ESTRADIOL 1MG TABLETS

Active substance: ESTRADIOL HEMIHYDRATE

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Rare (in less than 1 in 1,000, but more than 1 in 10,000 patients treated):
- liver disorders, which may include jaundice (yellowing of the skin), asthenia
(feeling weak) and general malaise
change in the surface of the eye
intolerance to contact lenses
pre-menstrual tension (PMT)
swelling of the breasts
-

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)
chorea (muscle twitches)
vomiting
skin discolouration
red or brown patches on the skin
worsening of porphyria (a metabolic disease).
-

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.

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.

POM

PL Number: 15184/1033 Zumenon 1mg Tablets

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

®

Zumenon 1mg Tablets

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

Leaflet revision date: 30/11/12

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited,
Tel: 01527 505414 for help.

In this leaflet:
1 What Zumenon is and what it is used for
2 Before you use Zumenon
3 How to use Zumenon
4 Possible side effects

1

How to store

2

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, Macrogol 400, Titanium dioxide E171.

Ref:1033/301112/1/F

(estradiol)

Patient Information Leaflet
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)

5 How to store Zumenon
6 Further information

The following side effects have been reported with other HRTs:
• various skin disorders:
- discoloration 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)

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 peri and postmenopausal women,
who may or may not still be having their periods and women switching from
standard (cyclic or sequential) HRT on the advice of their doctor.

If any of the side effects get serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.

5

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.

* Keep out of the sight and reach of childern.
* Do not store above 30°C.
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.

6

Before you use 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

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 oestrogen-sensitive cancer (such as having a
mother, sister or grandmother who has had breast cancer)
• high blood pressure.
• a liver disorder, such as a benign liver tumour
• diabetes
• gallstones
• migraine or severe headaches.
• a disease of the immune system that affects many organs of the body
(systemic lupus erythematosus, SLE)
epilepsy
asthma
a disease affecting the eardrum and hearing (otosclerosis)
a very high level of fat in your blood (triglycerides)
fluid retention due to cardiac or kidney problems






Stop taking 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.

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,
Page 4

Page 1

- 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 oestrogenprogestogen and possibly
also oestrogen-only HRT increases the risk of breast cancer. The extra risk
depends on how long you take HRT. The additional risk becomes clear within
a few years. However, it returns to normal within a few years (at most 5) after
stopping treatment.
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 14 in 1000
will be diagnosed with breast cancer over a 5-year period. For women aged
50 to 79 who are taking oestrogen-progestogen HRT over 5 years, there will
be 13 to 20 cases in 1000 users (i.e. an extra 4 to 6 cases).
• Regularly check your breasts. See your doctor if you notice any
changes such as:
• dimpling of the skin
• changes in the nipple
• any lumps you can see or feel
Ovarian cancer
Ovarian cancer is rare. A slightly increased risk of ovarian cancer has been
reported in women taking HRT for at least 5 to 10 years.
Women aged 50 to 69 who are not taking HRT, on average about 2 women
in 1000 will be diagnosed with ovarian cancer over a 5-year period. For
women who have been taking HRT for 5 years, there will be between 2 and 3
cases per 1000 users (i.e. up to 1 extra case).
Page 2

Effect of HRT on heart and circulation
Blood clots in a vein (thrombosis)
The risk of blood clots in the veins is about 1.3 to 3- times higher in HRT
users than in non-users, especially during the first year of taking it.
Blood clots can be serious, and if one travels to the lungs, it can cause chest
pain, breathlessness, fainting or even death.
You are more likely to get a blood clot in your veins as you get older and if
any of the following applies to you. Inform your doctor if any of these
situations applies to you:
• you are unable to walk for a long time because of major surgery, injury or
illness (see also section 3, If you need to have surgery)
• you are seriously overweight (BMI >30 kg/m2)
• you have any blood clotting problem that needs long-term treatment with a
medicine used to prevent blood clots
• if any of your close relatives has ever had a blood clot in the leg, lung or an
other 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 nonusers. 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.
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).

