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OESTROGEL PUMP PACK

Active substance(s): 17-BETA-OESTRADIOL / ESTRADIOL / ESTRADIOL HEMIHYDRATE / OESTRADIOL / ESTRADIOL / ESTRADIOL HEMIHYDRATE / OESTRADIOL / ESTRADIOL / ESTRADIOL HEMIHYDRATE / OESTRADIOL

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OESTROGELÆ PUMP-PACK
0.06% Gel
17 -ESTRADIOL
Read all of this lea et carefully before you
start using this medicine because it contains
important information for you.
ï Keep this lea et. You may need to read it again.
ï I f y o u h a v e a n y f u r t h e r q u e s t io n s , a s k y o u r d o c t o r
or pharmacist.
ï 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.
ï If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects
not listed in this lea et. See section 4.
What is in this lea et:
1. What Oestrogel is and what it is used for
2 . W h a t y o u n e e d t o k n o w b e f o re y o u u s e O e s t r o g e l
3. How to use Oestrogel
4. Possible side effects
5. How to store Oestrogel
6. Contents of the pack and other information
1. W h at O es t r o g el i s an d w h a t i t i s u s ed f o r

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. W h at y o u n e ed t o k n o w b ef o r e y o u u s e
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.

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.

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 benets and risks of continuing with Oestrogel.

Oestrogel is used for:
Relief of symptoms occuring after menopause

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

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 (ìhot ushesî). Oestrogel alleviates
these symptoms after menopause. You will only be
prescribed Oestrogel if your symptoms seriously
hinder your daily life.

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:
ï If you have or have ever had breast cancer, or if
you are suspected of having it,
ï I f y o u h a v e c a n c e r w h i c h is s e n s it i v e t o o e s t r o g e n ,
such as cancer of the womb lining (endometrium),
or if you are suspected of having it,
ï If you have any unexplained vaginal bleeding,
ï If y o u h a v e e x c e s s i v e th i ck e n i n g o f th e w o m b
lining (endometrial hyperplasia) that is not being
treated,
ï I f y o u h a v e o r h a v e e v e r h a d b lo o d c l o t s i n a v e i n
(thrombosis), such as in the legs (deep venous

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.

thrombosis) or lungs (pulmonary embolism),
ï I f y o u h a v e a b l o o d c l o tt i n g d i s o rd e r (s u c h a s
protein C, protein S, or antithrombin deciency),
ï I f y o u h a v e o r r e c e n t l y h a v e h a d a d is e a s e c a u s e d
by blood clots in the arteries, such as a heart
attack, stroke or angina,
ï I f y o u h a v e o r h a v e e v e r h a d a l i v e r d is e a s e a n d
your liver function tests have not returned to
normal,
ï If you have a rare blood problem called ìporphyriaî
which is passed down in families (inherited),
ï I f y o u a r e a ll e r g ic t o e s t r a d i o l o r a n y o t h e r
ingredients of this medicine (listed in section 6).
If any of the above conditions appear for the rst
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:
ï brosis inside your womb,
ï g r o w t h o f w o m b l in i n g o u t s i d e y o u r w o m b
(endometriosis) or a history of excessive growth of
the womb lining (endometrial hyperplasia),
ï i n c r e a s e d r i s k o f d e v e lo p i n g b l o o d c l o t s ( s e e
ìBlood clots in a vein (thrombosis)î),
ï i n c re a s e d ri s k o f g e t t i n g a o e s t r o g e n - s e n s i t i v e
cancer (such as having a mother, sister or
grandmother who has had breast cancer),
ï high blood pressure,
ï a liver disorder, such as a benign liver tumor,
ï diabetes,
ï gallstones,
ï migraine or severe headaches,
ï a disease of the immune system that affects
many organs of the body (Systemic Lupus
Erythematosus, SLE),
ï epilepsy,
ï asthma,
ï a disease affecting the eardrum and hearing
(otosclerosis),
ï a v e r y h i g h l e v e l o f f a t i n y o u r b l o o d ( t r ig l y c e r i d e s ) ,
ï uid 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:

