SANDRENA 1.0 MG GEL

Active substance: ESTRADIOL

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Transcript
Where to apply the gel
• Do not apply the gel to your breasts, face or on
irritated skin.
• Apply the gel on your lower body or thighs.
• Apply the gel to a different side of your body
each day.
Follow these instructions:
1. Apply the gel once a day to the skin on your
lower body or thighs.
2. Spread the gel over an area 1–2 times the size
of your hand.
3. Allow the gel to dry for a few minutes.
4. Wash your hands after applying the gel. Avoid
contact of the gel with your eyes. The gel may
irritate your eyes.
5.Do not wash the area where you have applied
the gel for at least one hour.
Refill box

Rare (affects up to 1 in 1000 people)
• hypertension
• venous thromboembolism
• alterations in liver function and biliary flow
• rash.
It is not known how many people will get:
• yellow-brown patches on the skin, especially on
the face. If you have had these patches before,
you should avoid sunbathing or using a sun-bed.
If you have any of these side effects tell your
doctor. They may decide to stop your treatment
for a while.
Dementia
HRT will not prevent memory loss. In one study
of women who started using combined HRT
after the age of 65, a small increase in the risk of
dementia was observed.

• The package contains a small plastic refill box.
This holds enough of your medicine for one
week.
• Use the refill box to help you remember if you
have used your daily dose.
• Fill the refill box with enough sachets for one
week.
• Mark on the side of the box the day and the
date when you started the package. This is Day
1 on the refill box.
• Every time you refill the plastic box tick off the
weeks marked on the side of the carton.
3.3 If you use more Sandrena gel than you
should
If you use more gel than you should, talk to your
doctor or pharmacist. You may feel bloated,
anxious or irritable, or your breasts may feel
tender.
3.4 If you swallow Sandrena
If you swallow Sandrena there is no need to
worry. However, you should talk to your doctor.
3.5 If you forget to use Sandrena
• Apply the missed dose when you remember,
unless you are more than 12 hours late.
• If you are more than 12 hours late just skip the
missed dose.
• Missed doses may cause some bleeding
between your periods. This is called
breakthrough bleeding.
3.6 If you stop using Sandrena
Keep using this medicine as prescribed by your
doctor. Keep using Sandrena, even if you seem to
be better. If you stop too early or too suddenly
your problem may return.
4. Possible side effects
Like all medicines, Sandrena can cause side
effects, although not everybody gets them.
Stop using the gel and see your doctor
straight away, if you notice any of the following
serious side effects:
• your blood pressure rises
• your skin or the whites of your eyes go yellow
(jaundice)
• you suddenly have migraine-type headaches
(see Section 2.4)
• you have signs of a blood clot (see Section 2.4)
• you get any of the problems listed in Section
2.1.
Other side effects:
Common (affects up to 1 in 10 people)
• itching of the skin
• breasts become swollen, tender or painful
• increase in your weight
• swollen feet and lower legs
• headache
• tummy pains, feeling sick or being sick
• bleeding or spotting
Uncommon (affects up to 1 in 100 people)
• changes to sex drive and mood
• migraine.

If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
tell your doctor or pharmacist.
5. How to store Sandrena

• KEEP OUT OF THE SIGHT AND REACH OF
CHILDREN.

• Do not store above 25°C.
• Do not use this medicine after the expiry date
shown on the carton or sachet label.

• If your medicine becomes discoloured or shows
any other signs of deterioration, consult your
pharmacist who will tell you what to do.
• Medicines should not be disposed of via waste
water or household waste. Ask your pharmacist
how to dispose of medicines no longer required.
These measures will help to protect the
environment.
6. Further Information
What Sandrena contains
Estradiol is one of the female hormones your body
makes. Sandrena sachets contain 1.0 milligrams
of estradiol in each sachet.
Sandrena gel also contains carbomer 974P,
trolamine, propylene glycol, ethanol 96% and
purified water.
What Sandrena looks like and contents of the
pack
Sandrena is a smooth, opalescent, alcohol-based
gel. The active ingredient in Sandrena is
estradiol.
This is the new name for oestradiol. The ingredient
has not changed.
Sandrena is supplied in packs of 28 or 91 sachets
Manufacturer and Licence Holder
This medicine is manufactured by Orion
Corporation, PO BOX 425, FIN-02101, Turku,
Finland and is procured from within the EU and
repackaged by the Product Licence Holder: Lexon
(UK) Limited, Unit 18, Oxleasow Road, East
Moons Moat, Redditch, Worcestershire, B98 0RE.
If you have any questions or are not sure about
anything, ask your doctor or pharmacist. They will
have additional information about this medicine
and will be able to advise you.

