Estradiol 1mg tablets

Main information

  • Trade name:
  • Estradiol 1mg tablets
  • Dosage:
  • 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:
  • Estradiol 1mg tablets
    United Kingdom
  • Language:
  • English

Therapeutic information

  • Product summary:
  • BNF: 06040101

Status

  • Source:
  • eMC
  • Authorization number:
  • PL 15184/1033
  • Last update:
  • 11-07-2019

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

Zumenon 1mg Tablets

Patient Information Leaflet

Read all of this leaflet carefully before you start using this medicine.

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. Do not pass it on to others. It

may harm them, even if their symptoms are the same as yours.

If any of the side effects gets serious, or if you notice any side effects not

listed in this leaflet, please tell your doctor or pharmacist.

Your medicine is called Zumenon 1mg Tablets but will be referred to as

Zumenon throughout this leaflet

In this leaflet:

What Zumenon is and what it is used for

Before you take Zumenon

How to take Zumenon

Possible side effects

How to store Zumenon

Further information

What Zumenon is and what it is used for

Zumenon is a Hormone Replacement Therapy (HRT). It contains the female

hormone oestrogen. Zumenon is used in postmenopausal women with at

least 6 months since their last natural period and women switching from

standard (cyclic or sequential) HRT on the advice of their doctor.

Zumenon 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”). Zumenon alleviates these symptoms after menopause. You

will only be prescribed Zumenon if your symptoms seriously hinder your daily

life.

Before you take Zumenon

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 Zumenon 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 Zumenon.

Go for regular breast screening, as recommended by your doctor.

- swelling of the ankles, feet or fingers (peripheral oedema)

- water retention (oedema)

- peripheral vascular disease

- varicose veins

- blood clots in the veins of the legs or lungs (venous thromboembolism)

- gall bladder disorder

- back pain

- indigestion

- nervousness

- dizziness

- problems with your sight

- faster heart beat (palpitations)

- breast pain or tenderness

Rare (in less than 1 in 1,000, but more than 1 in 10,000 patients treated):

- intolerance to contact lenses

- pre-menstrual tension (PMT)

- feeling anxious

- migraine

- vomiting

- feeling bloated

- excessive hair growth

- acne

- muscle cramps

- vaginal discharge

- feeling tired

- swelling of the breasts

- change in sex drive

Very rare (in less than 1 in 10,000 patients treated, not known (cannot

be estimated from the available data)):

- reduction in red blood cells which can make the skin pale and cause

weakness or breathlessness (anaemia)

If unscheduled bleeding occurs after some time on HRT, you should contact

your doctor. If unscheduled bleeding continues after stopping HRT, it may be

necessary to perform tests to exclude disease of the endometrium

(the lining of the uterus).

Changes can occur in the levels of certain proteins and hormones in the

blood. The action of the hormones in the body is not affected. You should tell

your doctor that you are taking HRT if you are to have a blood test.

The following side effects have been reported in association with estradiol

treatment (frequency unknown):

fibroids get bigger (growths in the womb increase)

chorea (muscle twitches)

worsening of fits (epilepsy)

blood clots in the arteries (arterial thromboembolism)

inflammation of the pancreas (pancreatitis) in women with pre-existing high

levels of certain blood fats (hypertriglyceridemia)

a condition where gastric juices, containing acid, travel back from the

stomach into the oesophagus (gastroesophageal reflux disease) symptoms

include heartburn

liver disorders, which may include jaundice (yellowing of the skin)

discolouration of the skin especially of the face or neck known as

‘’pregnancy patches’’ (chloasma)

rash with target shaped reddening or sores (erythema multiforme)

skin discolouration (purpura)

swelling of the skin around face and throat (angioedeme)

urinary incontinence

painful/lumpy breasts (fibrocystic breast disease)

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes

any possible side effects not listed on this leaflet. You can also report side

effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

or search for MHRA Yellow Card in the Google Play or Apple App Store. By

reporting side effects, you can help provide more information on the

safety of this medicine.

How to store Zumenon

*

Keep out of the sight and reach of childern.

*

No special storage conditions.

EXPIRY DATE

Do not use this medicine after the expiry date shown on the carton label or

blister strip. If your doctor tells you to stop taking this medicine, return any

unused medicine to your pharmacist for safe disposal. Only keep this

medicine, if your doctor tells you to.