ï a n y o f t h e c o n d it i o n s m e n t io n e d i n t h e D o n o t u s e
Oestrogel section
ï y e l lo w in g o f y o u r s k i n o r t h e w h i t e s o f y o u r e y e s
(jaundice). These may be signs of a liver disease
ï a large rise in your blood pressure (symptoms may
be headache, tiredness, dizziness)
ï m i g r a in e - l i k e h e a d a c h e s w h i c h h a p p e n f o r t h e
rst time
ï i f y o u b e c o m e p re g n a n t
ï if you notice signs of a blood clot, such as:
painful swelling and redness of the legs
sudden chest pain
difculty in breathing
F o r m o r e i n f o r m a t i o n , s e e B l o o d c lo t s i n a v e i n
(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 rst 3-6 months of using
Oestrogel. However, if the irregular bleeding:
ï carries on for more than the rst 6 months
ï starts after you have been using Oestrogel for
more than 6 months
ï carries on after you have stopped using Oestrogel
see your doctor as soon as possible.
Breast cancer
Evidence suggests that using combined oestrogenprogestogen and possibly also oestrogen-only HRT
increases the risk of breast cancer. The extra risk
depends on how long you take HRT. The additional
risk becomes clear within a few years. However,
it returns to normal within a few years (at most 5)
after stopping treatment.
For women who have had their womb removed and
who are using oestrogen-only HRT for 5 years, little
or no increase in breast cancer risk is shown.
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 oestrogenprogestogen HRT over 5 years, there will be 13 to
23 cases in 1000 users (i.e. an extra 4 to 6 cases).
ï Regularly check your breasts. See your doctor
if you notice any changes such as:
d im p l i n g o f t h e s k i n
changes in the nipple
any lumps you can see or feel.
Additionally, you are advised to join mammography
screening programs when offered to you. For
mammogram screening, it is important that you
inform the nurse/healthcare professional who is
actually taking the x-ray that you use HRT, as this
medication may increase the density of your breasts
which may affect the outcome of the mammogram.
Where the density of the breast is increased,
mammography may not detect all lumps.
Ovarian cancer
Ovarian cancer is rare, much rarer than breast
cancer. The use of oestrogen-only or combined
oestrogen-progestagen HRT has been associated
with a slightly increased risk of ovarian cancer.
The risk of ovarian cancer varies with age. For
example, in women aged 50 to 54 who are not

taking HRT, about 2 women in 2000 will be
diagnosed with ovarian cancer over a 5-year period.
For women who have been using HRT for 5 years,
there will be about 3 cases per 2000 users (i.e.
about 1 extra case).
Effect of HRT on heart and circulation
Blood clots in a vein (thrombosis)
The risk of blood clots in the veins is about 1.3
to 3- times higher in HRT users than in non-users,
especially during the rst 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:
ï 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)
ï you are seriously overweight (BMI >30 kg/m2)
ï you have any blood clotting problem that needs
long-term treatment with a medicine used to
prevent blood clots
ï if any of your close relatives has ever had a blood
clot in the leg, lung or another organ
ï you have systemic lupus erythematosus (SLE)
ï you have cancer.
For signs of a blood clot, see ìStop using Oestrogel
and see a doctor immediatelyî.
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
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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.

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.

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.

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

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

Driving and using machines
Not known.
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
ï If you have never used any other HRT medicines
or you are switching to Oestrogel from a periodfree HRT product, you can start using Oestrogel
on any convenient day.
ï If you are currently using another type of HRT
where you have a period, nish your current
medicine pack before you start using Oestrogel.
ï Do not ask anyone else to apply the gel. Only you
should apply your medicine.
ï Do not use strong skin cleaners or detergents when
washing the area where you will apply the gel.
ï Avoid close skin contact with your partner for one
hour after application.
ï Do not wash the skin or apply other skin care
products until at least one hour after application.
ï 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 rst
time, you need to prepare it for use as follows:
ï Remove the cap from the canister.
ï Remove the stopper from the spout.
ï Press the plunger down a few times until the gel
comes out.
ï Do not use the rst dose of gel from your Pump
Pack. This dose should be discarded.

ï Your Pump Pack is now ready to use.
How much to use and when to use
ï Apply the gel once a day, either in the morning or
evening.
ï Try to use the gel at about the same time each day.
ï Your doctor will prescribe the lowest dose for the
shortest time to treat your symptoms.
ï The usual daily dose is 2 measures of gel. The
Pump Pack will last four weeks.
ï If 4 measures of gel have been prescribed, the
Pump Pack will last two weeks.
ï Spread the gel on a large area of skin on each
shoulder, outer arm or each mid-inner 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 rmly. 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 midinner 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
ï Th e P u m p P a c k i s n e a r l y e m p t y w h e n t h e p l u n g e r
does not return back to its original position after
you have pushed it down.
ï 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, 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
ï 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.
ï If it is less than 12 hours until your next dose, skip
the missed dose and apply the next dose at the
normal time.
ï 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.

