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OESTROGEL PUMP PACK 0.06%

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Oestrogel 0.06% Pump Pack / Estradiol® Gel 0.06% Pump
Pack
Patient Information Leaflet
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 active ingredient in this medicine is Estradiol. This is the new
name for Oestradiol. The ingredient itself has not changed.
What is in this leaflet:
1. What Oestrogel is and what it is used for
2. What you need to know before you use Oestrogel
3. How to use oestrogel
4. Possible side effects
5. How to store Oestrogel
6. Contents of the pack and other information
1. What Oestrogel Pump Pack is and what it is used for
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.
Oestrogel is used for:
Relieve of symptoms occurring after the menopause
During the menopause, the amount of the oestrogen produced by
a woman’s body drops. This can cause symptoms such as hot
face, neck and chest (“hot flushes”). Oestrogel alleviates these
symptoms after menopause. You will only be prescribed
Oestrogel if your symptoms seriously hinder your daily life.
Prevention of osteoporosis
After the menopause some women may develop fragile bones
(osteoporosis). You should discuss all available options with your
doctor.
If you are at an increased risk of fractures due to osteoporosis
and other medicines are not suitable for you, you can use
Oestrogel to prevent osteoporosis after menopause.
How Oestrogel works
Oestrogel works by replacing the oestrogen in your body. This is
so that you have a similar amount of oestrogen as before your
menopause.
2. What you need to know before you use Oestrogel
Medical history and regular check-ups
The use of HRT carries risks which need to be considered when
deciding whether to start using it, or whether to carry on using it.
The experience in treating women with a premature menopause
(due to ovarian failure or surgery) is limited. If you have a
premature menopause the risks of using HRT may be different.
Please talk to your doctor.
Before you start (or restart) HRT your doctor will ask you about
your own and your family’s medical history. Your doctor may
decide to perform a physical examination. This may include an
examination of your breasts and/or an internal examination, if
necessary.
Once you have started on Oestrogel you should see your doctor
for regular check-ups (at least once a year). At these check-ups,
discuss with your doctor the benefits and risks of continuing with
Oestrogel.

Go for regular breast screening, as recommended by your doctor.
Do not use Oestrogel:
If any of the following applies to you. If you are not sure about
any of the points below, talk to your doctor before using
Oestrogel.
Do not use Oestrogel:

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

If you have cancer which is sensitive to oestrogen, such as
cancer of the womb lining (endometrium), or if you are
suspected of having it.

If you have any unexplained vaginal bleeding.

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

If you have or have ever had blood clots in a vein
(thrombosis), such as in the legs (deep venous thrombosis)
or lungs (pulmonary embolism).

If you have a blood clotting disorder (such as protein C,
protein S, or antithrombin deficiency).

If you have or recently have had a disease caused by blood
clots in the arteries, such as a heart attack, stroke or angina.

If you have or have ever had a liver disease and your liver
function tests have not returned to normal.

If you have a rare blood problem called “porphyria” which is
passed down in families (inherited)

If you are allergic to estradiol or any other ingredients of this
medicine (listed in section 6)
If any of the above conditions appear for the first time while using
Oestrogel, stop using it at once and consult your doctor
immediately.
Warnings and precautions
Tell your doctor if you have ever had any of the following
problems, before you start the treatment, as these may return or
become worse during treatment with oestrogel. If so, you should
see your doctor more often for check-ups:

Fibrosis inside your womb,

Growth of womb lining outside your womb (endometriosis) or
a history of excessive growth of the womb lining (endometrial
hyperplasia),

Increased risk of developing blood clots (see “Blood clots in a
vein (thrombosis”),

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

High blood pressure

A liver disorder, such as benign liver tumour,

Diabetes

Gallstones

Migraine or severe headaches

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

Epilepsy

Asthma

A disease affecting the eardrum and hearing (otosclerosis)#

A very high level of fat in your blood (triglycerides),

Fluid retention due to cardiac or kidney problems.
Stop 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 headache which happens for the first time

If you become pregnant

If you notice signs of blood clot, such as:
o Painful swelling and redness of the legs
o Sudden chest pain
o Difficulty in breathing
For more information, see ‘Blood clots in a vein
(thrombosis)’

