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ESTRADIOL 0.06% W/W GEL PUMP PACK

Active substance(s): ESTRADIOL

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Oestrogel® Pump-Pack
(estradiol)
Read all of this leaflet carefully before you
start using this medicine because it
contains important information for you.
Keep this leaflet. You may need to read it
again.
If you have any further questions, ask your
doctor or pharmacist.
This medicine has been prescribed for you
only. Do not pass it on to others. It may
harm them, even if their signs of illness
are the same as yours.
If you get any side effects, talk to your
doctor or pharmacist. This includes any
possible side effects not listed in this
leaflet.
The name of your medicine is Oestrogel
Pump-Pack but will be referred to as
Oestrogel throughout this leaflet.
What is in this leaflet:
1. What Oestrogel is and what it is used for
2. What you need to know before you use
Oestrogel
3. How to use Oestrogel
4. Possible side effects
5. How to store Oestrogel
6. Contents of the pack and other
information

1. What Oestrogel is and what it is
used for
Oestrogel is a Hormone Replacement
Therapy (HRT). It contains the female
hormone oestrogen. Oestrogel is used in
postmenopausal women with at least 6
months since their last natural period.
Oestrogel 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’). Oestrogel
alleviates these symptoms after menopause.
You will only be prescribed Oestrogel if your
symptoms seriously hinder your daily life.
Prevention of osteoporosis
After the menopause some women may
develop fragile bones (osteoporosis).

You should discuss all available options with
your doctor.
If you are at an increased risk of fractures due
to osteoporosis and other medicines are not
suitable for you, you can use Oestrogel to
prevent osteoporosis after menopause.
How Oestrogel works
Oestrogel works by replacing the oestrogen in
your body. This is so that you have a similar
amount of oestrogen as before your
menopause.

2. What you need to know before you
use Oestrogel
Medical history and regular check-ups
The use of HRT carries risks which need to be
considered when deciding whether to start
using it, or whether to carry on using 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 you 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 Oestrogel 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 Oestrogel.
Go for regular breast screening, as
recommended by your doctor.
Do not use Oestrogel
If any of the following applies to you. If you are
not sure about any of the points below, talk to
your doctor before using Oestrogel.
Do not use Oestrogel:
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
oestrogen, 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 blood clots in
a vein (thrombosis), such as in the legs
(deep venous thrombosis) or lungs
(pulmonary embolism),
If you have a blood clotting disorder (such
as protein C, protein S, or antithrombin
deficiency),
If you have or recently have had a disease
caused by blood clots in the arteries, such
as a heart attack, stroke or angina,
If you have or have ever had a liver
disease and your liver function tests have
not returned to normal,
If you have a rare blood problem called
‘porphyria’ which is passed down in
families (inherited),
If you are allergic to estradiol or any other
ingredients of this medicine (listed in
section 6).
If any of the above conditions appear for the
first time while using Oestrogel, stop using it at
once and consult your doctor immediately.
Warnings and precautions
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 Oestrogel. If so,
you should see your doctor more often for
check-ups:
fibrosis 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 affecting the eardrum and
hearing (otosclerosis),
a very high level of fat in your blood
(triglycerides),

fluid retention due to heart or kidney
problems.
Stop using Oestrogel and see a doctor
immediately
If you notice any of the following when taking
HRT:
any of the conditions mentioned in the ‘Do
not use Oestrogel’ 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: Oestrogel 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)
Using 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).
Using 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 using 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.
Irregular bleeding
You may have irregular bleeding or drops of
blood (spotting) during the first 3-6 months of
using Oestrogel. However, if the irregular
bleeding:
carries on for more than the first 6 months
starts after you have been using Oestrogel
for more than 6 months
carries on after you have stopped using
Oestrogel see your doctor as soon as
possible.
Breast cancer
Evidence suggests that using 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.
Compare
Women aged 50 to 79 who are not taking
HRT, on average, 9 to 17 in 1000 will be
diagnosed with breast cancer over a 5-year
period. For women aged 50 to 79 who are
taking oestrogen-progestogen HRT over 5
years, there will be 13 to 23 cases in 1000
users (i.e. an extra 4 to 6 cases).
Regularly check your breasts. See your
doctor if you notice any changes such
as:
dimpling of the skin
changes in the nipple
any lumps you can see or feel
Ovarian cancer
Ovarian cancer is rare. A slightly increased
risk of ovarian cancer has been reported in
women using HRT for at least 5 to 10 years.
Women aged 50 to 69 who are not using HRT,
on average about 2 women in 1000 will be
diagnosed with ovarian cancer over a 5-year
period. For women who have been using HRT
for 5 years, there will be between 2 and 3
cases per 1000 users (i.e. up to 1 extra case).