women using HRT compared to women not using HRT:
ï breast cancer,
ï abnormal growth or cancer of the lining of the
womb (endometrial hyperplasia or cancer),
ï ovarian cancer,
ï b lo o d c lo t s in t h e v e in s o f t h e le g s o r lu n g s
(venous thromboembolism),
ï heart disease,
ï stroke,
ï 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
ï Headache.
ï Nausea, abdominal pain.
ï Breast swelling or pain, breast enlargement,
menstrual cramps, heavy menstrual bleeding,
vaginal discharge.
ï Weight change (increase or decrease),
water retention with peripheral oedema.
Uncommon: may affect up to 1 in 100 people
4. Possible side effects
ï Depression, mood swings.
ï Vertigo.
Like all medicines, this medicine can cause side
ï Flatulence, vomiting.
effects, although not everybody gets them.
ï Benign breast or uterine tumour, increased volume
Please see your doctor immediately if you experience
of uterine, vaginitis or vaginal candidiasis.
the following:
ï Feeling weak (asthenia).
- Symptoms of an allergic reaction. This may include
Rare: may affect up to 1 in 1,000 people
skin rash, hives, itching (pruritus)
ï Glucose intolerance.
- Sudden chest pain
- Pain in your chest that spreads to your arm or neck ï Change in libido.
ï Hypertension.
- Difficulty in breathing
ï Liver function tests abnormalities.
- Painful swelling and redness of the legs
ï Skin decoloration, acne.
-Yellowing of the eyes and face, darkening of urine,
ï Appearance of milk secretion (galactorrhea).
itchy skin (jaundice)
- Unexpected vaginal bleeding or spotting
The following side effects have been reported with
(breakthrough bleeding) after using Oestrogel for
other HRTs:
some time, or after you stop treatment
ï gall bladder disease
- Breast change, including dimpling of the breast skin, various skin disorders:
change in the nipple, lumps that you can see or feel - discoloration of the skin especially of the face or
(breast cancer)
neck known as "pregnancy patches" (chloasma);
- painful menstrual periods
- painful reddish skin nodules (erythema nodosum)
- Unexplained migraine-like headaches
Reporting of side effects
- Oestrogel may aggravate epilepsy
If you get any side effects, talk to your doctor or
- Rash with target-shaped reddening or sores
pharmacist. This includes any possible side effects
(erythema multiforme)
not listed in this leaflet. You can also report side
- Anaphylactic reaction (in women with past history
effects directly via the Yellow Card
of allergic reaction)
Scheme at: www.mhra.gov.uk/yellowcard.
The following diseases are reported more often in

By reporting side effects you can help provide
more information on the safety of this medicine.
5. How to store Oestrogel
ï Keep this medicine out of the sight and the reach
of children.
ï Do not use this medicine after the expiry date
which is stated on both the carton and the
Oestrogel Pump Pack after ìExpî. The expiry date
refers to the last day of that month.
ï Do not store above 25∞C.
ï Do not throw away via wastewater or household
waste. Ask your pharmacist how to throw away
medicines you no longer use. These measures will
help protect the environment.
6. Content of the pack and other information
What Oestrogel Pump Pack contains
ï The active ingredient is 17fl-estradiol. This is a
manmade form of the female hormone oestrogen.
ï Each dose of 1.25g of Oestrogel contains 0.75mg
of estradiol.
ï The other ingredients are: carbomer,
        ed water.
What Oestrogel Pump Pack looks like and
contents of the pack
ï Gel for transdermal use in 80 g bottle with
metered-dose pump.
ï Oestrogel is a non-greasy, non-staining, odourless
transdermal gel.
ï Oestrogel Pump Pack delivers 64 metered doses.
Marketing Authorisation Holder
Besins Healthcare - Avenue Louise, 287
1050 Brussels - Belgium
Manufacturer
Besins Manufacturing Belgium, Groot
Bijgaardenstraat 128, 1620 Drogenbos, Belgium.
Distributed in the UK by
Besins Healthcare (UK) Ltd, 1st Floor, 28 Poland Street
London - W1F 8QN - United Kingdom
Tel. +44(0)203862 0920
This leaet was last revised in July 2017.
For information in large print, tape, CD or Braille,
telephone +44(0)203862 0920

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Expand Transcript

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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