Note: Oestrogel is not a contraceptive. If it is less than 12
months since your last menstrual period or you are under 50
years old, you may still need to use additional contraception to
prevent pregnancy. Speak to your doctor for advice.
HRT and cancer
Excessive thickening of the lining of the womb (endometrial
hyperplasia) and cancer of the lining of the womb
(endometrial cancer)
Using oestrogen-only HRT will increase the risk of excessive
thickening of the lining of the womb (endometrial hyperplasia) and
cancer of the womb lining (endometrial cancer).
Using a progestogen in addition to the oestrogen for at least 12
days of each 28 day cycle protects you from this extra risk. So
your doctor will prescribe a progestogen separately if you still
have your womb. If you have had your womb removed (a
hysterectomy), discuss with your doctor whether you can safely
take this product without a progestogen.
In women who still have a womb and who are not using HRT, on
average, 5 in 1000 will be diagnosed with endometrial cancer
between the ages of 50 and 65.
For women aged 50 to 65 who still have a womb and who take
oestrogen-only HRT, between 10 and 60 women in 1000 will be
diagnosed with endometrial cancer (i.e. between 5 and 55 extra
cases), depending on the dose and for how long it is taken.
Irregular bleeding
You may have irregular bleeding or drops of blood (spotting)
during the first 3-6 months of using Oestrogel. However, if the
irregular bleeding:

Carries on for more than the first 6 months

Starts after you have been using Oestrogel for more than 6
months

Carries on after you have stopped using Oestrogel
See your doctor as soon as possible
Breast cancer
Evidence suggests that using combined oestrogen-progestogen
and possibly also oestrogen-only HRT increases the risk of breast
cancer. The extra risk depends on how long you take HRT. The
additional risk becomes clear within a few years. However, it
returns to normal within a few years (at most 5) after stopping
treatment.
For women who have had their womb removed and who are
using oestrogen-only HRT for 5 years, little or no increase in
breast cancer risk is shown.
Compare
Women aged 50 to 79 who are not taking HRT, on average, 9 to
17 in 1000 will be diagnosed with breast cancer over a 5-year
period. For women aged 50 to 79 who are taking oestrogenprogestogen 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:
o Dimpling of the skin
o Changes in the nipple
o Any lumps you can see or feel
Ovarian cancer
Ovarian cancer is rare. A slightly increased risk of ovarian cancer
has been reported in women using HRT for at least 5 to 10 years.
Women aged 50 to 69 who are not using HRT, on average about
2 women in 1000 will be diagnosed with ovarian cancer over a 5
year period. For women who have been using HRT for 5 years,
there will be between 2 and 3 cases per 1000 users (i.e. up to 1
extra case)

Effects of HRT on heart and circulation
Blood clots in vein (thrombosis)
The risk of blood clots in the veins is about 1.3 to 3-times higher
in HRT users than in non-users, especially during the first year of
using it.
Blood clots can be serious, and if one travels to the lungs, it can
cause chest pain, breathlessness, fainting or even death.
You are more likely to get a blood clot in your veins as you get
older and if any of the following applies to you. Inform your doctor
if any of these situations applies to you.

You are unable to walk for a long time because of major
surgery, injury or illness (see also section 3, if you need to
have surgery)

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

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

If any of your close relatives has ever had a blood clot in the
leg, lung or another organ.

You have systemic lupus erythematosus (SLE)

You have cancer
For signs of a blood clot, see “Stop using Oestrogel and see a
doctor immediately”.
Compare:
Looking at women in their 50’s 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 50’s 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).
Heart disease (heart attack)
There is no evidence that HRT will prevent a heart attack.
Women over the age of 60 years who use oestrogen-progestogen
HRT are slightly more likely to develop heart disease than those
not using any HRT.
For women who have had their womb removed and are using
oestrogen-only therapy there is no increased risk of developing a
heart disease.
Stroke
The risk of getting stroke is about 1.5 times higher in HRT users
than in non-users. The number of extra cases of stroke due to
use of HRT will increase with age.
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 5year 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.
Children
None
Other medicines and Oestrogel
Some medicines may interfere with the effect of OESTROGEL.
This might lead to irregular bleeding. This applies to the following
medicines:

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









Other skin products containing alcohol e.g. astringents or
sunscreens.
Products to treat skin and scalp disorders e.g. products to
cure warts, acne or dandruff.
Other skin medications which change how skin is made, e.g.
anti-cancer products.
Medicines for epilepsy (such as phenobarbital, phenytoin and
carbamazepine)
Medicines for tuberculosis (such as rifampicin, rifabutin)
Medicines for HIV infection (such as nevirapine, efavirenz,
ritonavir and nelfinavir).
Herbal products containing St John’s wort (Hypericum
perforatum).

Please tell your doctor or pharmacist if you are using or have
recently used any other medicines including medicines obtained
without a prescription, herbal medicines or other natural products.
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
results of some tests.
Pregnancy and breast-feeding
Oestrogel is for use in postmenopausal women only. If you
become pregnant, stop using Oestrogel and contact your doctor.
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.
Your doctor will aim to prescribe the lowest dose to treat your
symptom for as short as necessary. Speak to your doctor if you
think this dose is too strong or not strong enough.
Preparing your new Pump Pack
Before using your new Pump Pack for the first time, you need to
prepare it for use as follows:

Remove the cap from the canister

Remove the stopper from the spout

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

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

Your pump Pack is now ready to use.
How much to use and when to use

Apply the gel once a day, either in the morning or evening.