Effect of HRT on heart and circulation
Blood clots in a vein (thrombosis)
The risk of blood clots in the veins is about
1.3 to 3- times higher in HRT users than in
non-users, especially during the first year of
using it.
Blood clots can be serious, and if one travels
to the lungs, it can cause chest pain,
breathlessness, fainting or even death.
You are more likely to get a blood clot in your
veins as you get older and if any of the
following applies to you. Inform your doctor if
any of these situations applies to you:
you are unable to walk for a long time
because of major surgery, injury or illness
(see also section 3, ‘If you need to have
surgery’)
you are seriously overweight
(BMI >30 kg/m2)
you have any blood clotting problem that
needs long-term treatment with a
medicine used to prevent blood clots
if any of your close relatives has ever had
a blood clot in the leg, lung or another
organ
you have systemic lupus erythematosus
(SLE)
you have cancer.
For signs of a blood clot, see ‘Stop using
Oestrogel and see a doctor immediately’.
Compare
Looking at women in their 50s who are not
using 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 using
oestrogen-progestogen 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 using
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
oestrogen-progestogen HRT are slightly more
likely to develop heart disease than those not
using any HRT.

For women who have had their womb
removed and are using 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.

Laboratory tests
If you need a blood test, tell your doctor or the
laboratory staff that you are using Oestrogel,
because this medicine can affect the result of
some tests.
Pregnancy and breast-feeding
Oestrogel is for use in postmenopausal
women only. If you become pregnant, stop
using Oestrogel and contact your doctor.

Compare

3. How to use Oestrogel

Looking at women in their 50s who are not
using 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 using
HRT, there will be 11 cases in 1000 users,
over 5 years (i.e. an extra 3 cases).

Always use Oestrogel exactly as your doctor
has told you. Check with your doctor or
pharmacist if you are not sure.

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.
Other medicines and Oestrogel
Some medicines may interfere with the effect
of Oestrogel. This might lead to irregular
bleeding.
This applies to the following medicines:
Skin cleansers and detergents e.g.
products containing benzalkonium
chloride or sodium lauryl sulphate.
Other skin products containing alcohol
e.g. astringents or sunscreens.
Products to treat skin and scalp disorders
e.g. products to cure warts, acne or
dandruff.
Other skin medications which change how
skin is made, e.g. anti-cancer products.
Medicines for epilepsy (such as
phenobarbital, phenytoin and
carbamazepine).
Medicines for tuberculosis (such as
rifampicin, rifabutin).
Medicines for HIV infection (such as
nevirapine, efavirenz, ritonavir and
nelfinavir).
Herbal products containing St John’s Wort
(Hypericum perforatum).
Please tell your doctor or pharmacist if you are
using or have recently used any other
medicines including medicines obtained
without a prescription, herbal medicines or
other natural products.