Further information

What Zumenon contains

Each film-coated tablet contains estradiol hemihydrate equivalent to 1mg of

estradiol as the active ingredient. Your medicine also contains the following

inactive ingredients: Lactose, Hypromellose, Maize Starch, Colloidal

anhydrous silica, Magnesium stearate, OPADRY Y-1-7000 White, Macrogol

400, Titanium dioxide E171.

What Zumenon looks like and contents of the pack

Zumenon are white, round, biconvex, film-coated tablets imprinted with 379

on one side and plain on the other.

Zumenon are available in boxes of 28 or 84 tablets.

Manufacturer and Licence Holder

The tablets are manufactured by Abbott Biologicals B.V., Veerweg 12, 8121

AA Olst, The Netherlands and are procured from within the EU and

repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18,

Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.

PL Number: 15184/1033 Zumenon 1mg Tablets

Zumenon is a registered trademark of Abbott Healthcare Products B.V.

Leaflet revision date: 17/12/18

Blind or partially sighted?

Is this leaflet hard to see or read?

Phone Lexon (UK) Limited,

Tel: 01527 505414 to obtain the leaflet

in a format suitable for you

Do not take Zumenon

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 Zumenon,

Do not take Zumenon

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 oestradial or any of the other

ingredients of Zumenon (listed in section 6 Further information)

if you still have your womb and are not currently taking some form of

progestogen hormone

If any of the above conditions appear for the first time while taking Zumenon,

stop taking it at once and consult your doctor immediately.

When to take special care with Zumenon

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 Zumenon. 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 a oestrogensensitive 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 af fecting the eardrum and hearing (otosclerosis)

a very high level of fat in your blood (triglycerides)

fluid retention due to cardiac or kidney problems

POM

Ref:1033/171218/1/F

1

6

4

5

2

3

1

2

6

5

®

(estradiol)

Page 1

Page 4

Using other medicines

Some medicines may interfere with the effect of Zumenon. This might lead to

irregular bleeding. This applies to the following medicines:

Medicines for epilepsy (such as phenobarbital, phenytoin and

carbamazepin)

Medicines for tuberculosis (such as rifampicin, rifabutin)

Medicines for HIV infection (such as nevirapine, efavirenz, ritonavir and

nelfinavir)

Herbal remedies containing St John’s Wort (Hypericum perforatum).

Problems due to high levels of the following medicines may occur when you

take Zumenon so careful drug monitoring and dose decrease may become

necessary:

- tacrolimus and cyclosporin – used, for example, for organ transplants

- fentanyl – a painkiller

- theophylline – used for asthma and other breathing problems

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 Zumenon, because this medicine can affect the results of some tests.

Pregnancy and breast-feeding

Zumenon is for use in peri and postmenopausal women only. If you become

pregnant, stop taking Zumenon and contact your doctor.

Important information about some of the ingredients of Zumenon

Zumenon tablets contain milk sugar (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.

How to take Zumenon

Always take Zumenon exactly as your doctor has told you. You should

check with your doctor or pharmacist if you are not sure.

Take one tablet every day, without a break between packs. Swallow the

tablet with water, with or without food.

In women with a uterus, a progestagen should normally be added to

Zumenon for 12 - 14 days of each month. If you are having regular periods

you should start taking Zumenon on day one of bleeding.

If you are not having regular periods and are not taking any other HRT

preparations, or you are switching from a combined continuous HRT product,

you can start taking Zumenon on any convenient day.

If you are currently using a ‘cyclic’ or ‘sequential’ HRT preparation (which

involves taking an oestrogen tablet or patch for part of the month, followed by

both oestrogen and progestagen tablet or patch for up to 14 days) start

taking Zumenon the day after you finish the pack i.e. at the end of the

progestagen phase.

Your doctor will aim to prescribe the lowest dose to treat your symptom for as

short as necessary. Speak to your doctor if you think this dose is too strong

or not strong enough.

You may experience some irregular bleeding or light bleeding (spotting)

during your first few months of taking Zumenon. If the bleeding is

troublesome, or continues beyond the first few months of treatment you

should discuss this with your doctor.

If you take more Zumenon than you should

Nausea (feeling sick), vomiting, sleepiness, dizziness and withdrawal

bleeding may occur. No treatment is necessary, but if you are worried contact

your doctor for advice.

