By reporting side effects, you can help provide more

information on the safety of this medicine.

5. HOW TO STORE ELLESTE DUET

Keep this medicine out of the sight and reach of

children.

Do not store Elleste Duet 1 mg Tablets above 30

Do not store Elleste Duet 2 mg Tablets above 25

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,

Manufacturer

Piramal Healthcare (UK) Ltd.

Whalton Road, Morpeth, Northumberland,

NE61 3YA,

This medicinal product is authorised in the Member

States of the EEA under the following names:

Austria Parapanol duo and Parapanol duo mite

Elleste Duet 1 mg Tablets and Elleste Duet

2 mg Tablets

This leaflet was last revised in 02/2016.

Mock ups PIL Elleste Duet 1mg and 2mg tabl UK 2017-02.pdf 2 2017-02-07 14:30:22