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.

3

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 within five days of the start 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
If you or somebody else takes too many Zumenon tablets, they are unlikely
to come to any harm. Nausea (feeling sick), vomiting, sleepiness and
dizziness 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 then 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 Zumeon.
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

4

Possible side Effects

Like all medicines, Zumenon 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 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 genital bleeding
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):
- migraine
- headache
- feeling sick
- leg cramps
- breast pain or tenderness
- abdominal pain
- pelvic pain
- unscheduled bleeding or spotting
- wind (flatulence)
- feeling weak (asthenia)
- weight changes
Uncommon (in less than 1 in 100, but more than 1in 1,000 patients
treated):
- allergic skin reactions (including rash or itching)
- feeling down (depression)
- vaginal thrush (a vaginal infection due to a fungus called Candida albicans)
- symptoms of cystitis
- high blood pressure
- swelling of the ankles, feet or fingers (peripheral oedema)
- peripheral vascular disease
- varicose veins
- gallbladder disease
- change in sex drive
- back pain
- indigestion
- nervousness
- dizziness
- vaginal discharge
- fibroids get bigger (growths in the womb increase)
- changes in the cervix (the lower end of the womb)
Ref:1033/301112/1/B

Page 3

Rare (in less than 1 in 1,000, but more than 1 in 10,000 patients treated):
- liver disorders, which may include jaundice (yellowing of the skin), asthenia
(feeling weak) and general malaise
change in the surface of the eye
intolerance to contact lenses
pre-menstrual tension (PMT)
swelling of the breasts
-

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)
chorea (muscle twitches)
vomiting
skin discolouration
red or brown patches on the skin
worsening of porphyria (a metabolic disease).
-

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.

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.

®

Oromone 1mg Tablets

Ref:1033/301112/2/F

(estradiol)

Patient Information Leaflet
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.

POM

PL Number: 15184/1033 Oromone 1mg Tablets

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

Leaflet revision date: 30/11/12

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited,
Tel: 01527 505414 for help.

The following side effects have been reported with other HRTs:
• various skin disorders:
- discoloration 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)

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)

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:
1 What Oromone is and what it is used for
2 Before you use Oromone
3 How to use Oromone
4 Possible side effects
5 How to store Oromone
6 Further information
1

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 peri and postmenopausal women,
who may or may not still be having their periods and women switching from
standard (cyclic or sequential) HRT on the advice of their doctor.

If any of the side effects get serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.

5

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.

How to store

* Keep out of the sight and reach of childern.
* Do not store above 30°C.
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.

6

2

Before you use 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

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, Macrogol 400, Titanium dioxide E171.

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,

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 oestrogen-sensitive cancer (such as having a
mother, sister or grandmother who has had breast cancer)
• high blood pressure.
• a liver disorder, such as a benign liver tumour
• diabetes
• gallstones
• migraine or severe headaches.
• a disease of the immune system that affects many organs of the body
(systemic lupus erythematosus, SLE)
epilepsy
asthma
a disease affecting the eardrum and hearing (otosclerosis)
a very high level of fat in your blood (triglycerides)
fluid retention due to cardiac or kidney problems






Stop taking 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.

Page 4

Page 1

- 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 oestrogenprogestogen and possibly
also oestrogen-only HRT increases the risk of breast cancer. The extra risk
depends on how long you take HRT. The additional risk becomes clear within
a few years. However, it returns to normal within a few years (at most 5) after
stopping treatment.
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 14 in 1000
will be diagnosed with breast cancer over a 5-year period. For women aged
50 to 79 who are taking oestrogen-progestogen HRT over 5 years, there will
be 13 to 20 cases in 1000 users (i.e. an extra 4 to 6 cases).
• Regularly check your breasts. See your doctor if you notice any
changes such as:
• dimpling of the skin
• changes in the nipple
• any lumps you can see or feel
Ovarian cancer
Ovarian cancer is rare. A slightly increased risk of ovarian cancer has been
reported in women taking HRT for at least 5 to 10 years.
Women aged 50 to 69 who are not taking HRT, on average about 2 women
in 1000 will be diagnosed with ovarian cancer over a 5-year period. For
women who have been taking HRT for 5 years, there will be between 2 and 3
cases per 1000 users (i.e. up to 1 extra case).
Page 2