If you forget to take Zumenon

Take the missed tablet as soon as you remember. If it is more than 12 hours

since you took the last one, take the next dose without taking the forgotten

tablet. Do not take a double dose. Bleeding or spotting may occur if

you miss a dose.

If you need to have surgery

If you are going to have surgery, tell the surgeon that you are taking

Zumenon. You may need to stop taking Zumenon 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 Zumenon again.

If you stop taking Zumenon

Do not stop taking Zumenon without first talking to your doctor.

If you have any further questions on the use of this product, ask your doctor

or pharmacist

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 over the age of 65

For more information about these side effects, see Section 2.

The following serious side effects may occur during treatment with

Zumenon:

- swelling of the skin around the face and neck. This may cause difficulty

breathing.

- heart attack

- heavy, irregular or painful bleeds

If any of these side effects occur you should stop treatment

immediately and contact your doctor.

The following side effects may occur during treatment:

Common (in less than 1 in 10, but more than 1 in 100 patients treated):

- headache

- feeling sick

- leg cramps

- abdominal pain

- pelvic pain

- unscheduled bleeding or spotting

- wind

- feeling weak (asthenia)

- weight changes

- rash or itching

Uncommon (in less than 1 in 100, but more than 1 in 1,000 patients

treated):

- hypersensitivity (allergic) reaction such as skin rash, itching, skin redness

- hives

- painful reddish skin nodules (erythema nodosum)

- feeling down

- vaginal thrush (a vaginal infection due to a fungus called Candida albicans)

- high blood pressure

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, on average 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 longterm 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 Zumenon and see a doctor

immediately”.

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 oestrogenprogestogen

HRT for over 5 years, there will be 9 to 12 cases in 1000 users (i.e. an extra

5 cases). For women in their 50s who have had their womb removed and

have been taking oestrogen-only HRT for over 5 years, there will be 5 to 8

cases in 1000 users (i.e. 1 extra case).

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. For women who

have had their womb removed and are taking oestrogen-only therapy there is

no increased risk of developing a heart disease.

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. 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.

Stop taking Zumenon 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

Zumenon’ 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: Zumenon

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).

Taking a progestogen in addition to the oestrogen for at least 12 days of

each 28 day cycle protects you from this extra risk. So your doctor will

prescribe a progestogen separately if you still have your womb. If you have

had your womb removed (a hysterectomy), discuss with your doctor whether

you can safely take this product without a progestogen.

In women who still have a womb and who are not taking HRT, on average, 5

in 1000 will be diagnosed with endometrial cancer between the ages of 50

and 65. For women aged 50 to 65 who still have a womb and who

take oestrogen-only HRT, between 10 and 60 women in 1000 will be

diagnosed with endometrial cancer (i.e. between 5 and 55 extra cases),

depending on the dose and for how long it is taken.

Unexpected bleeding

You will have a bleed once a month (so-called withdrawal bleed) while taking

Zumenon. 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 Zumenon more than 6 months

carries on after you have stopped taking Zumenon

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. For women who have had their womb

removed and who are using oestrogen-only HRT for 5 years, little or no

increase in breast cancer risk is shown. 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

oestrogenprogestogen 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

Ref:1033/171218/1/B

3

Page 2

Page 3

4

Oromone 1mg Tablets

Patient Information Leaflet

Read all of this leaflet carefully before you start using this medicine.

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. Do not pass it on to others. It

may harm them, even if their symptoms are the same as yours.

If any of the side effects gets serious, or if you notice any side effects not

listed in this leaflet, please tell your doctor or pharmacist.

Your medicine is called Oromone 1mg Tablets but will be referred to as

Oromone throughout this leaflet

In this leaflet:

What Oromone is and what it is used for

Before you take Oromone

How to take Oromone

Possible side effects

How to store Oromone

Further information

What Oromone is and what it is used for

Oromone is a Hormone Replacement Therapy (HRT). It contains the female

hormone oestrogen. Oromone is used in postmenopausal women with at

least 6 months since their last natural period and women switching from

standard (cyclic or sequential) HRT on the advice of their doctor.

Oromone 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”). Oromone alleviates these symptoms after menopause. You

will only be prescribed Oromone if your symptoms seriously hinder your daily

life.

Before you take Oromone

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 Oromone 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 Oromone.

Go for regular breast screening, as recommended by your doctor.