POM

PL 15184/1178 - Sandrena 1.0mg Gel

Sandrena is a registered trademark of Orion
Corporation.
Leaflet revision date: 06/08/13

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited,
Tel: 01527 505414 for help.

PATIENT INFORMATION LEAFLET

Ref: 1178/060813/1/F

®

Sandrena 1.0mg Gel
(estradiol)
Read all of this leaflet carefully before you
start taking 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 gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
Your medicine is called Sandrena 1.0mg Gel and
will be referred to as Sandrena throughout the rest
of this leaflet. Please note that the leaflet also
contains information about other strengths of the
medicine, Sandrena 0.5mg Gel.
In this leaflet:
1. What Sandrena is and what it is used for
2. Before you use Sandrena
3. How to use Sandrena
4. Possible side effects
5. How to store Sandrena
6. Further information
1. What Sandrena is and what it is used for
The name of your medicine is Sandrena 0.5 mg
gel or Sandrena 1 mg gel (called Sandrena in the
rest of this leaflet). Sandrena contains a medicine
called estradiol. This is the new name for
oestradiol – the medicine itself has not changed. It
belongs to a group of medicines called Hormone
Replacement Therapy (HRT).
What is Sandrena used for
Sandrena is used for problems caused by having
too little ‘oestrogen’.
How Sandrena works
Estradiol (the medicine in Sandrena) is one of the
natural oestrogens.
• Oestrogens are female sex hormones.
• They are produced in the ovaries.
• They cause sexual development in women and
control the menstrual cycle during the
childbearing years.
When women get older the ovaries gradually
produce less oestrogen.
• This happens at the menopause (usually
around the age of 50).
• If the ovaries are removed before the
menopause, oestrogen production stops very
suddenly.
Shortage of oestrogens may cause the vaginal
wall to become thin and dry. So sexual intercourse
may become painful. It may also cause hot
flushes and night sweats. These problems can be
relieved by using medicines like Sandrena which
contain oestrogen. It may take several days or
weeks before you notice an improvement.
2. Before you use Sandrena
As well as benefits, HRT has some risks that you
need to consider when you’re deciding whether
to start taking it, or whether to carry on taking it.
You should start HRT only for symptoms that
adversely affect quality of life.
Before you start taking HRT
Your doctor should ask about you and your
family’s medical history. Your doctor may decide to
examine your breasts or your stomach and may
do an internal examination. They will only do this
if it is necessary for you or if you have any special
concerns.
Tell your doctor if you have any medical
problems or illnesses.

Regular check-ups
Once you have started on HRT, see your doctor
for regular check-ups (at least once a year). At
these check-ups, your doctor may discuss the
benefits and risks of continuing to take 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 any lumps you can see or feel.
2.1 Do not use Sandrena if:
• you are allergic (hypersensitive) to any of the
ingredients of Sandrena (listed in Section 6)
• you have had angina or a heart attack
(myocardial infarction)
• you have had a blood clot (thrombosis)
• you have had breast cancer or suspect that
you have breast cancer
• you have had cancer of other sex
organs - such as cancer of the womb lining or
ovary
• you have vaginal bleeding that has not been
explained by your doctor
• you have excessive thickening of the womb
lining
• you have had a liver disease, and your liver is
still not working properly
• you have a rare blood problem called
‘porphyria’.
Do not use this medicine if any of the above
apply to you. If you are not sure, talk to your
doctor or pharmacist before using Sandrena.
Take special care with Sandrena
Check with your doctor or pharmacist before
using your medicine if you have had:
• a problem caused by growth of the womb
lining outside the womb (fibroids or
endometriosis)
• any problem with your heart or circulation
(including high blood pressure or risk factors
for a blood clot – see Section 2.3)
• relatives who have had blood clots
• asthma
• diabetes
• migraine or severe headaches
• epilepsy (fits)
• gallstones
• liver or kidney problems
• a rare problem called ‘systemic lupus
erythematosus’ (SLE)
• otosclerosis (a hearing disorder).
If you have any of these, talk to your doctor
or pharmacist before using Sandrena.
2.3 Sandrena and the risk of developing cancer
Breast cancer
• Women who have ever had breast cancer
should not take HRT.
Taking HRT slightly increases the risk of breast
cancer. The risk is also slightly increased if you
have a later menopause. The risk after the
menopause for a 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 taking HRT. The
risk for a woman who is taking oestrogen plus
progestogen HRT is higher than for oestrogen only
HRT. However, oestrogen plus progestogen
HRT is beneficial for the endometrium.
For all kinds of HRT, the extra risk of breast
cancer goes up the longer you take it. However, it
returns to normal 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 seriously overweight.

