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ESTRADIOL 0.06% W/W GEL PUMP PACK

Active substance(s): ESTRADIOL

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S1589 LEAFLET Oestrogel 20150603

5. How to store Oestrogel

PACKAGE LEAFLET: INFORMATION FOR THE USER
®

4. Possible side effects



KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

Like all medicines, this medicine can cause side effects, although
not everybody gets them.



Do not store above 25°C.



Pressurised container.

The following diseases are reported more often in women using
HRT compared to women not using HRT:



Do not expose the container to heat.





Keep this leaflet. You may need to read it again.

Do not puncture or burn even when it is empty.





Do not use Oestrogel after the expiry date which is stated on
the carton and pump-pack. The expiry date refers to the last
day of that month.

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.



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.



Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help to
protect the environment.

OESTROGEL PUMP-PACK
(estradiol)
Read all of this leaflet carefully before you start using this
medicine because it contains important information for you.



If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet.

HRT will not prevent memory loss.

What Oestrogel contains

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



The active ingredient is estradiol. This is a manmade form of
the female hormone oestrogen.



Each gram of gel contains 0.60mg of estradiol.

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



The other ingredients are: carbomer, triethanolamine, ethanol
96% v/v and purified water.

1. What Oestrogel is and what it is used for

Side effects observed with HRT products used in menopause are
reported below:
Common: may affect up to 1 in 10 people


6. Contents of the pack and other information

Headache.



Nausea, abdominal pain.

What Oestrogel looks like and contents of the pack



Breast swelling or pain, breast enlargement, menstrual cramps,
heavy menstrual bleeding, unexpected vaginal bleeding,
vaginal discharge endometrial hyperplasia.

It is a metered dose pump-action pack containing clear, non-greasy,
non-staining, transdermal gel with an alcoholic odour.



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).

It delivers 64 metered doses. Pack size: 80g.

The full name of your medicine is Oestrogel Pump- Pack. It is called
Oestrogel in this leaflet.
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.

Manufacturer
This product is manufactured by Laboratoires Besins International,
13 Rue Perier, 92120, Montrouge, France.
POM

PL 19488/1589

Leaflet revision date: 03 June 2015
Oestrogel is a registered trade mark of Laboratoires Besins
International, France.

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.



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.

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),

How Oestrogel works



high blood pressure,

Oestrogel works by replacing the oestrogen in your body. This is so
that you have a similar amount of oestrogen as before your
menopause.



a liver disorder, such as a benign liver tumor,



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.

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.

2. What you need to know before you use Oestrogel



Skin decoloration, acne.

Medical history and regular check-ups



Appearance of milk secretion (galactorrhea).



Anaphylactic reaction (in women with past history of allergic
reaction).

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.

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

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),

Prevention of osteoporosis

Liver function tests abnormalities.

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.



fibrosis inside your womb,



Reporting of side effects

If you have excessive thickening of the womb lining
(endometrial hyperplasia) that is not being treated,



Hypertension.

rash with target-shaped reddening or sores (erythema
multiforme)

If you have any unexplained vaginal bleeding,











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:

Aggravation of epilepsy.

painful reddish skin nodules (erythema nodosum)

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,

During the menopause, the amount of the oestrogen produced by a
woman’s body drops.







Warnings and precautions

Change in libido.

various skin disorders:

If you have or have ever had breast cancer, or if you are
suspected of having it,

Relief of symptoms occuring after menopause







Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House,
Alperton Lane, Wembley, HA0 1DX.

Glucose intolerance.

gall bladder disease

Do not use Oestrogel:

Oestrogel is used for:





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.

Product Licence holder

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

The following side effects have been reported with other HRTs:

Do not use Oestrogel

S1589 LEAFLET Oestrogel 20150603

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.

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



Effect of HRT on heart and circulation



Medicines for tuberculosis (such as rifampicin, rifabutin).

How to apply the gel

painful swelling and redness of the legs

Blood clots in a vein (thrombosis)



-

sudden chest pain

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

1. Make sure that your hands and the skin where you are going to
apply the gel are clean, dry and unbroken.

-

difficulty in breathing

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.



Herbal products containing St John’s wort (Hypericum
perforatum).

2. Remove the canister cap to reveal the plunger.

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

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

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:

4. Hold the Oestrogel Pump Pack in one hand and place your
other hand under the spout, ready to collect the gel.

Laboratory tests

6. Apply the gel to either:

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.