- swelling of the ankles, feet or fingers (peripheral oedema)

- water retention (oedema)

- peripheral vascular disease

- varicose veins

- blood clots in the veins of the legs or lungs (venous thromboembolism)

- gall bladder disorder

- back pain

- indigestion

- nervousness

- dizziness

- problems with your sight

- faster heart beat (palpitations)

- breast pain or tenderness

Rare (in less than 1 in 1,000, but more than 1 in 10,000 patients treated):

- intolerance to contact lenses

- pre-menstrual tension (PMT)

- feeling anxious

- migraine

- vomiting

- feeling bloated

- excessive hair growth

- acne

- muscle cramps

- vaginal discharge

- feeling tired

- swelling of the breasts

- change in sex drive

Very rare (in less than 1 in 10,000 patients treated, not known (cannot

be estimated from the available data)):

- reduction in red blood cells which can make the skin pale and cause

weakness or breathlessness (anaemia)

If unscheduled bleeding occurs after some time on HRT, you should contact

your doctor. If unscheduled bleeding continues after stopping HRT, it may be

necessary to perform tests to exclude disease of the endometrium

(the lining of the uterus).

Changes can occur in the levels of certain proteins and hormones in the

blood. The action of the hormones in the body is not affected. You should tell

your doctor that you are taking HRT if you are to have a blood test.

The following side effects have been reported in association with estradiol

treatment (frequency unknown):

fibroids get bigger (growths in the womb increase)

chorea (muscle twitches)

worsening of fits (epilepsy)

blood clots in the arteries (arterial thromboembolism)

inflammation of the pancreas (pancreatitis) in women with pre-existing high

levels of certain blood fats (hypertriglyceridemia)

a condition where gastric juices, containing acid, travel back from the

stomach into the oesophagus (gastroesophageal reflux disease) symptoms

include heartburn

liver disorders, which may include jaundice (yellowing of the skin)

discolouration of the skin especially of the face or neck known as

‘’pregnancy patches’’ (chloasma)

rash with target shaped reddening or sores (erythema multiforme)

skin discolouration (purpura)

swelling of the skin around face and throat (angioedeme)

urinary incontinence

painful/lumpy breasts (fibrocystic breast disease)

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes

any possible side effects not listed on this leaflet. You can also report side

effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

or search for MHRA Yellow Card in the Google Play or Apple App Store. By

reporting side effects, you can help provide more information on the

safety of this medicine.

How to store Oromone

*

Keep out of the sight and reach of childern.

*

No special storage conditions.

EXPIRY DATE

Do not use this medicine after the expiry date shown on the carton label or

blister strip. If your doctor tells you to stop taking this medicine, return any

unused medicine to your pharmacist for safe disposal. Only keep this

medicine, if your doctor tells you to.

Further information

What Oromone contains

Each film-coated tablet contains estradiol hemihydrate equivalent to 1mg of

estradiol as the active ingredient. Your medicine also contains the following

inactive ingredients: Lactose, Hypromellose, Maize Starch, Colloidal

anhydrous silica, Magnesium stearate, OPADRY Y-1-7000 White, Macrogol

400, Titanium dioxide E171.

What Oromone looks like and contents of the pack

Oromone are white, round, biconvex, film-coated tablets imprinted with 379

on one side and plain on the other.

Oromone are available in boxes of 28 or 84 tablets.

Manufacturer and Licence Holder

The tablets are manufactured by Abbott Biologicals B.V., Veerweg 12, 8121

AA Olst, The Netherlands and are procured from within the EU and

repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18,

Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.

PL Number: 15184/1033 Oromone 1mg Tablets

Oromone is a registered trademark of Abbott Healthcare Products B.V.

Leaflet revision date: 17/12/18

Blind or partially sighted?

Is this leaflet hard to see or read?

Phone Lexon (UK) Limited,

Tel: 01527 505414 to obtain the leaflet

in a format suitable for you

Do not take Oromone

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 Oromone,

Do not take Oromone

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 oestradial or any of the other

ingredients of Oromone (listed in section 6 Further information)

if you still have your womb and are not currently taking some form of

progestogen hormone

If any of the above conditions appear for the first time while taking Oromone,

stop taking it at once and consult your doctor immediately.