Try to use the gel at about the same time each day

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

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

If 4 measures of gel have been prescribed, the Pump Pack
will last two weeks.

Spread the gel on a large area of skin on each shoulder,
outer arm or each 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 firmly. This will dispense one
measure of the gel
6. Apply the gel to the skin of the outer arm and shoulder or the
mid-inner thigh
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 midinner 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 4-6)
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.

Undesirable effects observed with HRT products used in
menopause are reported in the table below:
System

Metabolism and
nutrition
disorders
Psychiatric
disorders
Nervous system
disorders

Gastrointestinal
disorders

4. Possible side effects
Like all medicines, this medicine can cause side effects, although
not everybody gets them.
The following diseases are reported more often in women using
HRT compared to women not using HRT:

breast cancer,

Abnormal growth or cancer of the lining of the womb
(endometrial hyperplasia or cancer),

Ovarian cancer

Blood clots in the veins of the legs or lungs (venous
thromboembolism)

Heart disease

Stroke

probable memory loss if HRT is started over the age of 65.
HRT will not prevent memory loss.
For more information about these side effects, see Section 2.

Uncommon
undesirable
effects (more
than 1/1000
person and
less than
1/100 person)

Depression,
Mood swings
Headache

Vascular
disorders
Nausea
Abdominal
pain

Vertigo
Migraine
Venous
thromboemboli
c disease
Flatulence
Vomiting

Hepato-biliary
disorders
Skin and
subcutaneous
tissue disorders
Reproductive
System and
breast disorders

If you forget to use Oestrogel

If it is more than 12 hours until your next dose, apply the gel
as soon as you remember and apply the next dose at the
normal time.

If it is less than 12 hours until your next dose, skip the missed
dose and apply the next dose at the normal time.

Do not use a double dose (two doses at the same time) to
make up for a forgotten dose.
If you forget a dose you may have breakthrough bleeding or
spotting.
If you need to have surgery
If you are going to have surgery, tell the surgeon that you are
using Oestrogel. You may need to stop using Oestrogel about 4
to 6 weeks before the operation to reduce the risk of a blood clot
(see section 2, Blood clots in a vein). Ask your doctor when you
can start using Oestrogel again.

Common
undesirable
effects (more
than 1/100
person and
less than
1/10 person)

General
disorders and
administration
site condition

Itch (pruritus)

Breast
swelling/
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

Benign breast
or uterine
neoplasm
increased
volume of
ulterine
vaginitis /
vaginal
candidiosis

Weakness
(asthenia)

Rare
undesirable
effects (more
than 1/10000
person and
less than
1/1000
person)
Glucose
intolerance
Change in
libido
Aggravation of
epilepsy

5. How to store Oestrogel
Do not use after the expiry date on both the carton and the
Oestrogel Pump Pack
KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
Store away from heat. Do not store above 25º C.
If the gel shows any signs of deterioration or discolouration, you
should seek the advice of your pharmacist who will tell you what
to do.
If your doctor decides to stop treatment return any unused
medicine to the pharmacist for safe disposal. Only keep the
medicine if your doctor tells you to.
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.
REMEMBER: This medicine is for you. Only a doctor
can prescribe it.
Never give it to someone else. It may harm them even if their
symptoms are the same as yours.

Hypertension
This leaflet does not contain the complete information about your
medicine. If you have any questions or are not sure about
anything ask your doctor or pharmacist.
Liver function
tests
abnormalities
Skin
decoloration
acne
Appearance of
milk secretion
(galactorrhea)

6. Contents of the pack and other information
What Oestrogel contains
Each Oestrogel Pump Pack contains 80g of gel. It delivers 64
metered doses. Each metered dose of 1.25g contains 0.75mg
17ß estradiol.
Also contains the following inactive ingredients: carbomer,
triethanolamine, ethanol and purified water.
Estradiol is the main estrogen (female sex hormone) produced by
the human ovary.
PL 20774/0154

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

The following side effects have been reported with other HRTs:

gall bladder disease

various skin disorders
o
painful reddish skin nodules (erythema nodosum)
o Rash with target-shaped reddening or sores
(erythema multiforme)
If you get any side effects, talk to your doctor. This includes any
side effects not listed in this leaflet.

POM

This product has been manufactured by Besins Manufacturing
Belgium NV, Groot – Bijgaardenstratt 128, 1620 Drogenbos,
Belgium. Procured from within the EU. Product Licence holder,
Quadrant Pharmaceuticals Ltd, Lynstock House, Lynstock Way,
Lostock, Bolton, BL6 4SA. Repackaged by Maxearn Ltd, Bolton,
BL6 4SA.
rd
Leaflet prepared 23 September 2013

Estradiol is a registered trademark of Laboratoires Besins
International
PP3/0154/V2

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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