Skip to Content

ESTRADIOL 0.06% (W/W) GEL

PDF options:  View Fullscreen   Download PDF

PDF Transcript

500060/PL1b

Patient Information Leaflet
Oestrogel® Pump-pack/
Estradiol 0.06% w/w Gel
(estradiol)
The name of your medicine is Oestrogel Pump-pack or
Estradiol 0.06% w/w Gel. Throughout this leaflet, it will be
referred to as Oestrogel.
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. See section 4.

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

Stop using Oestrogel and see a doctor immediately
If you notice any of the following when taking HRT:
• any of the conditions mentioned in the ‘Do not use
Oestrogel’ section
• yellowing of your skin or the whites of your eyes
(jaundice). These may be signs of a liver disease
• a large rise in your blood pressure (symptoms may be
headache, tiredness, dizziness)
• migraine-like headaches which happen for the
first time
• if you become pregnant
• if you notice signs of a blood clot, such as:
- painful swelling and redness of the legs
- sudden chest pain
- 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).

1. WHAT OESTROGEL IS AND WHAT IT IS USED FOR
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.

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.

Oestrogel is used for:
Relief of symptoms occurring after menopause
During the menopause, the amount of the oestrogen produced
by a woman’s body drops.
This can cause symptoms such as hot face, neck and chest
(“hot flushes”). Oestrogel alleviates these symptoms after
menopause. You will only be prescribed Oestrogel if your
symptoms seriously hinder your daily life.

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.

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 an oestrogen-sensitive cancer
(such as having a mother, sister or grandmother who
has had breast cancer),
• high blood pressure,
• a liver disorder, such as a benign liver tumor,
• diabetes,
• gallstones,
• migraine or severe headaches,
• a disease of the immune system that affects many
organs of the body (Systemic Lupus Erythematosus,
SLE),
• 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.

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 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
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:
- dimpling of the skin
- 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-progestogen 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
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 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 Oestrogel and see a
doctor immediately”.
Compare
Looking at women in their 50s who are not using HRT, on
average, over a 5-year period, 4 to 7 in 1000 would be
expected to get a blood clot in a vein.
For women in their 50s who have been using oestrogenprogestogen HRT for over 5 years, there will be 9 to 12 cases
in 1000 users (i.e.an extra 5 cases).
For women in their 50s who have had their womb removed and
have been using oestrogen-only HRT for over 5 years, there
will be 5 to 8 cases in 1000 users (i.e. 1 extra case).
Heart disease (heart attack)
There is no evidence that HRT will prevent a heart attack.
Women over the age of 60 years who use oestrogenprogestogen 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.
continued overleaf

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:
• 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).
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.
Pregnancy and breast-feeding
Oestrogel is for use in postmenopausal women only. If you
become pregnant, stop using Oestrogel and contact your
doctor.
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
• 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
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 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.
• 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. Hold the Oestrogel Pump-pack in one hand and place
your other hand under the spout, ready to collect the
gel.
4. Push the plunger down firmly. This will dispense one
measure of the gel.
5. Apply the gel to either:
- the outer arm and shoulder of both arms,
or
- the mid-inner thigh of both legs.
6. Do not apply on or near the breasts, or near the
genital area.
7. Spread the gel over a large area of skin on each
shoulder, outer arm or mid-inner thigh.
8. 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).
9. Replace the cap.
10. Leave to dry for 5 minutes before covering with clothes.
How you know when your Pump-pack is empty
• After 64 measures have been dispensed the Pumppack is nearly empty and the amount of gel released
may be less.
• 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
• 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.
4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects,
although not everybody gets them.
Please see your doctor immediately if you experience the
following:
- Symptoms of an allergic reaction. This may include skin
rash, hives, itching (pruritus)
- Sudden chest pain
- Pain in your chest that spreads to your arm or neck
- Difficulty in breathing
- Painful swelling and redness of the legs
- Yellowing of the eyes and face, darkening of urine, itchy
skin (jaundice)
- Unexpected vaginal bleeding or spotting
(breakthrough bleeding) after using Oestrogel for some
time, or after you stop treatment
- Breast change, including dimpling of the breast skin,
change in the nipple, lumps that you can see or feel
(breast cancer)
- painful menstrual periods
- Unexplained migraine-like headaches
- Oestrogel may aggravate epilepsy
- Rash with target-shaped reddening or sores
(erythema multiforme)
- Anaphylactic reaction (in women with past history of
allergic reaction)
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.
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, vaginal discharge.
• Weight change (increase or decrease),
water retention with peripheral oedema.
Uncommon: may affect up to 1 in 100 people
• Depression, mood swings.
• Vertigo.
• Flatulence, vomiting.
• Benign breast or uterine tumour, increased volume of
uterine, vaginitis or vaginal candidiasis.
• Feeling weak (asthenia).
Rare: may affect up to 1 in 1,000 people
• Glucose intolerance.
• Change in libido.
• Hypertension.
• Liver function tests abnormalities.
• Skin decoloration, acne.
• Appearance of milk secretion (galactorrhea).
The following side effects have been reported with
other HRTs:
• gall bladder disease
various skin disorders:
- discoloration of the skin especially of the face or neck
known as "pregnancy patches" (chloasma);
- painful reddish skin nodules (erythema nodosum)
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist.
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 or search for MHRA
Yellow Card in the Google Play or Apple App Store.
By reporting side effects you can help provide more information
on the safety of this medicine.
5. HOW TO STORE OESTROGEL

• Do not store above 25°C.
• Keep this medicine out of the sight and the reach of
children.
• Do not use this medicine after the expiry date which is
stated on both the carton and the Oestrogel Pump-pack
after “Exp”. The expiry date refers to the last day of that
month.
• 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.
• If you notice any signs of discolouration or deterioration
of your medicine, please tell your pharmacist
immediately.
66. CONTENTS OF THE PACK AND OTHER INFORMATION
What Oestrogel contains
• The active ingredient is estradiol. This is a manmade
form of the female hormone oestrogen.
• Each metered dose (1.25g) contains 0.75mg estradiol.
• The other ingredients are: carbomer, triethanolamine,
ethanol and purified water.
What Oestrogel Pump-pack looks like and contents of the
pack
• Gel for transdermal use in 80 g bottle with metered-dose
pump.
• Oestrogel is a colourless, transdermal gel with alcoholic
odour.
• Oestrogel Pump-pack delivers 64 metered doses.
Manufacturer
Besins Manufacturing Belgium, Groot, Bijgaardenstraat 128,
1620 Drogenbos, Belgium.
Product Licence Holder
Procured from within the EU. Product Licence Holder Ginova
Ltd, repackager Ginova UK Ltd, both of St James' House, 8
Overcliffe, Gravesend, Kent, DA11 0HJ.

POM

Oestrogel® Pump-pack
Estradiol 0.06% w/w Gel
PL No: 18067/0484

Oestrogel® is a registered trademark of Besins Healthcare
Luxembourg S.A.R.L..
This leaflet was last approved on 17th October 2017.

To request a copy of this leaflet in
Braille, large print or audio please
call 01622 690172.
500060/PL1b

+ 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.

Hide