When to take special care with Oromone

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 Oromone. 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 a oestrogensensitive 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 af fecting the eardrum and hearing (otosclerosis)

a very high level of fat in your blood (triglycerides)

fluid retention due to cardiac or kidney problems

POM

Ref:1033/171218/2/F

1

6

4

5

2

3

1

2

6

5

®

(estradiol)

Page 1

Page 4

Using other medicines

Some medicines may interfere with the effect of Oromone. This might lead to

irregular bleeding. This applies to the following medicines:

Medicines for epilepsy (such as phenobarbital, phenytoin and

carbamazepin)

Medicines for tuberculosis (such as rifampicin, rifabutin)

Medicines for HIV infection (such as nevirapine, efavirenz, ritonavir and

nelfinavir)

Herbal remedies containing St John’s Wort (Hypericum perforatum).

Problems due to high levels of the following medicines may occur when you

take Oromone so careful drug monitoring and dose decrease may become

necessary:

- tacrolimus and cyclosporin – used, for example, for organ transplants

- fentanyl – a painkiller

- theophylline – used for asthma and other breathing problems

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 Oromone, because this medicine can affect the results of some tests.

Pregnancy and breast-feeding

Oromone is for use in peri and postmenopausal women only. If you become

pregnant, stop taking Oromone and contact your doctor.

Important information about some of the ingredients of Oromone

Oromone tablets contain milk sugar (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.

How to take Oromone

Always take Oromone exactly as your doctor has told you. You should

check with your doctor or pharmacist if you are not sure.

Take one tablet every day, without a break between packs. Swallow the

tablet with water, with or without food.

In women with a uterus, a progestagen should normally be added to

Oromone for 12 - 14 days of each month. If you are having regular periods

you should start taking Oromone on day one of bleeding.

If you are not having regular periods and are not taking any other HRT

preparations, or you are switching from a combined continuous HRT product,

you can start taking Oromone on any convenient day.

If you are currently using a ‘cyclic’ or ‘sequential’ HRT preparation (which

involves taking an oestrogen tablet or patch for part of the month, followed by

both oestrogen and progestagen tablet or patch for up to 14 days) start

taking Oromone the day after you finish the pack i.e. at the end of the

progestagen phase.

Your doctor will aim to prescribe the lowest dose to treat your symptom for as

short as necessary. Speak to your doctor if you think this dose is too strong

or not strong enough.

You may experience some irregular bleeding or light bleeding (spotting)

during your first few months of taking Oromone. If the bleeding is

troublesome, or continues beyond the first few months of treatment you

should discuss this with your doctor.

If you take more Oromone than you should

Nausea (feeling sick), vomiting, sleepiness, dizziness and withdrawal

bleeding may occur. No treatment is necessary, but if you are worried contact

your doctor for advice.

If you forget to take Oromone

Take the missed tablet as soon as you remember. If it is more than 12 hours

since you took the last one, take the next dose without taking the forgotten

tablet. Do not take a double dose. Bleeding or spotting may occur if

you miss a dose.

If you need to have surgery

If you are going to have surgery, tell the surgeon that you are taking

Oromone. You may need to stop taking Oromone 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 Oromone again.

If you stop taking Oromone

Do not stop taking Oromone without first talking to your doctor.

If you have any further questions on the use of this product, ask your doctor

or pharmacist

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 over the age of 65

For more information about these side effects, see Section 2.

The following serious side effects may occur during treatment with

Oromone:

- swelling of the skin around the face and neck. This may cause difficulty

breathing.

- heart attack

- heavy, irregular or painful bleeds

If any of these side effects occur you should stop treatment

immediately and contact your doctor.

The following side effects may occur during treatment:

Common (in less than 1 in 10, but more than 1 in 100 patients treated):

- headache

- feeling sick

- leg cramps

- abdominal pain

- pelvic pain

- unscheduled bleeding or spotting

- wind

- feeling weak (asthenia)

- weight changes

- rash or itching

Uncommon (in less than 1 in 100, but more than 1 in 1,000 patients

treated):

- hypersensitivity (allergic) reaction such as skin rash, itching, skin redness

- hives

- painful reddish skin nodules (erythema nodosum)

- feeling down

- vaginal thrush (a vaginal infection due to a fungus called Candida albicans)

- high blood pressure

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, on average 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 longterm 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 Oromone and see a doctor

immediately”.