Using this medicine
If you have never used any other HRT
medicines or you are switching to
Oestrogel from a period-free HRT product,
you can start using Oestrogel on any
convenient day.
If you are currently using another type of
HRT where you have a period, finish your
current medicine pack before you start
using Oestrogel.
Do not ask anyone else to apply the gel.
Only you should apply your medicine.
Do not use strong skin cleaners or
detergents when washing the area where
you will apply the gel.
Avoid close skin contact with your partner
for one hour after application.
Do not wash the skin or apply other skin
care products until at least one hour after
application.
If the prescribed dose does not provide
relief, tell your doctor. Do not use more
than the prescribed dose.
Your doctor will aim to prescribe the lowest
dose to treat your symptoms for as short as
necessary.
Speak to your doctor if you think this dose is
too strong or not strong enough.
Preparing your new Pump Pack
Before using your new Pump Pack for the
first time, you need to prepare it for use as
follows:
Remove the cap from the canister.
Remove the stopper from the spout.
Press the plunger down a few times until
the gel comes out.
Do not use the first dose of gel from your
Pump Pack. This dose should be
discarded.
Your Pump Pack is now ready to use.

How much to use and when to use
Apply the gel once a day, either in the
morning or evening.
Try to use the gel at about the same time
each day.
Your doctor will prescribe the lowest dose
for the shortest time to treat your
symptoms.
The usual daily dose is 2 measures of gel.
The Pump Pack will last four weeks.
If 4 measures of gel have been
prescribed, the Pump Pack will last two
weeks.
Spread the gel on a large area of skin on
each shoulder, outer arm or each midinner thigh.
How to apply the gel
1. Make sure that your hands and the skin
where you are going to apply the gel are
clean, dry and unbroken.
2. Remove the canister cap to reveal the
plunger.
3. Remove the stopper from the spout.
4. Hold the Oestrogel Pump Pack in one
hand and place your other hand under the
spout, ready to collect the gel.
5. Push the plunger down firmly. This will
dispense one measure of the gel.
6. Apply the gel to either:
the outer arm and shoulder of both arms,
or
the mid-inner thigh of both legs.
7. Do not apply on or near the breasts, or
near the genital area.
8. Spread the gel over a large area of skin
on each shoulder, outer arm or mid-inner
thigh.
9. If your doctor has prescribed 2 measures
of gel, spread 1 measure over each outer
arm and shoulder, or each mid-inner thigh.
If 4 measures of gel have been
prescribed, spread 2 measures over each
outer arm and shoulder or each mid-inner
thigh. (See steps 4-8).
10. Cover the spout using the attached
stopper.
11. Replace the cap.
12. Leave to dry for 5 minutes before covering
with clothes.
How you know when your Pump Pack is
empty
The Pump Pack is nearly empty when the
plunger does not return back to its original
position after you have pushed it down.

When this happens, do not use the Pump
Pack any longer. Start using a new Pump
Pack.
If you use more Oestrogel than you should
The effects of overdosing are generally: breast
tension, abdominal and pelvic swelling,
nausea and vaginal bleeding. These
symptoms disappear when treatment is
stopped or the dose is reduced.
In case of the accidental using of an excessive
dose of the medicine tell your doctor
immediately.
If you forget to use Oestrogel
If it is more than 12 hours until your next
dose, apply the gel as soon as you
remember and apply the next dose at the
normal time.
If it is less than 12 hours until your next
dose, skip the missed dose and apply the
next dose at the normal time.
Do not use a double dose (two doses at
the same time) to make up for a forgotten
dose.
If you forget a dose you may have
breakthrough bleeding or spotting.
If you need to have surgery
If you are going to have surgery, tell the
surgeon that you are using Oestrogel. You
may need to stop using Oestrogel 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
using Oestrogel again.

4. Possible side effects
Like all medicines, this medicine can cause
side effects, although not everybody gets
them.
The following diseases are reported more
often in women using HRT compared to
women not using HRT:
breast cancer,
abnormal growth or cancer of the lining of
the womb (endometrial hyperplasia or
cancer),
ovarian cancer,
blood clots in the veins of the legs or lungs
(venous thromboembolism),
heart disease,
stroke,
probable memory loss if HRT is started
over the age of 65.