How likely is breast cancer?
Looking at women aged 50, on average, by the
time they reach 65:
• In women not taking HRT - 32 in 1,000 will
get breast cancer.
• In women who start taking oestrogen-only
HRT at age 50 and take it for 5 years between 33 and 34 in 1,000 will get breast
cancer. This means an extra 1 to 2 cases.
• In women taking oestrogen-only HRT for 10
years - 37 in 1,000 will get breast cancer. This
means an extra 5 cases.
• In women who start taking oestrogen plus
progestogen HRT at age 50 and take it for 5
years – 38 in 1,000 will get breast cancer. This
means an extra 6 cases.
• In women taking oestrogen plus progestogen
HRT for 10 years – 51 in 1,000 will get breast
cancer. This means an extra 19 cases.
If you notice any changes in your breast, such
as: dimpling of your skin, changes in your
nipple or 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)
Taking oestrogen-only HRT for a long time can
increase the risk of developing cancer of the
lining of the womb. Taking a progestogen as
well as the oestrogen helps to lower the extra
risk.
Your product, Sandrena, is an oestrogen-only
product.
If you still have your womb, your doctor may
prescribe a progestogen 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
progestogen.
If you have had your womb removed because
of endometriosis, any endometrium left in your
body may be at risk. This means your doctor may
prescribe HRT that includes a progestogen as
well as an oestrogen.
How likely is endometrial cancer?
Looking at women aged 50 who still have a
womb, on average, over the next 15 years:
• In women not taking HRT – 5 in 1000 will get
endometrial cancer.
• In women taking oestrogen-only HRT, the
number will be 2 to 12 times higher, depending
on the dose and how long you take it.
The addition of a progestogen to oestrogen-only
HRT substantially reduces the risk of endometrial
cancer.
If you get breakthrough bleeding or spotting, it is
usually nothing to worry about, especially during
the first few months of using HRT.

Ovarian cancer
Ovarian cancer (cancer of the ovaries) is very
rare, but it is serious. It can be difficult to
diagnose, because there are often no obvious
signs of the problem.
Some studies have shown that taking 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.
2.4 Sandrena and the 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 taking HRT.
HRT will not help to prevent heart disease.
Studies with one type of combined HRT
(containing the progestogen MPA and a different
oestrogen to the one in Sandrena) 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
Sandrena), 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 a 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 heartbeat.
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 take HRT.
How likely is a stroke?
Looking at women in their 50s, on average, over
5 years:
• In women not taking HRT:
3 in 1,000 would be expected to have a stroke.
• In women taking HRT:
4 in 1,000 would be expected to have a stroke.
Looking at women in their 60s, on average, over
5 years:
• In women not taking HRT:
11 in 1,000 would be expected to have a stroke.
• In women taking HRT:
15 in 1,000 would be expected to have a stroke.
If you get an unexpected migraine-type
headache, with or without disturbed vision:
See a doctor straight away, and do not use
any more HRT until a doctor says you can. These
headaches may be an early warning sign of a
stroke.

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 problem called SLE.
If any of these things apply to you, talk to your
doctor to see if you should take HRT.