Effect of HRT on heart and circulation
Blood clots in a vein (thrombosis)
The risk of blood clots in the veins is about 1.3 to 3- times higher in HRT
users than in non-users, especially during the first year of taking it.
Blood clots can be serious, and if one travels to the lungs, it can cause chest
pain, breathlessness, fainting or even death.
You are more likely to get a blood clot in your veins as you get older and if
any of the following applies to you. Inform your doctor if any of these situations applies to you:
• you are unable to walk for a long time because of major surgery, injury or
illness (see also section 3, If you need to have surgery)
• you are seriously overweight (BMI >30 kg/m2)
• you have any blood clotting problem that needs long-term treatment with a
medicine used to prevent blood clots
• if any of your close relatives has ever had a blood clot in the leg, lung or an
other 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 nonusers. 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.
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).

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.

3 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 within five days of the start 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
If you or somebody else takes too many Oromone tablets, they are unlikely
to come to any harm. Nausea (feeling sick), vomiting, sleepiness and
dizziness 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 then 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 Zumeon.
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

4

Possible side Effects

Like all medicines, Oromone 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 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 genital bleeding
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):
- migraine
- headache
- feeling sick
- leg cramps
- breast pain or tenderness
- abdominal pain
- pelvic pain
- unscheduled bleeding or spotting
- wind (flatulence)
- feeling weak (asthenia)
- weight changes
Uncommon (in less than 1 in 100, but more than 1in 1,000 patients
treated):
- allergic skin reactions (including rash or itching)
- feeling down (depression)
- vaginal thrush (a vaginal infection due to a fungus called Candida albicans)
- symptoms of cystitis
- high blood pressure
- swelling of the ankles, feet or fingers (peripheral oedema)
- peripheral vascular disease
- varicose veins
- gallbladder disease
- change in sex drive
- back pain
- indigestion
- nervousness
- dizziness
- vaginal discharge
- fibroids get bigger (growths in the womb increase)
- changes in the cervix (the lower end of the womb)
Ref:1033/301112/2/B

Page 3

Rare (in less than 1 in 1,000, but more than 1 in 10,000 patients treated):
- liver disorders, which may include jaundice (yellowing of the skin), asthenia
(feeling weak) and general malaise
change in the surface of the eye
intolerance to contact lenses
pre-menstrual tension (PMT)
swelling of the breasts
-

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)
chorea (muscle twitches)
vomiting
skin discolouration
red or brown patches on the skin
worsening of porphyria (a metabolic disease).
-

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.

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.

®

Estradiol 1mg Tablets

Ref:1033/301112/3/F

(estradiol)

Patient Information Leaflet
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.

POM

PL Number: 15184/1033 Estradiol 1mg Tablets

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)

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

Leaflet revision date: 30/11/12

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited,
Tel: 01527 505414 for help.

In this leaflet:
1 What Estradiol is and what it is used for
2 Before you use Estradiol
3 How to use Estradiol
4 Possible side effects
5 How to store Estradiol
6 Further information

The following side effects have been reported with other HRTs:
• various skin disorders:
- discoloration 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)

1

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 peri and postmenopausal women,
who may or may not still be having their periods and women switching from
standard (cyclic or sequential) HRT on the advice of their doctor.

If any of the side effects get serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.

5

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.

How to store

* Keep out of the sight and reach of childern.
* Do not store above 30°C.
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.