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)



Pregnancy and breast-feeding

you have any blood clotting problem that needs long-term
treatment with a medicine used to prevent blood clots

Oestrogel is for use in postmenopausal women only. If you become
pregnant, stop using Oestrogel and contact your doctor.



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 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 using oestrogen-only HRT for over 5 years, there will be
5 to 8 cases in 1000 users (i.e. 1 extra case).

You may have irregular bleeding or drops of blood (spotting) during
the first 3-6 months of using Oestrogel. However, if the irregular
bleeding:

Heart disease (heart attack)



carries on for more than the first 6 months

There is no evidence that HRT will prevent a heart attack.



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.

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.

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

For women who have had their womb removed and are using
oestrogen-only therapy there is no increased risk of developing a
heart disease.

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.

Stroke

Preparing your new Pump Pack

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:

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.

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.

Compare



Remove the stopper from the spout.

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).



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.

5. Push the plunger down firmly. This will dispense one measure
of the gel.
-

the outer arm and shoulder of both arms,

-

the mid-inner thigh of both legs.

or
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

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.

-

dimpling of the skin

Other medicines and Oestrogel

-

changes in the nipple

-

any lumps you can see or feel.

Some medicines may interfere with the effect of Oestrogel. This
might lead to irregular bleeding.
This applies to the following medicines:

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.

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).

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).

3. Remove the stopper from the spout.

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.

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 mid-inner thigh.

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.

S1589 LEAFLET Estradiol gel 20150603

5. How to store Estradiol gel

4. Possible side effects



KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

Like all medicines, this medicine can cause side effects, although
not everybody gets them.



Do not store above 25°C.



Pressurised container.

The following diseases are reported more often in women using
HRT compared to women not using HRT:



Do not expose the container to heat.



Do not puncture or burn even when it is empty.



Do not use Estradiol gel after the expiry date which is stated on
the carton and pump-pack. The expiry date refers to the last
day of that month.



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.



PACKAGE LEAFLET: INFORMATION FOR THE USER

Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help to
protect the environment.

ESTRADIOL GEL 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.



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),

The full name of your medicine is Estradiol 0.06% w/w Gel PumpPack. It is called Estradiol gel in this leaflet.



If you are allergic to Estradiol gel or any other ingredients of this
medicine (listed in section 6).

Estradiol gel is a Hormone Replacement Therapy (HRT). It contains
the female hormone oestrogen. Estradiol gel is used in
postmenopausal women with at least 6 months since their last
natural period.
Estradiol gel is used for:

If any of the above conditions appear for the first time while using
Estradiol gel, stop using it at once and consult your doctor
immediately.



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.

What Estradiol gel contains

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



The active ingredient is Estradiol. This is a manmade form of
the female hormone oestrogen.



Each gram of gel contains 0.60mg of Estradiol gel.



The other ingredients are: carbomer, triethanolamine, ethanol
96% v/v and purified water.

1. What Estradiol gel is and what it is used for



Headache.



Nausea, abdominal pain.

What Estradiol gel looks like and contents of the pack



Breast swelling or pain, breast enlargement, menstrual cramps,
heavy menstrual bleeding, unexpected vaginal bleeding,
vaginal discharge endometrial hyperplasia.

It is a metered dose pump-action pack containing clear, non-greasy,
non-staining, transdermal gel with an alcoholic odour.



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).

It delivers 64 metered doses. Pack size: 80g.
Product Licence holder
Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House,
Alperton Lane, Wembley, HA0 1DX.
Manufacturer
This product is manufactured by Laboratoires Besins International,
13 Rue Perier, 92120, Montrouge, France.
POM

PL 19488/1589

S1589 LEAFLET Estradiol 20150603

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

Relief of symptoms occuring 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 gel alleviates these symptoms after
menopause. You will only be prescribed Estradiol gel if your
symptoms seriously hinder your daily life.

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 gel. 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 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 tumor,



diabetes,



gallstones,



migraine or severe headaches,



a disease of the immune system that affects many organs of
the body (Systemic Lupus Erythematosus, SLE).

Prevention of osteoporosis
After the menopause some women may develop fragile bones
(osteoporosis). You should discuss all available options with your
doctor.

Leaflet revision date: 03 June 2015

Do not use Estradiol gel:
If you have or have ever had breast cancer, or if you are
suspected of having it,

HRT will not prevent memory loss.