How likely is a blood clot?
Looking at women in their 50s, on average, over
5 years:
• In women not taking HRT:
3 in 1,000 would be expected to get a blood clot.
• In women taking HRT:
7 in 1,000 would be expected to get a blood clot.
Looking at women in their 60s, on average, over
5 years:
• In women not taking HRT:
8 in 1,000 would be expected to get a blood clot.
• In women taking HRT:
17 in 1,000 would be expected to get a blood
clot.
If you get painful swelling in your leg, sudden
chest pain or have problems breathing:
See a doctor straight away
Do not use any more HRT until a doctor says you
can. These may be signs of a blood clot.
2.5 Taking other medicines
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 Sandrena can affect the way some other
medicines work. Also some other medicines can
affect the way Sandrena works.
Tell your doctor or pharmacist if you are taking
any of the following:
• medicines for epilepsy - such as phenobarbital,
phenytoin or carbamezapine
• medicines for infections - such as rifampicin,
rifabutin, nevirapine, efavirenz, ritonavir or
nelfinavir
• St John’s wort - a herbal medicine used for
depression.
If you are not sure if any of the above apply to
you, talk to your doctor or pharmacist before
using Sandrena.
2.6 Operations and blood tests
Tell your doctor you are using Sandrena 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 taking HRT again.
Tell your doctor you are using Sandrena if
you are going to have any blood tests. This is
because Sandrena can affect the tests.
2.7 Pregnancy and breast-feeding

• Do not use Sandrena if you are pregnant or
might become pregnant.

But if the bleeding or spotting:
• carries on for more than the first few months
• starts after you have been on HRT for a while
• carries on even after you’ve stopped taking
HRT.

Blood clots
HRT may increase the risk of blood clots in the
veins (also called deep vein thrombosis, or DVT).
This is especially during the first year of taking it.

Make an appointment to see your doctor.
It could be a sign that your endometrium has
become thicker.

These blood clots are not always serious.
However, if a clot travels to your lungs, it can
cause chest pain, feeling breathless, collapse or
even death. This is called a pulmonary embolism
or PE.

Please see Section 3 for information about when
to start using Sandrena if you have had your
womb removed.

• Do not breast-feed if you are using this
medicine.

• If you become pregnant, stop using Sandrena

2.9 Important information about some of the
ingredients of Sandrena
Sandrena contains propylene glycol, which may
cause skin irritation.
• Sandrena 0.5 mg gel contains 58.5 % vol
ethanol (alcohol), i.e. up to 293 mg per dose,
equivalent
to 6 ml beer, or 3 ml wine per dose. (A
teaspoon contains 5 ml).
• Sandrena 1.0 mg gel contains 58.5 % vol
ethanol (alcohol), i.e. up to 585 mg per dose,
equivalent to 12 ml beer, or 5 ml wine per dose.
(A teaspoon contains 5 ml).
This may be harmful for those suffering from
alcoholism. This should also be taken into account
in pregnant or breast-feeding women, children
and high risk groups such as patients with liver
disease, or epilepsy.
3. How to use Sandrena
Always use Sandrena exactly as your doctor or
pharmacist has told you. You should check with
your doctor or pharmacist if you are not sure.
When to start using Sandrena
You can start using Sandrena straight away if:
• You have never used HRT before
• You are changing over from a period-free HRT
Wait for your period to end if:

• You are changing over from another type of
HRT where you have a period
If you have not had your womb removed, your
doctor will normally also prescribe another
medicine containing the hormone
progestogen.
This is normally a tablet taken for 12 to 14 days in
each monthly cycle. After each course of
progestogen you will usually have a withdrawal
bleed, like a period.
3.1 How much to use
Sandrena comes in sachets of 0.5 mg Estradiol in
0.5 g of gel, or in sachets of 1 mg Estradiol in 1 g
of gel.
• Each pack of Sandrena 0.5 mg gel contains
only 0.5 g sachets.
• Each pack of Sandrena 1 mg gel contains only
1 g sachets.
Use the amount of Sandrena gel that your doctor
has prescribed.
• The usual dose is between 0.5 mg and 1.5 mg
of Estradiol a day.
• Use the following number of 0.5 g or 1 g
sachets depending on the dose, and the pack
size prescribed by your doctor:
For a 0.5 mg daily dose
- Use one 0.5 g sachet
For a 1 mg daily dose
There are two options:
- Use one 1 g sachet
or
- Use two 0.5 g sachets
For a 1.5 mg daily dose
There are two options:
- Use three 0.5 g sachets
or
- Use one 0.5 g sachet with one 1 g sachet

straight away and tell your doctor.
Ask your doctor or pharmacist for advice before
taking any medicine, if you are pregnant or
breastfeeding.

If you are also taking progestogen tablets, take
them as your doctor has told you. You will
normally have a withdrawal bleed after each
course of progestogen.