HRT will not prevent memory loss.
For more information about these side effects,
see Section 2.
Side effects observed with HRT products
used in menopause are reported below:
Common: may affect up to 1 in 10 people
Headache.
Nausea, abdominal pain.
Breast swelling or pain, breast
enlargement, menstrual cramps, heavy
menstrual bleeding, unexpected vaginal
bleeding, vaginal discharge endometrial
hyperplasia.
Weight change (increase or decrease),
water retention with peripheral oedema.
Uncommon: may affect up to 1 in 100 people
Depression, mood swings.
Vertigo, migraine.
Venous thromboembolic disease.
Flatulence, vomiting.
Itching (pruritus).
Benign breast or uterine neoplasm,
increased volume of uterine, vaginitis
or vaginal candidiasis.
Feeling weak (asthenia).
Rare: may affect up to 1 in 1,000 people
Glucose intolerance.
Change in libido.
Aggravation of epilepsy.
Hypertension.
Liver function tests abnormalities.
Skin decoloration, acne.
Appearance of milk secretion
(galactorrhea).
Anaphylactic reaction (in women with
past history of allergic reaction).
The following side effects have been reported
with other HRTs:
gall bladder disease
various skin disorders:
painful reddish skin nodules (erythema
nodosum)
rash with target-shaped reddening or
sores (erythema multiforme)
Reporting of side effects
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any
possible side effects not listed in this leaflet.
You can also report side effects directly via
the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.

By reporting side effects, you can help provide
more information on the safety of this
medicine.

5. How to store Oestrogel
Keep out of the sight and reach of
children.
Do not store above 25°C.
Do not use your gel after the expiry date
which is stated on the carton and bottle
label after ‘Exp’. The expiry date refers to
the last day of that month.
Medicines should not be disposed of via
wastewater or household waste. Ask
your doctor or pharmacist how to dispose
of medicines no longer required. These
measures will help to protect the
environment.

6. Contents of the pack and other
information
What Oestrogel contains
The active ingredient in Oestrogel is
estradiol. This is a man made form of the
female hormone oestrogen.
Each metered dose (1.25g) contains
0.75mg estradiol.
The other ingredients are: carbomer 980,
triethanolamine, ethanol 96% and
purified water.
What Oestrogel looks like and contents of
the pack
Colourless, transparent gel with alcoholic
odour.
Oestrogel is available as an 80g pump
action container which delivers
64 metered doses.
Manufactured by: Laboratoires Besins
International, 13 Rue Perier, 92120,
Montrouge, France.
Procured from within the EU and
repackaged by the Product Licence holder:
B&S Healthcare, Unit 4, Bradfield Road,
Ruislip, HA4 0NU, UK.
Oestrogel® Pump-Pack; PL 18799/2943
Leaflet date: 19.09.2016

POM

Oestrogel is registered trademark of Besins
Healthcare luxembourg S.A.R.L.

Estradiol 0.06% w/w gel
Pump-Pack
Read all of this leaflet carefully before you
start using this medicine because it
contains important information for you.
Keep this leaflet. You may need to read it
again.
If you have any further questions, ask your
doctor or pharmacist.
This medicine has been prescribed for you
only. Do not pass it on to others. It may
harm them, even if their signs of illness
are the same as yours.
If you get any side effects, talk to your
doctor or pharmacist. This includes any
possible side effects not listed in this
leaflet.
The name of your medicine is Estradiol
0.06% w/w Gel Pump-Pack but will be referred
to as Estradiol throughout this leaflet.
What is in this leaflet:
1. What Estradiol is and what it is used for
2. What you need to know before you use
Estradiol
3. How to use Estradiol
4. Possible side effects
5. How to store Estradiol
6. Contents of the pack and other
information

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
postmenopausal women with at least 6
months since their last natural period.
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.
Prevention of osteoporosis
After the menopause some women may
develop fragile bones (osteoporosis).

You should discuss all available options with
your doctor.
If you are at an increased risk of fractures due
to osteoporosis and other medicines are not
suitable for you, you can use Estradiol to
prevent osteoporosis after menopause.
How Estradiol works
Estradiol works by replacing the oestrogen in
your body. This is so that you have a similar
amount of oestrogen as before your
menopause.