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 oestrogenprogestogen

HRT for over 5 years, there will be 9 to 12 cases in 1000 users (i.e. an extra

5 cases). For women in their 50s who have had their womb removed and

have been taking oestrogen-only HRT for over 5 years, there will be 5 to 8

cases in 1000 users (i.e. 1 extra case).

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. For women who

have had their womb removed and are taking oestrogen-only therapy there is

no increased risk of developing a heart disease.

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. 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.

Stop taking Oromone 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

Oromone’ 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: Oromone

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).

Taking a progestogen in addition to the oestrogen for at least 12 days of

each 28 day cycle protects you from this extra risk. So your doctor will

prescribe a progestogen separately if you still have your womb. If you have

had your womb removed (a hysterectomy), discuss with your doctor whether

you can safely take this product without a progestogen.

In women who still have a womb and who are not taking HRT, on average, 5

in 1000 will be diagnosed with endometrial cancer between the ages of 50

and 65. For women aged 50 to 65 who still have a womb and who

take oestrogen-only HRT, between 10 and 60 women in 1000 will be

diagnosed with endometrial cancer (i.e. between 5 and 55 extra cases),

depending on the dose and for how long it is taken.

Unexpected bleeding

You will have a bleed once a month (so-called withdrawal bleed) while taking

Oromone. 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 Oromone more than 6 months

carries on after you have stopped taking Oromone

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. For women who have had their womb

removed and who are using oestrogen-only HRT for 5 years, little or no

increase in breast cancer risk is shown. 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

oestrogenprogestogen 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

Ref:1033/171218/2/B

3

Page 2

Page 3

4

Estradiol 1mg Tablets

Patient Information Leaflet

Read all of this leaflet carefully before you start using this medicine.

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. Do not pass it on to others. It

may harm them, even if their symptoms are the same as yours.

If any of the side effects gets serious, or if you notice any side effects not

listed in this leaflet, please tell your doctor or pharmacist.

Your medicine is called Estradiol 1mg Tablets but will be referred to as

Estradiol throughout this leaflet

In this leaflet:

What Estradiol is and what it is used for

Before you take Estradiol

How to take Estradiol

Possible side effects

How to store Estradiol

Further information

What Estradiol is and what it is used for

Estradiol is a Hormone Replacement Therapy (HRT). It contains the female

hormone oestrogen. Estradiol is used in postmenopausal women with at

least 6 months since their last natural period and women switching from

standard (cyclic or sequential) HRT on the advice of their doctor.

Estradiol 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”). Estradiol alleviates these symptoms after menopause. You will

only be prescribed Estradiol if your symptoms seriously hinder your daily life.

Before you take Estradiol

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 Estradiol 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 Estradiol.

Go for regular breast screening, as recommended by your doctor.

- swelling of the ankles, feet or fingers (peripheral oedema)

- water retention (oedema)

- peripheral vascular disease

- varicose veins

- blood clots in the veins of the legs or lungs (venous thromboembolism)

- gall bladder disorder

- back pain

- indigestion

- nervousness

- dizziness

- problems with your sight

- faster heart beat (palpitations)

- breast pain or tenderness

Rare (in less than 1 in 1,000, but more than 1 in 10,000 patients treated):

- intolerance to contact lenses

- pre-menstrual tension (PMT)

- feeling anxious

- migraine

- vomiting

- feeling bloated

- excessive hair growth

- acne

- muscle cramps

- vaginal discharge

- feeling tired

- swelling of the breasts

- change in sex drive

Very rare (in less than 1 in 10,000 patients treated, not known (cannot

be estimated from the available data)):

- reduction in red blood cells which can make the skin pale and cause

weakness or breathlessness (anaemia)

If unscheduled bleeding occurs after some time on HRT, you should contact

your doctor. If unscheduled bleeding continues after stopping HRT, it may be

necessary to perform tests to exclude disease of the endometrium

(the lining of the uterus).

Changes can occur in the levels of certain proteins and hormones in the

blood. The action of the hormones in the body is not affected. You should tell

your doctor that you are taking HRT if you are to have a blood test.