2.8 Driving and using machines
Sandrena has no effect on the ability to drive or
use machines.

3.2 How to apply the gel
Sandrena should be rubbed gently on the skin.
It should not be swallowed.

Ref: 1178/060813/1/B

Where to apply the gel
• Do not apply the gel to your breasts, face or on
irritated skin.
• Apply the gel on your lower body or thighs.
• Apply the gel to a different side of your body
each day.
Follow these instructions:
1. Apply the gel once a day to the skin on your
lower body or thighs.
2. Spread the gel over an area 1–2 times the size
of your hand.
3. Allow the gel to dry for a few minutes.
4. Wash your hands after applying the gel. Avoid
contact of the gel with your eyes. The gel may
irritate your eyes.
5.Do not wash the area where you have applied
the gel for at least one hour.
Refill box

Rare (affects up to 1 in 1000 people)
• hypertension
• venous thromboembolism
• alterations in liver function and biliary fl ow
• rash.
It is not known how many people will get:
• yellow-brown patches on the skin, especially on
the face. If you have had these patches before,
you should avoid sunbathing or using a sun-bed.
If you have any of these side effects tell your
doctor. They may decide to stop your treatment
for a while.
Dementia
HRT will not prevent memory loss. In one study
of women who started using combined HRT
after the age of 65, a small increase in the risk of
dementia was observed.

• The package contains a small plastic refill box.
This holds enough of your medicine for one
week.
• Use the refill box to help you remember if you
have used your daily dose.
• Fill the refill box with enough sachets for one
week.
• Mark on the side of the box the day and the
date when you started the package. This is Day
1 on the refill box.
• Every time you refill the plastic box tick off the
weeks marked on the side of the carton.
3.3 If you use more Estradiol gel than you
should
If you use more gel than you should, talk to your
doctor or pharmacist. You may feel bloated,
anxious or irritable, or your breasts may feel
tender.
3.4 If you swallow Estradiol
If you swallow Estradiol there is no need to
worry. However, you should talk to your doctor.
3.5 If you forget to use Estradiol
• Apply the missed dose when you remember,
unless you are more than 12 hours late.
• If you are more than 12 hours late just skip the
missed dose.
• Missed doses may cause some bleeding
between your periods. This is called
breakthrough bleeding.
3.6 If you stop using Estradiol
Keep using this medicine as prescribed by your
doctor. Keep using Estradiol, even if you seem to
be better. If you stop too early or too suddenly
your problem may return.
4. Possible side effects
Like all medicines, Estradiol can cause side
effects, although not everybody gets them.
Stop using the gel and see your doctor
straight away, if you notice any of the following
serious side effects:
• your blood pressure rises
• your skin or the whites of your eyes go yellow
(jaundice)
• you suddenly have migraine-type headaches
(see Section 2.4)
• you have signs of a blood clot (see Section 2.4)
• you get any of the problems listed in Section
2.1.
Other side effects:
Common (affects up to 1 in 10 people)
• itching of the skin
• breasts become swollen, tender or painful
• increase in your weight
• swollen feet and lower legs
• headache
• tummy pains, feeling sick or being sick
• bleeding or spotting
Uncommon (affects up to 1 in 100 people)
• changes to sex drive and mood
• migraine.

If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
tell your doctor or pharmacist.
5. How to store Estradiol

• KEEP OUT OF THE SIGHT AND REACH OF
CHILDREN.

• Do not store above 25°C.
• Do not use this medicine after the expiry date
shown on the carton or sachet label.
• If your medicine becomes discoloured or shows
any other signs of deterioration, consult your
pharmacist
who will tell you what to do.
• Medicines should not be disposed of via waste
water or household waste. Ask your pharmacist
how to dispose of medicines no longer required.
These measures will help to protect the
environment.
6. Further Information
What Estradiol contains
Estradiol is one of the female hormones your body
makes. Estradiol sachets contain 1.0 milligrams of
estradiol in each sachet.
Estradiol gel also contains carbomer 974P,
trolamine, propylene glycol, ethanol 96% and
purified water.

PATIENT INFORMATION LEAFLET

Estradiol 1.0mg Gel
Read all of this leaflet carefully before you
start taking 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 gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
Your medicine is called Estradiol 1.0mg Gel and
will be referred to as Estradiol throughout the rest
of this leaflet. Please note that the leaflet also
contains information about other strengths of the
medicine, Estradiol 0.5mg Gel.

