1 What Oestrogel is and what it is used for

PACKAGE LEAFLET: INFORMATION FOR THE USER
Oestrogel Pump-Pack
estradiol
Read all of this leaflet carefully before you start using this medicine.
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. Do not pass it on to others. It may
harm them, even if their symptoms are the same as yours.
If any of the side effects becomes serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Oestrogel is and what it is used for
2. Before you use Oestrogel
3. Safety of HRT
4. How to use Oestrogel
5. Possible side effects
6. How to store Oestrogel
7. Further information
1. What Oestrogel 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 contains a medicine called estradiol.
Estradiol is a man-made version of oestrogen (a female sex hormone). It
belongs to a group of medicines called hormone replacement therapy (HRT).
What Oestrogel is used for
Oestrogel is used to:
Prevent or relieve the signs of the menopause.
Prevent brittle bone problems (osteoporosis) if your bones are likely to break.
Oestrogel is used when you cannot use other medicines.
What is the menopause
The menopause (change of life) happens when your ovaries stop making the
hormone oestrogen. For most women this happens over the age of 40. It can
also happen at any time if you have surgery to take out your ovaries.
During the menopause your periods become irregular. The timing of your
periods and the amount of bleeding will change. Your periods will eventually
stop completely.
Other signs of the menopause can include hot flushes, night sweats, mood
swings, sleeping problems and vaginal dryness.
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.
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2. Before you use Oestrogel
Do not use Oestrogel if:
You are allergic (hypersensitive) to estradiol or any other of the ingredients of
Oestrogel (listed in Section 7).
You have ever had a blood clot.
You have heart problems such as angina or a heart attack.
You have ever had vaginal bleeding which you could not explain.
You have thickening of the lining of your womb, called endometrial
hyperplasia, which is not being treated.
You have serious liver problems.
You have a blood problem called ‘porphyria’.
You have ever had or think you may have breast cancer.
You have ever had a cancer that was made worse by oestrogen
(such as endometrial cancer).
Do not use Oestrogel if any of the above apply to you. If you are not sure, talk to
your doctor or pharmacist before using Oestrogel.
Take special care with Oestrogel
Check with your doctor or pharmacist before using Oestrogel if:
You still have your womb and your doctor has not prescribed another
medicine to use at the same time as using Oestrogel.
You have a family history of breast cancer.
You have high blood pressure.
You have gallstones.
You get migraines.
You have diabetes.
You have a hearing problem called ‘otosclerosis’.
You have ever had blood clots e.g. deep vein thrombosis or pulmonary
embolism
You have ever had thickening of the lining of your womb.
You have ever had an overgrowth of the lining of the womb (endometriosis)
You have fibroids in your womb.
You have liver problems such as liver adenoma.
You have a rare condition called Systemic Lupus Erythematosus (SLE).
You have epilepsy.
You have asthma.
If any of the above apply to you (or you are not sure), or if they were present and
got worse during pregnancy, talk to your doctor or pharmacist before using
Oestrogel.
Medical check-ups
Before you start using HRT, your doctor should ask you about your own and your
family’s medical history. Your doctor may decide to examine your breasts or
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your tummy, and may do an internal examination. They will only do this if it is
necessary for you or if you have any special concerns.
Once you have started on HRT, you should see your doctor for regular checkups
(at least once a year). At these check-ups, your doctor may discuss the
benefits and risks of continuing to use HRT.
Make sure that you:
Go for regular breast screening and cervical smear tests.
Regularly check your breasts for any changes such as dimpling of the skin,
changes in the nipple or for any lumps you can see or feel.
Using other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any
other medicines. This includes medicines obtained without a prescription,
including herbal medicines. This is because Oestrogel can affect the way some
other medicines work. Also some other medicines can affect the way Oestrogel
works.
In particular, do not use this medicine and tell your doctor or pharmacist if you
are using any of the following:
Skin cleansers which contain benzalkonium chloride or sodium lauryl
sulphate.
Skin products which contain alcohol such as astringents or sunscreens.
Products to treat skin and scalp problems such as products for warts, acne or
dandruff.
Other skin medicines which can change your skin, such as anti-cancer
medicines.
Medicines for epilepsy such as phenobarbital, phenytoin or carbamezapine.
Medicines for infections such as rifampicin, rifabutin, nevirapine, efavirenz,
ritonavir or nelfinavir.
Herbal medicines containing St John’s wort (Hypericum perforatum).
If you are not sure if any of the above apply to you, talk to your doctor or
pharmacist before using Oestrogel.
If you are taking another type of HRT
If you still have your womb your doctor will usually prescribe progestagen tablets
to take while using Oestrogel (see ‘Endometrial cancer’ in Section 3).
Take these tablets on the days your doctor has told you.
Take these tablets at the same time as you apply the gel.
While you are using Oestrogel and progestagen tablets you may have a period
towards the end of the treatment with the progestagen tablets. This is normal.
Operations or tests
Tell your doctor if you are going to have surgery. You may need to stop using
HRT about 4 to 6 weeks before the operation to reduce the risk of a blood clot.
