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ESTRADIOL 0.06% GEL PUMP PACK

Active substance(s): ESTRADIOL

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727 LEAFLET Oestrogel 20150827

5. How to store Oestrogel

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.



Oestrogel should not be stored above 25°C.



Do not use after the expiry date printed on the carton label or
pump-pack.

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



PACKAGE LEAFLET: INFORMATION FOR THE USER

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.



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),

6. Contents of the pack and other information



heart disease,

The active ingredient is estradiol.



stroke,



probable memory loss if HRT is started over the age of 65.

Each metered dose contains 1.25g of Oestrogel (0.75mg 17β estradiol).

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.

What Oestrogel contains

Oestrogel also contains the following inactive ingredients carbomer,
triethanolamine, ethanol and purified water.



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

OESTROGEL PUMP-PACK
(17ß-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 full name of your medicine is Oestrogel Pump- Pack. It is
called Oestrogel in this leaflet.

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

This product is manufactured by Besins Manufacturing Belgium
N.V., 1620 Drogenbos, Belgium.
POM

PL 08747/0727

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).



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)”),

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.



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.

Prevention of osteoporosis
Leaflet revision date: 27 August 2015
Oestrogel is a registered trade mark of Laboratoires Besins
International, France.
727 LEAFLET Oestrogel 20150827

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



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.



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:

2. What you need to know before you use Oestrogel

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.

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),

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

Liver function tests abnormalities.

Reporting of side effects



Warnings and precautions



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

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

Relief of symptoms occuring after menopause

Hypertension.



If you have any unexplained vaginal bleeding,



Oestrogel is used for:



painful reddish skin nodules (erythema nodosum)



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

Aggravation of epilepsy.



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,

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.

Product Licence holder



various skin disorders:





Change in libido.



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

1. What Oestrogel is and what it is used for



gall bladder disease



Each Oestrogel Pump-Pack contains 80g of gel and delivers 64
metered doses.

Glucose intolerance.



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:

Oestrogel is a clear, non-greasy, non-staining, hydro-alcoholic gel
with an alcoholic odour contained in a pump pack.

What Oestrogel looks like and contents of the pack



The following side effects have been reported with other HRTs:

Do not use Oestrogel

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

Manufacturer
Uncommon: may affect up to 1 in 100 people

®

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.

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

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.



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



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

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

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.

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).



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 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).

If you are currently using another type of HRT where you have
a period, finish your current medicine pack before you start
using Oestrogel.

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.
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.

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.

Stroke

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.

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.

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,

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

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.

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.

-

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.



-

The usual daily dose is 2 measures of gel. The Pump Pack will
last four weeks.

This applies to the following medicines:



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.

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.

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.

727 LEAFLET Estradiol 20150827

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.



Estradiol Gel should not be stored above 25°C.



Do not use after the expiry date printed on the carton label or
pump-pack.

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



PACKAGE LEAFLET: INFORMATION FOR THE USER

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.



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),

6. Contents of the pack and other information



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

(17ß-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.

The active ingredient is estradiol.



Each metered dose contains 1.25g of Estradiol Gel (0.75mg 17
β-estradiol).

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



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

What Estradiol Gel contains



ESTRADIOL 0.06% GEL PUMP-PACK

Estradiol Gel also contains the following inactive ingredients
carbomer, triethanolamine, ethanol and purified water.

What Estradiol Gel looks like and contents of the pack
Estradiol Gel is a clear, non-greasy, non-staining, hydro-alcoholic
gel with an alcoholic odour contained in a pump pack.
Each Estradiol Gel Pump-Pack contains 80g of gel and delivers 64
metered doses.

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

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.

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.

Do not use Estradiol Gel
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.
Do not use Estradiol Gel:


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 Gel 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 Gel, stop using it at once and consult your doctor
immediately.

Estradiol Gel is used for:

Warnings and precautions

Manufacturer

Relief of symptoms occuring after menopause

This product is manufactured by Besins Manufacturing Belgium
N.V., 1620 Drogenbos, Belgium.

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

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:

POM

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.

PL 08747/0727

Leaflet revision date: 27 August 2015



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)”),



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.

increased risk of getting a oestrogen-sensitive cancer (such as
having a mother, sister or grandmother who has had breast
cancer),



high blood pressure,

How Estradiol Gel works



a liver disorder, such as a benign liver tumor,

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.



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
727 LEAFLET Estradiol 20150827

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



Glucose intolerance.



Change in libido.



Aggravation of epilepsy.



Hypertension.



Liver function tests abnormalities.



Skin decoloration, acne.

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



Appearance of milk secretion (galactorrhea).

Medical history and regular check-ups



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,



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.

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

Stop using Estradiol Gel 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
Gel’ 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

Blood clots in a vein (thrombosis)

-

sudden chest pain

-

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.

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

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 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).

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:

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 Estradiol Gel for more than 6
months

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.



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

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

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.

Stroke

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

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:



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).

2. Remove the canister cap to reveal the plunger.



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

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

Effect of HRT on heart and circulation

The risk of getting stroke is about 1.5 times higher in HRT users
than in non-users. The number of extra cases of stroke due to use
of HRT will increase with age.
Looking at women in their 50s who are not 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).
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.

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.

Estradiol Gel is for use in postmenopausal women only. If you
become pregnant, stop using Estradiol Gel and contact your doctor.
3. How to use Estradiol Gel
Always use Estradiol Gel exactly as your doctor has told you.
Check with your doctor or pharmacist if you are not sure.


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.

12. Leave to dry for 5 minutes before covering with clothes.



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.



The Pump Pack is nearly empty when the plunger does not
return back to its original position after you have pushed it
down.



Do not ask anyone else to apply the gel. Only you should apply
your medicine.



When this happens, do not use the Pump Pack any longer.
Start using a new Pump Pack.



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.

In case of the accidental using of an excessive dose of the
medicine tell your doctor immediately.

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.

Preparing your new Pump Pack



Before using your new Pump Pack for the first time, you need to
prepare it for use as follows:

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.



Remove the cap from the canister.



Remove the stopper from the spout.



Press the plunger down a few times until the gel comes out.

If you forget a dose you may have breakthrough bleeding or
spotting.



Do not use the first dose of gel from your Pump Pack. This
dose should be discarded.

If you need to have surgery



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.



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.

This applies to the following medicines:

Other skin medications which change how skin is made, e.g.
anti-cancer products.

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.



any lumps you can see or feel.



If you use more Estradiol Gel than you should

If you forget to use Estradiol Gel

-

Products to treat skin and scalp disorders e.g. products to cure
warts, acne or dandruff.

How you know when your Pump Pack is empty

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.

Your doctor will prescribe the lowest dose for the shortest time
to treat your symptoms.



10. Cover the spout using the attached stopper.
11. Replace the cap.

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

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).

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).

Using this medicine

changes in the nipple

Other skin products containing alcohol e.g. astringents or
sunscreens.

the outer arm and shoulder of both arms,

or

8. Spread the gel over a large area of skin on each shoulder, outer
arm or mid-inner thigh.

-



6. Apply the gel to either:

Pregnancy and breast-feeding



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.

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

the mid-inner thigh of both legs.
7. Do not apply on or near the breasts, or near the genital
area.

Other medicines and Estradiol Gel

Skin cleansers and detergents e.g. products containing
benzalkonium chloride or sodium lauryl sulphate.

3. Remove the stopper from the spout.

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.

dimpling of the skin



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

Laboratory tests

-

Ovarian cancer

How to apply the gel

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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