1. What Estradiol is and what it is used for
The name of your medicine is Estradiol 0.5 mg
gel or Estradiol 1 mg gel (called Estradiol in the
rest of this leaflet). Estradiol contains a medicine
called estradiol. This is the new name for
oestradiol – the medicine itself has not changed. It
belongs to a group of medicines called Hormone
Replacement Therapy (HRT).
What is Estradiol used for
Estradiol is used for problems caused by having
too little ‘oestrogen’.
How Estradiol works
Estradiol (the medicine in Estradiol) is one of the
natural oestrogens.
• Oestrogens are female sex hormones.
• They are produced in the ovaries.
• They cause sexual development in women and
control the menstrual cycle during the
childbearing years.
When women get older the ovaries gradually
produce less oestrogen.
• This happens at the menopause (usually
around the age of 50).
• If the ovaries are removed before the
menopause, oestrogen production stops very
suddenly.

Manufacturer and Licence Holder
This medicine is manufactured by Orion
Corporation,PO BOX 425, FIN-02101, Turku,
Finland and is procured from within the EU and
repackaged by the Product Licence Holder: Lexon
(UK) Limited, Unit 18, Oxleasow Road, East
Moons Moat, Redditch, Worcestershire, B98 0RE.

Shortage of oestrogens may cause the vaginal
wall to become thin and dry. So sexual intercourse
may become painful. It may also cause hot
flushes and night sweats. These problems can be
relieved by using medicines like Estradiol which
contain oestrogen. It may take several days or
weeks before you notice an improvement.

POM

PL 15184/1178 - Estradiol 1.0mg Gel

Leaflet revision date: 06/08/13

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Regular check-ups
Once you have started on HRT, see your doctor
for regular check-ups (at least once a year). At
these check-ups, your doctor may discuss the
benefits and risks of continuing to take 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 any lumps you can see or feel.
2.1 Do not use Estradiol if:

• you are allergic (hypersensitive) to any of the
ingredients of Estradiol (listed in Section 6)

• you have had angina or a heart attack
(myocardial infarction)

In this leaflet:
1. What Estradiol is and what it is used for
2. Before you use Estradiol
3. How to use Estradiol
4. Possible side effects
5. How to store Estradiol
6. Further information

What Estradiol looks like and contents of the
pack
Estradiol is a smooth, opalescent, alcohol-based
gel. The active ingredient in Estradiol is
estradiol.
This is the new name for oestradiol. The ingredient
has not changed.
Estradiol is supplied in packs of 28 or 91 sachets

If you have any questions or are not sure about
anything, ask your doctor or pharmacist. They will
have additional information about this medicine
and will be able to advise you.

Ref: 1178/060813/2/F

2. Before you use Estradiol
As well as benefits, HRT has some risks that you
need to consider when you’re deciding whether
to start taking it, or whether to carry on taking it.
You should start HRT only for symptoms that
adversely affect quality of life.
Before you start taking HRT
Your doctor should ask about you and your
family’s medical history. Your doctor may decide to
examine your breasts or your stomach and may
do an internal examination. They will only do this
if it is necessary for you or if you have any special
concerns.
Tell your doctor if you have any medical
problems or illnesses.

• you have had a blood clot (thrombosis)
• you have had breast cancer or suspect that
you have breast cancer

• you have had cancer of other sex
organs - such as cancer of the womb lining or
ovary
• you have vaginal bleeding that has not been
explained by your doctor
• you have excessive thickening of the womb
lining
• you have had a liver disease, and your liver is
still not working properly
• you have a rare blood problem called
‘porphyria’.
Do not use this medicine if any of the above
apply to you. If you are not sure, talk to your
doctor or pharmacist before using Estradiol.
Take special care with Estradiol
Check with your doctor or pharmacist before
using your medicine if you have had:
• a problem caused by growth of the womb
lining outside the womb (fibroids or
endometriosis)
• any problem with your heart or circulation
(including high blood pressure or risk factors
for a blood clot – see Section 2.3)
• relatives who have had blood clots
• asthma
• diabetes
• migraine or severe headaches
• epilepsy (fits)
• gallstones
• liver or kidney problems
• a rare problem called ‘systemic lupus
erythematosus’ (SLE)
• otosclerosis (a hearing disorder).
If you have any of these, talk to your doctor
or pharmacist before using Estradiol.
2.3 Estradiol and the risk of developing cancer
Breast cancer
Women who have ever had breast cancer
should not take HRT.
Taking HRT slightly increases the risk of breast
cancer. The risk is also slightly increased if you
have a later menopause. The risk after the
menopause for a 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 taking HRT. The
risk for a woman who is taking oestrogen plus
progestogen HRT is higher than for oestrogenonly
HRT. However, oestrogen plus progestogen
HRT is beneficial for the endometrium.