The following side effects have been reported in association with estradiol

treatment (frequency unknown):

fibroids get bigger (growths in the womb increase)

chorea (muscle twitches)

worsening of fits (epilepsy)

blood clots in the arteries (arterial thromboembolism)

inflammation of the pancreas (pancreatitis) in women with pre-existing high

levels of certain blood fats (hypertriglyceridemia)

a condition where gastric juices, containing acid, travel back from the

stomach into the oesophagus (gastroesophageal reflux disease) symptoms

include heartburn

liver disorders, which may include jaundice (yellowing of the skin)

discolouration of the skin especially of the face or neck known as

‘’pregnancy patches’’ (chloasma)

rash with target shaped reddening or sores (erythema multiforme)

skin discolouration (purpura)

swelling of the skin around face and throat (angioedeme)

urinary incontinence

painful/lumpy breasts (fibrocystic breast disease)

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes

any possible side effects not listed on this leaflet. You can also report side

effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

or search for MHRA Yellow Card in the Google Play or Apple App Store. By

reporting side effects, you can help provide more information on the

safety of this medicine.

How to store Estradiol

*

Keep out of the sight and reach of childern.

*

No special storage conditions.

EXPIRY DATE

Do not use this medicine after the expiry date shown on the carton label or

blister strip. If your doctor tells you to stop taking this medicine, return any

unused medicine to your pharmacist for safe disposal. Only keep this

medicine, if your doctor tells you to.

Further information

What Estradiol contains

Each film-coated tablet contains estradiol hemihydrate equivalent to 1mg of

estradiol as the active ingredient. Your medicine also contains the following

inactive ingredients: Lactose, Hypromellose, Maize Starch, Colloidal

anhydrous silica, Magnesium stearate, OPADRY Y-1-7000 White, Macrogol

400, Titanium dioxide E171.

What Estradiol looks like and contents of the pack

Estradiol are white, round, biconvex, film-coated tablets imprinted with 379

on one side and plain on the other.

Estradiol are available in boxes of 28 or 84 tablets.

Manufacturer and Licence Holder

The tablets are manufactured by Abbott Biologicals B.V., Veerweg 12, 8121

AA Olst, The Netherlands and are procured from within the EU and

repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18,

Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.

PL Number: 15184/1033 Estradiol 1mg Tablets

Leaflet revision date: 17/12/18

Blind or partially sighted?

Is this leaflet hard to see or read?

Phone Lexon (UK) Limited,

Tel: 01527 505414 to obtain the leaflet

in a format suitable for you

Do not take Estradiol

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 Estradiol,

Do not take Estradiol

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 oestradial or any of the other

ingredients of Estradiol (listed in section 6 Further information)

if you still have your womb and are not currently taking some form of

progestogen hormone

If any of the above conditions appear for the first time while taking Estradiol,

stop taking it at once and consult your doctor immediately.

When to take special care with Estradiol

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 Estradiol. 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 a oestrogensensitive 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 af fecting the eardrum and hearing (otosclerosis)

a very high level of fat in your blood (triglycerides)

fluid retention due to cardiac or kidney problems

POM

Ref:1033/171218/3/F

1

6

4

5

2

3

1

2

6

5

(estradiol)

Page 1

Page 4

Using other medicines

Some medicines may interfere with the effect of Estradiol. This might lead to

irregular bleeding. This applies to the following medicines:

Medicines for epilepsy (such as phenobarbital, phenytoin and

carbamazepin)

Medicines for tuberculosis (such as rifampicin, rifabutin)

Medicines for HIV infection (such as nevirapine, efavirenz, ritonavir and

nelfinavir)

Herbal remedies containing St John’s Wort (Hypericum perforatum).

Problems due to high levels of the following medicines may occur when you

take Estradiol so careful drug monitoring and dose decrease may become

necessary:

- tacrolimus and cyclosporin – used, for example, for organ transplants

- fentanyl – a painkiller

- theophylline – used for asthma and other breathing problems

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 Estradiol, because this medicine can affect the results of some tests.

Pregnancy and breast-feeding

Estradiol is for use in peri and postmenopausal women only. If you become

pregnant, stop taking Estradiol and contact your doctor.

Important information about some of the ingredients of Estradiol

Estradiol tablets contain milk sugar (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.

How to take Estradiol

Always take Estradiol exactly as your doctor has told you. You should

check with your doctor or pharmacist if you are not sure.

Take one tablet every day, without a break between packs. Swallow the

tablet with water, with or without food.

In women with a uterus, a progestagen should normally be added to

Estradiol for 12 - 14 days of each month. If you are having regular periods

you should start taking Estradiol on day one of bleeding.