2. What you need to know 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
using it, or whether to carry on using 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 you 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.
Do not use 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 using Estradiol.
Do not use 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
oestrogen, 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 blood clots in
a vein (thrombosis), such as in the legs
(deep venous thrombosis) or lungs
(pulmonary embolism),
If you have a blood clotting disorder (such
as protein C, protein S, or antithrombin
deficiency),
If you have or recently have had a disease
caused by blood clots in the arteries, such
as a heart attack, stroke or angina,
If you have or have ever had a liver
disease and your liver function tests have
not returned to normal,
If you have a rare blood problem called
‘porphyria’ which is passed down in
families (inherited),
If you are allergic to estradiol or any other
ingredients of this medicine (listed in
section 6).
If any of the above conditions appear for the
first time while using Estradiol, stop using it at
once and consult your doctor immediately.
Warnings and precautions
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:
fibrosis 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 affecting the eardrum and
hearing (otosclerosis),
a very high level of fat in your blood
(triglycerides),

fluid retention due to heart or kidney
problems.
Stop using 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 use 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)
Using 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).
Using 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 using 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.
Irregular bleeding
You may have irregular bleeding or drops of
blood (spotting) during the first 3-6 months of
using Estradiol. However, if the irregular
bleeding:
carries on for more than the first 6 months
starts after you have been using Estradiol
for more than 6 months
carries on after you have stopped using
Estradiol see your doctor as soon as
possible.
Breast cancer
Evidence suggests that using 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.
Compare
Women aged 50 to 79 who are not taking
HRT, on average, 9 to 17 in 1000 will be
diagnosed with breast cancer over a 5-year
period. For women aged 50 to 79 who are
taking oestrogen-progestogen HRT over 5
years, there will be 13 to 23 cases in 1000
users (i.e. an extra 4 to 6 cases).
Regularly check your breasts. See your
doctor if you notice any changes such
as:
dimpling of the skin
changes in the nipple
any lumps you can see or feel
Ovarian cancer
Ovarian cancer is rare. A slightly increased
risk of ovarian cancer has been reported in
women using HRT for at least 5 to 10 years.
Women aged 50 to 69 who are not using HRT,
on average about 2 women in 1000 will be
diagnosed with ovarian cancer over a 5-year
period. For women who have been using HRT
for 5 years, there will be between 2 and 3
cases per 1000 users (i.e. up to 1 extra case).

Effect of HRT on heart and circulation
Blood clots in a vein (thrombosis)
The risk of blood clots in the veins is about
1.3 to 3- times higher in HRT users than in
non-users, especially during the first year of
using it.
Blood clots can be serious, and if one travels
to the lungs, it can cause chest pain,
breathlessness, fainting or even death.
You are more likely to get a blood clot in your
veins as you get older and if any of the
following applies to you. Inform your doctor if
any of these situations applies to you:
you are unable to walk for a long time
because of major surgery, injury or illness
(see also section 3, ‘If you need to have
surgery’)
you are seriously overweight
(BMI >30 kg/m2)
you have any blood clotting problem that
needs long-term treatment with a
medicine used to prevent blood clots
if any of your close relatives has ever had
a blood clot in the leg, lung or another
organ
you have systemic lupus erythematosus
(SLE)
you have cancer.
For signs of a blood clot, see ‘Stop using
Estradiol and see a doctor immediately’.
Compare
Looking at women in their 50s who are not
using 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 using
oestrogen-progestogen 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 using
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
oestrogen-progestogen HRT are slightly more
likely to develop heart disease than those not
using any HRT.

For women who have had their womb
removed and are using 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.

Laboratory tests
If you need a blood test, tell your doctor or the
laboratory staff that you are using Estradiol,
because this medicine can affect the result of
some tests.
Pregnancy and breast-feeding
Estradiol is for use in postmenopausal women
only. If you become pregnant, stop using
Estradiol and contact your doctor.

Compare

3. How to use Estradiol

Looking at women in their 50s who are not
using 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 using
HRT, there will be 11 cases in 1000 users,
over 5 years (i.e. an extra 3 cases).