For all kinds of HRT, the extra risk of breast
cancer goes up the longer you take it. However, it
returns to normal 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 seriously overweight.

How likely is breast cancer?
Looking at women aged 50, on average, by the
time they reach 65:
• In women not taking HRT - 32 in 1,000 will
get breast cancer.
• In women who start taking oestrogen-only
HRT at age 50 and take it for 5 years between 33 and 34 in 1,000 will get breast
cancer. This means an extra 1 to 2 cases.
• In women taking oestrogen-only HRT for 10
years - 37 in 1,000 will get breast cancer. This
means an extra 5 cases.
• In women who start taking oestrogen plus
progestogen HRT at age 50 and take it for 5
years – 38 in 1,000 will get breast cancer. This
means an extra 6 cases.
• In women taking oestrogen plus progestogen
HRT for 10 years – 51 in 1,000 will get breast
cancer. This means an extra 19 cases.
If you notice any changes in your breast, such
as: dimpling of your skin, changes in your
nipple or 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)
Taking oestrogen-only HRT for a long time can
increase the risk of developing cancer of the
lining of the womb. Taking a progestogen as
well as the oestrogen helps to lower the extra
risk.
Your product, Estradiol, is an oestrogen-only
product.
If you still have your womb, your doctor may
prescribe a progestogen 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
progestogen.
If you have had your womb removed because
of endometriosis, any endometrium left in your
body may be at risk. This means your doctor may
prescribe HRT that includes a progestogen as
well as an oestrogen.
How likely is endometrial cancer?
Looking at women aged 50 who still have a
womb, on average, over the next 15 years:
• In women not taking HRT – 5 in 1000 will get
endometrial cancer.
• In women taking oestrogen-only HRT, the
number will be 2 to 12 times higher, depending
on the dose and how long you take it.
The addition of a progestogen to oestrogen-only
HRT substantially reduces the risk of endometrial
cancer.
If you get breakthrough bleeding or spotting, it is
usually nothing to worry about, especially during
the first few months of using HRT.

Ovarian cancer
Ovarian cancer (cancer of the ovaries) is very
rare, but it is serious. It can be difficult to
diagnose, because there are often no obvious
signs of the problem.
Some studies have shown that taking
oestrogenonly 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.
2.4 Estradiol and the 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 taking HRT.
HRT will not help to prevent heart disease.
Studies with one type of combined HRT
(containing the progestogen MPA and a different
oestrogen to the one in Estradiol) 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
Estradiol), 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 a 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 heartbeat.
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 take HRT.
How likely is a stroke?
Looking at women in their 50s, on average, over
5 years:
• In women not taking HRT:
3 in 1,000 would be expected to have a stroke.
• In women taking HRT:
4 in 1,000 would be expected to have a stroke.
Looking at women in their 60s, on average, over
5 years:
• In women not taking HRT:
11 in 1,000 would be expected to have a stroke.
• In women taking HRT:
15 in 1,000 would be expected to have a stroke.
If you get an unexpected migraine-type
headache, with or without disturbed vision:
See a doctor straight away, and do not use
any more HRT until a doctor says you can. These
headaches may be an early warning sign of a
stroke.

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 problem called SLE.
If any of these things apply to you, talk to your
doctor to see if you should take HRT.
How likely is a blood clot?
Looking at women in their 50s, on average, over
5 years:
• In women not taking HRT:
3 in 1,000 would be expected to get a blood clot.
• In women taking HRT:
7 in 1,000 would be expected to get a blood clot.
Looking at women in their 60s, on average, over
5 years:
• In women not taking HRT:
8 in 1,000 would be expected to get a blood clot.
• In women taking HRT:
17 in 1,000 would be expected to get a blood
clot.
If you get painful swelling in your leg, sudden
chest pain or have problems breathing:
See a doctor straight away
Do not use any more HRT until a doctor says you
can. These may be signs of a blood clot.
2.5 Taking other medicines
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 Estradiol can affect the way some other
medicines work. Also some other medicines can
affect the way Estradiol works.
Tell your doctor or pharmacist if you are taking
any of the following:
• medicines for epilepsy - such as phenobarbital,
phenytoin or carbamezapine
• medicines for infections - such as rifampicin,
rifabutin, nevirapine, efavirenz, ritonavir or
nelfinavir
• St John’s wort - a herbal medicine used for
depression.
If you are not sure if any of the above apply to
you, talk to your doctor or pharmacist before
using Estradiol.
2.6 Operations and blood tests
Tell your doctor you are using Estradiol 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 taking HRT again.
Tell your doctor you are using Estradiol if
you are going to have any blood tests. This is
because Estradiol can affect the tests.
2.7 Pregnancy and breast-feeding