6

2

Before you use 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

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, Macrogol 400, Titanium dioxide E171.

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 oestrogen-sensitive cancer (such as having a
mother, sister or grandmother who has had breast cancer)
• high blood pressure.
• a liver disorder, such as a benign liver tumour
• diabetes
• gallstones
• migraine or severe headaches.
• a disease of the immune system that affects many organs of the body
(systemic lupus erythematosus, SLE)
epilepsy
asthma
a disease affecting the eardrum and hearing (otosclerosis)
a very high level of fat in your blood (triglycerides)
fluid retention due to cardiac or kidney problems






Stop taking 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.

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,
Page 4

Page 1

- 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 oestrogenprogestogen and possibly
also oestrogen-only HRT increases the risk of breast cancer. The extra risk
depends on how long you take HRT. The additional risk becomes clear within
a few years. However, it returns to normal within a few years (at most 5) after
stopping treatment.
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 14 in 1000
will be diagnosed with breast cancer over a 5-year period. For women aged
50 to 79 who are taking oestrogen-progestogen HRT over 5 years, there will
be 13 to 20 cases in 1000 users (i.e. an extra 4 to 6 cases).
• Regularly check your breasts. See your doctor if you notice any
changes such as:
• dimpling of the skin
• changes in the nipple
• any lumps you can see or feel
Ovarian cancer
Ovarian cancer is rare. A slightly increased risk of ovarian cancer has been
reported in women taking HRT for at least 5 to 10 years.
Women aged 50 to 69 who are not taking HRT, on average about 2 women
in 1000 will be diagnosed with ovarian cancer over a 5-year period. For
women who have been taking HRT for 5 years, there will be between 2 and 3
cases per 1000 users (i.e. up to 1 extra case).
Page 2

Effect of HRT on heart and circulation
Blood clots in a vein (thrombosis)
The risk of blood clots in the veins is about 1.3 to 3- times higher in HRT
users than in non-users, especially during the first year of taking it.
Blood clots can be serious, and if one travels to the lungs, it can cause chest
pain, breathlessness, fainting or even death.
You are more likely to get a blood clot in your veins as you get older and if
any of the following applies to you. Inform your doctor if any of these situations applies to you:
• you are unable to walk for a long time because of major surgery, injury or
illness (see also section 3, If you need to have surgery)
• you are seriously overweight (BMI >30 kg/m2)
• you have any blood clotting problem that needs long-term treatment with a
medicine used to prevent blood clots
• if any of your close relatives has ever had a blood clot in the leg, lung or an
other 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 nonusers. 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.
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).

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.

3 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 within five days of the start 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
If you or somebody else takes too many Estradiol tablets, they are unlikely to
come to any harm. Nausea (feeling sick), vomiting, sleepiness and
dizziness 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 then 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 Zumeon.
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

4

Possible side Effects

Like all medicines, Estradiol 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 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 genital bleeding
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):
- migraine
- headache
- feeling sick
- leg cramps
- breast pain or tenderness
- abdominal pain
- pelvic pain
- unscheduled bleeding or spotting
- wind (flatulence)
- feeling weak (asthenia)
- weight changes
Uncommon (in less than 1 in 100, but more than 1in 1,000 patients
treated):
- allergic skin reactions (including rash or itching)
- feeling down (depression)
- vaginal thrush (a vaginal infection due to a fungus called Candida albicans)
- symptoms of cystitis
- high blood pressure
- swelling of the ankles, feet or fingers (peripheral oedema)
- peripheral vascular disease
- varicose veins
- gallbladder disease
- change in sex drive
- back pain
- indigestion
- nervousness
- dizziness
- vaginal discharge
- fibroids get bigger (growths in the womb increase)
- changes in the cervix (the lower end of the womb)
Ref:1033/301112/3/B

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Source: Medicines and Healthcare Products Regulatory Agency

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