Always use Estradiol exactly as your doctor
has told you. Check with your doctor or
pharmacist if you are not sure.

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.
Other medicines and Estradiol
Some medicines may interfere with the effect
of Estradiol. This might lead to irregular
bleeding.
This applies to the following medicines:
Skin cleansers and detergents e.g.
products containing benzalkonium
chloride or sodium lauryl sulphate.
Other skin products containing alcohol
e.g. astringents or sunscreens.
Products to treat skin and scalp disorders
e.g. products to cure warts, acne or
dandruff.
Other skin medications which change how
skin is made, e.g. anti-cancer products.
Medicines for epilepsy (such as
phenobarbital, phenytoin and
carbamazepine).
Medicines for tuberculosis (such as
rifampicin, rifabutin).
Medicines for HIV infection (such as
nevirapine, efavirenz, ritonavir and
nelfinavir).
Herbal products containing St John’s Wort
(Hypericum perforatum).
Please tell your doctor or pharmacist if you are
using or have recently used any other
medicines including medicines obtained
without a prescription, herbal medicines or
other natural products.

Using this medicine
If you have never used any other HRT
medicines or you are switching to
Estradiol from a period-free HRT product,
you can start using Estradiol on any
convenient day.
If you are currently using another type of
HRT where you have a period, finish your
current medicine pack before you start
using Estradiol.
Do not ask anyone else to apply the gel.
Only you should apply your medicine.
Do not use strong skin cleaners or
detergents when washing the area where
you will apply the gel.
Avoid close skin contact with your partner
for one hour after application.
Do not wash the skin or apply other skin
care products until at least one hour after
application.
If the prescribed dose does not provide
relief, tell your doctor. Do not use more
than the prescribed dose.
Your doctor will aim to prescribe the lowest
dose to treat your symptoms for as short as
necessary.
Speak to your doctor if you think this dose is
too strong or not strong enough.
Preparing your new Pump Pack
Before using your new Pump Pack for the
first time, you need to prepare it for use as
follows:
Remove the cap from the canister.
Remove the stopper from the spout.
Press the plunger down a few times until
the gel comes out.
Do not use the first dose of gel from your
Pump Pack. This dose should be
discarded.
Your Pump Pack is now ready to use.

How much to use and when to use
Apply the gel once a day, either in the
morning or evening.
Try to use the gel at about the same time
each day.
Your doctor will prescribe the lowest dose
for the shortest time to treat your
symptoms.
The usual daily dose is 2 measures of gel.
The Pump Pack will last four weeks.
If 4 measures of gel have been
prescribed, the Pump Pack will last two
weeks.
Spread the gel on a large area of skin on
each shoulder, outer arm or each midinner thigh.
How to apply the gel
1. Make sure that your hands and the skin
where you are going to apply the gel are
clean, dry and unbroken.
2. Remove the canister cap to reveal the
plunger.
3. Remove the stopper from the spout.
4. Hold the Estradiol Pump Pack in one hand
and place your other hand under the
spout, ready to collect the gel.
5. Push the plunger down firmly. This will
dispense one measure of the gel.
6. Apply the gel to either:
the outer arm and shoulder of both arms,
or
the mid-inner thigh of both legs.
7. Do not apply on or near the breasts, or
near the genital area.
8. Spread the gel over a large area of skin
on each shoulder, outer arm or mid-inner
thigh.
9. If your doctor has prescribed 2 measures
of gel, spread 1 measure over each outer
arm and shoulder, or each mid-inner thigh.
If 4 measures of gel have been
prescribed, spread 2 measures over each
outer arm and shoulder or each mid-inner
thigh. (See steps 4-8).
10. Cover the spout using the attached
stopper.
11. Replace the cap.
12. Leave to dry for 5 minutes before covering
with clothes.
How you know when your Pump Pack is
empty
The Pump Pack is nearly empty when the
plunger does not return back to its original
position after you have pushed it down.