Side effects observed with HRT products used in menopause are
reported below:
Common: may affect up to 1 in 10 people

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 gel.


What is in this leaflet:
1. What Estradiol gel is and what it is used for
2. What you need to know before you use Estradiol gel
3. How to use Estradiol gel
4. Possible side effects
5. How to store Estradiol gel
6. Contents of the pack and other information

6. Contents of the pack and other information

Do not use Estradiol gel

If you are at an increased risk of fractures due to osteoporosis and
other medicines are not suitable for you, you can use Estradiol gel
to prevent osteoporosis after menopause.
How Estradiol gel works



Glucose intolerance.



Change in libido.



Aggravation of epilepsy.



Hypertension.



Liver function tests abnormalities.

2. What you need to know before you use Estradiol gel



Skin decoloration, acne.

Medical history and regular check-ups



Appearance of milk secretion (galactorrhea).

epilepsy,

Anaphylactic reaction (in women with past history of allergic
reaction).

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.







asthma,

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.



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.

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.

Estradiol gel works by replacing the oestrogen in your body. This is
so that you have a similar amount of oestrogen as before your
menopause.

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.

Stop using Estradiol gel and see a doctor immediately
If you notice any of the following when taking HRT:

Once you have started on Estradiol gel 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 gel.



any of the conditions mentioned in the ‘Do not use Estradiol gel’
section



yellowing of your skin or the whites of your eyes (jaundice).
These may be signs of a liver disease

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



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

Effect of HRT on heart and circulation



Medicines for tuberculosis (such as rifampicin, rifabutin).

How to apply the gel

sudden chest pain

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.

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

1. Make sure that your hands and the skin where you are going to
apply the gel are clean, dry and unbroken.



Herbal products containing St John’s wort (Hypericum
perforatum).

2. Remove the canister cap to reveal the plunger.

difficulty in breathing
For more information, see ‘Blood clots in a vein (thrombosis)’.
Note: Estradiol gel 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 gel. However, if the irregular
bleeding:




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:



Pregnancy and breast-feeding

you have any blood clotting problem that needs long-term
treatment with a medicine used to prevent blood clots

Estradiol gel is for use in postmenopausal women only. If you
become pregnant, stop using Estradiol gel and contact your doctor.

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 gel 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 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 using oestrogen-only HRT for over 5 years, there will be
5 to 8 cases in 1000 users (i.e. 1 extra case).

starts after you have been using Estradiol gel for more than 6
months

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:

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.

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


If you have never used any other HRT medicines or you are
switching to Estradiol gel from a period-free HRT product, you
can start using Estradiol gel 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 gel.



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.

Stroke

Preparing your new Pump Pack

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.

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.

Compare



Remove the stopper from the spout.

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).



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.

5. Push the plunger down firmly. This will dispense one measure
of the gel.
-

the outer arm and shoulder of both arms,

-

the mid-inner thigh of both legs.

or
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 gel 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 gel


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

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.

dimpling of the skin

-

changes in the nipple

Other medicines and Estradiol gel

-

any lumps you can see or feel.

Some medicines may interfere with the effect of Estradiol gel. This
might lead to irregular bleeding.
This applies to the following medicines:

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).

3. How to use Estradiol gel

For women who have had their womb removed and are using
oestrogen-only therapy there is no increased risk of developing a
heart disease.

-

Ovarian cancer

6. Apply the gel to either:

If you need a blood test, tell your doctor or the laboratory staff that
you are using Estradiol gel, because this medicine can affect the
result of some tests.

you are seriously overweight (BMI >30 kg/m2)

There is no evidence that HRT will prevent a heart attack.

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.

Laboratory tests



Heart disease (heart attack)

carries on after you have stopped using Estradiol gel see your
doctor as soon as possible.

4. Hold the Estradiol gel Pump Pack in one hand and place your
other hand under the spout, ready to collect the gel.

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)



3. Remove the stopper from the spout.

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.



carries on for more than the first 6 months

Breast cancer



Blood clots can be serious, and if one travels to the lungs, it can
cause chest pain, breathlessness, fainting or even death.



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).

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 mid-inner thigh.

If you are going to have surgery, tell the surgeon that you are using
Estradiol gel. You may need to stop using Estradiol gel 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 gel again.

Expand view ⇕

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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