Your doctor will tell you when you can start using HRT again.
Pregnancy and breast-feeding
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Do not use Oestrogel if you are pregnant, might become pregnant or are
breast-feeding.
If you get pregnant while using this medicine, stop using it straight away and
tell your doctor.
3. Safety of HRT
As well as benefits, HRT has some risks which you need to consider when you’re
deciding whether to use it, or whether to carry on using it.
Effects on your heart or circulation
Heart disease
HRT is not recommended for women who have had heart disease recently. If you
have ever had heart disease, talk to your doctor to see if you should be using
HRT.
HRT will not help to prevent heart disease.
Studies with one type of HRT (containing a progestagen and oestrogen) have
shown that women may be slightly more likely to get heart disease during the first
year of taking that type of HRT. For other types of HRT (like Oestrogel) the risk is
likely to be similar. However, this is not yet certain.
If you get a pain in your chest that spreads to your arm or neck:
See a doctor as soon as possible.
Do not use any more HRT until your doctor says you can.
This pain could be a sign of heart disease.
Stroke
Research suggests that HRT slightly increases the risk of having a stroke. Other
things that can increase the risk of stroke include:
Getting older.
High blood pressure.
Smoking.
Drinking too much alcohol.
An uneven heart beat.
If you are worried about any of these things, or if you have had a stroke in the
past, talk to your doctor to see if you should use HRT.
How likely is a stroke?
Looking at women in their 50s, on average, over 5 years:
Women not using HRT: 3 in 1000 would be expected to have a stroke.
Women using HRT: 4 in 1000 would be expected to have a stroke.
Looking at women in their 60s, on average, over 5 years:
Women not using HRT: 11 in 1000 would be expected to have a stroke.
Women using HRT: 15 in 1000 would be expected to have a stroke.
If you get migraine-type headaches which you cannot explain, with or without
disturbed vision:
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See a doctor as soon as possible.
Do not use any more HRT until your doctor says you can.
These headaches may be an early warning sign of a stroke.
Blood clots
HRT may increase the risk of blood clots in veins (also called deep vein
thrombosis or DVT) especially in the first year of using it.
These blood clots are not always serious. However if a clot travels to the lungs, it
can cause chest pain, breathlessness, collapse or even death. This condition is
called pulmonary embolism, or PE.
You are more likely to get a blood clot if:
You are very overweight.
You have had a blood clot before.
Any of your close family have had blood clots.
You have ever had a miscarriage.
You have any blood clotting problem that needs treatment with a medicine
such as warfarin.
You are off your feet for a long time because of major surgery, injury or
illness.
You have a rare condition called Systemic Lupus Erythematosus (SLE).
If any of these things apply to you, talk to your doctor to see if you should use
HRT.
How likely is a blood clot?
Looking at women in their 50s, on average, over 5 years:
Women not using HRT: 3 in 1000 would be expected to get a blood clot.
Women using HRT: 7 in 1000 would be expected to get a blood clot.
Looking at women in their 60s, on average, over 5 years:
Women not using HRT: 8 in 1000 would be expected to get a blood clot.
Women using HRT: 17 in 1000 would be expected to get a blood clot.
If you get painful swelling in your leg, sudden chest pain or difficulty breathing
see a doctor as soon as possible. Do not use any more HRT until your doctor
says you can. These may be signs of a blood clot.
Effects on your risk of developing cancer
Breast cancer
Women who have breast cancer, or have had breast cancer in the past,
should not use HRT.
Taking HRT for 5 years or more slightly increases the risk of breast cancer. The
risk is also slightly increased if you have a later menopause. The risk for a postmenopausal
woman taking oestrogen-only HRT for 5 years is about the same as
for a woman of the same age who is still having periods over that time and not
using HRT. The risk for a woman who is taking oestrogen plus progestagen HRT
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is higher than for oestrogen-only HRT. However, oestrogen plus progestagen
HRT is beneficial for the endometrium (see ‘Endometrial cancer’ below).
For all kinds of HRT, the extra risk of breast cancer goes up the longer you take
it. However, it returns to normal within about 5 years after stopping HRT.
Your risk of breast cancer is also higher if:
You have a close relative (mother, sister or grandmother) who has had
breast cancer.
You are very overweight.
How likely is breast cancer?
Looking at women aged 50, on average, by the time they reach 65:
Women not using HRT: 32 in 1000 will get breast cancer.
Women using oestrogen–only HRT for 5 years: between 33 and 34 in
1000 would be expected to get breast cancer. This is an extra 1 to 2 cases.
Women using oestrogen-only HRT for 10 years: 37 in 1000 would be
expected to get breast cancer. This is an extra 5 cases.
Women using oestrogen plus progestagen HRT for 5 years: 38 in 1000
would be expected to get breast cancer. This is an extra 6 cases.
Women using oestrogen plus progestagen HRT for 10 years: 51 in 1000
would be expected to get breast cancer. This is an extra 19 cases.