• Do not use Estradiol if you are pregnant or
might become pregnant.

But if the bleeding or spotting:
• carries on for more than the first few months
• starts after you have been on HRT for a while
• carries on even after you’ve stopped taking
HRT.

Blood clots
HRT may increase the risk of blood clots in the
veins (also called deep vein thrombosis, or DVT).
This is especially during the first year of taking it.

Make an appointment to see your doctor.
It could be a sign that your endometrium has
become thicker.

These blood clots are not always serious.
However, if a clot travels to your lungs, it can
cause chest pain, feeling breathless, collapse or
even death. This is called a pulmonary embolism
or PE.

Please see Section 3 for information about when
to start using Estradiol if you have had your
womb removed.

• Do not breast-feed if you are using this
medicine.

• If you become pregnant, stop using Estradiol

2.9 Important information about some of the
ingredients of Estradiol
Estradiol contains propylene glycol, which may
cause skin irritation.
• Estradiol 0.5 mg gel contains 58.5 % vol
ethanol (alcohol), i.e. up to 293 mg per dose,
equivalent
to 6 ml beer, or 3 ml wine per dose. (A
teaspoon contains 5 ml).
• Estradiol 1.0 mg gel contains 58.5 % vol
ethanol (alcohol), i.e. up to 585 mg per dose,
equivalent to 12 ml beer, or 5 ml wine per dose.
(A teaspoon contains 5 ml).
This may be harmful for those suffering from
alcoholism. This should also be taken into account
in pregnant or breast-feeding women, children
and high risk groups such as patients with liver
disease, or epilepsy.
3. How to use Estradiol
Always use Estradiol exactly as your doctor or
pharmacist has told you. You should check with
your doctor or pharmacist if you are not sure.
When to start using Estradiol
You can start using Estradiol straight away if:

• You have never used HRT before
• You are changing over from a period-free HRT
Wait for your period to end if:

• You are changing over from another type of
HRT where you have a period
If you have not had your womb removed, your
doctor will normally also prescribe another
medicine containing the hormone
progestogen.
This is normally a tablet taken for 12 to 14 days in
each monthly cycle. After each course of
progestogen you will usually have a withdrawal
bleed, like a period.
3.1 How much to use
Estradiol comes in sachets of 0.5 mg Estradiol in
0.5 g of gel, or in sachets of 1 mg Estradiol in 1 g
of gel.
• Each pack of Estradiol 0.5 mg gel contains
only 0.5 g sachets.
• Each pack of Estradiol 1 mg gel contains only
1 g sachets.
Use the amount of Estradiol gel that your doctor
has prescribed.
• The usual dose is between 0.5 mg and 1.5 mg
of Estradiol a day.
• Use the following number of 0.5 g or 1 g
sachets depending on the dose, and the pack
size prescribed by your doctor:
For a 0.5 mg daily dose
- Use one 0.5 g sachet
For a 1 mg daily dose
There are two options:
- Use one 1 g sachet
or
- Use two 0.5 g sachets
For a 1.5 mg daily dose
There are two options:
- Use three 0.5 g sachets
or
- Use one 0.5 g sachet with one 1 g sachet

straight away and tell your doctor.
Ask your doctor or pharmacist for advice before
taking any medicine, if you are pregnant or
breastfeeding.

If you are also taking progestogen tablets, take
them as your doctor has told you. You will
normally have a withdrawal bleed after each
course of progestogen.

2.8 Driving and using machines
Estradiol has no effect on the ability to drive or
use machines.

3.2 How to apply the gel
Estradiol should be rubbed gently on the skin.
It should not be swallowed.

Ref: 1178/060813/2/B

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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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