When this happens, do not use the Pump
Pack any longer. Start using a new Pump
Pack.
If you use more Estradiol than you should
The effects of overdosing are generally: breast
tension, abdominal and pelvic swelling,
nausea and vaginal bleeding. These
symptoms disappear when treatment is
stopped or the dose is reduced.
In case of the accidental using of an excessive
dose of the medicine tell your doctor
immediately.
If you forget to use Estradiol
If it is more than 12 hours until your next
dose, apply the gel as soon as you
remember and apply the next dose at the
normal time.
If it is less than 12 hours until your next
dose, skip the missed dose and apply the
next dose at the normal time.
Do not use a double dose (two doses at
the same time) to make up for a forgotten
dose.
If you forget a dose you may have
breakthrough bleeding or spotting.
If you need to have surgery
If you are going to have surgery, tell the
surgeon that you are using Estradiol. You may
need to stop using 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
using Estradiol again.

4. Possible side effects
Like all medicines, this medicine can cause
side effects, although not everybody gets
them.
The following diseases are reported more
often in women using HRT compared to
women not using HRT:
breast cancer,
abnormal growth or cancer of the lining of
the womb (endometrial hyperplasia or
cancer),
ovarian cancer,
blood clots in the veins of the legs or lungs
(venous thromboembolism),
heart disease,
stroke,
probable memory loss if HRT is started
over the age of 65.

HRT will not prevent memory loss.
For more information about these side effects,
see Section 2.
Side effects observed with HRT products
used in menopause are reported below:
Common: may affect up to 1 in 10 people
Headache.
Nausea, abdominal pain.
Breast swelling or pain, breast
enlargement, menstrual cramps, heavy
menstrual bleeding, unexpected vaginal
bleeding, vaginal discharge endometrial
hyperplasia.
Weight change (increase or decrease),
water retention with peripheral oedema.
Uncommon: may affect up to 1 in 100 people
Depression, mood swings.
Vertigo, migraine.
Venous thromboembolic disease.
Flatulence, vomiting.
Itching (pruritus).
Benign breast or uterine neoplasm,
increased volume of uterine, vaginitis
or vaginal candidiasis.
Feeling weak (asthenia).
Rare: may affect up to 1 in 1,000 people
Glucose intolerance.
Change in libido.
Aggravation of epilepsy.
Hypertension.
Liver function tests abnormalities.
Skin decoloration, acne.
Appearance of milk secretion
(galactorrhea).
Anaphylactic reaction (in women with
past history of allergic reaction).
The following side effects have been reported
with other HRTs:
gall bladder disease
various skin disorders:
painful reddish skin nodules (erythema
nodosum)
rash with target-shaped reddening or
sores (erythema multiforme)
Reporting of side effects
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any
possible side effects not listed in this leaflet.
You can also report side effects directly via
the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.

By reporting side effects, you can help provide
more information on the safety of this
medicine.

5. How to store Estradiol
Keep out of the sight and reach of
children.
Do not store above 25°C.
Do not use your gel after the expiry date
which is stated on the carton and bottle
label after ‘Exp’. The expiry date refers to
the last day of that month.
Medicines should not be disposed of via
wastewater or household waste. Ask
your doctor or pharmacist how to dispose
of medicines no longer required. These
measures will help to protect the
environment.

6. Contents of the pack and other
information
What Estradiol contains
The active ingredient in Estradiol is
estradiol. This is a man made form of the
female hormone oestrogen.
Each metered dose (1.25g) contains
0.75mg estradiol.
The other ingredients are: carbomer 980,
triethanolamine, ethanol 96% and
purified water.
What Estradiol looks like and contents of
the pack
Colourless, transparent gel with alcoholic
odour.
Estradiol is available as an 80g pump
action container which delivers 64
metered doses.
Manufactured by: Laboratoires Besins
International, 13 Rue Perier, 92120,
Montrouge, France.
Procured from within the EU and
repackaged by the Product Licence holder:
B&S Healthcare, Unit 4, Bradfield Road,
Ruislip, HA4 0NU, UK.
Estradiol 0.06% w/w Gel Pump-Pack
PL 18799/2943
Leaflet date: 19.09.2016

POM

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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