If you notice any changes in your breast, such as:
Dimpling of the skin.
Changes in the nipple.
Any lumps you can see or feel.
Make an appointment to see your doctor as soon as possible.
Endometrial cancer (cancer of the lining of the womb)
Using oestrogen-only HRT for a long time can increase the risk of cancer of
the lining of the womb. Taking a progestagen as well as the oestrogen helps to
lower the extra risk.
If you still have your womb, your doctor may prescribe a progestagen as well
as oestrogen. These may be prescribed separately, or as a combined HRT
product.
If you have had your womb removed (a hysterectomy), your doctor will discuss
with you whether you can safely take oestrogen without a progestagen.
If you have had your womb removed because of endometriosis, any
endometrium left in your body may be at risk of cancer. This means your doctor
may prescribe HRT that includes a progestagen as well as an oestrogen.
Your medicine, Oestrogel, is an oestrogen-only product.
How likely is endometrial cancer?
Looking at women aged 50 who still have a womb, on average, over the next 15
years:
Women not using HRT: 5 in 1000 will get endometrial cancer.
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Women using oestrogen-only HRT, the number will be 2 to 12 times
higher, depending on the dose and how long you use it.
The addition of a progestagen to oestrogen-only HRT substantially reduces the
risk of endometrial cancer.
If you get breakthrough bleeding or spotting, it’s usually nothing to worry
about, especially during the first few months of taking HRT.
But if the bleeding or spotting:
Carries on for more than the first few months.
Starts after you’ve been on HRT for a while.
Carries on even after you have stopped taking HRT.
Make an appointment to see you doctor. It could be a sign that your
endometrium has become thicker.
Ovarian Cancer
Ovarian cancer (cancer of the ovaries) is very rare, but it is serious. It can be
difficult to diagnose. This is because there are often no obvious signs of the
problem. Some studies have suggested that using oestrogen-only HRT for more
than 5 years may increase the risk of ovarian cancer. It is not yet known whether
other kinds of HRT increase the risk in the same way.
4. How to use Oestrogel
Always use Oestrogel exactly as your doctor has told you. You should 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.
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.
Press the plunger down a few times until the gel comes out.
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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
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.
The area of this leaflet when it is unfolded is about 375cm 2 . This is equal to
the area of skin on each shoulder and outer arm or each mid-inner thigh that
you should spread the gel.
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 an area the same size as this leaflet when it is opened
out.
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 on 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 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.
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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.
5. Possible side effects
Like all medicines, Oestrogel can cause side effects, although not everybody
gets them. The following side effects may happen with this medicine.
Stop using Oestrogel and see a doctor straight away if you notice any of
the following. You may need urgent medical treatment.
A new migraine or severe headache.
Yellowing of the skin or the whites of your eyes (jaundice).
An increase in blood pressure. This is usually found by your doctor.
You have the signs of blood clots (see Section 3 ‘Safety of HRT’ above).
You have the signs of a heart attack (see Section 3 ‘Safety of HRT’ above).
You have the signs of a stroke (see Section 3 ‘Safety of HRT’ above).
You have the signs of endometrial cancer (see Section 3 ‘Safety of HRT’
above).
You have any of the problems listed in Section 3 ‘Safety of HRT’ above.
Other side effects include:
Irritation, reddening or swelling of the skin where Oestrogel was applied. If
this happens, apply Oestrogel to a different part of your skin. If this does not
help, talk to your doctor. They may stop your treatment.
Rashes or blisters.
Pale brown patches of skin on the forehead, cheeks and nose (chloasma).
Headache or mood changes.
Feeling sick (nausea).
Increased discharge from your vagina.
Increase in the size of fibroids in your womb if you already have fibroids.
Tender or enlarged breasts or discharge from your breasts.
Gallstones.
Dementia
HRT will not prevent memory loss. In one study of women who started using
combined HRT (two different hormones) after the age of 65, there was a small
increase in the risk of dementia.
If any of the side effects becomes serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.
6. How to store Oestrogel
Keep out of the reach and sight of children.
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Do not use after the expiry date which is stated on both the carton and the
Oestrogel Pump Pack. The expiry date refers to the last day of that month.
Do not store Oestrogel above 25°C.
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.
7. Further information
What Oestrogel Pump Pack contains
The active ingredient is estradiol. This is a made-made form of the female
hormone oestrogen.
Each dose of 1.25g of Oestrogel contains 0.75mg of estradiol.
The other ingredients are: carbomer, triethanolamine, ethanol and purified
water.
What Oestrogel Pump Pack looks like and contents of the pack
Oestrogel is a non-greasy, non-staining, odourless transdermal gel.
Oestrogel Pump Pack delivers 64 metered doses.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation for Oestrogel Pump Pack is held by Besins
Healthcare, Rue Villain XIIII 19, 1000 Brussels, Belgium.
Oestrogel Pump Pack is made for Besins Healthcare by Besins Manufacturing
Belgium, Groot-Bijgaardenstraat 128, 1620 Drogenbos, Belgium.
Date of last revision – October 2009.
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