If you are not having regular periods and are not taking any other HRT

preparations, or you are switching from a combined continuous HRT product,

you can start taking Estradiol on any convenient day.

If you are currently using a ‘cyclic’ or ‘sequential’ HRT preparation (which

involves taking an oestrogen tablet or patch for part of the month, followed by

both oestrogen and progestagen tablet or patch for up to 14 days) start

taking Estradiol the day after you finish the pack i.e. at the end of the

progestagen phase.

Your doctor will aim to prescribe the lowest dose to treat your symptom for as

short as necessary. Speak to your doctor if you think this dose is too strong

or not strong enough.

You may experience some irregular bleeding or light bleeding (spotting)

during your first few months of taking Estradiol. If the bleeding is

troublesome, or continues beyond the first few months of treatment you

should discuss this with your doctor.

If you take more Estradiol than you should

Nausea (feeling sick), vomiting, sleepiness, dizziness and withdrawal

bleeding may occur. No treatment is necessary, but if you are worried contact

your doctor for advice.

If you forget to take Estradiol

Take the missed tablet as soon as you remember. If it is more than 12 hours

since you took the last one, take the next dose without taking the forgotten

tablet. Do not take a double dose. Bleeding or spotting may occur if

you miss a dose.

If you need to have surgery

If you are going to have surgery, tell the surgeon that you are taking

Estradiol. You may need to stop taking Estradiol 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 Estradiol again.

If you stop taking Estradiol

Do not stop taking Estradiol without first talking to your doctor.

If you have any further questions on the use of this product, ask your doctor

or pharmacist

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 over the age of 65

For more information about these side effects, see Section 2.

The following serious side effects may occur during treatment with

Estradiol:

- swelling of the skin around the face and neck. This may cause difficulty

breathing.

- heart attack

- heavy, irregular or painful bleeds

If any of these side effects occur you should stop treatment

immediately and contact your doctor.

The following side effects may occur during treatment:

Common (in less than 1 in 10, but more than 1 in 100 patients treated):

- headache

- feeling sick

- leg cramps

- abdominal pain

- pelvic pain

- unscheduled bleeding or spotting

- wind

- feeling weak (asthenia)

- weight changes

- rash or itching

Uncommon (in less than 1 in 100, but more than 1 in 1,000 patients

treated):

- hypersensitivity (allergic) reaction such as skin rash, itching, skin redness

- hives

- painful reddish skin nodules (erythema nodosum)

- feeling down

- vaginal thrush (a vaginal infection due to a fungus called Candida albicans)

- high blood pressure

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, on average 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 longterm 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 Estradiol and see a doctor

immediately”.

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 oestrogenprogestogen

HRT for over 5 years, there will be 9 to 12 cases in 1000 users (i.e. an extra

5 cases). For women in their 50s who have had their womb removed and

have been taking oestrogen-only HRT for over 5 years, there will be 5 to 8

cases in 1000 users (i.e. 1 extra case).

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. For women who

have had their womb removed and are taking oestrogen-only therapy there is

no increased risk of developing a heart disease.

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. 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.

Stop taking Estradiol 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

Estradiol’ 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: Estradiol

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).

Taking a progestogen in addition to the oestrogen for at least 12 days of

each 28 day cycle protects you from this extra risk. So your doctor will

prescribe a progestogen separately if you still have your womb. If you have

had your womb removed (a hysterectomy), discuss with your doctor whether

you can safely take this product without a progestogen.

In women who still have a womb and who are not taking HRT, on average, 5

in 1000 will be diagnosed with endometrial cancer between the ages of 50

and 65. For women aged 50 to 65 who still have a womb and who

take oestrogen-only HRT, between 10 and 60 women in 1000 will be

diagnosed with endometrial cancer (i.e. between 5 and 55 extra cases),

depending on the dose and for how long it is taken.

Unexpected bleeding

You will have a bleed once a month (so-called withdrawal bleed) while taking

Estradiol. 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 Estradiol more than 6 months

carries on after you have stopped taking Estradiol

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. For women who have had their womb

removed and who are using oestrogen-only HRT for 5 years, little or no

increase in breast cancer risk is shown. 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

oestrogenprogestogen 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

Ref:1033/171218/3/B

3

Page 2

Page 3

4